Canadian Journal of Cardiology 27 (2011) 27–30 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and Achieving Consensus Anne M. Gillis, MD, FRCPC,a Allan C. Skanes, MD, FRCPC,b and the CCS Atrial Fibrillation Guidelines Committeec Department of Cardiac Sciences, University of Calgary and Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada b Division of Cardiology, University Hospital, University of Western Ontario, London, Ontario, Canada c For a complete listing of committee members, see page 30. ABSTRACT O ED a RÉSUMÉ Dans cet article, nous décrivons le processus de mise à jour des lignes directrices de 2010 en matière de fibrillation auriculaire (FA) de la Société Canadienne de Cardiologie. L’élaboration des lignes directrices repose sur le système d’évaluation Grading of Recommandations Assessment, Development and Evaluation (GRADE). Le système d’évaluation GRADE distingue la qualité de la preuve (très faible, faible, moyenne ou élevée) de la force des recommandations (forte ou conditionnelle, i.e. faible). Le système d’évaluation GRADE permet de reconnaître les valeurs et les préférences en ce qui a trait à la prestation des soins cliniques, ainsi que les coûts des interventions, pour déterminer la force des recommandations. Les relations du groupe d’experts avec l’industrie ou autres conflits d’intérêts potentiels ont été divulguées initialement et annuellement. Chaque recommandation a été approuvée par au moins les deux tiers du groupe d’experts (ceux qui étaient en conflit d’intérêt se sont abstenus de voter sur certaines recommandations). EM BA R G This article describes the process of the Canadian Cardiovascular Society 2010 atrial fibrillation (AF) guidelines update. Guideline development was based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system of evaluation. GRADE separates the quality of evidence (very low, low, moderate, or high quality) from the strength of recommendations (strong or conditional, ie, weak). GRADE allows acknowledgement of values and preferences in the provision of clinical care as well as costs of interventions in determining the strength of recommendations. Disclosures of relationships with industry or other potential conflicts of interest were reported at the outset and annually. Each recommendation was approved by at least a two-thirds majority of the voting panel (those with a significant conflict recusing themselves from voting on those specific recommendations). Atrial fibrillation (AF) is the most common sustained arrhythmia treated in clinical practice and is associated with substantial morbidity. Indeed, the lifetime risk of developing AF in individuals older than 40 years is 1 in 4.1 The Canadian Cardiovascular Society (CCS) last published a set of recommendations on the diagnosis and management of AF in 2005.2 Since then, major advances in the management of AF have occurred, including the results of clinical trials providing guidance on pharmacologic therapies for management of AF,3-5 antithrombotic therapies for prevention of systemic thromboembolism,6,7 the continuing evolution of catheter ablation for treatment of AF,8-10 and the development of a simple semiquantitative scale that closely approximates patient-reported subjective measures of quality of life Received for publication November 4, 2010. Accepted November 11, 2010. Corresponding author: Dr Anne M. Gillis, Department of Cardiac Sciences, The University of Calgary, 3280 Hospital Dr NW, Calgary, Alberta, Canada T2N 4N1. Tel: 403-220-6841; fax: 403-270-0313. E-mail: mgillis@ucalgary.ca The disclosure information of the authors and reviewers are available from the CCS on the following Web sites: www.ccs.ca and www. ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. A complete list of the Primary and Secondary Panel Members are listed in the Appendix on page 30. 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.003 28 Canadian Journal of Cardiology Volume 27 2011 Table 1. GRADE: Rating quality of evidence Quality Comments High Future research unlikely to change confidence in estimate of effect; eg, multiple well-designed, well-conducted clinical trials Further research likely to have an important impact on confidence in estimate of effect and may change the estimate; eg, limited clinical trials, inconsistency of results or study limitations Further research very likely to have a significant impact on the estimate of effect and is likely to change the estimate; eg, small number of clinical studies or cohort observations The estimate of effect is very uncertain; eg, case studies, consensus opinion Moderate Low Very low Modified and reprinted with permission from Guyatt, et al.17 GRADE, Grading of Recommendations Assessment, Development, and Evaluation. O ED guage literature, using MEDLINE or Cochrane library searches and a critical appraisal of the evidence focusing predominantly on the results of randomized clinical trials and systematic reviews. In the absence of such data, recommendations were based on the results of large cohort studies or smaller clinical studies. The recommendations were finalized by informed consensus through one face-to-face meeting, conference calls, e-mail correspondence, and final review by all members of the primary panel. Specifically, the writing group presented each preliminary recommendation with its attendant supportive evidence in summary form. Following discussion, an anonymous vote was obtained in which a two-thirds majority was considered consensus. Failing consensus, further discussion was directed at areas of divergence of opinion until either consensus was reached or it was deemed by the chair(s) that consensus would not be reached and a recommendation could not be made. A two-thirds majority was achieved in all cases. The primary panelists were principally responsible for the document, but an independent secondary panel reviewed the recommendations and provided feedback. All members of the primary panel formally approved the final document prior to submission to the Guidelines Committee and CCS Executive for review and approval. As outlined in a separate communication, this is the first CCS Guidelines Panel to use the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system of evaluation,13,14 replacing the American College of Cardiology and American Heart Association scale for level of evidence that was used previously.15 In the past, guidelines have been criticized as being inconsistent in how they rate quality of evidence and strength of recommendations, which may lead to confusion in interpretation of the recommendations and failure to adhere to the guidelines.16 GRADE (www.gradeworkinggroup.org) was created by a group of international guideline developers, including a large Canadian representation to address the shortcomings of other rating systems.17-21 The approach separates the quality of evidence (very low, low, moderate, or high quality; see Table 1), from the strength of recommendations (strong or conditional, ie, weak; see Table 2). GRADE allows acknowledgment of values and preferences in the provision of clinical care, as well as of the cost of therapies, in determining the strength of recommendations. GRADE has already been adopted by more than 45 international organizations, including the World Health Organiza- EM BA R G in AF.11 In 2009, the CCS convened a primary panel of experts to undertake a comprehensive review of current knowledge and management strategies in the field of AF and to develop an up-to-date evidence-based set of recommendations, easily available to primary care physicians, emergency room physicians, internists, and cardiologists, on the diagnosis and management of patients with AF. The guidelines are broadly applicable across a spectrum of practice environments. It is expected that optimized management of AF may improve quality of life and reduce rates of stroke and hospitalization for AF-related causes across all levels of care in a large population of patients. Simultaneous with the evolution in treatments for AF, the CCS has been implementing a unique Canadian knowledge translation (KT) model for disseminating guidelines.12,13 Known as the CCS closed-loop model for KT, it has the aim of improving the uptake and integration of guidelines into clinical practice. The model involves assembling a multidisciplinary primary panel to draft guidelines and then using a multipronged, multimedia approach to dissemination. Dissemination strategies involve regional and national face-to-face, interactive, case-based workshops and a dedicated Web site featuring practical tools and tips for end users as well as synchronous and asynchronous e-learning programs. Feedback from KT program participants and guideline end users drives the selection and development of new content for subsequent annual guideline updates, which are then disseminated and evaluated as part of a regular annual cycle. This cyclical approach to guideline development, dissemination, and evaluation results in a powerful compendium of guidelines that address a specific topic and are highly relevant to and highly valued by care providers. The CCS experienced success with this model through applying it to heart failure beginning in 2005. As AF emerged as a major topic requiring updated, comprehensive, multidisciplinary guidelines, the CCS has embarked on this second closed-loop KT program. A primary working group was formed and met face-toface in October 2009 to agree on the process of achieving consensus, to address issues related to real or perceived conflict of interest related to specific recommendations, to discuss the process of weighing the strength of a recommendation and the quality of evidence supporting the recommendation, to identify the full membership of the primary panel, to finalize topics for guideline development, and to develop writing groups for each topic. Conflicts were disclosed prior to forming the writing groups. The Appraisal of Guidelines for Research and Evaluation instrument was used to guide primary panel structure and guideline development.14 Membership of the primary panel was expanded to include wide representation (from primary care, internal medicine, emergency medicine, and general cardiology, in addition to cardiac electrophysiology) and to increase the proportion of panel members having no conflict of interest or relationships with industry to 5 of 19 members (26%). Writing groups were developed with specific attention to content expertise and conflict of interest. It was decided that each recommendation must be approved by a two-thirds majority of the voting panel (those with a significant conflict recusing themselves from voting on those specific recommendations). The working groups undertook a review of the English lan- Gillis et al. Implementing GRADE 29 Table 2. Factors determining the strength of the recommendation Factor Comment Quality of evidence The higher the quality of evidence, the greater the probability that a strong recommendation is indicated; eg, strong recommendation that patients with AF at moderate to high risk of stroke be treated with oral anticoagulants. The greater the difference between desirable and undesirable effects, the greater the probability that a strong recommendation is indicated; eg, strong recommendation that patients with AF ⱖ 48-h duration receive oral anticoagulation therapy for at least 3 wk prior to planned cardioversion and 4 wk following. The greater the variation or uncertainty in values and preferences, the higher the probability that a conditional recommendation is indicated; eg, aspirin may be a reasonable alternative to oral anticoagulant therapy in patients at low risk of stroke. The higher the cost, the lower the likelihood that a strong recommendation is indicated; eg, conditional recommendation for catheter ablation as first-line therapy for AF. Difference between desirable and undesirable effects Values and preferences Cost AF, atrial fibrillation. Modified and reprinted with permission from Guyatt, et al.17 10. Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 2010;303:333-40. 11. Dorian P, Guerra PG, Kerr CR, et al. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophysiol 2009;2:218-24. 12. Graham MM, Pullen C. Renovating CCS guidelines and position statements: a new foundation. Can J Cardiol 2010;26:233-5. R G 1. Etiology and Initial Investigations 2. Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department 3. Rate and Rhythm Management 4. Catheter Ablation for Atrial Fibrillation/Atrial Flutter 5. Surgical Therapy 6. Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter 7. Prevention and Treatment of Atrial Fibrillation Following Cardiac Surgery 9. Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol 2010;3:32-8. O ED tion, the American College of Physicians, the Cochrane Collaboration, the American College of Chest Physicians, and many others. The updated guidelines are published in 7 articles: EM References BA A specific chapter on atrial tachyarrhythmias in the congenital heart disease population was not undertaken at this time but is planned for a future update. 1. Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004;110: 1042-6. 2. Kerr C, Roy D. Canadian Cardiovascular Society Consensus Conference: Atrial fibrillation 2004 executive summary. Available at: http:// www.ccs.ca/download/consensus_conference/consensus_conference_ archives/2004_Atrial_Fib_ES.pdf. Accessed November 11, 2010. 3. Roy D, Talajic M, Nattel S, et al. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med 2008;358:2667-77. 4. Van Gelder IC, Groenveld HF, Crijns HJ, et al. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med 2010;362:1363-73. 5. Hohnloser SH, Crijns HJ, van Eickels M, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009;360:668-78. 6. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51. 7. Connolly SJ, Pogue J, Hart RG, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;360:2066-78. 8. Nair GM, Nery PB, Diwakaramenon S, et al. A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation. J Cardiovasc Electrophysiol 2009;20:138-44. 13. Kerr CR. CCS guidelines and position statements are important, but do they make the GRADE? Can J Cardiol 2010;26:177-8. 14. The AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care 2003;12:18-23. 15. Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006;114:e257-354. 16. Sniderman AD, Furberg CD. Why guideline-making requires reform. JAMA 2009;301:429-31. 17. Guyatt GH, Oxman AD, Vist G, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 18. Guyatt GH, Oxman AD, Kunz R, et al. GRADE Working Group. Rating quality of evidence and strength of recommendations: what is “quality of evidence” and why is it important to clinicians? BMJ 2008;336:995-8. 19. Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008;336:1106-10. 20. Guyatt GH, Oxman AD, Kunz R, et al. Rating quality of evidence and strength of recommendations: incorporating considerations of resources use into grading recommendations. BMJ 2008;336:1170-3. 21. Guyatt GH, Oxman AD, Kunz R, et al. Rating quality of evidence and strength of recommendations: going from evidence to recommendations. BMJ 2008;336:1049-51. 30 Canadian Journal of Cardiology Volume 27 2011 Appendix 1. Primary and secondary panel members Primary panel members Cochair Cochair Member Member Member Member Member Member Member Member Member Member Member Member Member Member Mario Talajic, MD, FRCP(C) Teresa Tsang, MD, FRCP(C) Atul Verma, MD, FRCP(C) Jan Brozek, MD, PhD Grant Stotts, MD, FRCP(C) Member Member Member Special Collaborator Special Collaborator Dept of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta Division of Cardiology, University of Western Ontario Division of Cardiology, Department of Medicine, McMaster University Faculty of Medicine, University of British Columbia Division of Cardiology, Dalhousie University Division of Cardiology, University of Toronto Division of Cardiology, Medicine Department, McMaster University Electrophysiology Service, Montreal Heart Institute, Université de Montréal Division of Cardiology, University of Alberta University of Calgary, Libin Cardiovascular Institute of Alberta Montreal Heart Institute, Université de Montréal Montreal Heart Institute, Université de Montréal Division of Cardiology, Dalhousie University Department of Cardiac Sciences, and Physiology & Pharmacology, University of Calgary Representative of The College of Family Physicians of Canada, Ancaster, Ontario Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa Montreal Heart Institute, Université de Montréal Division of Cardiology, University of British Columbia Heart Rhythm Program, Southlake Regional Health Centre Departments of Clinical Epidemiology & Biostatistics and Medicine. McMaster University University of Ottawa, The Ottawa Hospital. Representative of the Canadian Stroke Network Secondary panel members Division of Cardiology, University of Western Ontario, St. John’s, New Brunswick Department of Cardiology, McGill University Health Center Division of Cardiology, Brampton Civic Hospital St. Paul’s Hospital Heart Centre, University of British Columbia St. Paul’s Hospital Heart Centre, University of British Columbia Division of Cardiac Surgery, University of Western Ontario Department of Medicine, Langley Memorial Hospital, Langley, BC Department of Cardiac Sciences, University of Calgary, Libin Cardiovascular Institute of Alberta R G Member Member Member Member Member Member Member Member Member EM BA Malcolm Arnold, MD, FRCP(C) David Bewick, MD, FRCP(C) Vidal Essebag, MD, MSc, FRCP(C) Milan Gupta, MD, FRCP(C) Brett Heilbron, MBChB, FRCP(C) Charles Kerr, MD, FRCP(C), Bob Kiaii, MD, FRCS(C) Jan Surkes, BA (hon) MD FRCP(C) George Wyse, MD, PhD, FRCP(C) O ED Anne M. Gillis, MD, FRCP(C) Allan Skanes, MD, FRCP(C) Stuart Connolly, MD, FRCP(C) John Cairns, MD, FRCP(C), Jafna Cox, BA, MD, FRCP(C), FACC Paul Dorian, MD, MSc. FRCP(C) Jeff Healey, MD, FRCP(C) Laurent Macle, MD, FRCP(C) Sean McMurty, MD, PhD, FRCP(C) Brent Mitchell, MD, FRCP(C) Stanley Nattel, MD, FRCP(C) Pierre Page, MD, FRCPS Ratika Parkash, MD, MSc, FRCP(C) P. Timothy Pollak, MD, PhD FRCP(C) Michael Stephenson, MD, CCFP, FCFP Ian Stiell, MD, MSc, FRCP(C) Canadian Journal of Cardiology 27 (2011) 31–37 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Etiology and Initial Investigations Jeff S. Healey, MD, MSc,a Ratika Parkash, MD, MSc,b Tim Pollak, MD,c Teresa Tsang, MD,d Paul Dorian, MD, FRCPC,e and the CCS Atrial Fibrillation Guidelines Committeef Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada b Dalhousie University, Halifax, Nova Scotia, Canada c d e f University of Calgary, Calgary, Alberta, Canada University of British Columbia, Vancouver, British Columbia, Canada St. Michael’s Hospital and University of Toronto, Toronto, Ontario, Canada O ED a For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and achieving consensus. Can J Cardiol 2011;27:27-30. ABSTRACT RÉSUMÉ L’évaluation initiale des patients présentant une fibrillation auriculaire (FA) devrait comprendre un questionnaire détaillé, un examen physique et un bilan sanguin de base. Cette première évaluation a pour but d’identifier l’étiologie (et particulièrement les causes réversibles) de la FA, de décrire le type de FA (paroxystique, persistante ou permanente), d’évaluer le degré de symptomatologie du patient, d’identifier ses co-morbidités et d’évaluer son risque tromboembolique. L’indication d’investigations supplémentaires et le plan de traitement spécifique au patient dépendent de cette évaluation initiale qui doit être complète et systématique. EM BA R G The initial evaluation of patients with atrial fibrillation (AF) should include a comprehensive history, physical examination, and initial investigations. The initial evaluation of patients with AF has several important purposes, including the identification of the etiology of AF, particularly the identification of reversible causes of AF; the description of the pattern of AF; the assessment of the degree of symptomatic impairment due to AF; the assessment of the thromboembolic risk of the patient; and the identification of common comorbidities. Additional investigations may then be undertaken, with the decision guided by the initial evaluation. A comprehensive and systematic initial evaluation forms the foundation for a patient-specific plan for the management of AF. Initial Evaluation of AF The initial evaluation of a patient with atrial fibrillation (AF) should consist of a comprehensive history (including social, drug, and family history), physical examination, and initial investigations (Table 1). This evaluation has many important purposes, including assessing the degree of symptomatic impairment due to AF, developing a therapeutic strategy for symptom relief, assessing and managing thromboembolic risk, establishing prognosis, and, where possible, identifying the underlying etiology of AF. The identification of the etiology of AF during the initial investigation is particularly important for several reasons: Received for publication November 9, 2010. Accepted November 9, 2010. on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. Corresponding author: Jeff S. Healey, Population Health Research Institute, McMaster University, DBCVSRI Building, Hamilton Health SciencesGeneral Site, 237 Barton St E, Room C3-121, Hamilton, Ontario, L8L 2X2 Canada. Tel.: 905-527-0271, ext 40319; fax: 905-523-9165. Email address: Jeff.Healey@phri.ca The disclosure information of the authors and reviewers is available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.015 32 Canadian Journal of Cardiology Volume 27 2011 Values and preferences. This recommendation places a high value on a comprehensive evaluation of patients with AF and a lower value on initial costs to the health care system. Documentation of AF and Its Characteristics It is incumbent upon the physician to document AF in at least one electrocardiogram lead, as the perception of “irregularly irregular” palpitations may be the result of a variety of arrhythmias, including atrial tachycardia, atrial flutter, premature atrial and/or ventricular contractions, or nonarrhythmic causes. The predominant pattern of AF should be determined, as this is helpful for directing therapy:1 1. First detected AF 2. Paroxysmal: AF is self-terminating within 7 days of recognized onset 3. Persistent: AF is not self-terminating within 7 days or is terminated electrically or pharmacologically or 4. Permanent: AF in which cardioversion has failed or in which clinical judgment has led to a decision not to pursue cardioversion One may not be able to identify the pattern of AF at the time of initial presentation, and the pattern may change over time. An assessment of the nature and severity of symptoms and their impact on quality of life should also be performed. Symptoms associated with AF are highly variable and may include palpitations, dyspnea, dizziness, weakness, or chest pain.2 The frequency and duration of symptoms vary, as can the severity, with some patients being truly asymptomatic and others having debilitating symptoms.2 The impact of these symptoms on lifestyle as well as a record of emergency department visits, hospital admissions, and cardioversions should be made, along with a record of all prior interventions (eg, drug therapy, catheter ablation, etc) for AF. Symptoms at the termination of paroxysms should be sought and if present, symptom–rhythm correlation can be made using an ambulatory electrocardiogram (Holter monitor, event monitor, or loop recorder). Patients with sick sinus syndrome often have sinus pauses, particularly following the termination of AF, which may limit the use of rate- or rhythmcontrolling medications and may require the use of permanent pacing. Any supraventricular tachycardia (SVT), including atrial tachycardia and atrial flutter, can lead to the development of AF, and successful ablation of the underlying SVT may eliminate the associated AF.3,4 Therefore, it is important to elicit and investigate any history of regular palpitations. This can be further explored using ambulatory electrocardiographic monitoring. EM BA R G History and physical examination Establish pattern (new onset, paroxysmal, persistent, or permanent) Establish severity (including impact on quality of life) Identify etiology Identify reversible causes (hyperthyroidism, ventricular pacing, supraventricular tachycardia, exercise, etc) Identify risk factors whose treatment could reduce recurrent AF or improve overall prognosis (ie, hypertension, sleep apnea, left ventricular dysfunction, etc) Take social history to identify potential triggers (ie, alcohol, intensive aerobic training, etc) Elicit family history to identify potentially heritable causes of AF (particularly in lone AF) Determine thromboembolic risk Determine bleeding risk to guide appropriate antiplatelet or antithrombotic therapy Review prior pharmacologic therapy for AF, both for efficacy and for adverse effects Measure blood pressure and heart rate Determine patient height and weight Comprehensive precordial cardiac examination and assessment of jugular venous pressure and carotid and peripheral pulses to detect evidence of structural heart disease 12-Lead electrocardiogram Document presence of AF by electrocardiography Assess for structural heart disease (myocardial infarction, ventricular hypertrophy, atrial enlargement, congenital heart disease) or electrical heart disease (ventricular preexcitation, Brugada syndrome) Identify risk factors for complications of therapy for AF (conduction disturbance, sinus node dysfunction, or repolarization); document baseline PR, QT, or QRS intervals Echocardiogram Document ventricular size, wall thickness, and function Evaluate left atrial size (if possible, left atrial volume) Exclude significant valvular or congenital heart disease (particularly atrial septal defects) Estimate ventricular filling pressures and pulmonary arterial pressure Complete blood count, coagulation profile, renal, thyroid, and liver function Fasting lipid profile, fasting glucose O ED Table 1. Baseline evaluation of atrial fibrillation for all patients 1. To identify risk factors for AF, which, if treated, could reduce or eliminate the occurrence of further AF 2. To identify important risk factors, which, if treated, could improve the overall outcome of the patient, independent of AF 3. To aid in assessing the prognosis of AF in the individual patient 4. To assist in the selection of optimal AF therapy in the individual patient RECOMMENDATION All patients with AF should undergo a complete history and physical examination, electrocardiogram, echocardiogram, and basic laboratory investigations. Details are highlighted in Table 1 (Strong Recommendation, Low-Quality Evidence). Other ancillary tests should be considered under specific circumstances. Details included in Table 2 (Strong Recommendation, Low-Quality Evidence). Evaluation of the Impact of AF on Quality of Life AF causes a greater degree of impairment of quality of life in most patients than is generally appreciated. Although rarely life threatening, AF can cause moderate and sometimes severe distress and substantially alter everyday functioning. In a referral practice, a majority of patients have a quality of life that is similar to that of patients following Healey et al. CCS Atrial Fibrillation Etiology and Initial Investigations 33 Table 2. Evaluation of quality of life (QOL) using the CCS SAF scale* Impact on quality of life Class 0 Class 1 Class 2 Class 3 Class 4 Asymptomatic Minimal effect on QOL Minor effect on QOL Moderate effect on QOL Severe effect on QOL * The intent of the CCS SAF scale is to capture AF-related symptoms and QOL. However, the scale evaluates not only symptoms that occur during episodes of AF but also the consequences of ongoing treatment for AF (ie, medication-related side effects). We recommend that the assessment of patient well-being, symptoms, and quality of life be part of the evaluation of every patient with AF (Strong Recommendation, LowQuality Evidence). We suggest that the quality of life of the AF patient be assessed in routine care using the CCS SAF scale (Conditional Recommendation, Low-Quality Evidence). Table 3. Additional investigations useful in selected cases Investigation Chest radiography Ambulatory electrocardiography (Holter monitor, event monitor, loop monitor) Treadmill exercise test EM BA R G myocardial infarction. Impaired quality of life is primarily the result of symptoms from AF but is also influenced by side effects from the AF therapies, illness perceptions, and patient factors such as depression. In the absence of a gold standard method to treat AF patients, improving quality of life and relieving symptoms are often the primary goals in the management of AF patients. Making treatment plans and assessing treatment effectiveness require a consistent and standardized approach to measuring the impact of overall quality of life of the AF syndrome. In 2005, the Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee set out to create and validate a standard approach to assessing overall quality of life in AF patients, by developing the Severity in Atrial Fibrillation (SAF) scale (Table 2). This semiquantitative scale ranges from 0 (no impact of AF or its treatment on overall quality of life and patient functioning) to SAF 4 (resulting in a severe impairment of functioning and overall quality of life). A multicentre Canadian study has shown that the results of this scale correlate well with previously validated symptom scores and generic measures of quality of life and that it can be easily applied by a variety of caregivers at the beside with minimal training.2,5,6 An increasing recognition that the presence of AF on an electrocardiogram or the frequency and duration of episodes of AF (“the AF burden”) are poorly correlated with long-term morbidity and overall quality of life has led to an increasing emphasis on subjective patient-defined outcomes to most effectively assess the usefulness of overall management and specific treatments in AF. An explicit assessment of the effect of AF on QOL, preferably using a scale such as the SAF scale in every patient seen with AF, is recommended and can be used as a baseline to assess the effects of new or changed therapy in individual patients (Table 3). Patients vary widely with respect to severity of symptoms and overall quality of life related to AF. It is difficult to give appropriate counsel and weigh risks and benefits of therapy without an explicit understanding of the consequences of AF and its treatment on the patient’s wellbeing. Such an approach serves to emphasize that simply slowing the ventricular rate under the strategy of rate control or restoring and maintaining sinus rhythm using a strategy of rhythm control may not necessarily improve patient well-being and quality of life. Careful evaluation and ongoing reevaluation of the impact of the disorder and its treatment on overall patient well-being are required.2 RECOMMENDATION O ED SAF score Transesophageal echocardiography Electrophysiological study Serum calcium and magnesium Sleep study (ambulatory oximetry or polysomnography) Ambulatory blood pressure monitoring Genetic testing Potential role Exclude concomitant lung disease, heart failure, baseline in patients receiving amiodarone Document AF, exclude alternative diagnosis (atrial tachycardia, atrial flutter, AVNRT/AVRT, ventricular tachycardia), symptom–rhythm correlation, assess ventricular rate control Investigation of patients with symptoms of coronary artery disease, assessment of rate control Rule out left atrial appendage thrombus, facilitate cardioversion in patients not receiving oral anticoagulation, more precise characterization of structural heart disease (mitral valve disease, atrial septal defects, cor triatriatum, etc) Patients with documented regular supraventricular tachycardia (ie, atrial tachycardia, AVNRT/ AVRT, atrial flutter) that is amenable to catheter ablation In cases of suspected deficiency (ie, diuretic use, gastrointestinal losses), which could influence therapy (ie, sotalol) In patients with symptoms of obstructive sleep apnea or in select patients with advanced symptomatic heart failure In cases of borderline hypertension In rare cases of apparent familial AF (particularly with onset at a young age) with additional features of conduction disease, Brugada syndrome, or cardiomyopathy AVNRT/AVRT, atrioventricular nodal reentrant tachycardia/atrioventricular reentrant tachycardia. 34 Canadian Journal of Cardiology Volume 27 2011 Cardiac causes Hypertension Heart failure* Coronary artery disease with prior myocardial infarction Left ventricular dysfunction (systolic and diastolic)* Including hypertrophic, dilated, and restrictive cardiomyopathies Valvular heart disease Congenital heart disease* (early repair of atrial septal defect) Pericardial disease Postsurgical (particularly cardiac surgery) Sick sinus syndrome AF as a result of ventricular pacing* Supraventricular tachycardia (including Wolff-Parkinson-White syndrome, atrial tachycardia, atrial flutter, or other)* Genetic/familial Noncardiac causes Obstructive sleep apnea* Obesity* Excessive alcohol ingestion (acute or chronic)* Hyperthyroidism* Vagally mediated (ie, habitual aerobic training)* Pulmonary disease (pneumonia, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary hypertension) Lone (idiopathic) AF * Denotes cause for which treatment may prevent the development or recurrence of AF. nosis of AF and may influence choices of therapy for both rate and rhythm control. Screening history and physical evaluation for obstructive and nonobstructive sleep apnea should be performed in all patients, and further testing, such as ambulatory oximetry or polysomnography, or appropriate referral to a specialist in sleep medicine should be considered if the history is suggestive of sleep apnea. EM BA R G Identification of the Etiology of AF AF is a disease of advancing age, whose prevalence increases from 0.1% in patients under age 50 to 10%-15% in those ⬎80 years old.7 This has important public health implications for the aging Canadian population. In most cases, AF is associated with underlying heart disease–most commonly, hypertension, heart failure, left ventricular systolic dysfunction, and valvular heart disease.8-11 Although these conventional risk factors are present in ⬎70% of North American patients,12,13 there are important additional considerations. First, additional risk factors such as hyperthyroidism,14 Wolff-Parkinson-White syndrome,3,15 and unnecessary ventricular pacing,16-19 although much less prevalent, are important to identify as they have additional deleterious effects and their treatment could eliminate further AF in affected patients. Second, because Canada is a country with a significant immigrant population, it is important to remember that in many patients, AF may be the result of conditions that are much less common among individuals born in North America, such as rheumatic heart disease, complicated hypertension, and pericarditis.20 Third, there are emerging data identifying additional conditions such as obesity, sleep apnea. and alcohol intake as risk factors for the development of AF and its complications.21-23 Finally, there are still approximately 15%20% of AF patients who do not have identifiable comorbidities.24 While these patients would be classified as having “lone” (idiopathic) AF, some may have a genetic predisposition to AF, an SVT that leads to the development of AF or have AF as a result of high vagal tone, such as secondary to intensive aerobic exercise.25 The underlying etiologic conditions associated with AF should be determined. In Canada, the most important of these risk factors is hypertension.11,13 Careful blood pressure measurement should be conducted, as outlined by the Canadian Hypertension Education Program guidelines for the diagnosis of hypertension.26,27 Clinicians should pursue a diagnosis of hypertension in patients with frequent borderline office readings, particularly those with significant left atrial enlargement or left ventricular hypertrophy. Ambulatory blood pressure monitoring may facilitate this in patients with paroxysmal AF; however, these devices are greatly influenced by the variable heart rate during AF, limiting their sensitivity and specificity in patients with persistent or permanent AF. Particular effort should also be given to identify potentially reversible causes of AF (Table 4), such as hyperthyroidism and excessive alcohol. Although only 3.1% of AF patients have hyperthyroidism, it is still an important example of a treatable cause.28 Identification of both of these disorders on the patient history may be particularly difficult in the elderly. Other common, conventional risk factors include coronary artery disease with prior myocardial infarction, left ventricular systolic dysfunction, and valvular heart disease. Identification of such structural heart disease is important, as it influences the prog- Table 4. Potential causes of atrial fibrillation O ED Values and preferences. These recommendations recognize that improvement in quality of life is a high priority for therapeutic decision making. RECOMMENDATION Underlying causes or precipitating factors for AF including hypertension should be identified and treated. Details are highlighted in Table 3 (Strong Recommendation, HighQuality Evidence). Values and preferences. This recommendation recognizes that therapy of underlying etiology can improve management of AF and that failure to recognize underlying factors may result in deleterious effects. Determination of Cardiovascular Risk in AF AF is associated with a 3- to 6-fold increased risk of stroke or non– central nervous system (CNS) systemic embolism.10,29-34. It is thought that ⬇15% of all strokes are due to AF and that this increases to 25% for patients ⬎80 years old.10 Both oral anticoagulation and antiplatelet medication reduce the risk of stroke in patients with AF but are associated with an increased risk of bleeding.33,35,36 For this reason, several risk stratification schemes have been developed to identify patients with the highest risk of stroke, in whom the benefit of oral anticoagulant therapy outweighs the risk of bleeding.37,38 Initial investigation of patients with AF should identify risk factors for stroke, as this is necessary to help guide the appropriate use of antico- Healey et al. CCS Atrial Fibrillation Etiology and Initial Investigations O ED and should be performed in all patients with AF. This will identify left ventricular hypertrophy or systolic dysfunction, significant valvular or congenital heart disease, and, rarely, complications such as left atrial appendage thrombus. All of these are necessary for making appropriate decisions regarding the use of rate- and rhythm-controlling agents and anticoagulant medications. An evaluation of left atrial size should also be conducted, as this provides important information about the likelihood of AF recurrence or the development of persistent or permanent AF, which can help guide optimal therapy for symptom improvement. In certain cases, such as the assessment of valvular or congenital heart disease or the exclusion of left atrial appendage thrombus, transesophageal echocardiography may be required. Routine blood work should be performed at the time of the initial evaluation of patients with AF. A complete blood count and coagulation studies should be performed as they will inform decisions about the use of anticoagulant and antiplatelet medications. Serum electrolytes and creatinine should also be determined because antiarrhythmic and newer anticoagulant medications may be more likely to cause adverse effects in those with electrolyte disorders or renal insufficiency. Serum creatinine and a urinalysis may also identify chronic kidney disease, another common complication of hypertension, the most prevalent risk factor for AF. Liver function tests should also be performed at baseline, both to aid in the identification of excessive alcohol intake and as a baseline for potentially hepatotoxic medications, such as amiodarone, that are frequently administered in the treatment of AF. A lipid profile is recommended in most patients as part of an overall assessment of cardiovascular risk. Ambulatory electrocardiography monitoring is not routinely required but has a number of important purposes, such as initial documentation of AF, identification of other forms of SCT, assessment of ventricular rate control, and the correlation of patient’s symptoms with both rhythm and heart rate. Although not routinely recommended, exercise testing may supplement ambulatory monitoring in certain patients with exercise-related symptoms. Invasive electrophysiological studies should be considered in those patients with idiopathic AF at a young age, particularly in those with documented SVT other than AF or symptoms suggestive of such arrhythmias. EM BA R G agulant and antiplatelet medication. Risk factors include a history of stroke, transient ischemic attack, or non-CNS systemic embolism; hypertension; heart failure; left ventricular ejection fraction ⱕ35%; increasing age; and diabetes mellitus. Other moderate risk factors include female gender and peripheral vascular disease.37 Many of these same conditions are also associated with an increased risk of bleeding. The initial evaluation of patients with AF should also elicit a bleeding history, prior antiplatelet and anticoagulant use, and degree of INR control39 to aid in the determination of the ideal strategy for stroke prevention. For a full discussion, see Cairns et al.40 The use of stroke risk stratification schemes is undergoing a period of reevaluation. First, there is increasing appreciation that the same clinical characteristics that predict stroke also predict bleeding;41 thus patients with a lower risk of stroke are also less likely to have bleeding complications of therapy. Second, there are 2 new therapies that have been shown to prevent stroke in patients with AF: clopidogrel (added to acetylsalicyclic acid [ASA])34 and dabigatran.42 These 2 agents have different bleeding profiles and are substantially easier for patients to take and have far fewer food and drug interactions than warfarin, thus changing the risk/benefit equation for stroke prevention in AF. Regardless of the specific agents used to prevent stroke and the threshold for their use, the identification of stroke risk factors remains vital to properly inform therapy. In contrast, it should be noted the pattern of AF (paroxysmal vs persistent or permanent) does not influence these decisions.43 Furthermore, the AFFIRM trial strongly suggests that the apparent suppression of AF with antiarrhythmic medications does not obviate the need for oral anticoagulation in patients with AF and additional risk factors for stroke.44 Traditionally, the prevention of cardiovascular events in patients with AF has focused on the prevention of stroke and non-CNS systemic embolism. It should be noted, however, that in recent clinical trials, the most common adverse cardiovascular event in patients with AF is now the development of heart failure.34,41,42 Patients with AF also frequently require hospitalization, and these patients have a particularly high subsequent mortality.45 Thus, the appropriate identification and treatment of hypertension and asymptomatic left ventricular systolic dysfunction, as well as the appropriate evidence-based management of heart failure, are also important in the management of patients with AF. 35 References The Physical Examination and Initial Investigations for AF The physical findings suggestive of AF include an irregular pulse (that may not be rapid), an irregular jugular venous pulse with loss of a-wave, and variation in the intensity of the first heart sound. The physical examination may also uncover causes of AF, including hypertension, left ventricular systolic dysfunction, heart failure, valvular heart disease, congenital heart disease (ie, fixed-split S2 in patient with an atrial septal defect), or hyperthyroidism. A number of routine investigations are warranted in all patients presenting with a history of AF (see Table 1). An electrocardiogram is useful both in AF and sinus rhythm. Evidence of left atrial enlargement, left ventricular hypertrophy, preexcitation, conduction disease, or myocardial infarction should be sought. A transthoracic echocardiogram is also invaluable 1. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol 2006;48: 854-906. 2. Dorian P, Guerra PG, Kerr CR, et al. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophsiol 2009;2:213-4. 3. Chen PS, Pressley JC, Tang AS, et al. New observations on atrial fibrillation before and after surgical treatment in patients with the Wolff-ParkinsonWhite syndrome. J Am Coll Cardiol 1992;19:974-81. 4. Haissaguerre M, Fischer B, Labbe T, et al. Frequency of recurrent atrial fibrillation after catheter ablation of overt accessory pathways. Am J Cardiol 1992;69:493-7. 36 Canadian Journal of Cardiology Volume 27 2011 5. Paquette M, Roy D, Talajic MM, et al. Role of gender and personality on quality-of-life impairment in intermittent atrial fibrillation. Am J Cardiol 2000;86:764-8. 24. Heuzey JY, Breithardt G, Camm AJ, et al. The RECORDAF study: design, baseline data and profile of patients according to chosen treatment strategy for atrial fibrillation. Am J Cardiol 2010;105:687-93. 6. Reynolds MR, Ellis E, Zimetbaum P. Quality of life in atrial fibrillation: measurement tools and impact of interventions. J Cardiovasc Electrophysiol 2006;19:762-8. 25. Molina L, Mont L, Marrugat J, et al. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace 2008;10:618-23. 7. Kannel WB, Wolf PA, Benjamin EJ. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol 1998;82:2N-9N. 26. Hackman DG, Khan NA, Hemmelgarn BR, et al. The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part 2 - therapy. Can J Cardiol 2010;26:249-58. 8. Benjamin EJ, Levy D, Vaziri SM, et al. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA 1994;271:840-4. 27. Quinn RR, Hemmelgarn BR, Padwal RS, et al. The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part 1 - blood pressure measurement, diagnosis and assessment of risk. Can J Cardiol 2010;26:241-8. 10. Wolf PA, Dawber TR, Thomas HE Jr, et al. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham Study. Neurology 1978;28:973-7. 11. Krahn AD. The natural history of atrial fibrillation: incidence, risk factors and prognosis in the Manitoba Follow-up Study. Am J Med 1995;98:47684. 12. Verdecchia P, Reboldi GP, Gattobigio R, et al. Atrial fibrillation in hypertension. Hypertension 2003;41:218-23. 29. Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Arch Intern Med 1994;154:1449-57. 30. Wolf PA, Abbot RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8. 31. Wolf PA, Abbot RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. Arch Intern Med 1987;147:1561-4. 32. Hart RG, Halperin JL. Atrial fibrillation and stroke. Revisiting the dilemmas. Stroke 1994;25:1337-41. 33. Poli D, Antonucci E, Grifoni E, et al. Stroke risk in atrial fibrillation patients on warfarin: predictive ability of risk stratification schemes for primary and secondary prevention. Thrombo Haemost 2009;101:367-72. R G 13. Healey JS, Connolly SJ. Atrial Fibrillation: hypertension as a causative agent, risk factor for complications and potential therapeutic target. Am Heart J 2003;91:9G-14G. 28. Kim DD, Young S, Cutfield R, et al. A survey of thyroid function test abnormalities in patients presenting with atrial fibrillation and atrial flutter to a New Zealand district hospital. N Z Med J 2008;121:82-6. O ED 9. Kannell WB, Abbot RD, Savage DD, et al. Epidemiologic features of chronic atrial fibrillation. The Framingham Study. N Engl J Med 1982; 306:1018-22. BA 14. Krahn AD, Klein GJ, Kerr C, et al. How useful is thyroid function testing in patients with recent-onset atrial fibrillation? The Canadian Registry of Atrial Fibrillation Investigators. Arch Intern Med 1996;156:2221-4. 15. Sharma AD, Klein GJ, Guiradon GM, et al. Atrial fibrillation in patients with Wolff-Parkinson-White syndrome: incidence after surgical ablation of the accessory pathway. Circulation 1985;72:161-9. EM 16. Skanes AC, Krahn AD, Yee R, et al. Progression to chronic atrial fibrillation after pacing: The Canadian Trial of Physiologic Pacing. J Am Coll Cardiol 2001;38:167-72. 34. Hart RG, Pearce LA, Aquilar MI. Meta-analysis: anti-thrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146:857-67. 35. ACTIVE Investigators, Connolly SJ, Pogue J, Hart RG, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;30:2066-78. 36. Hart RG. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med 1999;131:492-501. 17. Sweeney MO, Bank AJ, Nsah E, et al. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med 2007;357: 1000-8. 37. Hughes M, Lip GYH. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost-effectiveness data. Thrombo Haemost 2009;99:295-304. 18. Healey JS, Toff WD, Lamas GA, et al. Cardiovascular outcomes with atrialbased pacing compared with ventricular pacing: meta-analysis of randomized trials, using individual patient data. Circulation 2006;114:11-7. 38. Stroke Risk in Atrial Fibrillation Working Group. Comparison of 12 risk stratification schemes to predict stroke in patients with nonvalvular atrial fibrillation. Stroke 2008;39:1901-10. 19. Sweeny MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 2003;107:2932-7. 39. Connolly SJ, Pogue J, Eikelboom J, et al. Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centres and countries as measured by time in therapeutic range. Circulation 2008;118:2029-37. 20. Ntep-Gweth M, Zimmermann M, Meiltz A, et al. Atrial fibrillation in Africa: clinical characteristics, prognosis and adherence to guidelines in Cameroon. Europace 2010;12:482-7. 40. Cairns JA, Connolly S, McMurtry S, Stephenson M, Talajic M, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol 2011; 27:74-90. 21. Kanagala R, Murali NS, Friedman PA, et al. Obstructive sleep apnea and the recurrence of atrial fibrillation. Circulation 2003;107:2589-94. 22. Wang TJ, Parise H, Levy D, et al. Obesity and the risk of new-onset atrial fibrillation. JAMA 2004;292:2471-7. 23. Conen D, Tedrow UB, Cook NR, et al. Alcohol consumption and risk of incident atrial fibrillation in women. JAMA 2008;300:2489-96. 41. Healey JS, Hart RG, Pogue J, et al. Risks and benefits of oral anticoagulation compared with clopidogrel plus aspirin in patients with atrial fibrillation according to stroke risk: the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-W). Stroke 2008;39:1482-6. Healey et al. CCS Atrial Fibrillation Etiology and Initial Investigations 37 44. The AFFIRM Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 2002;347:1825-33. 43. Hart RG, Pearce LA, Rothbart RM, et al. Stroke with intermittent atrial fibrillation: incidence and predictors during aspirin therapy. Stroke Prevention in Atrial Fibrillation Investigators. J Am Coll Cardiol 2000;35: 183-7. 45. Rivero-Ayerza M, Scholte Op Reimer W, Lenzen M, et al. New-onset atrial fibrillation is an independent predictor of in-hospital mortality in hospitalized heart failure patients: results of the EuroHeart Failure Survey. Eur Heart J 2008 Jul;29(13):1618-24. Epub 2008 May 31. EM BA R G O ED 42. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51. Canadian Journal of Cardiology 27 (2011) 38 – 46 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department Ian G. Stiell, MD, MSc,a Laurent Macle, MD, FRCPC,b and the CCS Atrial Fibrillation Guidelines Committeec a b For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and achieving consensus. Can J Cardiol 2011;27:27-30. ABSTRACT O ED c Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada Department of Medicine, Electrophysiology Service, Montreal Heart Institute, Université de Montréal, Montreal, Québec, Canada RÉSUMÉ La fibrillation auriculaire (FA) est la forme d’arythmie la plus fréquemment rencontrée à la salle d’urgence. La plupart des patients présentant une FA ou un flutter auriculaire d’apparition récente peuvent être traités en toute sécurité au service des urgences sans nécessiter d’hospitalisation. Les priorités du traitement à l’urgence incluent une évaluation rapide de l’état hémodynamique ainsi que l’identification et le traitement de la cause sous-jacente et/ou des facteurs précipitants. Le patient doit être soigneusement questionné sur ses symptômes, pour tenter de déterminer le début d’apparition de l’arythmie. Le risque d’accident vasculaire cérébral (AVC) doit être déterminé dans tous les cas, en utilisant, par exemple, le score de CHADS2. Chez les patients hémodynamiquement stables et présentant une FA ou un flutter auriculaire d’apparition récente, une stratégie soit de contrôle de la fréquence ventriculaire soit de conversion et maintien du rythme sinusal doit être adoptée, en tenant compte de nombreux éléments comme la durée de la FA et la sévérité des symptômes. Si l’on retient une stratégie de conversion et maintien du rythme sinusal, la cardioversion pourra être électrique ou pharmacologique. Avant cardioversion chez les patients non anticoagulés, il faudra être certain que la durée de l’épisode de FA ou de flutter EM BA R G Atrial fibrillation (AF) is the most common arrhythmia managed by emergency physicians. There is increasing evidence that most patients with recent-onset AF or atrial flutter (AFL) can be safely managed in the emergency department (ED) without the need for hospital admission. The priorities for ED management of recent-onset AF/AFL include rapid assessment of potential hemodynamic instability and identification and treatment of the underlying or precipitating cause. A careful evaluation of the patient’s history should be performed to determine the time of onset of the arrhythmia. All patients should be stratified using a predictive index for the risk of stroke (eg, CHADS2). For stable patients with recent-onset AF/AFL, a strategy of either rate control or rhythm control could be selected based on multiple factors including the duration of AF and the severity of symptoms. If a strategy of rhythm control has been selected, either electrical or pharmacologic cardioversion may be used. Before proceeding to cardioversion in the absence of systemic anticoagulation, physicians must be confident that the duration of AF/AFL is clearly ⬍48 hours and that the patient is not at a particularly high risk of stroke. When the duration of AF/AFL is ⬎48 hours or uncertain, rate control should be optimized first and Atrial fibrillation (AF) is the most common arrhythmia managed by emergency physicians and accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances.1 In Canada, the estimated overall rate of hospitalization with AF is 583 per 100,000 population.2 Hospital admissions for AF have increased by 66% over the past 20 years due to an aging Received for publication November 9, 2010. Accepted November 10, 2010. specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. Corresponding author: Ian G. Stiell, MD, MSc, Clinical Epidemiology Unit, F657, Ottawa Hospital, 1053 Carling Ave, Ottawa, Ontario, Canada K1Y 4E9. Tel.: ⫹1-613-798-5555, ext.: 18683; fax: ⫹1-613-761-5351. E-mail: istiell@ohri.ca The disclosure information of the authors and reviewers is available from the CCS on the following websites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease- 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.014 Stiell et al. Atrial Fibrillation and Flutter in the ED 39 Emergency Department Management of RecentOnset AF/AFL Overall approach The priorities for ED management of recent-onset AF/AFL (Fig. 1) include rapid assessment of potential hemodynamic instability, the identification and treatment of the underlying or precipitating cause, and a careful assessment of the patient’s history with particular attention to the risk of thromboembolism. At this time, evidence equally supports a strategy of rate control or rhythm control for stable patients with known onset of AF/AFL within 48 hours. Both approaches are presented here. The decision regarding the initial strategy of rate versus rhythm control depends upon multiple factors including patient and physician preference, clarity of the history of onset of symptoms, type and duration of AF, severity of symptoms, associated cardiovascular disease and medical conditions, and age. EM BA R G population and a rising prevalence of chronic heart disease.3,4 The overall mortality rate for patients with AF is approximately double that for patients in normal sinus rhythm.5 The rate of ischemic stroke among patients with nonvalvular AF averages 5% per year, 2 to 7 times that of the population without AF.5-7 Atrial flutter (AFL) may also occur in the patient with AF or may present as an isolated arrhythmia. The goals of therapy and management approaches for AFL are similar to those for AF. In the emergency department (ED), physicians often manage patients with either recent-onset (first detected or recurrent) or those with permanent AF/AFL.8 In the case of permanent AF/AFL, cardioversion has previously failed or clinical judgment has led to a decision not to pursue cardioversion, and ED care focuses on rate control and treatment of underlying conditions.9 When AF terminates spontaneously within 7 days of recognized onset, it is designated paroxysmal; when sustained beyond 7 days, AF is designated persistent. This chapter will focus on those with symptomatic, recent-onset episodes of AF/AFL (either newly detected, recurrent paroxysmal, or recurrent persistent episodes), the most common arrhythmia managed in the ED.10,11 There are 2 competing strategies for management: rate-control and rhythm-control treatment.1,12-14 The ratecontrol approach consists of ventricular rate control, oral anticoagulation, no attempt to return the patient to sinus rhythm in the ED, and delayed cardioversion after 4 weeks, if indicated. With the rhythm-control approach, attempts are made to cardiovert patients to sinus rhythm in the ED, either pharmacologically or electrically, and then discharge them home in sinus rhythm.15-17 auriculaire est inférieure à 48 heures et que le patient ne présente pas un risque particulièrement élevé d’AVC. Lorsque la durée de l’épisode de FA ou de flutter auriculaire est incertaine ou supérieure à 48 heures, la fréquence cardiaque sera optimisée et les patients seront anticoagulés pour 3 semaines précédant et 4 semaines suivant la cardioversion. Au départ de la salle d’urgence, tous les patients avec FA ou flutter auriculaire d’apparition récente devront faire l’objet d’un suivi rapproché pour déterminer la présence de cardiopathie sousjacente et évaluer la nécessité d’un traitement antithrombotique ou antiarythmique au long cours. O ED the patients should receive therapeutic anticoagulation for 3 weeks before and 4 weeks after planned cardioversion. Adequate follow-up of patients with recent-onset AF/AFL is recommended to identify structural heart disease and evaluate the need for long-term antithrombotic or antiarrhythmic therapy. Evidence for Emergency Department Management Variation in practice within Canadian EDs has been observed, and this variation likely reflects a lack of high-quality evidence to guide the acute management of recent-onset AF patients.18,19 Standard guidelines and textbooks are unable to offer clear evidence-based direction for emergency physicians.1,20 Particularly controversial is the issue of using rhythm control or rate control.1,12-14 The very large AFFIRM and AF-CHF clinical trials compared rate and rhythm control but did not explore the optimal management for recent-onset AF/AFL patients presenting to the ED with ⬍48 hours of symptoms.21,22 In the United States, patients are often admitted to hospital under the cardiology service or discharged home after rate-control therapy only.23-25 One Canadian site has described 2 cohorts of patients successfully treated with rhythm control with good results.11,26 Other studies of rhythm control in the ED have been small or did not include both pharmacologic and electrical cardioversion as an option.15,17,23,27,28 RECOMMENDATION We recommend that in stable patients with recent-onset AF/AFL, a strategy of rate control or rhythm control could be selected (Strong Recommendation, High-Quality Evidence). Values and preferences. This recommendation places a high value on the randomized controlled trials investigating rate control as an alternative to rhythm control for AF/AFL, recognizing that these trials did not specifically address the ED environment. Assessment Uncommonly, patients with recent-onset AF/AFL will present with hemodynamic instability and must be immediately cardioverted as described later. Most patients are stable, presenting with palpitations, chest tightness, or weakness, although some patients, especially the elderly, are often unaware that they have a tachyarrhythmia or when it started. A careful history should be taken to determine the time of onset, if known, and particularly to determine if it was within the past 48 hours. Other important points to determine include previous episodes and treatment, associated cardiac conditions, current antiarrhythmic agents, anticoagulation and current INR level, rhythm on most recent ECG, and risk of thromboembolism per the CHADS2 [Congestive Heart Failure, Hypertension, Age, Diabetes, Stroke/Transient Ischemic Attack] score (see Table 1 and Therapies for Prevention of Stroke and Vas- 40 Canadian Journal of Cardiology Volume 27 2011 Strategy of rhythm-control for recent-onset AF/AFL Known duraon < 48 h (and not high-risk paents1) Duraon > 48 h or unknown or high-risk paents1 Failed CV Hemodynamically unstable Urgent electrical cardioversion2 Rate-control Hemodynamically stable Therapeuc OAC for 3 weeks before cardioversion Pharmacological or electrical cardioversion2 TEE-guided cardioversion (OAC iniated with heparin bridging)3 Successful CV Anthromboc therapy Anthromboc therapy 1Paents at parcularly high risk of stroke (e.g. mechanical valve, rheumac heart disease, recent stroke/TIA) biphasic waveform preferred must be iniated and connued unl a therapeuc level of oral ancoagulaon has been established. 2150-200J 3Heparin -OAC connued for 4 consecuve weeks. -If AF/AFL persists or recurs or if AF/AFL has been recurrent, anthromboc therapy as appropriate (per CHADS2 score) should be connued indefinitely. -Early follow-up should be arrange to review ongoing anthromboc strategy. O ED -In general, no prior or subsequent ancoagulaon is required. -If AF/AFL persists or recurs or if AF/AFL has been recurrent, anthromboc therapy as appropriate (CHADS2 score) should be iniated and connued indefinitely. -Early follow-up should be arranged to review anthromboc strategy. R G Figure 1. A management strategy for patients with recent-onset AF/AFL. Unstable patients EM BA cular Events). AF may be related to acute, temporary causes including alcohol use (eg, “holiday heart syndrome”), myocardial ischemia or infarction, myocarditis or pericarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders. In such cases, successful treatment of the underlying condition may promote the resolution of AF. Routine chemistry and hematology are indicated as well as, in some cases, troponin and thyroid-stimulating hormone levels. Transesophageal echocardiography, if available, is useful to exclude the presence of left atrial clot in patients in whom the onset of arrhythmia is unclear and cardioversion is desired. If recent-onset AF/AFL has caused hemodynamic instability with hypotension, acute coronary syndrome, or florid pulmonary edema, then patients must undergo immediate electrical cardioversion. This is a relatively uncommon presentation of recent-onset AF/AFL, and physicians must ensure that the patient is not in long-standing persistent AF/AFL, as attempts to cardiovert such patients are likely to fail and may increase morbidity. In this case, the rapid AF may be secondary to an Table 1. CHADS2 risk criteria for stroke in patients with nonvalvular atrial fibrillation if not treated with anticoagulation Risk criteria Prior stroke or TIA Age ⬎75 Hypertension Diabetes mellitus Congestive heart failure Data from Gage BF, et al54 and Wang TJ, et al.55 Score 2 1 1 1 1 acute decompensation of an underlying condition such as sepsis or hypovolemia. Generally, unstable patients need not be given an anticoagulant either before or following cardioversion if the duration of AF/AFL is known to have occurred ⬍48 hours. However, if the duration of AF/AFL is ⱖ48 hours or unknown or the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic valve disease, recent stroke, or transient ischemic attack), we suggest administering the patient intravenous unfractionated heparin or low-molecular-weight heparin before cardioversion if possible or immediately thereafter if even a brief delay is unacceptable. Such a patient should then be bridged with heparin and started on a course of oral anticoagulants for ⱖ4 weeks postcardioversion. RECOMMENDATION We recommend for patients with acute hemodynamic instability secondary to rapid recent-onset AF/AFL, immediate electrical conversion to sinus rhythm (Strong Recommendation, Low-Quality Evidence). Values and preferences. This recommendation places a high value on the immediate management of hemodynamic instability and a lower value on anticoagulation status under these circumstances. It is also recognized that this is a relatively rare circumstance and that, in most cases, stroke risk and anticoagulation status can be considered prior to immediate cardioversion. Rate control Criteria for adequate rate control vary. A sustained, uncontrolled tachycardia over weeks may lead to deterioration of left Stiell et al. Atrial Fibrillation and Flutter in the ED 41 Drug Diltiazem* Metoprolol Verapamil* Digoxin Dose Risks 0.25 mg/kg IV bolus over 10 min; repeat at 0.35 mg/kg IV 2.5-5 mg IV bolus over 2 min; up to 3 doses 0.075-0.15 mg/kg over 2 min 0.25 mg IV each 2 h; up to 1.5 mg Hypotension, bradycardia Hypotension, bradycardia Hypotension, bradycardia Bradycardia, digitalis toxicity * Calcium-channel blockers should not be used in patients with heart failure or left ventricular dysfunction. RECOMMENDATION In hemodynamically stable patients with AF/AFL of known duration ⬍48 hours in whom a strategy of rhythm control has been selected: We recommend that rate-slowing agents alone are acceptable while awaiting spontaneous conversion (Strong Recommendation, Moderate-Quality Evidence). We recommend that synchronized electrical cardioversion or pharmacologic cardioversion may be used when a decision is made to cardiovert patients in the emergency department. See Table 2 for drug recommendations (Strong Recommendation, Moderate-Quality Evidence). We suggest that antiarrhythmic drugs may be used to pretreat patients before electrical cardioversion in ED in order to decrease early recurrence of AF and to enhance cardioversion efficacy (Conditional Recommendation, Low-Quality Evidence). R G ventricular function, a condition called tachycardia-related cardiomyopathy, so it is important that adequate rate control be achieved.29 Physicians should attempt to reduce the heart rate prior to discharge from the ED to target rates of ⬍100 beats per minute (bpm) at rest and ⬍110 bpm during moderate exercise (such as a walk test). The most commonly used drugs are intravenous diltiazem, verapamil, and metoprolol (Table 2). Digoxin is not considered a first-line agent for rate control because of slow onset of action and it affects only resting heart rate. It may be useful in patients with heart failure and left ventricular systolic dysfunction or as an adjunctive agent, allowing lower doses of beta-blockers or calcium channel blockers to be used. At discharge from the ED, physicians should ensure the patient is placed on oral rate-control medications and the appropriate prophylaxis for stroke. capability. Prevention of thromboembolism for patients managed with rhythm control is discussed later. Spontaneous conversion of recent-onset AF to sinus rhythm within 24 hours is common. Some emergency physicians have the patients return the following day for cardioversion at that time if spontaneous conversion has not occurred.5,35 In this scenario, after documentation of appropriate rate control, patients at low risk of stroke can be discharged on rate control alone to return the following day for reevaluation. Patients who remain in AF can then undergo DC cardioversion at this time as long as the total duration of AF remains ⬍48 hours. O ED Table 2. Recommended intravenous drugs for heart rate control in the ED BA Rhythm control EM Cardioversion in the absence of systemic anticoagulation carries a risk of thromboembolism when AF/AFL has been present for ⬎48 hours. When the duration of AF/AFL has been ⬍48 hours, cardioversion appears to have an acceptably low risk of thromboembolism except in particularly high-risk groups.30,31 Such high-risk situations include the presence of a mechanical valve, rheumatic valve disease, or recent stroke or transient ischemic attack unless the patient is already on oral anticoagulation with a therapeutic INR. There is no evidence that the risk of thromboembolism or stroke differs between pharmacologic and electrical cardioversion. Before proceeding to immediate cardioversion in the absence of systemic anticoagulation, physicians must be confident that the onset of AF/ AFL is clearly ⬍48 hours and that the patient is not at a particularly high risk of stroke. Most patients in the ED are acutely aware of the time of onset of symptoms but some are not. In such situations, a transesophageal echocardiogram may be used to establish the safety of immediate cardioversion. If patients are on warfarin, it is important to ensure that their INR has been therapeutic for ⱖ3 consecutive weeks.1,32 Rate-control drugs have not been shown to enhance the rate of conversion when a rhythm-control approach is used. Physician and patient preferences dictate whether to start rhythmcontrol treatment with drugs or with electrical cardioversion. Initial use of antiarrhythmic agents may also prevent immediate recurrence of AF after electrical cardioversion.33,34 All patients undergoing pharmacologic or electrical cardioversion require continuous electrocardiographic monitoring and temporary pacing Values and preferences. These recommendations place a high value on determination of the duration of AF/AFL as a determinant of stroke risk with cardioversion. Also, individual considerations of the patient and treating physician are recognized in making specific decisions about method of cardioversion. Pharmacologic cardioversion Physicians may consider several drugs for the pharmacologic cardioversion of recent-onset AF/AFL in the ED13,15,16,36,37 (Table 3). Procainamide is administered intravenously over 60 minutes at a dose of 15-17 mg/kg and occasionally is accompanied by transient hypotension. A recent report described the successful use of procainamide in the ED, where this drug was 60% effective for conversion of recentonset AF.38 This study showed procainamide to have an excellent safety profile, even for patients already taking oral antiarrhythmic agents. Oral propafenone or flecainide, both Class IC agents, can be safely administered in the ED but can be expected to have slower onset of action than intravenous drugs.39-41 The Class III agent ibutilide is administered intravenously and has been shown to effectively and quickly terminate AF and AFL of recent onset.42 Ibutilide is associated with a 2%-3% risk of torsades de pointes but this risk can be mitigated by pretreatment with intravenous magnesium sulphate.43 Amiodarone and sotalol are not recommended for recent-onset AF as they are no more effective than placebo in the initial 6-8 hours and are associated with adverse reac- 42 Canadian Journal of Cardiology Volume 27 2011 Drug Class IA Procainamide Dose Efficacy Risks 15-17 mg/kg IV over 60 min ⫹⫹ 5% Hypotension Class IC* Propafenone 450-600 mg PO ⫹⫹⫹ Flecainide 300-400 mg PO ⫹⫹⫹ Hypotension, 1:1 flutter, bradycardia Hypotension, 1:1 flutter, bradycardia 1-2 mg IV over 10-20 min Pretreat with MgSO4 1-2 mg IV ⫹⫹ Class III Ibutilide 2-3% Torsades de pointes * Class IC drugs should be used in combination with AV nodal blocking agents (beta-blockers or calcium channel inhibitors). Class IC agents should also be avoided in patients with structural heart disease. RECOMMENDATION We recommend that electrical cardioversion may be conducted in the ED with 150-200 joules biphasic waveform as the initial energy setting (Strong Recommendation, LowQuality Evidence). Values and preferences. This recommendation places a high value on the avoidance of repeated shocks and the avoidance of ventricular fibrillation that can occur with synchronized cardioversion of AF at lower energy levels. It is recognized that the induction of VF is a rare but easily avoidable event. R G tions.44-49 Adenosine transiently slows heart rate, does not cardiovert AF, and is associated with a significant risk of ventricular arrhythmias in Wolff-Parkinson-White syndrome with AF (see Rapid Preexcitation later). Recent trials of vernakalant have demonstrated high clinical efficacy of this intravenous agent for conversion of recent-onset AF.50,51 This atrial selective antiarrhythmic drug was recently approved for use in the European Union, but in North America it is currently available only for investigational use. successful electrical cardioversion in the ED, after pretreatment with intravenous procainamide. Patients had no serious adverse events and their ED lengths of stay averaged only 4-6 hours.26 Current guidelines recommend starting with a higher energy level, such as 150-200 joules for biphasic waveform devices in order to increase the likelihood of initial success and thus limit the cumulative energy dose with multiple attempts at cardioversion.1,52 Likewise, an anterior-posterior pad positioning may be more effective than an anterior-lateral approach.1,53 Sedation typically involves rapid acting agents such as intravenous fentanyl, propofol, and midazolam. O ED Table 3. Recommended drugs for pharmacologic conversion in the ED Electrical cardioversion AF occurring in the setting of Wolff-Parkinson-White syndrome (Fig. 2) is a precarious situation because rapid atrioventricular conduction through the accessory pathway may precipitate ventricular fibrillation. In these patients, drugs that block atrioventricular conduction (digoxin, calcium channel blockers, beta-blockers, and adenosine) are contraindicated because they do not slow conduction EM BA Synchronized electrical cardioversion is highly effective and physicians have the option of pretreating with antiarrhythmic drugs or proceeding directly to electrical shock. In a series of 660 patients, one Canadian site described 91.0% Rapid preexcitation during AF Figure 2. Electrocardiogram of rapid ventricular preexcitation (Wolff-Parkinson-White syndrome) during atrial fibrillation. Note very rapid (up to 300 bpm) irregular wide QRS complexes. Stiell et al. Atrial Fibrillation and Flutter in the ED 43 RECOMMENDATION We recommend, in patients with rapid ventricular preexcitation during AF (Wolff-Parkinson-White syndrome): Urgent electrical cardioversion if the patient is hemodynamically unstable (Strong Recommendation, Low-Quality Evidence). Intravenous antiarrhythmic agents procainamide or ibutilide in stable patients (Strong Recommendation, LowQuality Evidence). AV nodal blocking agents (digoxin, calcium channel blockers, beta-blockers, adenosine) are contraindicated (Strong Recommendation, Low-Quality Evidence). RECOMMENDATION We recommend that hemodynamically stable patients with AF/AFL of ⱖ48 hours’ or uncertain duration for whom a strategy of rhythm control has been selected should have rate control optimized and receive therapeutic oral anticoagulants (OAC) therapy (warfarin [INR 2-3] or dabigatran) for 3 weeks before and at least 4 weeks postcardioversion. Following attempted cardioversion: If AF/AFL persists or recurs or if symptoms suggest that the presenting AF/AFL has been recurrent, the patient should have antithrombotic therapy continued indefinitely (using either OAC or aspirin as appropriate). If sinus rhythm is achieved and sustained for 4 weeks, the need for ongoing antithrombotic therapy should be determined based on the risk of stroke, and in selected cases, expert consultation may be required (Strong Recommendation, Moderate-Quality Evidence). R G Values and preferences. These recommendations place a high value on avoidance of the degeneration of preexcited AF to ventricular fibrillation. It is recognized that degeneration can occur spontaneously or it can be facilitated by the administration of specific agents that in the absence of ventricular preexcitation would be the appropriate therapy for rate control of AF. or oral anticoagulants as appropriate based on the patient’s risk of thromboembolism. If sinus rhythm is achieved and sustained for 4 weeks, the need for ongoing antithrombotic therapy should be based on the risk of stroke. If rhythm control is not anticipated, aspirin is sufficient for those with a CHADS2 score of 0, whereas oral anticoagulants are preferred if the CHADS2 score is 1 and strongly recommended if the CHADS2 score is ⱖ2 (see Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter).60 If the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic valve disease, recent stroke or transient ischemic attack), even when the duration of newonset AF/AFL is ⬍48 hours, we recommend that cardioversion be delayed and that oral anticoagulants be prescribed for 3 weeks before and at least 4 weeks postcardioversion. Subsequent antithrombotic therapy should be based on balancing the risks of stroke and bleeding. O ED through the accessory pathway and, therefore, may precipitate VF. We recommend urgent electrical cardioversion if the patient is hemodynamically unstable or intravenous antiarrhythmic agents procainamide or ibutilide in stable patients. Amiodarone should be used with caution in the case of preexcited AF as several case reports have described the occurrence of VF after intravenous administration.45 EM BA Practical tip. Identification of preexcited AF can be challenging and should be considered with any very rapid (240-300 bpm) sustained, highly irregular wide complex tachycardia (Fig. 2). Spontaneous degeneration of preexcited AF to VF can occur in the absence of administration of medication. As such, DC cardioversion is most often the preferred option when preexcited AF is very rapid. Prevention of thromboembolism Perhaps the most important and controversial aspect of ED management for recent-onset AF/AFL is ensuring that patients do not sustain a stroke. Physicians should be familiar with the CHADS2 risk scoring system54,55 (Table 1). If warfarin is prescribed, patients need careful follow-up to minimize the risk of bleeding.56,57 Dabigatran is a promising new oral anticoagulant that reversibly inhibits thrombin and can be used with a fixed-dose regimen without the need for routine coagulation monitoring.58,59 a. Duration of AF/AFL 48 hours or high-risk patient. In stable patients with AF/AFL ⬎48 hours or of uncertain duration in which a strategy of rhythm control has been selected, rate control should first be optimized. The patient should also receive therapeutic warfarin (INR 2-3) or dabigatran for 3 weeks before and at least 4 weeks after attempted cardioversion.1,32 Antithrombotic therapy should be continued indefinitely if symptoms suggest that AF/AFL has been recurrent or if AF/AFL persists, using either aspirin Values and preferences. These recommendations place a high value on minimizing stroke risk by rate control, appropriate anticoagulation and delayed cardioversion, and a lower value on symptomatic improvement associated with immediate cardioversion. b. Duration of AF/AFL 48 hours and not high risk. In stable patients with AF of known duration ⬍48 hours in whom a strategy of rhythm control has been selected, we recommend that they may generally be cardioverted without prior or subsequent anticoagulation or use of heparin. If symptoms suggest that AF/AFL has been recurrent or if AF/AFL persists, then antithrombotic therapy should be commenced and continued indefinitely as the risk of stroke with paroxysmal AF is equivalent to that of permanent AF.61,62 Aspirin is sufficient for those with a CHADS2 score of 0, whereas oral anticoagulants are preferred for patients with a CHADS2 score of 1 and strongly recommended if the CHADS2 score is ⱖ2 (see Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter).60 44 Canadian Journal of Cardiology Volume 27 2011 We recommend that hemodynamically stable patients with AF/AFL of known duration ⬍48 hours for whom a strategy of rhythm control has been selected may generally undergo cardioversion without prior or subsequent anticoagulation. However, if the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic heart disease, recent stroke, or transient ischemic attack), cardioversion should be delayed and the patient should receive OAC for 3 weeks before and at least 4 weeks postcardioversion. Following attempted cardioversion: If AF or AFL persists, recurs, or if symptoms suggest that the presenting AF/AFL has been recurrent, antithrombotic therapy (OAC or aspirin as appropriate) should be commenced and continued indefinitely. If NSR is achieved, the need for ongoing antithrombotic therapy should be determined based on the risk of stroke according to CHADS2 score and early consultant follow-up should be arranged (Strong Recommendation, Low-Quality Evidence). Disposition and follow-up Most patients with recent-onset AF/AFL may be discharged home from the ED within a period of 6-12 hours, once adequate rate or rhythm control has been achieved. We recommend hospital admission of symptomatic patients with decompensated heart failure or myocardial ischemia. Occasionally, admission may be required for highly symptomatic patients in whom adequate rate or rhythm control cannot be achieved. RECOMMENDATION We recommend hospital admission for highly symptomatic patients with decompensated heart failure or myocardial ischemia (Strong Recommendation, Low-Quality Evidence). We suggest limiting hospital admission to highly symptomatic patients in whom adequate rate control cannot be achieved (Conditional Recommendation, Low-Quality Evidence). BA R G Values and preferences. These recommendations place a high value on minimizing stroke risk by appropriate anticoagulation prior to cardioversion in all patients except those at very low risk of stroke due to a short duration of AF/AFL. A lower value is placed on symptomatic improvement associated with immediate cardioversion in patients who are deemed not to be at very low risk of stroke despite an apparent short duration of AF/AFL. Values and preferences. This recommendation places a higher value on the symptomatic improvement with immediate cardioversion as well as avoidance of precardioversion anticoagulation. A lower value is placed on the small risks associated with transesophageal echocardiography. O ED RECOMMENDATION EM c. Transesophageal echocardiography. If the onset of symptoms is not clearly ⬍48 hours or there is a particularly high risk of stroke, we suggest that patients may undergo cardioversion guided by transesophageal echocardiography, as an alternative to anticoagulation prior to cardioversion.63,64 Patients with no identifiable left atrial thombus may undergo immediate cardioversion. Prior to cardioversion, pretreatment with heparin must be initiated and continued until a therapeutic level of oral anticoagulation has been established. Oral anticoagulation must be continued for a minimum of 4 weeks (as discussed). For patients in whom thrombus is identified by transesophageal echocardiography, oral anticoagulation should be prescribed for ⱖ3 weeks and transesophageal echocardiography repeated to confirm the resolution of thrombus before proceeding to cardioversion. Values and preferences. This recommendation places a high value on the need for monitoring of the response to therapy and its reassessment, as well as ancillary investigation and treatment not available in the ED in patients with complex medical conditions associated with AF/AFL. A lower value is placed on the attendant costs of admission to hospital in patients with complex medical conditions associated with AF/AFL. Adequate follow-up is recommended to identify structural heart disease and the possible need for long-term anticoagulation or antiarrhythmic therapy. Patients with newly detected AF/AFL should have outpatient echocardiography and referral to a cardiologist or internist. Adequate and early follow-up are necessary to safely monitor the INR of patients discharged on warfarin. The need for long-term antithrombotic therapy may be reviewed by the appropriate consultant, weighing the risks and benefits. Long-term rhythm management should also be reviewed by a consultant, based on the estimated probability of recurrence, the symptoms during AF, and other factors. RECOMMENDATION RECOMMENDATION When the duration of an episode of AF/AFL is uncertain, we suggest that patients may undergo cardioversion guided by transesophageal echocardiography, as an alternative to anticoagulation prior to cardioversion. However, anticoagulation needs to be simultaneously started and maintained for ⱖ4 weeks postcardioversion (Conditional Recommendation, High-Quality Evidence). We suggest that after conversion to sinus rhythm has been achieved, whether antiarrhythmic drug therapy is indicated should be based on the estimated probability of recurrence and the symptoms during AF. Long-term therapy will need to be determined by an appropriate outpatient consultation (Conditional Recommendation, Low-Quality Evidence). Stiell et al. Atrial Fibrillation and Flutter in the ED 45 Conclusion Physicians frequently encounter ED patients with recentonset AF/AFL and may safely manage these patients with either a rate-control or rhythm-control strategy. Immediate specialist consultation or admission to hospital is not often necessary. Careful consideration of the risks of thromboembolism is a priority and appropriate follow-up is important. 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Vernakalant hydrochloride for rapid conversion of atrial fibrillation. A phase 3, randomized, placebocontrolled trial. Circulation 2008;117:1518-25. 52. Wyse DG. Initial energy for electrical cardioversion of atrial fibrillation: is more better? Am J Cardiol 2000;86:324-5. 53. de la Morandiere KP, Morriss H. Paddle position in emergency cardioversion of atrial fibrillation. Emerg Med J 2005;22:44-6. 54. Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285:2864-70. 55. Wang TJ, Massaro JM, Levy D, et al. A risk score for predicting stroke or death in individuals with new-onset atrial fibrillation in the community: The Framingham Heart Study. JAMA 2003;290:1049-56. 56. Hylek EM, Evans-Molina C, Shea C, et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007;115:2689-96. R G 39. Blanc JF, De Ledinghen V, Trimoulet P, et al. Premalignant lesions and hepatocellular carcinoma in a non-cirrhotic alcoholic patient with iron overload and normal transferrin saturation. J Hepatol 1999;30:325-9. 50. Roy D, Rowe BH, Stiell IG, et al. A randomized, controlled trial of RSD1235, a novel anti-arrhythmic agent, in the treatment of recent onset atrial fibrillation. J Am Coll Cardiol 2004;44:2355-61. O ED 33. Oral H, Ozaydin M, Sticherling C, et al. Effect of atrial fibrillation duration on probability of immediate recurrence after transthoracic cardioversion. J Cardiovasc Electrophysiol 2003;14:182-5. 40. Khan IA. Single oral loading dose of propafenone for pharmacological cardioversion of recent-onset atrial fibrillation. J Am Coll Cardiol 2001; 37:542-7. 57. Wyse DG. Bleeding while starting anticoagulation for thromboembolism prophylaxis in elderly patients with atrial fibrillation: from bad to worse. Circulation 2007;115:2684-6. 58. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51. 42. Hongo RH, Themistoclakis S, Raviele A, et al. Use of ibutilide in cardioversion of patients with atrial fibrillation or atrial flutter treated with class IC agents. J Am Coll Cardiol 2004;44:864-8. 59. van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate: a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103: 1116-27. EM BA 41. Alboni P, Botto GL, Baldi N, et al. Outpatient treatment of recent-onset atrial fibrillation with the “pill-in-the-pocket” approach. N Engl J Med 2004;351:2384-91. 43. Gowda RM, Khan IA, Wilbur SL, Vasavada BC, Sacchi TJ. Torsade de pointes: the clinical considerations. Int J Cardiol 2004;96:1-6. 44. Martinez-Marcos FJ, Garcia-Garmendia JL, Ortega-Carpio A, et al. Comparison of intravenous flecainide, propafenone and amiodarone for conversion of acute atrial fibrillation to sinus rhythm. Am J Cardiol 2000;86: 950-3. 45. Tijunelis MA, Herbert ME. Myth: intravenous amiodarone is safe in patients with atrial fibrillation and Wolff-Parkinson-White syndrome in the emergency department. Can J Emerg Med 2005;7:262-5. 46. Hilleman DE, Spinler SA. Conversion of recent-onset atrial fibrillation with intravenous amiodarone: a meta-analysis of randomized controlled trials. Pharmacotherapy 2002;22:66-74. 47. Chevalier P, Durand-Dubief A, Burri H, et al. Amiodarone versus placebo and classic drugs for cardioversion of recent-onset atrial fibrillation: a meta-analysis. J Am Coll Card 2003;41:255-62. 60. Cairns JA, Connolly S, McMurtry S, Stephenson M, Talajic M, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol 2011; 27:74-90. 61. Nieuwlaat R, Dinh T, Olsson SB, et al. Should we abandon the common practice of withholding oral anticoagulation in paroxysmal atrial fibrillation? Eur Heart J 2008;29:915-22. 62. Stramba-Badiale M. Atrial fibrillation subtypes, risk of stroke, and antithrombotic therapy. Eur Heart J 2008;29:840-2. 63. Klein AL, Grimm RA, Murray D, et al. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med 2001;344:1411-20. 64. Manning WJ. Strategies for cardioversion of atrial fibrillation: time for a change? (Editorial). N Engl J Med 2001;344:1468-70. Canadian Journal of Cardiology 27 (2011) 47–59 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Rate and Rhythm Management Anne M. Gillis, MD, FRCPC,a Atul Verma, MD, FRCPC,b Mario Talajic, MD, FRCPC,c Stanley Nattel, MD, FRCPC,c Paul Dorian, MD, FRCPC,d and the CCS Atrial Fibrillation Guidelines Committeee a University of Calgary/Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada b Montreal Heart Institute, Université de Montréal and McGill University, Montreal, Québec, Canada d e Southlake Regional Health Centre, Newmarket, Ontario, Canada St Michael’s Hospital and University of Toronto, Toronto, Ontario, Canada O ED c For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and Achieving Consensus. Can J Cardiol 2011;27:27-30. ABSTRACT RÉSUMÉ Les principaux objectifs du traitement de la fibrillation auriculaire (FA) et du flutter auriculaire sont d’atténuer les symptômes des patients, d’améliorer leur qualité de vie et de réduire au minimum la morbidité associée à la FA et au flutter auriculaire. Le traitement de l’arythmie consiste d’abord à ralentir la fréquence ventriculaire. La décision d’un traitement avec antiarythmiques de classe I ou III pour la conversion et/ou le maintien du rythme sinusal repose sur la présence de symptômes et les préférences du patient. L’objectif du contrôle de la fréquence ventriculaire pour la FA ou le flutter auriculaire persistant ou permanent est une fréquence cardiaque inférieure à 100/min au repos. Les béta-bloquants ou les inhibiteurs calciques (non-dihydropyridine) sont les médicaments de premier choix pour le contrôle de la fréquence ventriculaire de la FA et du flutter auriculaire chez la plupart des patients sans antécédent d’infarctus du myocarde ou dysfonction ventriculaire gauche. La digoxine n’est pas recommandée en monothérapie pour le contrôle de la fréquence ventriculaire chez les patients actifs. L’ajout de digoxine ou de dronédarone en combinaison avec d’autres agents peut être considéré pour optimiser le traitement. Chez les patients dont la fonction ventriculaire EM BA R G The goals of atrial fibrillation (AF) and atrial flutter (AFL) arrhythmia management are to alleviate patient symptoms, improve patient quality of life, and minimize the morbidity associated with AF and AFL. Arrhythmia management usually commences with drugs to slow the ventricular rate. The addition of class I or class III antiarrhythmic drugs for restoration or maintenance of sinus rhythm is largely determined by patient symptoms and preferences. For rate control, treatment of persistent or permanent AF and AFL should aim for a resting heart rate of ⬍100 beats per minute. Beta-blockers or nondihydropyridine calcium channel blockers are the initial therapy for rate control of AF and AFL in most patients without a history of myocardial infarction or left ventricular dysfunction. Digoxin is not recommended as monotherapy for rate control in active patients. Digoxin and dronedarone may be used in combination with other agents to optimize rate control. The first-choice antiarrhythmic drug for maintenance of sinus rhythm in patients with non structural heart disease can be any one of dronedarone, flecainide, propafenone, or sotalol. In patients with abnormal ventricular function but left ventricular ejection fraction Atrial fibrillation (AF) and atrial flutter (AFL) are often associated with rapid and irregular ventricular rates causing palpitations, dyspnea, fatigue, reduced exercise tolerance, other symp- toms, and in some cases, left ventricular dysfunction and congestive heart failure. The approach to the management of AF and AFL includes, in parallel, identification and treatment Received for publication November 4, 2010. Accepted December 3, 2010. with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. Corresponding author: Dr Anne M. Gillis, University of Calgary, Cardiac Sciences, 3280 Hospital Drive N.W., Calgary, Alberta, Canada T2N 4Z6. Tel: ⫹1-403-220-6841, fax: ⫹1-403-270-0313. E-mail: amgillis@ucalgary.ca The disclosure information of the authors and reviewers is available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.001 48 Canadian Journal of Cardiology Volume 27 2011 Goals of AF Arrhythmia Management The major goals of AF and AFL arrhythmia management are to ● Identify and treat underlying structural heart disease and other predisposing conditions ● Relieve symptoms ● Improve functional capacity and quality of life (QOL) ● Reduce morbidity and mortality associated with AF and AFL, that is, ● Prevent tachycardia-induced cardiomyopathy ● Reduce or prevent emergency room visits or hospitalizations secondary to AF and AFL ● Prevent stroke or systemic thromboembolism EM BA R G of precipitating causes, antithrombotic therapy based on risk factors for stroke, drug therapy to control ventricular rates, and antiarrhythmic therapy as required to restore and/or maintain sinus rhythm with the major goal of alleviating patient symptoms and minimizing the morbidity associated with AF (Fig. 1).1,2 Arrhythmia management usually commences with drugs to slow the ventricular rate. The addition of class I or class III antiarrhythmic drugs for restoration or maintenance of sinus rhythm is largely determined by patient symptoms and preferences as, to date, none of the large randomized trials has demonstrated that pharmacologic therapy to maintain sinus rhythm has improved survival or reduced the risk of stroke.3-7 AF may be classified as newly detected, paroxysmal (self-terminating episodes lasting ⬍7 days), persistent (non–self-terminating episodes lasting ⬎7 days), or permanent (no further attempts or no initial attempt to restore sinus rhythm to be undertaken).8-9 The nature of AF is recurrent and frequently progressive (Fig. 2). Although a treatment strategy of rate control or rhythm control may be selected initially, the treatment strategy may change over time if the selected treatment strategy has been unsuccessful, as the arrhythmia progresses, or as the patient’s condition changes (Fig. 1).10 Thus, treatment strategies and their effectiveness, safety, and acceptability must be constantly reevaluated. Factors that might influence a decision for rate control versus rhythm control are summarized in Table 1. AFL may also occur in the patient with AF or may present as an isolated arrhythmia. The goals of therapy and management approaches for AFL are similar to those for AF. est normale, les anti-arythmiques de premier choix pour le maintien du rythme sinusal incluent la dronédarone, la flécaïnide, la propafénone ou le sotalol. Chez les patients dont la fonction ventriculaire est anormale mais avec fraction d’éjection ventriculaire gauche supérieure à 35 %, on recommande la dronédarone, le sotalol ou l’amiodarone. Chez les patients dont la fraction d’éjection ventriculaire gauche est inférieure à 35 %, seule l’amiodarone est recommandée. Un traitement anti-arythmique occasionnel (“pill-in-the-pocket”) peut-être considéré comme alternative au traitement antiarythmique quotidien chez les patients symptomatiques qui présentent des épisodes de FA ou de flutter auriculaire infréquents mais de longue durée. L’ablation par cathéter doit être considérée chez les patients symptomatiques après échec du traitement antiarythmique et pour lesquels une stratégie de maintien du rythme sinusal demeure indiquée. O ED ⬎35%, dronedarone, sotalol, or amiodarone is recommended. In patients with left ventricular ejection fraction ⬍35%, amiodarone is the only drug usually recommended. Intermittent antiarrhythmic drug therapy (“pill in the pocket”) may be considered in symptomatic patients with infrequent, longer-lasting episodes of AF or AFL as an alternative to daily antiarrhythmic therapy. Referral for ablation of AF may be considered for patients who remain symptomatic after adequate trials of antiarrhythmic drug therapy and in whom a rhythm control strategy remains desired. RECOMMENDATION We recommend that the goals of ventricular rate control should be to improve symptoms and clinical outcomes which are attributable to excessive ventricular rates (Strong Recommendation, Low-Quality Evidence). We recommend that the goals of rhythm control therapy should be to improve patient symptoms and clinical outcomes and that these goals do not necessarily imply the elimination of all AF (Strong Recommendation, ModerateQuality Evidence). Overview of AF Management Detecon and Treatment of Precipitang Causes AF Detected Patterns of AF Newly Diagnosed AF Managementt off M Arrhythmia A Assessment t off Thromboembolic Risk (CHADS2 ) P Paroxysmal l OAC Aspirin Rate Control P i Persistent Rhythm Control No anthromboc may be appropriate in selected young paents with no stroke risk factors Figure 1. Overview of AF management. If a strategy of rate or rhythm control is not successful, crossover to the alternate strategy may be required. AF, atrial fibrillation; OAC, oral anticoagulation. Permanent Figure 2. Interrelationships among categories of AF. Arrows indicate most common forms of progression. AF, atrial fibrillation. Adapted and reprinted with permission from Fuster V, et al.8 Circulation 2006; 114(7):e257-e354. ©2006 American Heart Association, Inc. Gillis et al. Rate and Rhythm Management 49 Favours rate control Favours rhythm control Persistent AF Paroxysmal AF Newly detected AF More symptomatic Aged ⬍65 years No hypertension Congestive heart failure clearly exacerbated by AF No previous antiarrhythmic drug failure Patient preference Less symptomatic Aged ⱖ65 years Hypertension No history of congestive heart failure Previous antiarrhythmic drug failure Patient preference AF, atrial fibrillation. Values and preferences. These recommendations place a high value on the decision of individual patients to balance relief of symptoms and improvement in QOL and other clinical outcomes with the potentially greater adverse effects of class I or class III antiarrhythmic drugs compared with rate-control therapy. EM BA R G Referral for Specialty Care Most patients with a history of AF or AFL should be considered for referral to a cardiologist or an internist with an interest in cardiovascular disease for an expert opinion on management of AF or AFL, as well as any underlying cardiovascular conditions. Patients aged ⱕ35 years with symptomatic AF should be referred to an arrhythmia specialist to rule out other forms of supraventricular tachycardia that may trigger AF (so-called “tachycardia-induced tachycardia”) and that would be best treated by radiofrequency ablation. Patients with isolated AFL may also be considered for referral for curative ablation therapy.11 Patients who remain highly symptomatic despite multiple trials of antiarrhythmic drug therapy or who remain unresponsive to or intolerant of rate-controlling therapies should be referred to an arrhythmia specialist for an expert opinion on management alternatives. rate-control strategies.15 No difference in the primary outcome (composite of cardiovascular death, heart failure hospitalization, stroke, systemic embolism, bleeding, and arrhythmic events) was found, and the lenient strategy rate goal was achieved in a larger proportion of patients, with lower drug doses and fewer combinations of drugs, resulting in far fewer visits to achieve the intended target.15 Relatively few patients randomized to lenient rate control had resting heart rates ⬎ 100 to 110 bpm. Furthermore, at the end of the first year, average resting heart rates were 86 ⫾ 15 and 75 ⫾ 12 bpm in the lenient and strict rate-control arms, respectively, and the difference of 10 to 11 bpm remained through the remainder of the trial. Thus, although the definition of lenient seems quite liberal, in the trial itself the difference in heart rates in the 2 groups was quite small. Since few patients had resting heart rates ⬎100 bpm and previous studies cannot conclusively show the safety of resting heart rates ⬎100 bpm, we recommend that a heart rate target of ⬍100 bpm at rest be used for most patients. In all cases, the heart rate target may need modification based on patient symptoms and preferences. Patients with persistent or permanent AF or AFL who have exertional symptoms possibly due to excessive heart rates should have an assessment of rate response to exercise. Activity heart rate assessment can be achieved in a variety of ways, including recording heart rate after brisk hall walking or stair climbing, 24-hour ambulatory monitoring, or formal exercise testing. Correlation of symptoms and heart rate may also be achieved by patient-activated electrocardiogram (ECG) rhythm strips (“event recorders”). In all patients, it is reasonable to verify that symptoms are caused by rapid ventricular rates. Finally, it should be noted that rate control in paroxysmal AF is empirical, and heart rate targets are impractical for these briefer episodes of AF. O ED Table 1. Factors favouring rate versus rhythm control Rate Control of AF and AFL Rate control is an important part of therapy for all patients with AF or AFL. The primary goal of rate control is to improve symptoms and prevent deterioration of cardiac function associated with excessively rapid ventricular rates during AF or AFL. In addition, therapy for rate control should aim to improve exercise tolerance, QOL, and to avoid hospitalization. Tachycardia-induced cardiomyopathy refers to a condition characterized by reversible left ventricular systolic dysfunction occurring in patients with chronic rapid heart rates. This complication can occur in some patients with AF or AFL and very rapid ventricular rates (eg, ⬎120/min for most or all of the time) and is totally or partially reversible and preventable with adequate rate control.12 Heart rate targets In the past, adequate heart rate control had been empirically defined as ⱕ80 beats per minute (bpm) at rest.3-6,8,13,14 A recent study randomized patients to strict (ⱕ80 bpm at rest and ⱕ110 bpm during moderate exercise) or lenient (⬍110 bpm at rest) RECOMMENDATION We recommend that ventricular rate be assessed at rest in all patients with persistent and permanent AF or AFL (Strong Recommendation, Moderate-Quality Evidence). We recommend that heart rate during exercise be assessed in patients with persistent or permanent AF or AFL and associated exertional symptoms (Strong Recommendation, Moderate-Quality Evidence). We recommend that treatment for rate control of persistent or permanent AF or AFL should aim for a resting heart rate of ⬍100 bpm (Strong Recommendation, High-Quality Evidence). Values and preferences. These recommendations place a high value on the randomized clinical trials and other clinical studies demonstrating that ventricular rate control of AF is an effective treatment approach for many patients with AF. Heart rate control agents Beta-blockers, nondihydropyridine calcium channel blockers (diltiazem, verapamil), and digitalis are the primary drugs used for ventricular rate control during AF or AFL. The approach to selection of rate-control agents is shown in Figure 3. The doses, adverse effects, and practical tips about the different rate-control agents are summarized in Table 2. All these drugs act by slowing atrioventricular (AV) nodal conduction and prolonging AV nodal refractoriness. Many 50 Canadian Journal of Cardiology Volume 27 2011 Rate-control Drug Choices No Heart Disease Hypertension CAD Heart Failure β-blocker Dilazem Verapamil Combinaon Rx Digitalis† Di it li † β-blocker* Dilazem Verapamil β -blocker bl k ± digitalis *β-blockers preferred in CAD †Digitalis may be considered as monotherapy in sedentary individuals beta-adrenoceptor blockers or calcium channel blockers during exercise. Digitalis should thus be avoided as the sole agent in active patients.21,22 On its own, digoxin does not routinely control the heart rate and frequently has to be combined with another rate-slowing drug. Drug combinations are frequently effective when treatment with a single agent fails. Dronedarone is a newly released analogue of amiodarone with significant rate-controlling properties23 which may also be useful in selected patients. Amiodarone has significant rate-controlling properties in addition to its antiarrhythmic actions and may be used in refractory patients. However, because of the risk of toxicity associated with long-term use, it should be used only when other ratecontrol strategies are not feasible or are insufficient. RECOMMENDATION Figure 3. Selection of rate-control drug therapy is based on the presence or absence of underlying heart disease and other comorbidities. Combination therapy (Rx) may be required. CAD, coronary artery disease. EM BA R G small comparative drug trials have been performed but have not shown major advantages of one agent over another.13-19 In small, mostly blinded randomized trials, beta-adrenoceptor blockers led to lower heart rates at rest and exercise but no change or a decrease in exercise capacity.14 Calcium channel blockers were less effective at heart rate lowering on exercise but led to an increase or no change in exercise capacity. In one study, beta-adrenoceptor blockers added to digoxin did not result in improved QOL, whereas calcium blockers resulted in small improvements in physical and emotional function.20 Digitalis prolongs AV nodal refractoriness by enhancing vagal tone. During exercise, vagal tone is withdrawn, and therefore digitalis controls the heart rate less effectively than We recommend beta-blockers or nondihydropyridine calcium channel blockers as initial therapy for rate control of AF or AFL in most patients without a past history of myocardial infarction or left ventricular dysfunction (Strong Recommendation, Moderate-Quality Evidence). We suggest that digoxin not be used as initial therapy for active patients and be reserved for rate control in patients who are sedentary or who have left ventricular systolic dysfunction (Conditional Recommendation, Moderate-Quality Evidence). We suggest that digoxin be added to therapy with betablockers or calcium channel blockers in patients whose heart rate remains uncontrolled (Conditional Recommendation, Moderate-Quality Evidence). We suggest that dronedarone may be added for additional rate control in patients with uncontrolled ventricular rates despite therapy with beta-blockers, calcium channel blockers, or digoxin (Conditional Recommendation, Moderate-Quality Evidence). We suggest that amiodarone for rate control should be reserved for exceptional cases in which other means are not feasible or are insufficient (Conditional Recommendation, Low-Quality Evidence). O ED Dronedarone Table 2. Drugs for heart rate control Class Dose Adverse effects Beta-blockers Atenolol 50-150 mg orally daily Bradycardia, hypotension, fatigue, depression As per atenolol As per atenolol Bisoprolol Metoprolol Nadolol Propranolol* Calcium channel blockers Verapamil* Diltiazem* Digoxin 2.5-10 mg orally daily 25-200 mg orally twice a day 20-160 mg orally daily to twice a day 80-240 mg orally 3 times a day 120 mg orally daily to 240 mg orally twice a day 120-480 mg orally daily 0.125-0.25 mg orally daily Values and preferences. These recommendations recognize that selection of rate-control therapy needs to be individualized on the basis of the presence or absence of underlying structural heart disease, the activity level of the patient, and other individual considerations. As per atenolol As per atenolol Bradycardia, hypotension, constipation Bradycardia, hypotension, ankle swelling Bradycardia, nausea, vomiting, visual disturbances * Sustained release preparations are available and generally preferred to prolong the dose interval and improve patient convenience or compliance. Rate control in specific patient populations Beta-blockers are preferred as a rate-control agent in patients after myocardial infarction and in patients with congestive heart failure.24 Calcium channel blockers should be avoided in these populations but may be preferred in patients with chronic pulmonary disease and at risk of bronchoconstriction.14,19 Digitalis may be useful as monotherapy in sedentary patients and is often useful in combination with beta-blockers or calcium channel blockers. Practical tip. Carvedilol is a less-potent -adrenergic blocking agent compared to metoprolol. Carvedilol is less effective for rate control of AF compared to metoprolol.25 Gillis et al. Rate and Rhythm Management 51 We recommend beta-blockers as initial therapy for rate control of AF or AFL in patients with myocardial infarction or left ventricular systolic dysfunction (Strong Recommendation, High-Quality Evidence). Values and preferences. This recommendation places a high value on the results of multiple randomized clinical trials reporting the benefit of beta-blockers to improve survival and decrease the risk of recurrent myocardial infarction and prevent new-onset heart failure following myocardial infarction, as well as the adverse effects of calcium channel blockers in the setting of heart failure. RECOMMENDATION We recommend the optimal treatment of precipitating or reversible predisposing conditions of AF prior to attempts to restore or maintain sinus rhythm (Strong Recommendation, Low-Quality Evidence). We recommend a rhythm-control strategy for patients with AF or AFL who remain symptomatic with rate-control therapy or in whom rate-control therapy is unlikely to control symptoms (Strong Recommendation, Moderate-Quality Evidence). We recommend that the goal of rhythm-control therapy should be improvement in patient symptoms and clinical outcomes, and not necessarily the elimination of all AF (Strong Recommendation, Moderate-Quality Evidence). EM BA R G Nonpharmacologic Treatment Some patients may require the implantation of a permanent pacemaker to manage drug-exacerbated symptomatic bradycardia, particularly in patients with paroxysmal AF and sinus node disease associated with symptomatic sinus pauses, and thus safely allow adequate pharmacologic control of rapid ventricular rates. Isolated nocturnal pauses are often observed in asymptomatic patients with persistent or permanent AF and do not constitute an indication for pacing. AV junction ablation requiring the implantation of a permanent pacemaker should be considered in patients with refractory symptoms associated with excessive heart rates despite adequate trials of rate-control drugs, including combination drug therapy. This procedure results in adequate rate control in virtually all patients and has been associated with improvements in clinical symptoms, exercise tolerance, QOL, and ventricular function.26 Biventricular pacing should be considered after AV junction ablation in patients with left ventricular systolic dysfunction.27 In selected patients, control of AF by left atrial or pulmonary vein catheter ablation to restore sinus rhythm can be considered as an alternative to AV nodal ablation requiring permanent pacing.9,11 Practical tip. As an alternative to AV junction ablation, an attempt at restoration of sinus rhythm via electrical or pharmacologic cardioversion may be warranted to control heart rate in cases in which this can be achieved, such as in the setting of persistent AF or AFL. shown to decrease mortality or reduce the incidence of thromboembolic complications in AF patients compared to rate control alone.3-7 Thus, the decision to pursue sinus rhythm maintenance should be directed to patients who remain symptomatic with AF or AFL despite adequate rate control (Table 1). Symptoms may include palpitations, fatigue, exercise intolerance, or symptoms of heart failure. In these patients, restoration and maintenance of sinus rhythm can alleviate these symptoms and improve QOL. Improvement in patient QOL and function, and not the total elimination of AF, should always be the focus of rhythm control. The benefits of any antiarrhythmic drug therapy must also be balanced against the side effects and toxicities of such therapy. If drug therapy fails to achieve a meaningful improvement in patient QOL, then alternatives to the strategy of pharmacologic rhythm control should be considered, including catheter ablation of AF or rate control alone. Practical tip. When pursuing a rhythm-control strategy for AF, there needs to be a reasonable expectation of maintenance of sinus rhythm. O ED RECOMMENDATION Values and preferences. These recommendations place a high value on the decision of individual patients to balance relief of symptoms and improvement in QOL and other clinical outcomes with the potentially greater adverse effects of the addition of class I or class III antiarrhythmic drugs to rate-control therapy. RECOMMENDATION We recommend AV junction ablation and implantation of a permanent pacemaker in symptomatic patients with uncontrolled ventricular rates during AF despite maximally tolerated combination pharmacologic therapy (Strong Recommendation, Moderate-Quality Evidence). Values and preferences. This recommendation places a high value on the results of many small randomized trials and one systematic review reporting significant improvements in QOL and functional capacity as well as a decrease in hospitalizations for AF following AV junction ablation in highly symptomatic patients. Rhythm Control of AF and AFL It is important to emphasize that compared with rate control alone, the strategy of maintaining sinus rhythm has never been Mechanism of action of antiarrhythmic drugs The mechanisms underlying AF are complex, likely differing among patients and even within individual patients as a function of the evolution of their cardiac condition.28 It has been hypothesized that AF is initiated by arrhythmogenic foci, often originating in the pulmonary veins.29 However, AF is maintained by multiple small reentrant wavelets, sometimes described as “rotors.”30 Formation and persistence of these wavelets is favoured by a shortened atrial refractory period and action potential duration, which occur during AF.31 The primary action of many antiarrhythmic medications is to lengthen refractory periods by prolonging action potential duration, to inhibit the formation of wavelets responsible for AF maintenance,32 or to reduce the phase-0 sodium current to destabilize AF-maintaining rotors.33-35 52 Canadian Journal of Cardiology Volume 27 2011 Table 3. Antiarrhythmic drugs for rhythm control I Dosage Efficacy at 1 Year Toxicity Comments Flecainide 50-150 mg twice/d 30%-50% Propafenone 150-300 mg 3 times/d 30%-50% Contraindicated in patients with CAD or LV dysfunction Should be combined with an AV nodal blocking agent Contraindicated in patients with CAD or LV dysfunction Should be combined with an AV nodal blocking agent Amiodarone 100-200 mg OD (after 10 g loading) 60%-70% Dronedarone 400 mg twice/d 40% Ventricular tachycardia Bradycardia Rapid ventricular response to AF or atrial flutter (1:1 conduction) Ventricular tachycardia Bradycardia Rapid ventricular response to AF or atrial flutter (1:1 conduction) Abnormal taste Photosensitivity Bradycardia GI upset Thyroid dysfunction Hepatic toxicity Neuropathy, tremor Pulmonary toxicity Torsades de pointes (rare) GI upset Bradycardia Sotalol 40-160 mg twice/d 30%-50% Torsades de pointes Bradycardia Beta-blocker side effects R G III Drug Low risk of proarrhythmia in a wide range of populations Limited by systemic side effects Most side effects are dose and duration related Very effective for rate control Only antiarrhythmic shown to reduce hospitalizations and cardiovascular mortality in ATHENA trial May increase mortality in patients with recently decompensated heart failure, EF ⬍35% (ANDROMEDA trial) Effective rate-control agent New drug – limited experience outside trials Should be avoided in patients at high risk of torsades de pointes VT - especially women aged ⬎65 y taking diuretics or those with renal insufficiency QT interval should be monitored 1 wk after starting Use cautiously when EF ⬍40% Heart rhythm specialists may use with lower EFs if patient has ICD O ED Class BA ANDROMEDA, Antiarrhythmic Trial With Dronedarone in Moderate to Severe Congestive Heart Failure Evaluating Morbidity Decrease; ATHENA, A Placebo-Controlled Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 Mg Bid for the Prevention of Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Flutter; AV, atrioventricular; CAD, coronary artery disease; EF, ejection fraction; ICD, implantable cardioverter defibrillator; LV, left ventricular; VT, ventricular tachycardia. EM Class I drugs, such as flecainide and propafenone, block sodium channels.35 This slows atrial conduction, lengthens atrial refractoriness, and suppresses automaticity.36 By destabilizing AF-maintaining rotors, this class of drugs can prevent the persistence of AF.33-35 Class III drugs such as sotalol or dofetilide block potassium channels and thus prolong action potential duration.37 With sufficient action potential prolongation, class III drugs prevent AF recurrence. Drugs such as amiodarone and dronedarone have multiple effects, including both class I and class III mechanisms of action.38 Both drugs also have noncompetitive beta-blocking and calcium channel blocking effects. Thus, both not only are capable of maintaining sinus rhythm but can be effective ratecontrol agents as well.23,39 Antiarrhythmic drug therapy to maintain sinus rhythm In the absence of an antiarrhythmic drug, the recurrence rate of AF is about 75% over 1 year.8 Thus, recurrences are very likely once the AF process starts. If a decision is made to pursue a longterm strategy of rhythm control, patients will often require maintenance oral antiarrhythmic drug therapy. While antiarrhythmic drugs will not completely eliminate AF, they can substantially reduce AF burden and improve QOL. Reduction of AF burden by itself without demonstration of alleviated symptoms or reduced morbidity is insufficient to recommend the routine use of class I or class III antiarrhythmic drugs. Ideally, such therapy should also reduce other, more quantitative outcomes such as hospitalization or even mortality, but to date, only limited data exist to support the notion that rhythm-control therapy can accomplish such goals.39-41 The dosages, efficacy, side effects, and some practical tips about the various antiarrhythmic drugs are summarized in Table 3. The choice of drugs to use depends on an individual patient’s profile and the presence or absence of underlying structural heart disease, as summarized in Figures 4 and 5. Of all the currently available antiarrhythmic drugs, amiodarone has been demonstrated to have the highest efficacy in reducing AF burden.42,43 Unfortunately, it also has numerous important noncardiac side effects, which prevent it from being used as an agent of first choice.44 Other antiarrhythmic drugs are less efficacious but have fewer side effects compared with amiodarone.42 These drugs still carry some risk however, particularly in patients with underlying heart disease.45 Thus, the choice of which antiarrhythmic agent to use long-term should be guided by evidence-based outcomes (where available) and the safety and efficacy profile of each agent in the context of the specific clinical profile of the patient (see Table 3 and Figs. 4 and 5). In patients with normal ventricular function, the firstchoice antiarrhythmic drug can be either dronedarone, flecai- Gillis et al. Rate and Rhythm Management 53 Dronedarone Flecainide* Propafenone* Propafenone Sotalol Catheter Ablation Amiodarone * Class I agents should be AVOIDED in CAD They should be combined with AV-nodal blocking agents Figure 4. Antiarrhythmic drug choices for prevention of atrial fibrillation in patients without structural heart disease. Antiarrhythmic drugs are presented in alphabetical order. Given the side effect profile of amiodarone, its use is generally reserved for occasions when other drug choices have been demonstrated to be ineffective, contraindicated, or not well-tolerated. CAD, coronary artery disease; AV, atrioventricular. EM BA R G nide, propafenone, or sotalol. These drugs are less effective (with respect to reducing the number and duration of recurrences) than amiodarone42,43 but also have fewer side effects. Flecainide, propafenone, sotalol, and dronedarone likely have similar efficacy in maintaining sinus rhythm, based on their efficacies.39,42,43,46-48 However, direct comparisons of these drugs for suppression of AF have not been made. Propafenone and flecainide must be combined with an AV nodal blocking agent in order to avoid paradoxically increasing the ventricular rate during AF or AFL (see below).45 Furthermore, a specific effort (eg, stress test) should be made to exclude ischemic heart disease in those ⬎50 years of age or anyone with symptoms suggestive of ischemic heart disease, or Framingham high-risk patients when propafenone and flecainide drugs are to be used. Sotalol carries a higher risk of torsades de pointes, particularly in women or those with renal insufficiency.48-50 Dronedarone has a structure similar to amiodarone, although dronedarone is known to be less effective in maintaining sinus rhythm.51,52 Dronedarone is generally well-tolerated, with a relatively low incidence of side effects or proarrhythmia. In the ATHENA (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 Mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/ Flutter) trial, dronedarone was shown to reduce hospitalization and cardiovascular mortality in AF patients.39 The panel chose not to make a specific recommendation that dronedarone should be the first antiarrhythmic drug considered for prevention of AF since dronedarone’s efficacy for maintenance of sinus rhythm is comparable to other modestly effective rhythm-control agents (flecainide, propafenone, and sotalol). Also, dronedarone has been shown to be harmful in patients with decompensated heart failure (see below).53 It is possible that the rate-control effects of dronedarone contributed to the reduction in hospitalizations for AF reported in ATHENA. In patients with abnormal ventricular function but left ventricular ejection fraction ⬎35%, dronedarone, sotalol, and amiodarone are all reasonable choices (Fig. 5). However, in patients with left ventricular ejection fraction ⬍35%, amiodarone, is the only drug usually recommended because of its low risk of proarrhythmia in heart failure.4,54 Sotalol or dronedarone could be considered for treatment of AF in dronedarone patients with a left ventricular ejection fraction ⬍35% and in the absence of symptoms of severe heart failure, particularly if they have an implantable cardioverter defibrillator. There is an increased risk of proarrhythmia in heart failure patients taking sotalol,45 likely because of downregulation of potassium currents and loss of repolarization reserve with heart failure.55 However, sotalol is used selectively by heart rhythm specialists in patients protected by an implantable defibrillator. The ANDROMEDA (Antiarrhythmic Trial With Dronedarone in Moderate to Severe Congestive Heart Failure Evaluating Morbidity Decrease) trial found that dronedarone may increase the risk of mortality in recently decompensated heart failure patients in recently decompensated individuals (New York Heart Association classes III and IV) who were hospitalized.53 Although the American College of Cardiology, American Heart Association, and European Society of Cardiology 2006 AF guidelines do not recommend the use of propafenone, flecainide, or sotalol in the setting of hypertension and documented left ventricular hypertrophy,8 the writing group felt that the scientific data supporting this recommendation is weak. Certainly, concern about the use of these drugs due to increased risk of proarrhythmia is warranted if abnormalities of repolarization are noted in the ECG. However, in this setting the choice of antiarrhythmic drug should be individualized on the basis of the patient profile and consideration of the risks and benefits of each drug.8 O ED Antiarrhythmic Drug Choices N l Ventricular V t i l Function F ti Normal Antiarrhythmic Drug Choices Abnormal Left Ventricular Function EF > 35% EF ≤ 35% Amiodarone Dronedarone Sotalol* Amiodarone Catheter Ablation * Sotalol should be used with caution with EF 35-40% Contraindicated in women >65 yrs taking diuretics Figure 5. Antiarrhythmic drug choices for prevention of AF in patients with depressed left ventricular systolic function. Dronedarone is contraindicated in patients with acutely decompensated heart failure. Sotalol may be used with caution in selected patients with mild to moderate reduction in left ventricular ejection fraction. EF, ejection fraction. 54 Canadian Journal of Cardiology Volume 27 2011 RECOMMENDATION R G We recommend use of maintenance oral antiarrhythmic therapy as first-line therapy for patients with recurrent AF in whom long-term rhythm control is desired (see Figs. 4 and 5) (Strong Recommendation, Moderate-Quality Evidence). We recommend that oral antiarrhythmic drug therapy should be avoided in patients with AF or AFL and advanced sinus or AV nodal disease unless the patient has a pacemaker or implantable defibrillator (Strong Recommendation, Low-Quality Evidence). We recommend that an AV blocking agent should be used in patients with AF or AFL being treated with a class I antiarrhythmic drug (eg, propafenone or flecainide) in the absence of advanced AV node disease (Strong Recommendation, Low-Quality Evidence). therefore cause an increased ventricular response due to a reduction in the number of concealed activations in the AV node. In the most extreme cases with very slow organized atrial activation, conversion of AF to AFL and subsequent 1:1 conduction of AFL can ensue, causing a very high ventricular rate and risk of ventricular tachyarrhythmia. Practical tip. Class I agents should be combined with an AV nodal blocking agent (beta-blocker, verapamil, diltiazem, or digoxin) to avoid this risk. Certain class III agents, such as sotalol, lengthen the QT interval and carry a risk of torsades de pointes polymorphic ventricular tachycardia (VT) (1%-3%). Any additional risk factor that prolongs the QT interval increases the likelihood of torsades de pointes VT. This includes female sex, left ventricular dysfunction, significant left ventricular hypertrophy, bradycardia, or hypokalemia or hypomagnesemia (often resulting from diuretic use). By reducing net repolarizing current,45,55,58 these factors can individually or collectively reduce “repolarization reserve” and increase the risk of drug-induced torsades de pointes. Advanced age reduces the efficiency of drug-eliminating systems (renal function, biotransforming capacity), as well as the volume of distribution for many drugs, and is therefore also a risk factor for druginduced torsades de pointes. Since sotalol is cleared via the kidneys, any renal dysfunction also increases the proarrhythmic risk. Periodic ECG monitoring of the QT interval should be performed and the drug should be reassessed if the QT is longer than 500 ms or the QTc exceeds 480 ms. Other drugs that increase the QT interval (erythromycin, clarithromycin, antipsychotics) should be avoided by a patient while on sotalol (a full list is available at www.torsades.org). Amiodarone and dronedarone both carry a low risk of proarrhythmia because of their multiple class effects. Dronedarone is generally safe and well-tolerated. In patients with decompensated heart failure, however, it has been shown to increase mortality (Table 3).53 Amiodarone rarely causes torsades de pointes VT, but has numerous noncardiac toxicities.44 Patients should avoid direct sun exposure to avoid photosensitivity. A clinical exam, with careful history to elicit symptoms of toxicity (eg, sleep disturbance, tremor, gait instability, constipation), and pulmonary assessment should be performed periodically to check for toxicity. Hepatic enzymes and thyrotropin should be measured every 6 months in all patients on amiodarone, regardless of symptoms. Bradycardia can be exacerbated by any antiarrhythmic agent, whether because of sinus node or AV node dysfunction. If bradycardia results in symptoms, the drug should be discontinued, or consideration should be given to implantation of a permanent pacemaker. Generally, class I or class III antiarrhythmic drugs may be initiated as an outpatient, in spite of the risk of proarrhythmia. Particularly in patients with no underlying heart disease, the risk of proarrhythmia is quite low. If a conduction disturbance (such as sinus or AV node dysfunction) is present or if a patient has risk factors for torsades de pointes VT or significant underlying heart disease, then consideration should be given to drug initiation in hospital. Amiodarone is the only medication that has been shown to be safe when initiated as an outpatient in patients with heart failure and left ventricular dysfunction.4,5 O ED As previously discussed, the goal of antiarrhythmic drug therapy should be reduction (not necessarily elimination) of AF burden with concomitant improvement in QOL. If a patient has occasional breakthroughs of AF, but few symptoms, therapy may be considered successful. Antiarrhythmic drug therapy should be reassessed periodically based on both efficacy and side effects. If patients fail to respond to or cannot tolerate a particular drug, an alternative drug may be tried after an appropriate washout period. If a patient fails multiple medications, then alternatives to consider include catheter ablation of AF to maintain sinus rhythm (SR) or abandonment of rhythm control in favour of rate control alone (Fig. 1). EM BA Values and preferences. These recommendations place a high value on the decision of individual patients to balance relief of symptoms and improvement in QOL and other clinical outcomes with the potentially greater adverse effects of class I and class III antiarrhythmic drugs compared with rate-control therapy. Risks of antiarrhythmic drug therapy Risks of the various antiarrhythmic drugs are listed in Table 3. All antiarrhythmic drugs carry the potential of proarrhythmia, so that treatment of AF or AFL may increase the risk of other, more malignant arrhythmias (often ventricular in origin).45 The class I agents (flecainide and propafenone) can increase the risk of ventricular arrhythmias in patients with coronary artery disease or left ventricular dysfunction, so these agents should be avoided in these populations.56,57 Class I agents slow the atrial rate in AF by slowing conduction in reentrant rotors or wavelets. The ventricular response to AF is determined by complex interactions between the rate and pattern of activation of the proximal AV node from the atrium on one hand and the refractory properties of the AV node on the other. Because of the decremental conduction properties of AV nodal tissue (involving Ca2⫹-current– dependent action potentials and zones of poor cell-to-cell coupling), atrial impulses that fail to conduct through the AV node leave the node partially refractory to the next impulse, a phenomenon called concealed conduction. Paradoxically, a slowing in atrial rate can Gillis et al. Rate and Rhythm Management 55 Pretreatment with antiarrhythmic drugs for 1 to 4 weeks prior to cardioversion can improve the acute efficacy of cardioversion and reduce the chance of early recurrence of AF postcardioversion, particularly in patients with prior recurrence postcardioversion.60-62 Cardioversion may need to be repeated if antiarrhythmic drug therapy is changed because of recurrent persistent AF. Even when a patient is doing well on maintenance antiarrhythmic therapy, occasional recurrences of persistent AF can occur and may require a change in the antiarrhythmic drug regimen. In such patients, intermittent cardioversion to restore sinus rhythm may be an integral part of the long-term rhythm-control strategy. RECOMMENDATION O ED We recommend electrical or pharmacologic cardioversion for restoration of sinus rhythm in patients with AF or AFL who are selected for rhythm-control therapy and are unlikely to convert spontaneously (Strong Recommendation, Low-Quality Evidence). We recommend pretreatment with antiarrhythmic drugs prior to electrical cardioversion in patients who have had AF recurrence postcardioversion without antiarrhythmic drug pretreatment (Strong Recommendation, Moderate-Quality Evidence). Values and preferences. These recommendations place a high value on the decision of individual patients to pursue a rhythm-control strategy for improvement in QOL and functional capacity. RECOMMENDATION BA R G Intermittent Antiarrhythmic Drug Therapy (“Pill in the Pocket”) Some patients with symptomatic AF have relatively long-lasting episodes (eg, ⬎4 hours) but with long intercurrent periods of sinus rhythm between episodes (eg, ⬍2-6/y). In these patients, a strategy of daily maintenance antiarrhythmic drug therapy may be unnecessary. An alternative possibility is to prescribe oral antiarrhythmic drugs that can be taken at the time of an episode for acute termination of AF. Clinical trial data have shown this “pill in the pocket” strategy to be both safe and effective.59 The drugs most commonly used for this purpose are class I agents given as a single dose at the onset of AF. Flecainide is given as a single or cumulative 200 to 300-mg dose, and propafenone is given as a single 450 to 600-mg dose. Both these agents have a 50% to 80% efficacy in acutely terminating AF. Some physicians also prescribe a rapidly acting beta-blocker (eg, metoprolol 50 to 100 mg), to be taken at the same time as the class I antiarrhythmic agent in order to minimize the risk of accelerating the ventricular response. In patients taking daily medication, an additional dose of the drug can be used in this manner. Practical tip. Because of the risk of 1:1 AV conduction of AFL or the risk of bradycardia, an initial trial of this strategy may be performed in a monitored setting to verify safety and efficacy of this approach in a given patient. Combination with a rapidly acting betablocker or calcium blocker is recommended (for patients not already on AV nodal blocking medication or known significant AV nodal dysfunction), particularly in patients in whom this approach has been verified in a monitored setting or in patients with little risk of bradycardia or hypotension associated with this therapy. Patients should ensure their drugs have not expired if the time between episodes is very long. EM We recommend intermittent antiarrhythmic drug therapy (“pill in the pocket”) in symptomatic patients with infrequent, longer-lasting episodes of AF or AFL as an alternative to daily antiarrhythmic therapy (Strong Recommendation, Moderate-Quality Evidence). Values and preferences. This recommendation places a high value on the results of clinical studies demonstrating the efficacy and safety of intermittent antiarrhythmic drug therapy in selected patients. Cardioversion as part of the rhythm-control strategy Maintenance antiarrhythmic drug therapy can be very effective at preventing AF recurrences. However, these drugs, given at maintenance doses, are unlikely to convert patients to sinus rhythm if AF is already present. Longer durations of AF (⬎48 hours) are particularly less likely to convert to sinus rhythm in response to antiarrhythmic drugs. Thus, patients in AF for whom rhythm control is desired should be considered for electrical cardioversion prior to initiation of maintenance antiarrhythmic therapy. Pharmacologic cardioversion is much less effective than electrical cardioversion. If the patient has never had an attempt at restoration of sinus rhythm, it may be appropriate to observe the patient postcardioversion without antiarrhythmic therapy. Drug conversion of AF Acute restoration of sinus rhythm from recent onset AF is most commonly performed using electrical cardioversion. Drug conversion may, however, be an effective alternative. While less effective than the electrical method, pharmacologic conversion avoids the need for general anaesthesia and may reduce the risk of early recurrence of AF. Oral antiarrhythmic agents such as flecainide and propafenone may be given as single doses (see discussion of “pill in the pocket,” above).59 Ibutilide is an intravenous class III medication that is typically given as a single dose of 1 mg, which may be repeated once. It is superior to intravenous procainamide, but its use is limited by a 2% to 3% risk of torsades de pointes VT.63,64 Ibutilide is more effective for AFL than for AF. The risk of torsades de pointes VT associated with ibutilide can be reduced by pretreatment with 1 to 2 g magnesium sulphate administered intravenously.65 Intravenous procainamide can also be used as a single dose of 15 to 17 mg/kg over 20 to 30 minutes but is associated with a 5% risk of hypotension and is less effective than ibutilide.63,64 Intravenous and oral amiodarone are not effective for acute conversion (conversion in ⬍6-8 hours) of AF and therefore should not be used routinely for this purpose.66,67 Need for anticoagulation When considering either electrical or pharmacologic cardioversion of AF, patients should be adequately anticoagulated to prevent postconversion thromboembolic complications.2,8,68 The risk of thromboembolism is the same whether conversion is achieved electrically or with drugs.2-8 Although oral antiarrhythmic drug therapy given in maintenance doses is less likely to acutely convert AF to sinus rhythm, 56 Canadian Journal of Cardiology Volume 27 2011 Table 4. Randomized trials of pacing modes and impact on AF occurrence Number Age (y) Pacing indication Follow-up (y) Pacing modes AF occurrence (%/y) Risk reduction (%) P value Danish80 AAI vs VVI CTOPP81 Extended82 CTOPP MOST83 Danish87 AAI vs DDD 225 71 ⫾ 17 SND 5.5 AAI vs VVI 4.1 vs 6.6 46 .012 2568 73 ⫾ 10 All pacemaker patients 3.1 AAI/R or DDD/R vs VVI/R 5.3 vs 6.3 18 .05 2568 73 ⫾ 10 All pacemaker patients 6.4 AAI/R or DDD/R vs VVI/R 4.5 vs 5.7 20 .009 2050 74 (67-80) SND 2.7 DDDR vs VVIR 7.9 vs 10.0 21 .008 177 74 ⫾ 9 SND 2.9 AAI vs DDDR-s vs DDDR-l 2.4 vs 8.3 vs 6.2 73 .02 AF, atrial fibrillation; AAI, atrial pacing; AAAIR, atrial rate adaptive pacing; CTOPP, Canadian Trial of Physiologic Pacing; DDDR, dual chamber rate adaptive pacing; DDDR-l, long atrioventricular delay; DDDR-s, short atrioventricular delay; SND, sinus node disease; VVI, ventricular pacing; VVIR, ventricular rate adaptive pacing. O ED trophysiologic parameters important for AF which might provide novel therapeutic targets for therapy of AF.9,70,71 Candidates for upstream therapy include statins (3 hydroxy-3-methyl-glutaryl-CoA reductase inhibitors), drugs that suppress the renin-angiotensin-aldosterone system, and omega-3 fatty acids. Statins may prevent adverse atrial electrical remodelling associated with AF by anti-inflammatory antioxidant, anti-proliferatory, or antiapoptotic effects.70-74 Blockers of the renin angiotensin system may prevent myocyte hypertrophy, apoptosis, and intercellular fibrosis, as well as exerting indirect effects on atrial myocyte electrophysiology.70,75 Clinical studies have reported that statin therapy may prevent AF, particularly in patients following cardiac surgery.76 However, a consistent benefit has not been observed in all patient groups evaluated.77 Drugs which inhibit the renin angiotensin system have been reported to be effective for primary and secondary prevention of AF, with the greatest benefit observed in patients with left ventricular hypertrophy and/or heart failure.78 However, valsartan did not prevent AF recurrence in the largest randomized prospective trial to date, testing the hypothesis that angiotensin receptor blockade might be an effective therapy for AF.79 At present, studies are underway evaluating the role of omega-3 fatty acids for prevention of AF.71,73,74 The evidence to date, however theoretically appealing, does not support specific recommendations directed at upstream molecular targets as part of the management strategy for AF. BA R G one should consider appropriate anticoagulation prior to starting any antiarrhythmic drug therapy in patients who are in persistent AF. This applies even to patients who have low risk of stroke and may not require long-term systemic anticoagulation.2,68 Although the objective of the rhythm-control strategy is to reduce the burden of AF, there is no evidence that AF reduction reduces the risk of stroke or systemic embolism.68 Many patients may have ongoing episodes of asymptomatic AF despite elimination of symptomatic episodes.69 In the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial, the risk of stroke was the same in both groups for most of the trial, but in the fifth year, a nonsignificant trend toward increased risk of stroke was observed in patients assigned to rhythm control. In both arms of the AFFIRM trial, many of the strokes occurred after anticoagulation was stopped or when the international normalized ratio was subtherapeutic, which happened more often in the rhythm-control arm because of inappropriate withdrawal of oral anticoagulation with restoration of sinus rhythm, one of the presumed advantages of rhythm control in that era.68 Thus, patients should continue on appropriate anticoagulation or antiplatelet therapy or a combination, according to their individual embolic risk as determined by the CHADS2 score.2 Nonpharmacologic therapy for rhythm control EM If antiarrhythmic drug therapy is ineffective at reducing symptoms or not well-tolerated, consideration of AF ablation may be desirable.11 If AF ablation is a serious option, the patient should be referred to an arrhythmia expert for further discussion. RECOMMENDATION We recommend radiofrequency ablation of AF in patients who remain symptomatic following adequate trials of antiarrhythmic drug therapy and in whom a rhythm-control strategy remains desired (Strong Recommendation, Moderate-Quality Evidence). Values and preferences. This recommendation places a high value on the decision of individual patients to balance relief of symptoms and improvement in QOL with the small but measurable risk of serious complication with catheter ablation. Novel therapeutic targets Experimental research into the substrates that initiate and maintain AF have identified some molecular targets upstream of the elec- Prevention of AF in the pacemaker population A number of prospective, randomized clinical trials have reported that atrial- or dual-chamber pacing reduces the risk of paroxysmal and permanent AF in patients with symptomatic bradycardia as the primary indication for cardiac pacing.80-84 The data from these trials are summarized in Table 4. In contrast, the United Kingdom Pacing and Cardiovascular Events Trial Investigators did not observe a benefit of dual-chamber pacing over ventricular for prevention of AF in patients with AV block as the indication for pacing.85 Thus, these data suggest that the primary benefit of dual-chamber pacing for reducing the risk of AF is observed in patients with sinus node disease and intact AV node conduction. The Mode Selection Trial Investigators reported that patients who were more frequently paced in the ventricle were more likely to develop AF.86 The risk of developing AF increased approximately 1% for each 1% increase in ventricular pacing. Nielsen et al87 also reported that patients with sick sinus syndrome randomized to atrial rate adaptive pacing pacing were less likely to develop AF during follow-up (7.4%) compared with patients randomized to dual-chamber rate adaptive pacing with a short (ⱕ150 ms) or long (300 ms) AV intervals (23.3% and 17.5%, respectively). There are no data to Gillis et al. Rate and Rhythm Management 57 RECOMMENDATION We suggest that patients requiring pacing for the treatment of symptomatic bradycardia secondary to sinus node dysfunction, atrial or dual-chamber pacing be generally used for the prevention of AF (Conditional Recommendation, High-Quality Evidence). We suggest that, in patients with intact AV conduction, pacemakers be programmed to minimize ventricular pacing for prevention of AF (Conditional Recommendation, Moderate-Quality Evidence). Values and preferences. These recommendations recognize a potential benefit of atrial or dual-chamber pacing programmed to minimize ventricular pacing to reduce the probability of AF development following pacemaker implantation. 5. Van Gelder IC, Hagens VE, Bosker HA, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 2002;347:1834-40. 6. Testa L, Biondi-Zoccai GG, Dello Russo A, et al. Rate-control vs. rhythmcontrol in patients with atrial fibrillation: a meta-analysis. Eur Heart J 2005;26:2000-6. 7. Ogawa S, Yamashita T, Yamazaki T, et al. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM study. Circ J 2009;73:242-8. 8. Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006;114:e257-354. 9. Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010;31:2369429. O ED suggest that atrial overdrive pacing substantially reduces AF.88 Recently, algorithms designed to minimize ventricular pacing have been shown to reduce the risk of persistent AF following pacemaker implantation in patients with sinus node disease.89 10. Wyse DG, Simpson CS. Rate control versus rhythm control— decision making. Can J Cardiol 2005;21(suppl B):15B-18B. 11. Verma A, Macle L, Cox JL, Skanes AC, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: catheter ablation for atrial fibrillation/atrial flutter. Can J Cardiol 2011;27:60-6. EM BA R G Management of AF: Chronic Disease Management Principles Chronic disease management principles dictate that the primary care physician is central to coordination of patient care. Ideally, support for the primary care physician should facilitate delivery of care, with specialty clinics providing care to more complex cases and tertiary care specialists reserved for the most challenging cases. To facilitate management of AF patients, specialty clinics have been formed in some regions, and others are in planning stages.90 Participation of the referring physicians is essential to the success of AF clinics, in which nurse clinicians or nurse practitioners play a key role in patient education and reassurance about both AF and the treatment plan. Direct contact with an AF physician specialist may not be required in all cases. In some instances, recommendations about urgent intervention to control the ventricular rate and initiate anticoagulation to prevent stroke are provided by the AF physician specialist, with reassessment at a later date. 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New ideas about atrial fibrillation 50 years on. Nature 2002;415: 219-26. 29. Haïssaguerre M, Jaïs P, Shah DC, et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med 1998;339:659-66. 41. Corley SD, Epstein AE, DiMarco JP, et al. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation 2004; 109:1509-13. 42. Roy D, Talajic M, Dorian P, et al; Canadian Trial of Atrial Fibrillation Investigators. Amiodarone to prevent recurrence of atrial fibrillation. N Engl J Med 2000;342:913-20. 43. Singh BN, Singh SN, Reda DJ, et al; Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) Investigators. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med 2005;352:1861-72. 44. Doyle JF, Ho KM. Benefits and risks of long-term amiodarone therapy for persistent atrial fibrillation: a meta-analysis. Mayo Clin Proc 2009;84: 234-42. 45. Roden, DM. Mechanisms and management of proarrhythmia. Am J Cardiol 1998;82:491-571. 46. UK Propafenone PSVT Study Group. A randomized, placebo-controlled trial of propafenone in the prophylaxis of paroxysmal supraventricular tachycardia and paroxysmal atrial fibrillation. Circulation 1995;92:2550-7. 47. Naccarelli GV, Dorian P, Hohnloser SH, Coumel P; Flecainide Multicenter Atrial Fibrillation Study Group. Prospective comparison of flecainide versus quinidine for the treatment of paroxysmal atrial fibrillation/ flutter. Am J Cardiol 1996;77:53A-59A. R G 30. Jalife J, Berenfeld O, Mansour M. Mother rotors and fibrillatory conduction: a mechanism of atrial fibrillation. Cardiovasc Res 2002;54:204-16. 40. Connolly SJ, Crijns HJ, Torp-Pedersen C, et al. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter. Circulation 2009;120:1174-80. O ED 23. Davy JM, Herold M, Hoglund C, et al. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J 2008;156:527e1-e9. 31. Allessie M, Ausma J, Schotten U. Electrical, contractile and structural remodelling during atrial fibrillation. Cardiovasc Res 2002;54:230-46. BA 32. Wang J, Bourne GW, Wang Z, et al. Comparative mechanisms of antiarrhythmic drug action in experimental atrial fibrillation: importance of use-dependent effects on refractoriness. Circulation 1993;88: 1030-44. EM 33. Comtois P, Kneller J, Nattel S. Of circles and spirals: bridging the gap between the leading circle and spiral wave concepts of cardiac reentry. Europace 2005;7(suppl 2):10-20. 34. Kneller J, Kalifa J, Zou R, et al. Mechanisms of atrial fibrillation termination by pure sodium channel blockade in an ionically-realistic mathematical model. Circ Res 2005;96:e35-47. 35. Kawase A, Ikeda T, Nakazawa K, et al. Widening of the excitable gap and enlargement of the core of reentry during atrial fibrillation with a pure sodium channel blocker in canine atria. Circulation 2003;107: 905-10. 36. Danse PW, Garratt CJ, Allessie MA. Flecainide widens the excitable gap at pivot points of premature turning wavefronts in rabbit ventricular myocardium. J Cardiovasc Electrophysiol 2001;12:1010-7. 37. Derakhchan K, Villemaire C, Talajic M, Nattel S. The class III antiarrhythmic drugs dofetilide and sotalol prevent AF induction by atrial premature complexes at doses that fail to terminate AF. Cardiovasc Res 2001; 50:75-84. 48. Benditt DG, Williams JH, Jin J, et al; d,l-Sotalol Atrial Fibrillation/Flutter Study Group. Maintenance of sinus rhythm with oral d,l-sotalol therapy in patients with symptomatic atrial fibrillation and/or atrial flutter. Am J Cardiol 1999;84:270-7. 49. Lehmann MH, Hardy S, Archibald D, Quart B, MacNeil DJ. Sex difference in risk of torsade de pointes with d,l-sotalol. Circulation 1996;94: 2535-41. 50. Wanless RS, Anderson K, Joy M, Joseph SP. Multicenter comparative study of the efficacy and safety of sotalol in the prophylactic treatment of patients with paroxysmal supraventricular tachyarrhythmias. Am Heart J 1997;133:441-6. 51. Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007;357:98799. 52. Heuzey JY, Ferrari GM, Radzik D, et al. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol 2010;21:597-605. 53. Køber L, Torp-Pedersen C, McMurray JJ, et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 2008;358: 2678-87. 38. Shinagawa K, Shiroshita-Takeshita A, Schram G, Nattel S. Effects of antiarrhythmic drugs on fibrillation in the remodeled atrium: insights into the mechanism of the superior efficacy of amiodarone. Circulation 2003; 107:1440-6. 54. Deedwania PC, Singh BN, Ellenbogen K, et al; Department of Veterans Affairs CHF-STAT Investigators. Spontaneous conversion and maintenance of sinus rhythm by amiodarone in patients with heart failure and atrial fibrillation: observations from the veterans affairs congestive heart failure survival trial of antiarrhythmic therapy (CHF-STAT). Circulation 1998;98:2574-9. 39. Hohnloser SH, Crijns HJ, van Eickels M, et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009;360:66878. 55. Nattel S, Maguy A, Le Bouter S, Yeh YH. Arrhythmogenic ion-channel remodeling in the heart: heart failure, myocardial infarction, and atrial fibrillation. Physiol Rev 2007;87:425-56. Gillis et al. Rate and Rhythm Management 59 57. Boriani G, Biffi M, Capucci A, et al. Oral propafenone to convert recentonset atrial fibrillation in patients with and without underlying heart disease: a randomized, controlled trial. Ann Intern Med 1997;126:621-5. 58. Kannankeril PJ, Roden DM. Drug-induced long QT and torsade de pointes: recent advances. Curr Opin Cardiol 2007;22:39-43. 59. Alboni P, Botto GL, Baldi N, et al. Outpatient treatment of recent-onset atrial fibrillation with the “pill-in-the-pocket” approach. N Engl J Med 2004;351:2384-91. 60. Brodsky MA, Allen BJ, Walker CJ III, et al. Amiodarone for maintenance of sinus rhythm after conversion of atrial fibrillation in the setting of a dilated left atrium. Am J Cardiol 1987;6:572-5. 61. Van Gelder IC, Crijns HJ, Van Gilst WH, et al. Efficacy and safety of flecainide acetate in the maintenance of sinus rhythm after electrical cardioversion of chronic atrial fibrillation or atrial flutter. Am J Cardiol 1989; 64:1317-21. 62. Plewan A, Lehmann G, Ndrepepa G, et al. Maintenance of sinus rhythm after electrical cardioversion of persistent atrial fibrillation: sotalol vs bisoprolol. Eur Heart J 2001;22:1504-10. 63. Volgman AS, Carberry PA, Stambler B, et al. Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation. Am Coll Cardiol 1998;31: 1414-9. 75. Kuzniatsova N, Shantsila E, Lip GY. Atrial fibrillation: blockade of the renin-angiotensin system in atrial fibrillation. Nat Rev Cardiol 2010;7: 428-30. 76. Fauchier L, Pierre B, de Labriolle A, Grimard C, Zannad N, Babuty D. Antiarrhythmic effect of statin therapy and atrial fibrillation: a meta-analysis of randomized controlled trials. J Am Coll Cardiol 2008;51:828-35. 77. Negi S, Shukrullah I, Veledar E, Bloom HL, Jones DP, Dudley SC. Statin Therapy for the Prevention of Atrial Fibrillation Trial (SToP AF trial) [published online ahead of print October 13, 2010]. J Cardiovasc Electrophysiol doi: 10.1111/j.1540-8167.2010.01925.x. 78. Schneider MP, Hua TA, Böhm M, Wachtell K, Kjeldsen SE, Schmieder RE. Prevention of atrial fibrillation by renin-angiotensin system inhibition: a meta-analysis. J Am Coll Cardiol 2010;55:2299-307. 79. GISSI-AF Investigators, Disertori M, Latini R, Barlera S, et al. Valsartan for prevention of recurrent atrial fibrillation. N Engl J Med. 2009;360: 1606-17. 80. Andersen HR, Nielsen JC, Thomsen PE, et al. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet 1997;350:1210-6. 81. Connolly SJ, Kerr CR, Gent M, et al. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. N Engl J Med 2000;342:1385-91. 82. Kerr CR, Connolly SJ, Abdollah H, et al. Canadian Trial of Physiological Pacing: effects of physiological pacing during long-term follow-up. Circulation 2004;109:357-62. R G 64. Slavik RS, Tisdale JE, Borzak S. Pharmacologic conversion of atrial fibrillation: a systematic review of available evidence. Prog Cardiovasc Dis 2001;44:121-52. 74. Savelieva I, Camm J, Statins and polyunsaturated fatty acids for treatment of atrial fibrillation. Nat Clin Pract Cardiovasc Med 2008;5:30-41. O ED 56. Teo KK, Yusuf S, Furberg CD. Effects of prophylactic antiarrhythmic drug therapy in acute myocardial infarction: an overview of results from randomized controlled trials. JAMA 1993;270:1589-95. BA 65. Tercius AJ, Kluger J, Coleman CI, White CM. Intravenous magnesium sulfate enhances the ability of intravenous ibutilide to successfully convert atrial fibrillation or flutter. Pacing Clin Electrophysiol 2007;30:1331-5. EM 66. Siu CW, Lau CP, Lee WL, Lam KF, Tse HF. Intravenous diltiazem is superior to intravenous amiodarone or digoxin for achieving ventricular rate control in patients with acute uncomplicated atrial fibrillation. Crit Care Med 2009;37:2174-9 [quiz: 2180]. 67. Galve E, Rius T, Ballester R, et al. Intravenous amiodarone in treatment of recent-onset atrial fibrillation: results of a randomized, controlled study. J Am Coll Cardiol 1996;27:1079-82. 68. Sherman DG, Kim SG, Boop BS, et al. Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study. Arch Intern Med 2005; 165:1185-91. 69. Flaker GC, Belew K, Beckman K, et al. Asymptomatic atrial fibrillation: demographic features and prognostic information from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J 2005;149:657-63. 70. Dobrey D, Nattel S. New antiarrhythmic drugs for treatment of atrial fibrillation. Lancet 2010;375:1212-23. 71. Raven U. Antiarrhythmic therapy in atrial fibrillation. Pharmacol Ther 2010;128:129-45. 72. Smit MD, Van Gelder IC, Upstream therapy of atrial fibrillation. Expert Rev Cardiovasc Ther 2009;7:763-78. 73. Savelieva I, Kourliouros A, Camm J. Primary and secondary prevention of atrial fibrillation with statins and polyunsaturated fatty acids: review of evidence and clinical relevance. Naunyn Schmiedebergs Arch Pharmacol 2010;381:1-13. 83. Lamas GA, Lee KL, Sweeney MO, et al. Mode selection trial in sinus-node dysfunction: ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med 2002;346:1854-62. 84. Skanes AC, Krahn AD, Yee R, et al; CTOPP Investigators. Progression to chronic atrial fibrillation after pacing: the Canadian Trial of Physiologic Pacing. J Am Coll Cardiol 2001;38:167-72. 85. Toff WD, Camm AJ, Skehan JD; United Kingdom Pacing and Cardiovascular Events Trial Investigators. Single-chamber versus dualchamber pacing for high-grade atrioventricular block. N Engl J Med 2005;353:145-55. 86. Sweeney MO, Hellkamp AS, Ellenbogen KA, et al; Mode Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 2003;107:2932-7. 87. Nielsen JC, Kristensen L, Andersen HR, et al. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol 2003;42:614-23. 88. Gillis AM. Selective pacing algorithms for prevention of atrial fibrillation: the final chapter? Heart Rhythm 2009;6:295-301. 89. Sweeney MO, Bank AJ, Nsah E, et al. Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial: minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med 2007;357:1000-8. 90. Gillis AM, Burland L, Arnburg B, et al. Treating the right patient at the right time: an innovative approach to the management of atrial fibrillation. Can J Cardiol 2008;24:195-8. Canadian Journal of Cardiology 27 (2011) 60 – 66 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Catheter Ablation for Atrial Fibrillation/Atrial Flutter Atul Verma, MD, FRCPC,a Laurent Macle, MD, FRCPC,b Jafna Cox, MD, FRCPC,c Allan C. Skanes, MD, FRCPC,d and the CCS Atrial Fibrillation Guidelines Committeee a Southlake Regional Health Centre, Newmarket, Ontario, Canada b Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada d e Montreal Heart Institute, Montreal, Québec, Canada London Health Sciences Centre, London, Ontario, Canada O ED c For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and achieving consensus. Can J Cardiol 2011;27:27-30. ABSTRACT RÉSUMÉ L’ablation par cathéter est un traitement reconnu visant le maintien du rythme sinusal chez les patients atteints de fibrillation auriculaire (FA) ou de flutter auriculaire. Il a été démontré que dans la majorité des cas de FA (et particulièrement sa forme paroxystique), cette arythmie est déclenchée par des salves d’extrasystoles qui prennent origine dans les veines pulmonaires. L’ablation par cathéter, réalisée par cautérisations à la jonction des veines pulmonaires et de l’oreillette gauche, isole les foyers initiateurs de l’arythmie. Lors de l’intervention, d’autres cautérisations peuvent être effectuées dans les oreillettes, pour tenter d’éliminer le substrat de l’arythmie, notamment dans les cas de FA persistante. Il n’est pas encore démontré que cette procédure est associée à une réduction de la mortalité ou du risque thrombo-embolique. Son indication actuelle est essentiellement d’améliorer les symptômes de la FA. L’ablation par cathéter est plus efficace que les médicaments antiarythmiques pour le maintien du rythme sinusal chez les patients avec FA. Son taux de succès (absence de récidive d’arythmie) est de 75-90 % après 1-2 procédures. Par contre, le taux EM BA R G Catheter ablation of atrial fibrillation (AF) offers a promising treatment for the maintenance of sinus rhythm in patients for whom a rhythm control strategy is desired. While the precise mechanisms of AF are incompletely understood, there is substantial evidence that in many cases (particularly for paroxysmal AF), ectopic activity most commonly located in and around the pulmonary veins of the left atrium plays a central role in triggering and/or maintaining arrhythmic episodes. Catheter ablation involves electrically disconnecting the pulmonary veins from the rest of the left atrium to prevent AF from being triggered. Further substrate modification may be required in patients with more persistent AF. Successful ablation of AF has never been shown to alter mortality or obviate the need for oral anticoagulation; thus, the primary indication for this procedure should be improvement of symptoms caused by AF. The success rate of catheter ablation for AF is superior to the efficacy of antiarrhythmic drugs, but success is still in the range of 75%-90% after 2 procedures. Ablation is also associated As discussed in detail by Gillis et al,1 studies have failed to show that a rhythm control strategy improves mortality or reduces the incidence of thromboembolic complications in atrial fibril- lation (AF) compared to the use of rate control alone. Thus, the decision to pursue rhythm control should be directed to patients who are symptomatic with their AF despite rate control, Received for publication November 5, 2010. Accepted November 16, 2010. specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. Corresponding author: Atul Verma, MD, FRCPC, Southlake Regional Health Centre, 712 Davis Dr, Suite 105, Newmarket, Ontario, L3Y 8C3 Canada. Tel.: 905-953-7917; fax: 905-953-0046. E-mail: atul.verma@utoronto.ca The disclosure information of the authors and reviewers is available from the CCS on the following websites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease- 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.011 Verma et al. Catheter Ablation for Atrial Fibrillation/Atrial Flutter 61 In patients with more persistent AF, electrical and structural remodelling of the atria occur, creating an abnormal atrial substrate that tends to perpetuate AF.6 Changes include a decrease in atrial refractoriness, atrial fibrosis, and atrial stretch.7 Thus, while PV isolation remains the primary AF ablation approach in persistent AF, it is believed that further ablation of the substrate is required to treat AF in this population. The most common forms of substrate modification are linear ablation and electrogram-guided ablation. Linear ablation involves creating lines of block along the LA roof and the mitral annulus and occasionally in the RA, mimicking the original surgical maze procedure.8 Electrogram-guided ablation involves targeting specific electrical signals (eg, complex “fractionated” signals) that may represent critical areas of AF perpetuation.9 The optimal strategy of substrate modification remains an area of active investigation. Procedural Considerations AF ablation is a complex procedure, requiring a high degree of operator expertise and advanced technological support. R G with the aim of improving quality of life. Many of these symptomatic patients, such as younger patients with “lone” AF, were underrepresented in trials comparing rate and rhythm control. Furthermore, in all of these trials, antiarrhythmic drug therapy was used for the rhythm control strategy. Antiarrhythmic drugs remain “first-line” therapy for the maintenance of sinus rhythm, but these medications have only modest efficacy at maintaining sinus rhythm over the long term. They are also associated with side effects, in particular proarrhythmia, which limit their long-term use, especially in younger patients. Catheter ablation offers an alternative to maintaining sinus rhythm when drugs have been ineffective or cannot be tolerated. Data have shown that the success rate of catheter ablation in maintaining sinus rhythm is superior to that of drug therapy and is associated with improved quality of life (see later). While there are clearly upfront risks associated with this invasive procedure, the risks have decreased substantially over time and, if successful, the procedure obviates the long-term risks of antiarrhythmic drugs. Thus, for many highly symptomatic patients who cannot be pharmacologically controlled, catheter ablation offers a promising alternative. de complications majeures est important, de l’ordre de 2-3 %. Aussi, l’ablation par cathéter ne doit elle être considérée que chez les patients avec FA symptomatique et qui ne répondent pas au traitement pharmacologique. L’ablation par cathéter du flutter auriculaire est encore plus efficace et comporte moins de risques. Elle peut donc être considérée en première intention, comme alternative aux médicaments antiarythmiques. O ED with a complication rate of 2%-3%. Thus, ablation should primarily be used as a second-line therapy after failure of antiarrhythmic drugs. In contrast to AF, catheter ablation of atrial flutter has a higher success rate with a smaller incidence of complications. Thus, catheter ablation for atrial flutter may be considered a first-line alternative to antiarrhythmic drugs. EM BA Mechanism of Action of Catheter Ablation of AF Catheter ablation for AF should be distinguished from atrioventricular (AV) junction ablation and pacemaker implantation, which is used for rate control but for not maintenance of sinus rhythm. It should also be distinguished from catheter ablation of typical right atrial flutter, which is a distinct procedure (described later in this article). Catheter ablation of AF aims to eliminate both the triggers of AF and the substrate that maintains AF, to achieve long-term sinus rhythm. While the mechanism of AF is very complex, rapid ectopic activity from the pulmonary veins (PVs) may be responsible for both triggering and maintaining AF, in particular paroxysmal AF.2 Scherf and colleagues3 first described how rapidly firing ectopic foci within the atria could degenerate the atria into a fibrillatory rhythm. It was the seminal report by Haissaguerre and colleagues,4 however, that first applied this principle in clinical practice. In their report, they described how most of the triggering foci for AF in the human originated in or around the PVs of the left atrium (LA). More than 90% of the foci originate in this region, with 10% originating in other areas such as the LA posterior wall, interatrial septum, coronary sinus, superior vena cava, and crista terminalis in the right atrium (RA).4 By ablating around the PVs and electrically isolating them from the rest of the atria, the triggering foci can be eliminated and AF prevented (Fig. 1). The procedure is sometimes referred to as a “pulmonary vein isolation” procedure for this reason. Over time, this technique has proved to be widely effective at maintaining sinus rhythm, particularly in patients with paroxysmal AF, and has evolved to become the cornerstone of AF catheter ablation procedures.5 Figure 1. Ablation lesion set for pulmonary vein isolation. Computed tomography scan of the posterior view of the left atrium including the pulmonary veins. Veins are labelled as follows: LSPV, left superior; LIPV, left inferior; RSPV, right superior; RIPV, right inferior pulmonary vein. The red dots represent point-by-point ablation lesions created by radiofrequency energy in the left atrium surrounding the pulmonary veins, thus electrically disconnecting them from the rest of the atrium. The darker dots represent lesions on the posterior wall of the left atrium, and the lighter dots represent circumferential lesions along the anterior aspect of the left atrium. 62 Canadian Journal of Cardiology Volume 27 2011 O ED therapy alone.18 Ablation also resulted in a significant improvement in quality of life. Another trial has demonstrated similar results.19 Failures most commonly occur as a result of electrical reconnection between the PVs and the LA due to recovery of previous ablation sites.20 Improved outcomes have been demonstrated with repeat procedures to isolate electrically reconnected PVs. Technologies that will help create more permanent lesions during the first ablation may improve long-term success rates and decrease the need for repeat procedures. In patients with persistent AF, the success rates are 10%15% lower than those described for paroxysmal AF with a higher need for repeat procedures.21 This lower success rate is predominantly due to the fact that the substrate has to be targeted and ablated in addition to PV isolation, meaning more complex and lengthy procedures. Furthermore, the optimal lesion set to target the substrate has yet to be fully determined, although there are data to suggest that hybrid techniques targeting more than just PV isolation may be required.22 With 2 procedures, the success rate of ablation for persistent AF may approach the success rates for paroxysmal AF.21 Lower success rates (by 5%-10% compared with paroxysmal AF) have also been reported in patients with structural heart disease, such as cardiomyopathy,23 although the benefit in this population may still be significant. The PABA-CHF trial, for example, reported improvements in ejection fraction in patients with congestive heart failure despite the lower overall procedural success rate.24 In patients who do not have a successful outcome postablation, some may become responsive to antiarrhythmic drug therapy that was previously ineffective. While many patients undergoing ablation wish to discontinue antiarrhythmic drugs, those who cannot maintain sinus rhythm postablation may achieve good rhythm control with adjuvant antiarrhythmic drug therapy. Most studies have looked at 1-year outcomes for AF ablation. Very few longer-term data are available. It appears that after 12-18 months, most patients will continue to do well, but 5%-10% of patients will have late recurrences beyond that time period.25-28 Further data are required to understand better the long-term durability of the results of AF ablation. EM BA R G While AF ablation is performed as an outpatient, day procedure, the intervention often takes about 3-5 hours or longer to complete. Patients need to be orally anticoagulated with warfarin for at least 1-2 months prior to the procedure and at least 3-6 months postablation to minimize the risk of a thromboembolic complication. Some centres will routinely perform preprocedural transesophageal echocardiography to rule out atrial thrombus prior to performing the ablation.10 The procedure itself may be performed under general anaesthesia or heavy conscious sedation using benzodiazepines and/or opiates.11,12 The entire procedure is performed through systemic venous access via the femoral and/or subclavian or internal jugular veins. Access to the LA is achieved by performing a transseptal puncture across the interatrial septum to cross from the RA to the LA. Because the major focus for ablation is in the LA, the patient is systemically anticoagulated to minimize thromboemboic events. In general, the procedure is performed with the patient adequately anticoagulated, either by sustaining the preprocedure warfarin (usually allowing the INR to fall to the lower end of the therapeutic range) or with use of bridging low-molecular-weight heparin both before and after the procedure. In the latter case, unfractionated heparin is administered with access to the LA. Likewise, bridging low-molecular-weight heparin is reinitiated within hours of the sheath removal and continued until a therapeutic INR is reestablished with oral anticoagulant therapy. The anatomy and electrical activity of the LA are often reconstructed using a 3-dimensional mapping system that then guides the rest of the procedure. Ablation is most commonly performed with radiofrequency energy delivered from a catheter tip. Technologies are evolving, however, to use different catheter designs and energy sources to maximize energy delivery while minimizing the risks, such as perforation. Following ablation, patients are evaluated at regular intervals with electrocardiograms and Holter monitoring to determine the success of the procedure. Early recurrences of AF may occur within the first 3 months postablation due to acute inflammation in the LA but do not necessarily indicate long-term failure of the procedure; at least 50% of these recurrences will resolve spontaneously after 3 months.13,14 Efficacy of Catheter Ablation for AF Since AF ablation was first described ⬎10 years ago, the technique and technology have evolved such that fairly consistent success rates can be achieved for patients with paroxysmal AF and minimal associated structural heart disease.15 In these patients, the success rate of maintaining sinus rhythm off antiarrhythmic drug therapy is 60%-75% after 1 procedure and 75%-90% after 2 procedures.12 In a recent meta-analysis of 6 clinical trials that compared ablation with antiarrhythmic drug therapy in a total of 693 patients, ablation was associated with a significantly increased odds of freedom from AF at 12 months (odds ratio [OR] 9.74; 95% confidence interval [CI] 3.9823.87).16 Ablation was also associated with a decreased rate of cardiovascular hospitalization (OR 0.15; 95% CI 0.10-0.23). These results were achieved with a repeat ablation rate of 17%. The results were also quite consistent between trials.17 In a recent multicenter, randomized trial comparing catheter ablation with antiarrhythmic drug therapy, 66% of patients maintained sinus rhythm off drugs after a single ablation of paroxysmal AF compared with only 16% with antiarrhythmic drug Risks of Catheter Ablation of AF As with any invasive procedure, catheter ablation of AF is associated with procedural risk. While the risk of any complication was reported to be 6%-8% in early experiences,29 these risks have decreased appreciably in the past 5 years30 and are currently in the range of 2%-3%. The most common risk is a vascular access complication such as hematoma, pseudoaneurysm, and AV fistula, occurring in 1%-2% of cases. Less common but more serious risks include those of cardiac perforation (0.5%-1%) and thromboembolism (0.5%-1%). Cardiac perforation can often be managed by percutaneous drainage (pericardiocentesis), although surgical repair is rarely required. Acute thromboembolic stroke results in transient deficits in most affected patients. Pulmonary vein stenosis used to be a more common complication when ablation was initially performed by ablation within the PVs. However, current ablation techniques deliver energy outside of the PVs within the LA, thus avoiding the stenosis hazard and making this complication quite uncommon today (⬍0.5%). Verma et al. Catheter Ablation for Atrial Fibrillation/Atrial Flutter 63 First-line Failed first-line drug Failed second-line drug Failed multiple drugs Longstanding* Persistent Paroxysmal –– –– ⫹ ⫹⫹ – ⫹ ⫹⫹ ⫹⫹⫹ ⫹ ⫹⫹ ⫹⫹⫹ ⫹⫹⫹ ⫹, Balance of risk and benefit in favour of catheter ablation. * Ongoing symptomatic AF for ⱖ1 year. Values and preferences. This recommendation recognizes that the balance of risk with ablation and benefit in symptom relief and improvement in quality of life must be individualized. It also recognizes that patients may have relative or absolute cardiac or noncardiac contraindications to specific medications. Because most of the patients included in clinical trials to date have been with paroxysmal AF and because the success rate is higher in this population, these patients are favoured for ablation therapy. However, patients with symptomatic persistent AF are increasingly undergoing ablation. The risk/benefit ratio of performing catheter ablation for AF in various subtypes of AF is detailed in Table 1. EM BA R G Candidates for Catheter Ablation of AF The decision to pursue a strategy of maintaining sinus rhythm should be aimed at reduction of patient symptoms.1 To date, there are no clinical trial data available demonstrating a reduction in mortality or stroke through maintenance of sinus rhythm, including through the use of catheter ablation. Thus, the primary indication for catheter ablation is in patients with symptomatic AF for whom the symptoms are adversely affecting quality of life. Patients with totally asymptomatic AF are not candidates for ablation, with the possible exception of patients in whom AF is thought to be adversely affecting left ventricular function (such as with tachycardia-induced cardiomyopathy). Antiarrhythmic drug therapy is still considered first-line therapy for maintenance of sinus rhythm,5 while catheter ablation should only be considered for patients for whom adequate trials of drug therapy fail. This hierarchy generally means a trial of ⱖ2 drugs in most patients. More recent clinical trials have demonstrated superiority of ablation in patients for whom ⱖ1 antiarrhythmic drugs have failed, and these trials form the basis for a conditional recommendation for select patients to be considered for catheter ablation as the initial treatment of AF. Younger patients, for example, may want to avoid long-term amiodarone treatment use given the drug’s accompanying (or cumulative) risks. Patients may also have cardiac or noncardiac absolute or relative contraindications to certain drugs1 (see Table 3 in Gillis et al1 in this issue). Also, patients are unlikely to benefit from specific medications if 1 medication in the same class has already failed. Table 1. Risk/benefit ratio for ablation in patients with symptomatic AF O ED Fatal complications are quite rare, occurring in approximately 1:1000 cases. However, because of the proximity of the esophagus to the posterior LA wall, the esophagus may be damaged as a result of ablation in the LA. Rarely, this damage can result in a fistula forming between the LA and esophagus, which most often presents 2-4 weeks postablation as an unexplained fever with or without chest pain and unexplained neurologic events.31 Because this complication often goes unrecognized, it leads to sepsis and death. Use of lower power outputs during ablation, esophageal monitoring, and postprocedural proton pump inhibition may all reduce the already small risk of this complication. RECOMMENDATION We recommend catheter ablation of AF in patients who remain symptomatic following adequate trials of anti-arrhythmic drug therapy and in whom a rhythm control strategy remains desired (Strong Recommendation, ModerateQuality Evidence). Values and preferences. This recommendation recognizes that failure of multiple antiarrhythmic drugs results in few alternative strategies if maintenance of sinus rhythm is preferred based on symptom burden reduction and quality of life improvement. We suggest catheter ablation to maintain sinus rhythm in select patients with symptomatic atrial fibrillation and mild-moderate structural heart disease who are refractory or intolerant to ⱖ1 antiarrhythmic medication (Conditional Recommendation, Moderate-Quality Evidence). Practical tip. There is no formal definition for “adequate trials of anti-arrhythmic drug therapy” mentioned in the first recommendation. Early studies assessing AF ablation required that patients have failed therapeutic doses of ⱖ2 different antiarrhythmics. This “strong” recommendation stems from both the data and the belief of the consensus committee that AF ablation be reserved for patients who have had trials of therapeutic doses of ⱖ2 different antiarrhythmics drugs prior to being considered for catheter ablation. Electing to perform ablation after a trial of ⬍2 drugs may be appropriate in carefully selected patients but meets only a “conditional” recommendation based on the more limited availability of data to support this approach. In highly selected patients, AF ablation may be offered as firstline therapy. Data from 1 small pilot study of 70 patients showed a 63% recurrence rate in the antiarrhythmic arm versus only 13% in the ablation arm (P ⬍ .001) with a significant reduction in hospitalization and improvement in quality of life.32 In addition, although this has not been studied in detail, some patients with tachybrady syndrome are unable to tolerate drug therapy because of bradyarrhythmic complications in the absence of a permanent pacemaker. If the AF can be successfully ablated, then antiarrhythmic therapy and the need for permanent pacing may be avoided, especially in younger patients.33 RECOMMENDATION We suggest catheter ablation to maintain sinus rhythm as first-line therapy for relief of symptoms in highly selected patients with symptomatic, paroxysmal atrial fibrillation (Conditional Recommendation, Low-Quality Evidence). 64 Canadian Journal of Cardiology Volume 27 2011 While there is no absolute age limit for ablation, most clinical experiences have included few patients ⱖ75 years old and almost no patients ⱖ80 years old due to concern of increased complication rates. Finally, if the LA size is too enlarged (typically ⬎55-mm diameter in the parasternal long-axis view on standard echo), the success rate of catheter ablation is poor. Thus, if ablation is to be considered, it should be done prior to severe LA enlargement. Practical tip. The following represents a typical, but not exclusive, profile of a patient who is referred for consideration of AF ablation today: Age ⬍80 years Patients who are symptomatic with their AF Patients who have tried but failed or are intolerant of antiarrhythmic drug therapy Paroxysmal AF or short-standing persistent AF Minimal to moderate structural heart disease (eg, LV dysfunction or valvular disease). RECOMMENDATION We recommend curative catheter ablation for symptomatic patients with typical atrial flutter as first line therapy or as a reasonable alternative to pharmacologic rhythm or rate control therapy (Strong Recommendation, ModerateQuality Evidence). EM BA R G Need for Anticoagulation With Catheter Ablation of AF To date, there is no clinical evidence to suggest that successful catheter ablation of AF affects long-term stroke risk. One major reason is that some asymptomatic AF may continue to occur postablation undetected by intermittent monitoring. Data show that more intensive or continuous monitoring may detect episodes of asymptomatic AF in patients who have had a “successful” outcome,34 and this AF may contribute to ongoing thromboembolic risk. Even in patients in whom AF is eliminated, there is a lack of data to support anticoagulation withdrawal in patients with other risk factors for stroke. Trials to evaluate this question are currently under way, including the large-scale CABANA study. At present, if a patient has sufficient risk to warrant oral anticoagulation for their AF preablation (eg, a CHADS2 [Congestive Heart Failure, Hypertension, Age, Diabetes, Stroke/Transient Ischemic Attack] risk score of ⱖ2), then it is recommended that oral anticoagulation be continued indefinitely postablation regardless of apparent procedural success.35,36 Furthermore, because the very long-term results of ablation have not been fully elucidated beyond 2-5 years, the very late recurrence rate may also warrant ongoing anticoagulation. Avoidance of oral anticoagulation is not an indication for catheter ablation of AF at present. Catheter Ablation of Atrial Flutter Typical right atrial flutter is a distinct arrhythmia from AF, although the 2 often coexist, occurring together in up to 40%50% of patients with atrial flutter. Typical flutter is characterized by the classic “sawtooth” pattern on the electrocardiogram and often conducts 2:1 with a ventricular response of 150 beats per minute. Atrial flutter carries the same thromboembolic risk as AF and should be anticoagulated according to the same guidelines as AF. In contrast to AF, however, typical right atrial flutter involves a single reentrant circuit around the tricuspid annulus. By ablating a line along the isthmus that extends from the tricuspid annulus to the inferior vena cava, flutter can easily be eliminated in a single procedure with a success rate of ⬎85%-90%.37 Given the simplicity of this procedure (in contrast to AF ablation) with its accompanying low risk and given that atrial flutter is very hard to control pharmacologically, flutter ablation is recommended as an alternative first-line therapy to drugs. This has been supported by a number of clinical trials comparing atrial flutter ablation to drug therapy.15,38 However, after elimination of AFL, over the next 5 years, approximately 60%-65% of patients will develop AF as a stand-alone problem.39 O ED Values and preferences. This recommendation recognizes that individual patients may have a strong intolerance or aversion to antiarrhythmic drugs such that the risk of ablation is deemed warranted. Practical tip. AF ablation should not be considered as an alternative to oral anticoagulation. If a patient has a high thromboembolic risk profile (eg, CHADS2 risk score of ⱖ2), then the patient should continue oral anticoagulation even after successful AF ablation. Studies of long-term monitoring have consistently shown asymptomatic episodes of AF both prior to and following ablation. Initiation of oral anticoagulation should also not be delayed when indicated in patients pending referral for AF ablation. Values and preferences. This recommendation recognizes the high efficacy, low complication rate of catheter ablation and low efficacy of pharmacologic therapy, whether rate or rhythm control. Practical tip. Typical atrial flutter is more challenging to control medically with antiarrhythmic drugs than is AF and adequate rate control is more difficult to achieve. Given the high success rate and low complication rate of atrial flutter ablation, it is a strongly recommended as a first-line therapy in comparison to AF ablation. Ablation of Accessory Pathways and Other Arrhythmias in AF The presence of an accessory pathway (eg, Wolff-Parkinson-White syndrome) with evidence of preexcitation (delta wave) during AF presents a rare but potentially life-threatening situation.40 If the pathway has a short refractory period, it may allow AF to conduct to the ventricles with a very high ventricular rate response. High ventricular rates can occasionally lead to degeneration into ventricular tachycardia or fibrillation, resulting in a cardiac arrest. Administration of an AV nodal blocking agent during preexcited AF can exacerbate this problem and should be avoided. In these cases, especially if the patient has a history of syncope or rapid AF, catheter ablation of the accessory pathway is strongly recommended to avoid any possibility of cardiac arrest. Verma et al. Catheter Ablation for Atrial Fibrillation/Atrial Flutter 65 6. Nattel S, Burstein B, Dobrev D: Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol 2008;1:62-73. In patients with evidence of ventricular preexcitation during AF, we recommend catheter ablation of the accessory pathway, especially if AF is associated with rapid ventricular rates, syncope, or a pathway with a short refractory period (Strong Recommendation, Low-Quality Evidence). Values and preferences. This recommendation places a high value on the prevention of sudden cardiac death in patients at high risk and a low value on the small complication rate of catheter ablation of the accessory pathway. RECOMMENDATION In young patients with lone, paroxysmal AF, we suggest an electrophysiological study to exclude a reentrant tachycardia as a cause of AF; if present, we suggest curative ablation of the tachycardia (Conditional Recommendation, Very Low-Quality Evidence). Values and preferences. This recommendation recognizes that supraventricular tachycardia can initiate AF when the substrate for AF is present and can be ablated with a high success rate and minimal risk. 8. Willems S, Klemm H, Rostock T, et al. Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a prospective randomized comparison. Eur Heart J 2006;27:2871-8. 9. Nademanee K, McKenzie J, Kosar E, et al. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol 2004;43:2044-53. 10. Michael KA, Redfearn DP, Baranchuk A, et al. Transesophageal echocardiography for the prevention of embolic complications after catheter ablation for atrial fibrillation. J Cardiovasc Electrophysiol 2009;20: 1217-22. 11. Verma A, Marrouche NF, Natale A: Pulmonary vein antrum isolation: intracardiac echocardiography-guided technique. J Cardiovasc Electrophysiol 2004;15:1335-40. 12. Finta B, Haines DE: Catheter ablation therapy for atrial fibrillation. Cardiol Clin 2004;22:127-45, ix. 13. Themistoclakis S, Schweikert RA, Saliba WI, et al. Clinical predictors and relationship between early and late atrial tachyarrhythmias after pulmonary vein antrum isolation. Heart Rhythm 2008;5:679-85. 14. Koyama T, Sekiguchi Y, Tada H, et al. Comparison of characteristics and significance of immediate versus early versus no recurrence of atrial fibrillation after catheter ablation. Am J Cardiol 2009;103:1249-54. References EM BA R G In younger patients, other reentrant supraventricular tachycardias, such as AV nodal reentry or AV reentrant tachycardia using an accessory pathway, can degenerate into AF. Elimination of the reentrant tachycardia can therefore prevent episodes of AF. Thus, clear onset of AF resulting from another supraventricular tachycardia is an indication for seeking and eliminating the underlying tachycardia by ablation, if possible. If no such onset is clearly demonstrable, in younger patients it may be warranted to perform a general electrophysiological study prior to AF ablation, to look for and eliminate other underlying tachyarrhythmias, and assess the outcome prior to performing AF ablation. 7. Allessie M, Ausma J, Schotten U: Electrical, contractile and structural remodeling during atrial fibrillation. Cardiovasc Res 2002;54:230-46. O ED RECOMMENDATION 1. Gillis AM, Verma A, Talajic M, Nattel S, Dorian P, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: rate and rhythm management. Can J Cardiol 2011;27:47-59. 2. Nattel S, Opie LH: Controversies in atrial fibrillation. Lancet 2006;367: 262-72. 3. Scherf D, Schaffer AI, Blumenfeld S: Mechanism of flutter and fibrillation. AMA Arch Intern Med 1953;91:333-52. 4. Haissaguerre M, Jais P, Shah DC, et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med 1998;339:659-66. 5. Calkins H, Brugada J, Packer DL, et al. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2007;4:816-61. 15. Verma A, Natale A: Should atrial fibrillation ablation be considered firstline therapy for some patients? Why atrial fibrillation ablation should be considered first-line therapy for some patients. Circulation 2005;112:121422; discussion 1231. 16. Piccini JP, Lopes RD, Kong MH, et al. Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a metaanalysis of randomized, controlled trials. Circ Arrhythm Electrophysiol 2009;2:626-33. 17. Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol 2009;2:349-61. 18. Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 2010;303:333-40. 19. Jais P, Cauchemez B, Macle L, et al. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation 2008;118:2498-505. 20. Verma A, Kilicaslan F, Pisano E, et al. Response of atrial fibrillation to pulmonary vein antrum isolation is directly related to resumption and delay of pulmonary vein conduction. Circulation 2005;112:627-35. 21. Bhargava M, Di Biase L, Mohanty P, et al. Impact of type of atrial fibrillation and repeat catheter ablation on long-term freedom from atrial fibrillation: results from a multicenter study. Heart Rhythm 2009;6:1403-12. 22. Verma A, Mantovan R, Macle L, et al. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J 2010;31:1344-56. 23. Chen MS, Marrouche NF, Khaykin Y, et al. Pulmonary vein isolation for the treatment of atrial fibrillation in patients with impaired systolic function. J Am Coll Cardiol 2004;43:1004-9. 24. Khan MN, Jais P, Cummings J, et al. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med 2008;359:1778-5. 66 Canadian Journal of Cardiology Volume 27 2011 25. Sawhney N, Anousheh R, Chen WC, Narayan S, Feld GK: Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol 2009;104:366-72. 33. Khaykin Y, Marrouche NF, Martin DO, et al. Pulmonary vein isolation for atrial fibrillation in patients with symptomatic sinus bradycardia or pauses. J Cardiovasc Electrophysiol 2004;15:784-9. 26. Wokhlu A, Hodge DO, Monahan KH, et al. Long-term outcome of atrial fibrillation ablation: impact and predictors of very late recurrence. J Cardiovasc Electrophysiol 2010;21:1071-8. 34. Hindricks G, Piorkowski C, Tanner H, et al. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation 2005;112:30713. 28. Hunter RJ, Berriman TJ, Diab I, et al. Long-term efficacy of catheter ablation for atrial fibrillation: impact of additional targeting of fractionated electrograms. Heart 2010;96:1372-8. 29. Cappato R, Calkins H, Chen SA, et al. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 2005;111:1100-5. 30. Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol 2010;3:32-8. 31. Cummings JE, Schweikert RA, Saliba WI, et al. Brief communication: atrial-esophageal fistulas after radiofrequency ablation. Ann Intern Med 2006;144:572-4. 36. Themistoclakis S, Corrado A, Marchlinski FE, et al. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol 2010;55:735-43. 37. Spector P, Reynolds MR, Calkins H, et al. Meta-analysis of ablation of atrial flutter and supraventricular tachycardia. Am J Cardiol 2009;104: 671-7. 38. Da Costa A, Cucherat M, Pichon N, et al. Comparison of the efficacy of cooled-tip and 8-mm-tip catheters for radiofrequency catheter ablation of the cavotricuspid isthmus: a meta-analysis. Pacing Clin Electrophysiol 2005;28:1081-7. 39. Perez FJ, Schubert CM, Parvez B, et al. Long-term outcomes after catheter ablation of cavo-tricuspid isthmus dependent atrial flutter: a meta-analysis. Circ Arrhythm Electrophysiol 2009;2:393-401. 40. Berry VA: Wolff-Parkinson-White syndrome and the use of radiofrequency catheter ablation. Heart Lung 1993;22:15-25. EM BA R G 32. Wazni OM, Marrouche NF, Martin DO, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA 2005;293: 2634-40. 35. Oral H, Chugh A, Ozaydin M, et al. Risk of thromboembolic events after percutaneous left atrial radiofrequency ablation of atrial fibrillation. Circulation 2006;114:759-65. O ED 27. Lo LW, Tai CT, Lin YJ, et al. Predicting factors for atrial fibrillation acute termination during catheter ablation procedures: implications for catheter ablation strategy and long-term outcome. Heart Rhythm 2009;6:311-8. Canadian Journal of Cardiology 27 (2011) 67–73 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Surgical Therapy Pierre Pagé, MD,a and the CCS Atrial Fibrillation Guidelines Committeeb a b From the Research Center, Hôpital du Sacré-Coeur de Montréal, Montreal, Québec, Canada For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and Achieving Consensus. Can J Cardiol 2011;27:27-30. RÉSUMÉ Surgery for atrial fibrillation (AF) has been demonstrated as an effective treatment to restore and maintain sinus rhythm in patients for whom a rhythm control strategy is desired. It is usually offered to patients undergoing other types of cardiac surgery (eg, mitral valve repair or replacement, coronary artery bypass grafting, aortic valve surgery, intracardiac defects, ascending aortic surgery). It is also feasible as a stand-alone procedure, bearing a high success rate. In the past few years, less-invasive procedures have been described. AF is a triggered arrhythmia, resulting from ectopic activity most commonly located in and around the pulmonary veins of the left atrium. Therefore, electrical isolation of the pulmonary veins from the rest of the left atrium in order to prevent AF from being triggered is the rationale common to all surgical techniques. Further substrate modification may be required in patients with more persistent AF. This is done by adding ablation of the posterior left atrium with connecting lines of block between pulmonary veins, to the mitral valve annulus, as well as in specific sites in the right atrium. The left atrial appendage is resected or occluded at the same time. Despite patients’ high rate of freedom from AF after surgery (70%– 85% at 1 year), surgical ablation of AF has never been clearly shown to alter long-term mortality. The available literature supports the recommendation to stop oral anticoagulation therapy 6 months after surgery when sinus rhythm can be documented, because a very low rate of thromboembolic events is reported. However, Il est démontré que la chirurgie de fibrillation auriculaire (FA) est un traitement efficace pour restaurer et maintenir le rythme sinusal chez les patients pour qui une stratégie de contrôle du rythme est indiquée. On l’offre habituellement aux patients qui doivent subir d’autres types de chirurgie cardiaque (par exemple réparation ou remplacement d’une valvule mitrale, pontage coronarien, chirurgie de la valvule aortique). Cette chirurgie est également possible en tant qu’intervention primaire et isolée et présente un taux de succès élevé. Au cours des dernières années, des interventions moins effractives ont été décrites. La FA étant une arythmie déclenchée par l’activité ectopique localisée le plus souvent dans les veines pulmonaires, l’isolation électrique des veines pulmonaires demeure le fondement habituel de toutes les techniques chirurgicales. D’autres modifications du substrat peuvent être nécessaires chez les patients présentant une FA plus persistante. Cela est fait par l’ajout de lignes d’ablation dans l’oreillette gauche postérieure entre les veines pulmonaires, vers l’anneau valvule mitrale, ainsi que dans des sites spécifiques dans l’oreillette droite. L’oblitération ou la résectionde concomitantel’appendice auriculaire gauche est fortement recommandée. Malgré le taux élevé de patients qui sont épargnés d’une FA après la chirurgie (70 %– 85 % à 1 an), il n’a jamais été clairement démontré que l’ablation chirurgicale d’une FA pouvait modifier la mortalité à long terme. Selon la littérature chirurgicale, l’arrêt du traitement par anticoagulants EM BA R G O ED ABSTRACT It appears essential to evaluate the surgical approaches to atrial fibrillation (AF) in view of the following clinical objectives: (1) to avoid symptoms associated with rapid and irregular heart beat; (2) to avoid blood stasis in the atrium and the attendant risk of throm- boembolic events; and (3) to preserve atrial function, which ensures optimal cardiac performance. There is a need to balance the priority given to each of these objectives in relation to the clinical condition associated with the arrhythmia, as one objective may Received for publication November 13, 2010. Accepted November 19, 2010. on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. Corresponding author: Pierre Pagé, MD, Research Center, Hôpital du Sacré-Coeur de Montréal, 5400, Gouin B. West, Montreal, Québec, H4J 1C5, Canada. E-mail: pierre.page@umontreal.ca The disclosure information of the authors and reviewers is available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.008 68 Canadian Journal of Cardiology Volume 27 2011 dominate, depending on the clinical presentation of AF and the associated cardiac pathology. For instance, symptoms may be the main target in the case of occasional paroxysmal “lone” AF, prevention of thromboembolism may be the major motivation to terminate permanent or persistent AF, and improvement of cardiac performance may be the main objective in treating AF associated with congestive heart failure or valvular disease. The maze procedure, designed and first reported by Cox et al,1 was based on the assumption that many electrophysiological mechanisms coexist in the atrium, thus necessitating a standardized procedure that would address each of them. These assumptions were as follows: tion of preoperative AF exceeds 6 months, 70% to 80% of patients remain in AF if they do not undergo a specific AF procedure.31,37 Therefore, ablation has been recommended concomitant with a mitral valve procedure in any patient who has had AF for more than 6 months.29 Meta-analyses including prospective randomized trials have documented a high success rate of AF surgery (typically the Cox Maze procedure or several of its later modifications) in terms of restoration of sinus rhythm.38-54 In the Mayo Clinic experience, there was a significant difference in freedom from AF 2 years after a concomitant maze operation (74% ⫾ 8%) compared with 27% ⫾ 7% for a control group with mitral valve surgery alone.55 One of the largest series of patients undergoing the maze surgery associated with other primary cardiac operations was published by Beukema et al in 2008.54 They performed surgery concomitant with a radiofrequencymodified maze procedure in 258 patients (updated to 700 in 2010)56 with permanent AF. Sustained sinus rhythm, including an atrial rhythm or an atrial-based paced rhythm, was present in 69% of their patients at 1 year, in 56% at 3 years, and in 52% at 5 years.54,56 In a recent study by Kim et al including 540 patients undergoing mitral valve repair or replacement, the maze procedure was also performed in 36% of this group.57 After 5 years, the incidence of sinus rhythm was 86% in the patients who had undergone the maze procedure but only 24% in patients who did not undergo the procedure. Therefore, there is moderately high-quality evidence to demonstrate the 1-year efficacy of concomitant AF surgery to eliminate AF in patients undergoing cardiac surgical interventions. R G 1. According to the conceptual notion of Garrey,2 fractionation of the atrial tissue into smaller segments would not allow multiple reentrant wavelets to be maintained. 2. To preserve atrial contraction, mandatory for the transport function and for eliminating the risk of thromboembolic events, all these segments should be linked to each other. Impulse propagation into dead-end pathways would not allow reentry to occur but would allow depolarization of sufficient atrial myocardium to ensure contraction. 3. The numerous atrial incisions required to address the first 2 assumptions would interrupt any possible macroreentrant pathway. oraux 6 mois après la chirurgie est recommandé lorsque le rythme sinusal peut être documenté de façon certaine et puisqu’il y a un taux très faible de thromboembolies. Par ailleurs, peu de données probantes sont disponible pour appuyer l’innocuité de l’omission d’un traitement anticoagulant à prise orale à long terme. C’est donc dire que la chirurgie devra surtout être utilisée comme procédure concomitante pendant la chirurgie cardiaque pour d’autres maladies ou comme procédure distincte après l’échec de tentatives précédentes d’ablation par cathéter et de médicaments antiarythmiques. O ED there is no evidence-based data to support the safety of omitting long-term oral anticoagulation. Thus, surgery should be used primarily as a concomitant procedure during cardiac surgery for other diseased states or as a stand-alone procedure after failure of prior attempts of catheter ablation and antiarrhythmic drugs. EM BA This procedure has been applied clinically since 1987 and has proven extremely effective.3-12 However, despite this success, the maze procedure was perceived as difficult and associated with significant morbidity,13 leading several authors to develop novel strategies aimed at simplifying the procedure without compromising the results. Less-invasive approaches have been designed to avoid sternotomy by accessing the left atrium through minimal incisions and to avoid cardiopulmonary bypass by accessing atrial tissue from the epicardium.14-26 Furthermore, new information regarding the role of the pulmonary vein–left atrial junction, drivers and rotors occurring in the posterior left atrium, and the role of the intrinsic cardiac nervous system has been incorporated into the evolving surgical rationale.27,28 In addition, it has been recognized that the underlying cardiac disorders might alter treatment outcomes. A number of factors, therefore, need to be considered when reengineering the surgical algorithm for AF management.29,30 Elimination of AF A number of studies have shown that preoperative AF in patients undergoing cardiac surgical interventions is an independent factor for late major adverse cardiac events and poorer survival.31-36 The literature also indicates that once AF appears in patients with mitral valve disease, it is uncommon for mitral valve surgery alone to restore sinus rhythm.31,34,36,37 In this context, the duration of AF is a critical factor in predicting the return of sinus rhythm. When AF has been present for 3 months or less, sinus rhythm may resume in up to 80% of patients, but when the dura- Outcome Benefit: Cardiac Events and Survival Whether AF surgery affords improved clinical outcome to patients with preoperative AF remains controversial.13,52,54-58 Although it is generally accepted that preoperative AF is predictive of cardiac mortality and morbidity, it is unclear whether direct surgical correction of AF restores the survival curves of AF patients to the same level as those of patients without preoperative AF. Shortterm and intermediate-term rates of sinus rhythm after classical maze or its variant procedures differ widely: between 44% and 95%.4-13,38-61 However, none of the 6 randomized trials comparing outcomes in patients undergoing surgery with and without concomitant maze procedures has shown a clear benefit on mortality or stroke.56 Nevertheless, many observational reports suggest that concomitant AF correction has the potential to improve longterm survival. In the study by Kim et al, a multivariate analysis indicated that the absence of a maze procedure in the presence of AF during mitral valve replacement or repair was an independent predictor of cardiac death and major adverse events.57 Overall, the maze procedure was associated with better event-free survival. Bando et al also reported better survival in mitral valve patients who Pagé et al. Surgical Therapy 69 RECOMMENDATION We recommend that a surgical AF ablation procedure be undertaken in association with mitral valve surgery in patients with AF when there is a strong desire to maintain sinus rhythm, the likelihood of success of the procedure is deemed to be high, and the additional risk is low (Strong Recommendation, Moderate-Quality Evidence). RECOMMENDATION We recommend that closure (excision or obliteration) of the left atrial appendage be undertaken as part of the surgical ablation of AF associated with mitral valve surgery (Strong Recommendation, Low-Quality Evidence). We suggest that closure of the left atrial appendage be undertaken as part of the surgical ablation of persistent AF in patients undergoing aortic valve surgery or coronary artery bypass surgery if this does not increase the risk of the surgery (Conditional Recommendation, Low-Quality Evidence). Values and preferences. These recommendations place a high value on stroke reduction and a lower value on any concomitant loss of atrial transport with left atrial appendage closure. R G Values and preferences. This recommendation recognizes that individual institutional experience and patient considerations best determine for whom the surgical procedure is performed. tion of sinus rhythm not only improves survival in this group but also reduces the risks for stroke, other thromboembolism, and anticoagulant-related hemorrhage.58,59,62,63 Furthermore, one study reported that the absence of a maze procedure was the only risk factor for late stroke in patients undergoing mechanical mitral valve replacement.62 This high freedom from late stroke likely is attributable to excision or obliteration of the left atrial appendage—an integral component of the maze procedure—in addition to restoration of sinus rhythm in the majority of patients. O ED underwent the maze procedure in the presence of preoperative AF, compared with patients who underwent mitral valve surgery alone.58 On the other hand, there was no significant difference in survival data in the Mayo Clinic experience,55 whereas Bando et al have, in a retrospective study, reported that patients with the adjunct of a maze procedure showed a similar high degree of freedom from cardiovascular-related death (96.9%) and stroke (98.2%), compared with a group of patients without preoperative AF.58,59,62 Although these reports constitute low-quality evidence because of their retrospective design, they suggest that the maze procedure may improve survival when combined with mitral valve repair. In addition, other reports have failed to demonstrate a difference in mortality and morbidity early after surgery, whether the maze procedure is carried out concomitantly with mitral valve surgery or not.41,54,58-61 RECOMMENDATION BA We recommend that patients with asymptomatic lone AF, in whom AF is not expected to affect cardiac outcome, should not be considered for surgical therapy for AF (Strong Recommendation, Low-Quality Evidence). EM Values and preferences. This recommendation recognizes that patients with lone AF are at low risk for stroke or other adverse cardiovascular outcomes. Thus, elimination of AF in the absence of a high number of symptoms is unlikely to result in an improvement in quality of life. RECOMMENDATION In patients with AF who are undergoing aortic valve surgery or coronary artery bypass surgery, we suggest that a surgical AF ablation procedure be undertaken when there is a strong desire to maintain sinus rhythm, the success of the procedure is deemed to be high, and the additional risk low (Conditional Recommendation, Low-Quality Evidence). Values and preferences. This recommendation recognizes that left atrial endocardial access is not routinely required for aortic or coronary surgery. This limits ablation to newer epicardial approaches. Stroke The risk for late stroke after a maze procedure remains remarkably low throughout the surgical literature.4-7,9,13,36,46,52,54-63 Recent data suggest that restora- Lesion Set The original cut-and-sew Cox Maze III procedure has been modified in 2 main ways: (1) the use of ablative energy sources deployed with new devices and (2) the elimination of some lines of block. The latter changes consisted of limiting the lesions to electrically isolating the pulmonary veins (PVs) from the rest of the left atrium (Fig. 1), avoiding connecting lines to the base of the left atrial appendage and to the mitral isthmus, and also avoiding ablation in the right atrium. According to the Heart Rhythm Society recommendation document, the term maze should apply only to the lesion sets mimicking that of the Cox Maze III procedure.30 Modifications allowed to this terminology include the replacement of most of the Cox Maze III incisions with bipolar radiofrequency (Fig. 2, often referred to as the “Cox Maze IV procedure”)13,41,44,45,47-50,54,64 or with cryothermic devices.60 Less extensive lesion patterns should not be referred to as a maze. Although new technologies such as bipolar radiofrequency may reliably produce transmural lines of block and can be applied minimally invasively for PVs, they do not allow secure performance of connecting lines in the left atrial isthmus or inside the right atrium.13,25,26 Thus, they cannot allow the complete performance of the original lesion pattern of the Cox Maze III procedure necessary for optimal results in cases of persistent or permanent AF. On the other hand, recent studies have begun to explore the role of isolation of the PVs for paroxysmal AF.14-26 These studies usually report small sample sizes and limited follow-up. In a series of minimally invasive bilateral PVs, Edgerton et al reported that at 6-month follow-up, 86% of patients with paroxysmal AF were in normal sinus rhythm as evaluated by Holter monitor, pacemaker interrogation, or event monitor.15 Unfortunately, the 70 Canadian Journal of Cardiology Volume 27 2011 Ao LAA exclusion PA LAA PV isolation lesions PV PV PV PV LV IVC R G Figure 1. Isolation of the left- and right-sided pulmonary veins performed with the use of an irrigated bipolar radiofrequency probe (fat dotted lines). Pattern referred to the PVI procedure in Table 1. The site of exclusion of the left atrial appendage is indicated by the sharp dotted lines. Ao, ascending aorta; IVC, projection of the inferior vena cava; LAA, left atrial appendage; LV, left ventricle; PA, pulmonary artery; PV, pulmonary veins. Postoperative Care and Anticoagulation After AF Surgery Ad et al developed a strict follow-up program designed to adhere to the Heart Rhythm Society guidelines.30,65 In brief, it consisted of a detailed AF registry that included a statistical platform that interacted with an institutional database. The AF registry tracked all patients’ preoperative, operative, and postoperative characteristics, as well as patients’ health-related quality of life. Clinical information and algorithm-driven protocols served as a basis for recommendations to the referring physicians. The clinical information collected included (1) patients’ self-reported rhythm, (2) current medications, (3) any readmissions and cardiac intervention that had taken place during the interim, and (4) the date of the last visit to the cardiologist. Diagnostic (electrocardiography, Holter monitoring, 1-week monitoring, or pacemaker interrogation) rhythm information and echocardiography were obtained. Then the appropriateness of antiarrhythmic drugs and anticoagulation was decided on, depending on the clinical algorithm.65 Incidentally, the authors recommended discontinuation of warfarin therapy whenever long-term monitoring confirmed rhythm status and atrial contraction assured the absence of intra-atrial stasis for a long period of time after surgery. However, Beukema and Sie recommend a more conservative approach with respect to anticoagulation.54,56 Since reliable monitoring was not always available and a low flow state could not be ruled out in several patients, most of their patients were still on anticoagulant therapy at long-term follow-up, including patients with bioprosthetic mitral valve replacement. It should also be emphasized that the rate of recurrence of AF is not stable over time and that the moment of AF reappearance is uncertain.54 Therefore, in the absence of strict continuous monitoring capabilities and the lack of a clinical program with algorithm-driven treatment protocols, it is probably best to maintain anticoagulation therapy despite its inherent inconveniences. This conservative approach constitutes the rationale for our recommendation on postoperative anticoagulation therapy. There are new and less troublesome options than warfarin for thromboembolism prophylaxis soon to be available for many of these patients.66 O ED Pulmonary vein isolation procedure EM BA results of their PV approach have been disappointing in patients with persistent or longstanding AF because freedom from AF off drugs was achieved in only 32% at 6 months.15 Thus, we propose the following algorithm of surgical ablation, which is based on the type of AF and the nature of underlying cardiac abnormalities (Table 1): The recommended lesion set ranges from PVs alone (as shown in Fig. 1) to a bi-atrial complete Cox Maze lesion pattern (as shown in Fig. 2). In between these extremes, PVs (in pairs or with a box lesion) may be associated with connecting lines to the left atrial appendage and the mitral valve annulus (PVI⫹ in Table 1, also termed left atrial procedure and Fig. 2, A). The full Cox Maze lesion set (CM in Table 1) should include the left atrial procedure (Fig. 2, A) plus right atrial lines along the sulcus terminalis and a line from the right atrial free wall to the annulus of the tricuspid valve (Fig. 2, B), plus right atrial isthmus ablation (Fig. 2, C). All procedures must include exclusion or resection of the left atrial appendage. Based on our review of the recent literature, we would recommend the full modified Cox Maze III pattern (as shown in Fig. 2, A to Fig. 2, C)64 for patients with persistent or long-standing AF. Alternatively, the left atrial procedure (termed “PVI⫹” in Table 1 and also shown in Fig. 2, A) may be used in these patients on the surgeon’s judgement to shorten the operative time. The PVI procedure (as shown in Fig. 1) should be confined to patients with lone paroxysmal AF and paroxysmal AF with nonmitral valve disease. RECOMMENDATION We recommend that oral anticoagulant therapy be continued following surgical AF ablation in patients with a CHADS2 score ⱖ2 (Strong Recommendation, ModerateQuality Evidence). We suggest that oral anticoagulant therapy be continued following surgical AF ablation in patients who have undergone mechanical or bioprosthetic mitral valve replacement (Conditional Recommendation, Low-Quality Evidence). Values and preferences. These recommendations place a high value on minimizing the risk of stroke and a lower value in the utility of long-term monitoring to document the absence of AF. Conclusion The Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation suggests the following Pagé et al. Surgical Therapy 71 Cox Maze III ablation pattern A. Left atrial lesions MV LAA LPV RPV B. Right atrial lesions External view C. Right atrial lesions Internal view RAA O ED RAA TV SVC IVC SVC FO CS RSPV IVC R G RIPV EM BA Figure 2. Cox Maze III ablation pattern. (A) Left-sided lesion set. The left atrium is shown as viewed from the right side by the surgeon through an atriotomy in the Waterston’s groove. Ablation lines inside the left atrium (dotted lines) shown as they can be performed using various ablation devices. Irrigated radiofrequency probes or cryosurgical probes are preferred. LAA indicates left atrial appendage excised. (B) Right-sided lesion set. The right atrium is shown as viewed from the right side by the surgeon. The vertical dotted line indicates an ablation line in the right atrium between the superior and inferior vena cavae; it can be performed with a bipolar radiofrequency probe or cryosurgical probe. An incision on the central part of this line is made to open the right atrium. Additional lines are performed on the free wall until the right atrioventricular groove and along the right atrial appendage. The double dotted line indicates isolation of the right pulmonary veins with radiofrequency energy. (C) Right-sided lesion set (continued). The right atrium is shown open as viewed from the right side by the surgeon. Ablation lines (dark dotted lines) are performed inside the right atrium. See text and reference 64 for details. CS, coronary sinus; FO, fossa ovalis; IVC, inferior vena cava; LAA, left atrial appendage; LPV, left pulmonary veins; MV, mitral valve; RAA, right atrial appendage; RIPV, right inferior pulmonary vein; RPV, right pulmonary veins; RSPV, right superior pulmonary vein; SVC, superior vena cava; TV, tricuspid valve. indications for surgical treatment of AF: (1) symptomatic patients with AF undergoing other cardiac surgical procedures; (2) selected asymptomatic patients with AF undergoing cardiac surgery in whom the ablation can be performed with minimal Table 1. Recommended type-specific surgical strategies* Cardiac status or type of atrial fibrillation Lone atrial fibrillation Mitral valve surgery Aortic valve/CABG surgery Paroxysmal Persistent, mixed, or continuous PVI PVI⫹ PVI PVI⫹ Bi-atrial (CM) or PVI⫹ PVI⫹ CABG, coronary artery bypass grafting procedure; CM, lesion set mimicking the full Cox Maze III procedure including left atrial procedure (as in Fig. 2, A) plus right atrial lines along the sulcus terminalis and to the tricuspid valve, plus right atrial isthmus ablation (as in Fig. 2, B); PVI, pulmonary vein isolation (see Fig. 1); PVI⫹, left atrial procedure consisting of pulmonary vein isolation (in pairs or with a box lesion) and connecting lines to the left atrial appendage and the mitral valve annulus (see Fig. 2, A). * All procedures must include exclusion or resection of the left atrial appendage. risk; and (3) symptomatic patients with AF who prefer a surgical approach, have experienced 1 or more failed attempts at catheter ablation, or are not candidates for catheter ablation.30 We modified these recommendations to take into account the recent data on the results of the various surgical options to treat AF. It should also be recognized that all treatment options are not available in all centres dealing with challenging cardiac disorders. There may be significant differences in the experience and skills of the teams in various institutions. The quality of evidence varies significantly with regard to the multiple aspects of surgical care in the field of AF. We therefore developed the recommendations with respect to AF surgery, along with a type-specific surgical algorithm shown in Table 1, to help surgeons select the most appropriate procedure based on the patient’s underlying cardiac status and pattern of AF. References 1. Cox JL, Canavan TE, Schuessler RB, et al. The surgical treatment of atrial fibrillation II. Intraoperative electrophysiologic mapping and description 72 Canadian Journal of Cardiology Volume 27 2011 2. Garrey WE. Auricular fibrillation. Physiol Rev 1924;4:215-50. 3. Cox JL, Ad N, Palazzo T, et al. Current status of the maze procedure for the treatment of atrial fibrillation. Semin Thorac Cardiovasc Surg 2000; 12:15-9. 4. Raanani E, Albage A, David T, Yau T, Armstrong S. The efficacy of the Cox/maze procedure combined with mitral surgery: a matched control study. Eur J Cardiothorac Surg 2001;19:438-42. 5. Prasad SM, Maniar HS, Camillo CJ, et al. The Cox maze III procedure for lone atrial fibrillation: long-term efficacy in patients undergoing lone versus concomitant procedures. J Thorac Cardiovasc Surg 2003; 126:1822-8. 6. McCarthy PM, Gillinov AM, Castle L, Chung M, Cosgrove D III. The Cox-maze procedure: the Cleveland Clinic experience. Semin Thorac Cardiovasc Surg 2000;12:25-9. 7. Schaff HV, Dearani JA, Daly RC, Orszulak TA, Danielson GK. Coxmaze procedure for atrial fibrillation: Mayo Clinic experience. Semin Thorac Cardiovasc Surg 2000;12:30-7. 8. Arcidi JM Jr, Doty DB, Millar RC. The maze procedure: the LDS hospital experience. Semin Thorac Cardiovasc Surg 2000;12:38-43. 9. Ballaux PKEW, Geuzebroek GSC, van Hemel NM, et al. Freedom from atrial arrhythmias after classic maze III surgery: a 10-year experience. J Thorac Cardiovasc Surg 2006;132:1433-40. 22. Gillinov AM, Svensson LG. Ablation of atrial fibrillation with minimally invasive mitral surgery. Ann Thorac Surg 2007;84:1041-2. 23. Moten SC, Rodriguez E, Cook RC, et al. New ablation techniques for atrial fibrillation and the minimally invasive cryo-maze procedure in patients with lone atrial fibrillation. Heart Lung Circ 2007;16(suppl 3): S88-93. 24. Suwalski P, Suwalski G, Wilimski R, et al. Minimally invasive off-pump video-assisted endoscopic surgical pulmonary vein isolation using bipolar radiofrequency ablation—preliminary report. Kardiol Pol 2007;65:370-4. 25. Saltman AE. Minimally invasive surgery for atrial fibrillation. Semin Thorac Cardiovasc Surg 2007;19:33-8. 26. Beyer E, Lee R, Lam, BK. Point: Minimally invasive bipolar radiofrequency ablation of lone atrial fibrillation: early multicenter results. J Thorac Cardiovasc Surg 2009;137:521-6 27. Haissaguerre M, Jais P, Shah DC, et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med 1998;339:659-66. 28. Oral H. Mechanisms of atrial fibrillation: lessons from studies in patients. Prog Cardiovasc Dis 2005;48:29-40. 29. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation— executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol 2006;48:854-906. Available at: http:// content.onlinejacc.org. Accessed August 22, 2006. R G 10. Jessurun ER, van Hemel NM, Defauw JAMT, et al. Results of maze surgery for lone paroxysmal atrial fibrillation. Circulation 2000;101: 1559-67. 21. Pruitt JC, Lazzara RR, Ebra G. Minimally invasive surgical ablation of atrial fibrillation: the thoracoscopic box lesion approach. J Interv Card Electrophysiol 2007;20:83-7. O ED of the electrophysiologic basis of AFL and atrial fibrillation. J Thorac Cardiovasc Surg 1991;101:406-26. BA 11. Lönnerholm S, Blomström P, Nilsson L, et al. Effects of the maze operation on health-related quality of life in patients with atrial fibrillation. Circulation 2000;101:2607-11. 12. Kosakai Y. Treatment of atrial fibrillation using the maze procedure: the Japanese experience. Semin Thorac Cardiovasc Surg 2000;12:44-52. EM 13. Shen J, Bailey MS, Damiano RJ. The surgical treatment of atrial fibrillation. Heart Rhythm 2009;6:S45-S50. 14. Wolf RK, Schneeberger EW, Osterday R, et al. Video-assisted bilateral pulmonary vein isolation and left atrial appendage exclusion for atrial fibrillation. J Thorac Cardiovasc Surg 2005;130:797-802. 15. Edgerton JR, Edgerton ZJ, Weaver T, et al. Minimally invasive pulmonary vein isolation and partial autonomic denervation for surgical treatment of atrial fibrillation. Ann Thorac Surg 2008;86:35-9. 16. McClelland JH, Duke D, Reddy R. Preliminary results of limited thoracotomy: new approach to treat atrial fibrillation. J Cardiovasc Electrophysiol 2007;18:1289-95. 30. Calkins H, Brugada J, Packer DL, et al; Heart Rhythm Society (HRS) Task Force on Catheter Ablation of Atrial Fibrillation, European Heart Rhythm Association (EHRA), European Cardiac Arrhythmia Society (ECAS), American College of Cardiology (ACC), American Heart Association (AHA), and Society of Thoracic Surgeons (STS). Report of the HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. Europace 2007;9:330-79. 31. Chua LY, Schaff HV, Orszulak TA, Morris JJ. Outcome of mitral valve repair in patients with preoperative atrial fibrillation. J Thorac Cardiovasc Surg 1994;107:408-11. 32. Quader MA, McCarthy PM, Gillinov AM, et al. Does preoperative atrial fibrillation reduce survival after coronary artery bypass grafting? Ann Thorac Surg 2004;77:1514-22. 33. Ngaage DL, Schaff HV, Mullany CJ, et al. Does preoperative atrial fibrillation influence early and late outcomes of coronary artery bypass grafting? J Thorac Cardiovasc Surg 2007;133:182-9. 17. Wudel JH, Chaudhuri P, Hiller JJ. Video-assisted epicardial ablation and left atrial appendage exclusion for atrial fibrillation: extended follow-up. Ann Thorac Surg 2008;85:34-8. 34. Ngaage DL, Schaff HV, Barnes SA, et al. Prognostic implications of preoperative atrial fibrillation in patients undergoing aortic valve replacement: is there an argument for concomitant arrhythmia surgery? Ann Thorac Surg 2006;82:1392-9. 18. Yilmaz A, Van Putte BP, Van Boven WJ. Completely thoracoscopic bilateral pulmonary vein isolation and left atrial appendage exclusion for atrial fibrillation. J Thorac Cardiovasc Surg 2008;136:521-2. 35. Ngaage DL, Schaff HV, Mullany CJ, et al. Influence of preoperative atrial fibrillation on late results of mitral repair: is concomitant ablation justified? Ann Thorac Surg 2007;84:434-42. 19. Sirak J, Jones D, Sun B, et al. Toward a definitive, totally thoracoscopic procedure for atrial fibrillation. Ann Thoracic Surgery 2008;86:1960-4. 36. Lim E, Barlow CW, Hosseinpour AR, et al. Influence of atrial fibrillation on outcome following mitral valve repair. Circulation 2001;104(12 suppl 1):I59-I63. 20. Matsutani N, Takase B, Ozeki Y, et al. Minimally invasive cardiothoracic surgery for atrial fibrillation: a combined Japan-US experience. Circ J 2008;72:434-6. 37. Obadia JF, el Farra M, Bastien OH. Outcome of atrial fibrillation after mitral valve repair. J Thorac Cardiovasc Surg 1997;114:179-85. Pagé et al. Surgical Therapy 73 38. Geidel S, Ostermeyer J, Lass M, et al. Three years experience with monopolar and bipolar radiofrequency ablation surgery in patients with permanent atrial fibrillation. Eur J Cardiothorac Surg 2005;27:243-9. 53. Khargi K, Hutten BA, Lemke B, Deneke TH. Surgical treatment of atrial fibrillation: a systematic review. Eur J Cardiothorac Surg 2005; 27:258-65. 39. Jessurun ER, van Hemel NM, Kelder JC, et al. Mitral valve surgery and atrial fibrillation: is atrial fibrillation surgery also needed? Eur J Cardiothorac Surg 2000;17:530-7. 54. Beukema WP, Sie HT, Ramdat Misier AR, Delnoy PPHM, Wellens HJJ, Elvan A. Intermediate to long-term results of radiofrequency modified maze procedure as an adjunct to open-heart surgery. Ann Thorac Surg 2008;86:1409-14. 41. Sie HT, Beukema WP, Elvan A, Ramdat Misier AR. Long-term results of irrigated radiofrequency modified maze procedure in 200 patients with concomitant cardiac surgery: six years experience. Ann Thorac Surg 2004; 77:512-7. 42. Raanani E, Albage A, David T, Yau T, Armstrong S. The efficacy of the Cox/Maze procedure combined with mitral surgery: a matched control study. Eur J Cardiothorac Surg 2001;19:438-42. 43. Pasic M, Bergs P, Muller P, et al. Intraoperative radiofrequency maze ablation for atrial fibrillation: the Berlin modification. Ann Thorac Surg 2001;72:1484-91. 44. Mohr FW, Fabricius AM, Falk V, et al. Curative treatment of atrial fibrillation with intraoperative radiofrequency ablation: short-term and midterm results. J Thorac Cardiovasc Surg 2002;123:919-27. 45. Raman J, Ishikawa S, Storer MM, Power JM. Surgical radiofrequency ablation of both atria for atrial fibrillation: results of a multicenter trial. J Thorac Cardiovasc Surg 2003;126:1357-66. 56. Beukema WP, Sie HT. General discussion. In: Beukema WP, Sie HT, eds. Radiofrequency Ablation in the Treatment of Atrial Fibrillation: Cardiological and Surgical Perspectives [thesis]. Nigmegen, The Netherlands: Universiteit van Nigmegen, 2010:243-76. 57. Kim JB, Kim HJ, Moon DH, et al. Long-term outcomes after surgery for rheumatic mitral valve disease: valve repair versus mechanical valve replacement. Eur J Cardiothorac Surg 2010;37:1039-46. 58. Bando K, Kobayashi J, Kosakai Y, et al. Impact of Cox maze procedure on outcome in patients with atrial fibrillation and mitral valve disease. J Thorac Cardiovasc Surg 2002;124:575-83. 59. Itoh A, Kobayashi J, Bando K, et al. The impact of mitral valve surgery combined with maze procedure. Eur J Cardiothorac Surg 2006;29:1030-5. 60. Baek MJ, Na CY, Oh SS, et al. Surgical treatment of chronic atrial fibrillation combined with rheumatic mitral valve disease: effect of the cryomaze procedure and predictors for late outcome. Eur J Cardiothorac Surg 2006;30:728-36. R G 46. Jessurun ER, van Hemel NM, Defauw JJ, et al. A randomized study of combining maze surgery for atrial fibrillation with mitral valve surgery. J Cardiovasc Surg 2003;44:9-18. 55. Handa N, Schaff HV, Morris JJ. Outcome of valve repair and the Cox maze procedure for mitral regurgitation and associated atrial fibrillation. J Thorac Cardiovasc Surg 1999;118:628-35. O ED 40. Reston JT, Shuhaiber JH. Meta-analysis of clinical outcomes of mazerelated surgical procedures for medically refractory atrial fibrillation? Eur J Cardiothorac Surg 2005;28:724-30. BA 47. Doukas G, Samani NJ, Alexiou C, et al. Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation. JAMA 2005; 294:2323-9. EM 48. Filho CAC, Lisboa LAF, Dallan L, et al. Effectiveness of the maze procedure using cooled-tip radiofrequency ablation in patients with permanent atrial fibrillation and rheumatic mitral valve disease. Circulation 2005; 112(suppl 1):20-5. 49. Akpinar B, Guden M, Sagbas E, et al. Combined radiofrequency modified maze and mitral valve procedure through a port access approach: early and mid-term results. Eur J Cardiothorac Surg 2003;24:223-30. 50. Deneke T, Khargi K, Grewe PH, et al. Efficacy of an additional maze procedure using cooled-tip radiofrequency ablation in patients with chronic atrial fibrillation and mitral valve disease: a randomized, prospective trial. Eur Heart J 2002;23:558-66. 51. de Lima G, Kalil RA, Leiria TLL, et al. Randomized study of surgery for patients with permanent atrial fibrillation as a result of mitral valve disease. Ann Thorac Surg 2004;77:2089-95. 52. Barnett SD, Ad N. Surgical ablation as treatment for the elimination of atrial fibrillation: a meta-analysis. J Thorac Cardiovasc Surg 2006;131:1029-35. 61. Maltais S, Forcillo J, Bouchard D, et al. Long-term results following concomitant radiofrequency modified maze ablation for atrial fibrillation. J Card Surg 2010;25:608-13. 62. Bando K, Kobayashi J, Hirata M, et al. Early and late stroke after mitral valve replacement with a mechanical prosthesis: risk factor analysis of a 24-year experience. J Thorac Cardiovasc Surg 2003;126:358-64. 63. Cox JL, Ad N, Palazzo T. Impact of the maze procedure on the stroke rate in patients with atrial fibrillation. J Thorac Cardiovasc Surg 1999;118: 833-40. 64. Yii M, Yap CH, Nixon I, Chao V. Modification of the Cox-maze III procedure using bipolar radiofrequency ablation. Heart Lung Circ 2007; 16:37-49. 65. Ad N, Henry L, Hunt S, Stone L. The implementation of a comprehensive clinical protocol improves long-term success after surgical treatment of atrial fibrillation. J Thorac Cardiovasc Surg 2010;139: 1146-52. 66. Cairns JA, Connolly S, McMurtry S, Stephenson M, Talajic M, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol 2011; 27:74-90. Canadian Journal of Cardiology 27 (2011) 74 –90 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Prevention of Stroke and Systemic Thromboembolism in Atrial Fibrillation and Flutter John A. Cairns, MD, FRCPC,a Stuart Connolly, MD, FRCPC,b Sean McMurtry, MD, PhD, FRCPC,c Michael Stephenson, MD, FCFP,b Mario Talajic, MD, FRCPC,d and the CCS Atrial Fibrillation Guidelines Committeee From the University of British Columbia, Vancouver, British Columbia, Canada b McMaster University, 1280 Main Street West, Hamilton, Ontario, Canada c d e O ED a University of Alberta, Edmonton, Alberta, Canada Université de Montréal, Montréal, Québec, Canada For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and Achieving Consensus. Can J Cardiol 2011;27:27-30. ABSTRACT RÉSUMÉ L’incidence annuelle de l’accident vasculaire cérébral (AVC) attribuable à la fibrillation auriculaire (FA) est de 4.5 %, causant la mort ou l’invalidité permanente dans plus de la moitié des cas. Cette incidence varie de moins de 1 % à plus de 20 % par année en fonction des facteurs de risque: insuffisance cardiaque, hypertension, âge, diabète et antécédents d’AVC ou d’ischémie cérébrale transitoire. Le risque d’hémorragie majeure sous traitement avec les antagonistes de la vitamine K varie entre 1 % et 12 % par année et s’avère lié à beaucoup d’autres facteurs. L’index de CHADS2 et le score HAS-BLED sont utiles pour la prédiction du risque d’AVC ou d’hémorragie. Le risque d’AVC est réduit de 64% avec le traitement aux antagonistes de la vitamine K et de 19% avec l’aspirine. Comparativement à l’aspirine, les antagonistes de la vitamine K réduisent ce risque de 39%. Le Dabigatran est supérieur à la warfarine pour la prévention du risque d’AVC sans augmentation du risque de saignement majeur. Nous recommandons que le risque d’AVC et de saignement majeur soit déterminé chez tous les patients avec FA ou flutter auriculaire (paroxystique, persistant ou permanent) et que la plupart reçoivent un traitement antithrom- EM BA R G The stroke rate in atrial fibrillation is 4.5% per year, with death or permanent disability in over half. The risk of stroke varies from under 1% to over 20% per year, related to the risk factors of congestive heart failure, hypertension, age, diabetes, and prior stroke or transient ischemic attack (TIA). Major bleeding with vitamin K antagonists varies from about 1% to over 12% per year and is related to a number of risk factors. The CHADS2 index and the HAS-BLED score are useful schemata for the prediction of stroke and bleeding risks. Vitamin K antagonists reduce the risk of stroke by 64%, aspirin reduces it by 19%, and vitamin K antagonists reduce the risk of stroke by 39% when directly compared with aspirin. Dabigatran is superior to warfarin for stroke prevention and causes no increase in major bleeding. We recommend that all patients with atrial fibrillation or atrial flutter, whether paroxysmal, persistent, or permanent, should be stratified for the risk of stroke and for the risk of bleeding and that most should receive antithrombotic therapy. We make detailed recommendations as to the preferred agents in various types of patients and for Received November 11, 2010. Accepted November 24, 2010. Corresponding author: Dr John A. Cairns, GLD Health Care Centre, Room 9113, 2775 Laurel St, Vancouver, BC, V5Z 1M9, Canada. E-mail: jacairns@medd.med.ubc.ca The disclosure information of the authors and reviewers is available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.007 Cairns et al Stroke Prevention in Atrial Fibrillation 75 Risk of Stroke Risk factors and risk estimation schemes by about 2.0% for each 1-point increase in CHADS2 score (from 1.9% with a score of 0 to 18.2% with a score of 6). This scheme was also evaluated in comparison with several others among 2580 patients receiving aspirin in 6 prospective trials.15 The CHADS2 index identified increments in stroke risk similar to those identified in the prior validation and was better than the other schema at discriminating medium- and highrisk patients. Although a recent systematic review16 of 12 risk stratification schemes noted that none has been compared in a single cohort of adequate size and diversity, the CHADS2 index has appropriately become the favoured choice for determining risk of stroke and guiding choice of antithrombotic therapy.13 The European Society of Cardiology (ESC) has recently updated its guidelines for the management of AF17 and has incorporated the new Birmingham 2009 schema (known by the acronym CHA2DS2-VASc) for the prediction of stroke risk.18 The schema was validated and compared with standard criteria in a subset of 1577 patients documented in the Euro Heart Survey on AF population. The schema is similar to the CHADS2, but gives 2 points for age of 75 years or older and 1 point for age between 65 and 74 years, 1 point for vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque), and 1 point for female sex. The ESC recommends that the widely used and easily remembered CHADS2 be applied first; only if the score is under 2 should the new schema be applied to further grade risk of stroke in patients at low risk. The degree of risk can be refined, and if any of the additional risk factors embodied in the CHA2DS2-VASc are present, the score will be increased and may influence the physician to choose more potent antithrombotic management. Conversely, if the score remains at 0, the patient is clearly at very low risk of stroke and may not require any antithrombotic agent. The ESC recommends that a patient EM BA R G In the 5 landmark randomized clinical trials of oral anticoagulants (OACs) among patients with nonvalvular atrial fibrillation (AF),1-6 most of whom had no previous stroke or TIA, control subjects had a mean 4.5% annual incidence of stroke (range, 3%-7%), over half of which resulted in death or permanent disability.7 The mean annual incidence of the composite of stroke or other systemic emboli was 5% (range, 3%7.4%). These subjects had no contraindications to warfarin and no echocardiographic evidence of rheumatic valvular disease. The observed rates of stroke and other systemic embolism were similar to those reported in earlier cohorts8 and likely are representative of individuals in the general population with AF and not receiving antithrombotic therapy. In the United States, the annual risk of stroke attributable to AF is 1.5% in the age group 50 to 59 years, rises to 23.5% in the age group 80 to 89 years, and overall is 15%.9 An overview of the randomized control trials of warfarin therapy in AF7 determined that previous stroke or TIA, increasing age, history of hypertension, and diabetes were statistically significant multivariate predictors of stroke. Annual stroke risk ranged from 0 (patients younger than 60 years) to 1.3% (patients younger than 80 years with no other risk factors) and to 11.7% (patients with prior stroke or TIA). A recent systematic review10 examined the evidence identifying independent risk factors for stroke as reported in 7 studies selected according to rigourously defined criteria. The absolute annual risk of stroke varied 20 fold among patients grouped by various risk factors. Independent risk factors for stroke were the same as those previously identified7: stroke or TIA (relative risk [RR] 2.5), age (RR 1.5/decade), history of hypertension (RR 2.0), and diabetes mellitus (RR 1.7). Female sex was an independent risk factor in 3 of 6 cohorts, but coronary artery disease and clinical congestive heart failure were not found to be independent risk factors in any of these studies. Even though congestive heart failure and reduced ejection fraction have been identified only as univariate risk factors,7,10-12 they are included in current risk classification schemes.13,14 The review10 emphasized a variety of shortcomings of the studies, including inconsistencies in definitions of some of the risk factors, the use of antiplatelet therapies, and the stroke outcomes (ischemic strokes only, all strokes, strokes plus other systemic emboli, and strokes plus TIAs). The CHADS2 index14 (see Table 1 for the components of the acronym) assigns 1 point each for congestive heart failure, hypertension, age 75 years or older, and diabetes mellitus and 2 points for a history of stroke or TIA (Table 1). The scheme was validated and compared with 2 other schemes among 1733 Medicare beneficiaries aged 65 to 95 years who had been discharged from hospital with nonrheumatic AF and had not been prescribed warfarin. The CHADS2 index was the most accurate predictor of stroke, with the annual stroke rate increasing botique. Nos recommandations font état des agents antithrombotiques à favoriser dans les contextes cliniques de cardioversion, maladie cardiaque athérosclérotique concomitante, procédures diagnostiques ou chirurgicales avec risque d’hémorragie majeure associée, et en cas d’AVC ou de saignement majeur. Les alternatives au traitement antithrombotique sont brièvement discutées. O ED the management of antithrombotic therapies in the common clinical settings of cardioversion, concomitant coronary artery disease, surgical or diagnostic procedures with a risk of major bleeding, and the occurrence of stroke or major bleeding. Alternatives to antithrombotic therapies are briefly discussed. Table 1. The CHADS2 score for estimating stroke risk in patients with atrial fibrillation according to the presence of major risk factors CHADS2 risk criteria Score C H A D S2 Congestive heart failure Hypertension Age ⬎75 years Diabetes mellitus (Prior) stroke or TIA 1 1 1 1 2 CHADS2 score Adjusted stroke rate, %/y (95% CI) 0 1 2 3 4 5 6 1.9 (1.2-3.0) 2.8 (2.0-3.8) 4.0 (3.1-5.1) 5.9 (4.6-7.3) 8.5 (6.3-11.1) 12.5 (8.2-17.5) 18.2 (10.5-27.4) Data from Gage BF, et al.14 76 Canadian Journal of Cardiology Volume 27 2011 heart failure are uncertain. The risk of stroke is also substantial among patients with hypertrophic cardiomyopathy and AF. These risks have not been rigourously evaluated, and antithrombotic therapies for patients with AF and thyrotoxicosis or hypertrophic cardiomyopathy should be based on the presence of validated stroke risk factors.9,13,17 Atrial flutter There is a widespread perception that the risk of stroke is less with atrial flutter than with AF. However, a retrospective analysis of a large database of elderly hospitalized patients found little difference in the risk ratios for atrial flutter (1.4) and AF (1.6).25 By 8 years of follow-up, more than half the patients with atrial flutter had developed AF, and these patients were more likely to experience a stroke. The development of AF was more likely among patients with congestive heart failure, rheumatic heart disease, hypertension, and diabetes mellitus. O ED Trials of Antithrombotic Therapies Oral vitamin K antagonists and antiplatelet agents An overview7 of the initial 5 randomized trials of oral vitamin K antagonists compared with no treatment found the incidence of ischemic stroke was reduced from 4.5% per year to 1.4% per year (relative risk reduction [RRR] 68%; 95% CI, 50%-79%; P ⬍ .001). The rate of major hemorrhage with vitamin K antagonists was 1.3% per year vs 1% per year in controls. The most recent meta-analysis of such trials26 in- R G Figure 1. Randomized controlled trials (RCTs) of adjusted-dose warfarin (or other vitamin K antagonist in a small proportion of patients) vs placebo or no treatment. Point estimates of the relative risk reductions of stroke (ischemic plus hemorrhagic) with their associated 95% CIs are depicted for 5 trials of primary prevention and 1 of secondary prevention. The overall relative risk reduction is 64% (95% CI, 49%-74%). AFASAK, Atrial Fibrillation, ASpirin, AntiKoagulation; SPAF, Stroke Prevention in Atrial Fibrillation; BAATAF, Boston Area Anticoagulation Trial for Atrial Fibrillation; CAFA, Canadian Atrial Fibrillation; SPINAF, Stroke Prevention in Nonrheumatic Atrial Fibrillation; EAFT, European Atrial Fibrillation Trial. Reprinted from Hart RG et al26 with permission from Ann Intern Med. Paroxysmal AF EM BA with a score of 0 according to the CHA2DS2-VASc schema should receive either aspirin or no antithrombotic therapy, with the latter preferred; a patient with a score of 1 should receive either aspirin or OAC, with the latter preferred; and a patient with a score of 2 should receive OAC. This new schema may eventually be useful for patient management, but for the present, the CCS recommends ongoing use of the CHADS2 schema. The Stroke Prevention in Atrial Fibrillation (SPAF) trial6 found similar annual rates of ischemic stroke in patients with “recurrent” (3.2%) and “chronic” (3.3%) AF. A report from the Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events-Warfarin (ACTIVE-W), based on 1202 patients with paroxysmal AF and 5495 with persistent or permanent AF, confirmed similar rates of thromboembolic events.19 However, it is possible that the risk of stroke is less in patients whose episodes of AF are brief (⬍1 day) and selfterminating.20 The short-term risk of stroke appears to be higher in patients with recent-onset AF than in those with AF that first occurred more than 1 to 2 years ago.21,22 Among AF patients with prior stroke, the annual recurrence rate is about 12% without antithrombotic treatment.7,23 Several case series reported recurrence rates of 0.1% to 1.3% per day during the first 2 weeks following a cardioembolic stroke.24 Thyrotoxicosis and hypertrophic cardiomyopathy The risk of stroke in patients with thyrotoxic AF is substantial, although the mechanism and the relative role of congestive Figure 2. Randomized controlled trials (RCTs) of aspirin vs placebo or no treatment. Point estimates of the relative risk reductions of stroke (ischemic plus hemorrhagic) with their associated 95% CIs are depicted for 4 trials of primary prevention and 3 of secondary prevention. The overall relative risk reduction is 19% (95% CI, ⫺1% to 35%). AFASAK, Atrial Fibrillation, ASpirin, AntiKoagulation; SPAF, Stroke Prevention in Atrial Fibrillation; EAFT, European Atrial Fibrillation Trial; ESPS, European Stroke Prevention Study; LASAF, Low-dose Aspirin, Stroke, Atrial Fibrillation; UK-TIA, United Kingdom Transient Ischemic Attack; JAST, Japan Atrial fibrillation Stroke Trial. Reprinted from Hart RG et al26 with permission from Ann Intern Med. Cairns et al Stroke Prevention in Atrial Fibrillation 77 pidogrel might be noninferior to warfarin for the prevention of stroke, while offering the advantages of less bleeding and greater convenience. However, the ACTIVE-W trial32 found the RR for the composite outcome of stroke, non– central nervous system embolus, myocardial infarction, and vascular death was 1.44 (95% CI, 1.18-1.76; P ⫽ .0003) for the combination of clopidogrel plus aspirin (75 mg and 75-100 mg/d) vs warfarin (INR 2-3). Somewhat surprisingly, the RR for major bleeding was 1.10 (95% CI, 0.83-1.45) with the combination. It had also been expected that in patients not suitable for warfarin therapy, the combination of aspirin and clopidogrel might be more effective than aspirin alone. The ACTIVE-A trial33 did find that after a mean of 3.6 years, the risk of major vascular events was reduced by the combination (RR 0.89; 95% CI, 0.81-0.98; P ⫽ .01). However, major bleeding was increased by the combination (2.0% vs 1.3% per year; RR 1.57; 95% CI, 1.29-1.92; P ⬍ .01). O ED New non–vitamin-K-antagonist anticoagulants Ximelagatran is an oral direct thrombin inhibitor with predictable and stable pharmacokinetics and relatively low potential for interactions with other drugs and with foods. Coagulation monitoring and dose adjustments are not required. This agent was evaluated in 2 large trials employing noninferiority designs.34,35 In both, it was concluded that ximelagatran was noninferior to warfarin. The incidence of major bleeding was similar with the 2 agents, but all bleeding was significantly less with ximelagatran. However, both studies found a 6-fold excess of patients with elevations of alanine aminotransferase to greater than 3 times the upper limit of normal, usually within the first 6 months. The Food and Drug Administration did not approve the new agent, having concluded that the more convenient dose and monitoring regimens and less total bleeding did not outweigh concerns about hepatic toxicity and the inappropriately large noninferiority margins. Dabigatran is an oral direct thrombin inhibitor that is licensed for use in Canada and the United States. It was compared with warfarin in the Randomized Evaluation of LongTerm Anticoagulation Therapy (RE-LY) trial,36 in which 18,113 patients with AF (mean CHADS2⫽ 2.1) were randomized to dabigatran 110 mg twice daily, dabigatran 150 mg twice daily, or warfarin (INR 2-3) and followed for a median of 2.0 years. The mean time in the therapeutic range for warfarin was 64%. Rates of discontinuation of therapy by 2 years were 16.6% for warfarin, 20.7% for dabigatran 110 mg, and 21.2% for dabigatran 150 mg. Approximately 20% of subjects were taking aspirin in addition to their study drug. The rates of the principal outcome of all stroke (ischemic or hemorrhagic) or non– central nervous system embolus were 1.69% per year with warfarin, 1.53% per year with dabigatran 110 mg (RR 0.91; 95% CI, 0.74-1.11; P ⬍ .001 for noninferiority), and 1.11% per year with dabigatran 150 mg (RR 0.66; 95% CI, 0.53-0.82; P ⬍ .001 for superiority; Fig. 4). The RR of stroke or systemic embolus for dabigatran 150 mg vs 110 mg was 0.73 (95% CI, 0.58-0.91; P ⫽ .005). The rates of major bleeding were 3.36% per year with warfarin, 2.71% per year with dabigatran 110 mg (RR vs warfarin 0.8, P ⫽ .003), and 3.11% per year with dabigatran 150 mg (RR vs warfarin 0.93, P ⫽ .31 and RR vs dabigatran 110 mg 1.16, P ⫽ .052). The rates of the net clinical benefit outcome (a composite of stroke, systemic em- R G Figure 3. Randomized trials of adjusted-dose warfarin (or other vitamin K antagonist in a small proportion of patients) vs aspirin. Point estimates of the relative risk reductions of stroke (ischemic or hemorrhagic) with their associated 95% CIs are depicted for 7 trials of primary prevention and 1 of secondary prevention. The overall relative risk reduction is 39% (95% CI, 19%-53%). AFASAK, Atrial Fibrillation, ASpirin, AntiKoagulation; BAFTA, Birmingham Atrial Fibrillation Treatment of the Aged; Chinese ATAFS, Chinese Antithrombotic Therapy in Atrial Fibrillation; EAFT, European Atrial Fibrillation Trial; PATAF, Prevention of Arterial Thromboembolism in Atrial Fibrillation; SPAF, Stroke Prevention in Atrial Fibrillation. Reprinted from Hart RG et al27 with permission from Ann Intern Med. EM BA cluded 1 additional trial (of secondary prevention of stroke) and calculated an RRR of 64% (95% CI, 49% to 74%) for the more clinically meaningful outcome of all stroke (ischemic or hemorrhagic; Fig. 1). The absolute risk reduction (ARR) was 2.7% per year in primary prevention trials and 8.4% per year in the only secondary prevention trial. There was an excess of 0.3% per year (P ⫽ not significant) of major extracranial hemorrhage with vitamin K antagonist therapy but a statistically significant ARR of mortality of about 1.6% per year. The overview included trials of aspirin vs no treatment26 and reported an RRR for all stroke of 19% (95% CI, 1% to 35%; Fig. 2), with an ARR of 0.8% per year in primary prevention trials and 2.5% per year in secondary prevention trials. There were no significant differences in major extracranial hemorrhage or mortality. An update of this overview27 assessed trials of vitamin K antagonists vs aspirin and reported an RRR for all stroke of 39% (95% CI, 19%-53%) in favour of vitamin K antagonists (Fig. 3), equivalent to an ARR of about 0.9% per year for primary prevention and 7% per year for secondary prevention. There were no significant differences in major extracranial hemorrhage or mortality. The inclusion of 3 further trials comparing vitamin K antagonists with other antiplatelet agents did not importantly alter the findings. Warfarin adjusted to an international normalized ratio (INR) of 2 to 3 has been compared with various regimens of lower-dose warfarin plus aspirin28 and to warfarin at lower intensity and low fixed dose,29-31 but none of these regimens was as effective. It had been expected that in patients suitable for warfarin therapy, the combination of aspirin plus clo- 78 Canadian Journal of Cardiology Volume 27 2011 EM BA R G bolism, pulmonary embolism, myocardial infarction, death, or major bleeding) were 7.64% per year with warfarin, 7.09% per year with dabigatran 110 mg (RR vs warfarin 0.92; 95% CI, 0.84-1.02), and 6.91% per year with dabigatran 150 mg (RR vs warfarin 0.91; 95% CI, 0.82-1.00). Hence, in this group of patients with clear indications for warfarin therapy, dabigatran 110 mg twice daily was associated with rates of stroke and systemic embolism similar to those associated with warfarin, but with a rate of major hemorrhage that was lower. Compared with warfarin, dabigatran 150 mg twice daily was associated with lower rates of stroke and systemic embolism and a similar rate of major hemorrhage. Compared with dabigatran 110 mg, the 150-mg dose was associated with lower rates of stroke and systemic embolus but a strong trend toward more major hemorrhage. The data for the comparative beneficial and harmful effects of dabigatran vs warfarin among patients with AF are derived only from RE-LY and a relatively small pilot study (Prevention of Embolic and ThROmbotic events in patients with persistent atrial fibrillation).37 However, RE-LY enrolled over 18,000 patients. The recommendations made by previous national guidelines exercises have been based on a total of 2900 patients in the randomized trials of warfarin vs control, 3990 patients in the trials of aspirin vs control, and 3647 patients in the trials of warfarin vs aspirin. The results of RE-LY and studies of other newer anticoagulants, as they are published, must be taken into account in all subsequent guidelines exercises. Although dabigatran 110 mg twice daily was found to be as effective as warfarin and caused less major bleeding, and dabigatran 150 mg twice daily was found to be more effective than warfarin and with a similar risk of major bleeding, additional considerations are necessary in arriving at sensible recommendations for use. The subjects all had at least 1 risk factor for stroke (mean CHADS2 was 2.0), and patients with CrCl ⬍30 mL per minute and any condition that increased the risk of bleeding were excluded. Dyspepsia was twice as common in the dabigatran groups, gastrointestinal bleeding was more common, and patients receiving dabigatran discontinued study therapy almost 50% more often in the first year of therapy than O ED Figure 4. Cumulative hazard rates (y-axis) vs time in years (x-axis) for the primary outcome of stroke (ischemic or hemorrhagic) or systemic embolism, according to treatment group (dabigatran 150 mg twice daily, dabigatran 110 mg twice daily, or warfarin [INR 2-3]). RR, relative risk. Reprinted from Connolly SJ, et al36 with permission from N Engl J Med, © Massachusetts Medical Society. did those receiving warfarin. Although there was a trend to a reduction of the composite clinical outcome in the dabigatran groups, there was a trend to more frequent myocardial infarction with dabigatran, which was significant at the 150-mg dose. There was no hint of greater hepatic toxicity with dabigatran than with warfarin, but the total clinical experience extends to only a mean of 2 years, and careful long-term follow-up data are needed. Dabigatran tablets are much more costly than warfarin, but rigourous cost-effectiveness analyses will be needed to assess total costs. We recommend that when an OAC is indicated for stroke prevention, most patients should receive dabigatran in preference to warfarin. Possible exceptions would include patients with a propensity to dyspepsia, gastrointestinal bleeding, or both and those at substantial risk of coronary events (see more detailed discussion under the heading Coronary Artery Disease). The dose of 150 mg twice a day is preferable to 110 mg twice a day, except in patients of low body weight, decreased renal function, or at increased risk of major bleeding. Idraparinux is a specific inhibitor of activated factor X, which may be given in a fixed, weekly subcutaneous injection without coagulation monitoring. This agent was compared with vitamin K antagonists (INR 2-3) in the AMADEUS trial of 4576 patients.38 The trial was stopped early because of excess clinically relevant bleeding with idraparinux (19.7% vs 11.3% per year, P ⬍ .0001), at which point idraparinux was noninferior for the principal outcome of all stroke or systemic embolism (hazard ratio 0.71; 95% CI, 0.39-1.30; P ⫽ .007). Elderly patients and those with renal insufficiency were more at risk of excess bleeding, but clearly at the dose regimen tested, idraparinux would not be a suitable alternative to vitamin K antagonist therapy in AF patients. There are several available oral, direct-acting factor Xa inhibitor drugs that have proven effective and safe in studies of deep venous thrombosis and offer promise in the setting of AF. In the Apixaban Versus ASA to Reduce the Rate Of Embolic Stroke (AVERROES) trial,39 apixaban (5 mg twice a day) was compared with aspirin (81-324 mg daily) among patients with AF at more than very low risk of stroke in whom vitamin K antagonist therapy was unsuitable. The trial was terminated for early efficacy in 2010. In the Apixaban for the Prevention of Stroke in Subjects with Atrial Fibrillation (ARISTOTLE) trial,40 apixaban (5 mg twice a day) is being compared with warfarin (INR 2.5) among patients at somewhat higher risk of stroke. The expected enrollment is 15,000 patients, with completion in 2010. In the Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trial,41 which enrolled over 14,000 patients, rivaroxaban (20 mg/d) was compared to warfarin (INR 2.5) among patients with AF at risk of stroke and suitable for warfarin therapy. Rivaroxiban was noninferior to warfarin for the principal outcome of all stroke or systemic embolus. Atrial flutter Although there are no rigourous prospective data on the incidence of stroke among patients with atrial flutter, nor are there randomized trials of the value of anticoagulation, it is generally recommended that patients with atrial flutter be risk stratified and treated in the same manner as patients with AF.9,13 Cairns et al Stroke Prevention in Atrial Fibrillation 79 Clinical characteristic Score Hypertension Abnormal renal or liver function (1 point each) Stroke Bleeding Labile INRs Elderly (eg, age ⬎65 yr) Drugs or alcohol (1 point each) 1 1 or 2 1 1 1 1 1 or 2 Risk factor score Major bleeds (%/y) 0 1 2 3 4 5 1.13 1.02 1.88 3.74 8.70 12.50 Data from Pisters R, et al.46 EM BA R G Risk of Hemorrhage The efficacy of any antithrombotic therapy for the prevention of ischemic stroke must be balanced against the risk of major hemorrhage, particularly cerebral hemorrhage, which is often fatal. In each of the initial randomized trials of antithrombotic therapies, the principal outcome was the composite of ischemic stroke or systemic embolus. Although hemorrhage and the subsets of intracranial and intracerebral hemorrhage were generally reported, the net benefit for major clinical outcomes was not always clear. More recent trials and overviews have focused on the principal outcome of all stroke (ischemic plus hemorrhagic) or systemic embolus, a more meaningful outcome for patients and treating physicians. The incidence of extracranial major hemorrhage (usually without long-term sequellae among survivors) can be subjectively compared to the reduced incidence of all stroke in order to reach conclusions about the net patient benefits of antithrombotic therapies. The risk of hemorrhage depends on the specific antithrombotic agent (including dose and monitoring) and on a variety of patient characteristics. The risks of hemorrhage are lowest with either aspirin (75-325 mg/d) or clopidogrel (75 mg/d) alone, higher when they are combined, higher still with dabigatran 110 mg twice a day, and highest with dabigatran 150 mg per day and vitamin K antagonists, which carry similar risks. When vitamin K antagonists are used, the bleeding risk depends on the INR, the quality of monitoring, the duration of therapy (the risk is higher during the initial few weeks of therapy), and the stability of dietary and other factors that may alter the INR at a given dose of the chosen agent. The risk of bleeding is likely to be higher in common clinical practice than in the rigourous setting of a clinical trial or a dedicated, expert anticoagulation service. For most patients who are candidates for warfarin, an INR range of 2.0 to 3.0 with a target of 2.5 appears optimal.9,13 In a large cohort of patients, the risk of ischemic stroke, severity of stroke, and mortality rose sharply when INR fell to 1.5 to 1.9, but the risk of intracranial hemorrhage did not rise until INR values exceeded 3.9.42 A recent meta-analysis43 of studies that assigned hemorrhagic and thromboembolic events in patients taking anticoagulants to discrete INR ranges found that 44% of hemorrhages occurred when INRs were above the therapeutic range, 48% of thromboembolic events took place when INRs were below it, and the mean proportion of events that occurred when the patient’s INR was outside the therapeutic range was higher in the studies of shorter follow-up. Patients with a previous TIA or minor stroke may benefit from a somewhat higher INR of 2.0 to 3.5, with a target of 3.0.13,17,44 Patients at higher risk of cerebral hemorrhage, particularly those older than 75 years, may benefit from a somewhat lower INR range of 1.6 to 2.5, with a target of 2.0,13 although protection against ischemic stroke drops off sharply when INRs fall below this target. The HEMORR2HAGES scheme45 was developed from 3 previously published prediction rules, a recent systematic review, and a formal literature search. The scheme allotted 2 points for a previously documented episode of bleeding and 1 point each for hepatic or renal disease, ethanol abuse, malignancy, age ⬎75 years, reduced platelet count or function, rebleeding risk, hypertension (uncontrolled), anemia, genetic factors (CYP 2C19 SNPs), excessive falls (including neuropsychiatric disease), and stroke. When compared with the 3 earlier prediction rules in a population of elderly patients with AF45 who were receiving warfarin, aspirin, or no antithrombotic therapy, the new scheme provided good discrimination among patients with an annual risk of hospitalization for hemorrhage while receiving warfarin, which ranged from 1.9% to 12.3%. The new ESC guidelines for management of AF46 suggest the use of a new schema for the prediction of bleeding risk (Table 2). It is based on the presence of hypertension, abnormal liver or renal function, history of stroke or bleeding, labile INRs, elderly age (⬎65 years), and concomitant use of drugs that promote bleeding or excess alcohol use (HAS-BLED is the acronym)46 and was derived from the Euro Heart Survey on AF. The proposed schema relies on fewer and more readily obtained risk factors than earlier schemata do and performs at least as well as the HEMOR2RHAGES schema in the prediction of bleeding events. Documentation of a HAS-BLED score allows the clinician to assign the patient a risk of major bleeding ranging from about 1% (score 0-1) to 12.5% (score 5) and can be useful in decisions about the relative risks of stroke vs major bleeding with various antithrombotic therapies. Patients at high risk of major bleeding warrant caution in the use of antithrombotic therapies and closer monitoring and follow-up. We suggest the use of this new schema as a simpler alternative to the HEMOR2RHAGES schema. O ED Table 2. The HAS-BLED score for estimating the risk of major bleeding among AF patients RECOMMENDATION We recommend that all patients with AF or AFL (paroxysmal, persistent, or permanent) should be stratified using a predictive index for stroke (eg, CHADS2) and for the risk of bleeding (eg, HAS-BLED) and that most patients should receive antithrombotic therapy (Strong Recommendation, High-Quality Evidence). We recommend that patients at very low risk of stroke (CHADS2 ⫽ 0) should receive aspirin (75-325 mg/d) (Strong Recommendation, High-Quality Evidence). We recommend that patients at low risk of stroke (CHADS2 ⫽ 1) should receive OAC therapy (either warfarin [INR 2 to 3] or Dabigatran) (Strong Recommendation, 80 Canadian Journal of Cardiology Volume 27 2011 Overview of Thromboembolic Management Elderly patients CHADS2 = 0 CHADS2 = 1 CHADS2 ≥ 2 aspirin OAC OAC Aspirin is a reasonable alternave in some as indicated by risk-benefit Dabigatran is preferred OAC over warfarin in most paents. Figure 5. A summary of our recommendations for thromboembolic management guided by the CHADS2 score. See Tables 1 and 2 for definitions of CHADS2 and HAS-BLED. OAC, oral anticoagulant. R G High-Quality Evidence). We suggest, based on individual risk-benefit considerations, that aspirin is a reasonable alternative for some (Conditional Recommendation, Moderate-Quality Evidence). Advanced age (⬎75 years) has been consistently noted as a risk factor for both ischemic stroke and major hemorrhage, particularly intracranial. Hylek et al53 reported a series of 472 patients aged ⱖ65 years (153 patients aged ⱖ80 years), with electrocardiogram-verified AF, newly started on warfarin at the study institution, and managed by the on-site anticoagulation clinic. Anticoagulation control was very good, with 56% of person-time within the INR range of 2.0 to 3.0, 29% below 2.0, 11% within 3.0 to ⬍4.0, and only 2% ⱖ4.0. Even within this optimized setting, the rate of major hemorrhage (100% follow-up) was 7.2 per 100 patient-years (intracranial hemorrhage 2.5 per 100 patient-years). The incidence of major hemorrhage was 13.1% for patients aged ⱖ80 years vs 4.75% for those ⬍80 years. The risk during the first 90 days of therapy was 3 times that of the remainder of the year. The risk of major hemorrhage was increased 20 times among patients with an INR ⬎ 4.0. Most of the intracranial bleeds occurred in patients aged ⱖ75 years. The rate of major hemorrhage was higher in patients with higher CHADS2 scores. In contrast, the Birmingham Atrial Fibrillation Treatment of the Aged study54 found that in patients aged ⬎75 years, warfarin was more efficacious than aspirin in preventing all strokes (ischemic plus hemorrhagic) and did not cause more major extracranial hemorrhage (1.4% per year with warfarin vs 1.6% per year with aspirin). The lower bleeding risk may be attributable to more restrictive patient selection for a clinical trial than for the Hylek survey and to the fact that 40% of them had been taking warfarin safely prior to entering the trial. A more recent cohort study found an annual incidence of major extracranial bleeding of 1.3% with careful INR management.55 These observations point to the challenges in choosing the optimal antithrombotic therapy for very elderly patients in order to ensure a favourable risk-benefit ratio.56 For those with no stroke risk factors other than age ⱖ75 years, some guidelines have recommended consideration of aspirin in preference to warfarin.13 Nevertheless, ischemic stroke, with its dire consequences, is relatively frequent, and the competing risk of intracranial hemorrhage with warfarin may be acceptable. If warfarin is to be used, great care must be taken to rigourously maintain the selected therapeutic INR with frequent monitoring in the first 3 months and more often than the “standard” monthly interval subsequently. O ED Assess Thromboembolic Risk (CHADS2) and Bleeding Risk (HAS-BLED) No anthromboc may be appropriate in selected young paents with no stroke risk factors Selected Clinical Settings EM BA Values and preferences. This recommendation places relatively greater weight on the absolute reduction of stroke risk with both warfarin and dabigatran compared with aspirin and less weight on the absolute increased risk for major hemorrhage with an OAC compared with aspirin. We recommend that patients at moderate risk of stroke (CHADS2 ⱖ2 should receive OAC therapy (either warfarin [INR 2-3] or Dabigatran) (Strong Recommendation, High-Quality Evidence). We suggest that when OAC therapy is indicated, most patients should receive dabigatran in preference to warfarin. In general, the dose of dabigatran 150 mg by mouth twice a day is preferable to a dose of 110 mg by mouth twice a day (exceptions discussed in text) (Conditional Recommendation, High-Quality Evidence). Values and preferences. This recommendation places a relatively high value on the greater efficacy of dabigatran during a relatively short time of follow-up, particularly among patients who have not previously received an OAC; the lower incidence of intracranial hemorrhage; and its ease of use—and less value on the long safety experience with warfarin. Figure 5 is a flow chart outlining our recommendations for the choice of antithrombotic therapy. Recent practice guidelines9,13 stress the importance of appropriate antithrombotic therapy for AF, and yet practice surveys indicate that rates of compliance range from rather low47-51 to reasonably high.52 Cardioversion Although the randomized trials have shown no improvement in major outcomes, including thromboembolism, with a rhythm control strategy vs rate control, individual patients may gain symptomatic benefit and even long-term freedom from AF after electrical or pharmacologic cardioversion. The strongest predictor of initial and persistent success with cardioversion is short duration of the AF before cardioversion. In general, it may be expected that AF occurring in conjunction with surgery (see accompanying article titled “Prevention and Treatment of Atrial Fibrillation Following Cardiac Surgery”57), viral illness, alcohol excess, or in association with thyrotoxicosis or pulmonary embolus has a high likelihood of reversion with persistence of sinus rhythm if there has been resolution of the precipitating cause. Successful and sustained reversion to sinus Cairns et al Stroke Prevention in Atrial Fibrillation 81 Stroke risk with cardioversion Atrial flutter Retrospective studies of patients with atrial flutter undergoing cardioversion suggest that the risk of thromboembolism may not be importantly different from that for patients with AF.68,69 Case series note a very low incidence of thromboemboli when patients with atrial flutter are adequately anticoagulated prior to cardioversion.69-71 It is generally recommended that patients with atrial flutter who are to be cardioverted receive an anticoagulant regimen identical to that for patients with AF.9,13,17 Emergency cardioversion Emergency cardioversion may be required because of ischemia or hemodynamic compromise in some situations and should not be delayed, even if the AF has been present for more than 48 hours and the patient is not already anticoagulated. In such a situation, concomitant anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) may offer some benefit, but there are no published evaluations. (See accompanying article titled “Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department.”70) EM BA R G Cardioversion is appropriate for selected patients with AF or AFL,57,58 necessitating consideration of the possibility of associated thromboembolism. A well-designed prospective cohort study reported a reduction of postcardioversion systemic embolism of from 5.3% to 0.8% among anticoagulated patients.59 These observations have been supported by several published case series.13 Two more-recent studies reported remarkably similar incidences of cerebral embolization among patients receiving OAC in the setting of electrical cardioversion.60,61 It is generally believed that a newly formed thrombus will become organized and adherent to the left atrial wall within 2 weeks of formation. Transesophageal echocardiography (TEE) reveals that in the majority of patients, thrombus resolves, rather than simply becoming firmly adherent to the wall of the left atrium or left atrial appendage.62 Accordingly, it is generally recommended that documented systemic anticoagulation at therapeutic levels be instituted at least 3 weeks before cardioversion.9,13 An analysis that pooled data from 32 studies found that 98% of thromboembolic events occurred within 10 days of cardioversion of AF or flutter.63 However, evidence exists that even after successful electrical cardioversion, atrial contraction may not normalize for weeks when AF has been present for some time,64,65 and therefore maintenance of anticoagulation for at least 4 weeks after cardioversion seems prudent.9,13 If AF or AFL persists or recurs after attempted cardioversion, or if symptoms suggest that the presenting AF or AFL has been recurrent, antithrombotic therapy should be continued indefinitely with either aspirin or OAC as appropriate. If normal sinus rhythm is achieved and sustained for 4 weeks, the need for ongoing antithrombotic therapy depends on the risk of stroke, and in difficult cases, the practitioner may require expert consultative advice. There is no evidence that the incidence of thromboembolism is less with pharmacologic than with electrical cardioversion,66,67 and accordingly, it is generally recommended that anticoagulant management should not differ.13 New-onset AF is generally not thought to warrant anticoagulation if cardioversion is undertaken within 48 hours of its onset, based on case series showing an incidence of thromboembolism ⬍1%9,13,68,69 without OAC. Even when the duration of the current episode of AF is ⬍48 hours, if the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic heart disease, recent stroke, or TIA), it would be appropriate to delay cardioversion to allow the patient to receive OAC for 3 weeks before the procedure and to continue indefinitely. Following attempted cardioversion, if AF persists or recurs or if symptoms suggest the presenting AF or AFL has been recurrent, antithrombotic therapy (OAC or aspirin) should be commenced and continued indefinitely. If normal sinus rhythm is achieved and sustained, the need for ongoing antithrombotic therapy de- pends on the risk of stroke. (See accompanying article titled “Management of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department.”70) O ED rhythm is associated with relatively young age and freedom from underlying heart disease. Some patients have intolerable symptoms and poor exercise tolerance during AF and may prefer attempted rhythm control to rate control. The rate of initial success in restoring sinus rhythm is high, but in the contemporary Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, vigorous efforts to establish and sustain sinus rhythm resulted in prevalences of only 82.5%, 73.3%, and 62.6% at 1, 3, and 5 years, respectively.58 RECOMMENDATION We recommend that hemodynamically stable patients with AF or AFL of ⱖ48 hours or uncertain duration for whom electrical or pharmacologic cardioversion is planned should receive therapeutic OAC therapy (warfarin [INR 2-3] or dabigatran) for 3 weeks before and at least 4 weeks post-cardioversion. Following attempted cardioversion, If AF or AFL persists or recurs or if symptoms suggest that the presenting AF or AFL has been recurrent, the patient should have antithrombotic therapy continued indefinitely (using either OAC or aspirin, as appropriate). If sinus rhythm is achieved and sustained for 4 weeks, the need for ongoing antithrombotic therapy should be determined on the basis of the risk of stroke, and in selected cases expert consultation may be required (Strong Recommendation, Moderate-Quality Evidence). We recommend that hemodynamically stable patients with AF or AFL of known duration 48 hours may undergo cardioversion without prior or subsequent anticoagulation. However, if the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic heart disease, recent stroke, or TIA), cardioversion should be delayed, and the patient should receive OAC for 3 weeks before and at least 4 weeks post-cardioversion. Following attempted cardioversion, If AF or AFL persists or recurs or if symptoms suggest that the presenting AF or AFL has been recurrent, antithrombotic therapy (OAC or aspirin, as appropriate) should be commenced and continued indefinitely. If normal sinus rhythm is achieved and sustained for 4 weeks, the need for ongoing antithrombotic therapyshould 82 Canadian Journal of Cardiology Volume 27 2011 Antithrombotic Strategies for Cardioversion of AF/AFL Hemodynamically unstable Hemodynamically stable Urgent electrical cardioversion Pharmacological or electrical cardioversion Anthromboc therapy -In general, no prior or subsequent ancoagulaon is required. -If AF/AFL persists or recurs or if AF/AFL has been recurrent, anthromboc therapy (aspirin or OAC) should be iniated and connued indefinitely; if NSR is ongoing, anthromboc therapy according to CHADS2 - early follow-up to review anthromboc strategy, expert consultaon may be required) 1 Duraon > 48 hours or uncertain or high-risk paents 1 Rate-control Therapeuc OAC for 3 weeks before cardioversion TEE-guided cardioversion (OAC initiated with heparin bridging)2 Anthromboc therapy -OAC connued for 4 consecuve weeks. -If AF/AFL persists or recurs or if AF/AFL has been recurrent, anthromboc therapy (aspirin or OAC) should be connued indefinitely; if NSR is ongoing, anthromboc therapy according to CHADS2 -early follow-up to review anthromboc strategy, expert O ED Known duraon < 48 hours (and not high-risk paents1) consultaon may be required Paents at parcularly high risk of stroke (e.g. mechanical valve INR<2.5, rheumac heart disease, recent stroke/TIA, CHADS 2 ≥ 3) R G Figure 6. A summary of our recommended strategies for antithrombotic therapy in conjunction with cardioversion. CHADS2, please see Table 1; INR, international normalized ratio; NSR, normal sinus rhythm; OAC, oral anticoagulant; TEE, transesophageal echocardiography; TIA, transient ischemic attack. EM BA be determined on the basis of the risk of stroke according to CHADS2 score, and in selected cases expert consultation may be required (Strong Recommendation, ModerateQuality Evidence). We suggest that hemodynamically unstable patients with AF or AFL who require emergency cardioversion be managed as follows: If the AF or AFL is of known duration 48 hours, the patient may generally undergo cardioversion without prior anticoagulation. However, if the patient is at particularly high risk of stroke (eg, mechanical valve, rheumatic heart disease, recent stroke, or TIA), the patient should receive IV UFH or LMWH before cardioversion if possible, or immediately thereafter if even a brief delay is unacceptable, and then be converted to OAC for at least 4 weeks post-cardioversion. If the AF or AFL is of ⱖ48 hours or of uncertain duration, we suggest the patient receive intravenous UFH or LMWH before cardioversion if possible, or immediately thereafter if even a brief delay is unacceptable. Such a patient should then be converted to OAC for at least 4 weeks post-cardioversion. Following attempted cardioversion, the guidelines for subsequent antithrombotic therapy are identical to those for the management of hemodynamically stable patients undergoing cardioversion (Conditional Recommendation, LowQuality Evidence). Figure 6 is a flow chart outlining our recommendations for antithrombotic therapy in conjunction with cardioversion. Transesophageal echocardiography guidance The potential role of TEE to rule out the presence of atrial thrombi and the avoidance of anticoagulation was studied in several case series. An overview of these studies71 reported that patients with no atrial thrombus who then underwent electrical cardioversion had an unacceptably high incidence of embolization by comparison with anticoagulated patients in separate case series. It is generally accepted that the absence of thrombi on TEE does not eliminate the requirement for a period of 4 weeks of anticoagulation following cardioversion. The Assessment of Cardioversion Utilizing Echocardiography (ACUTE) was a multicentre randomized prospective of trial of 1222 patients with AF of more than 2 days’ duration.60 Patients were assigned to therapy guided by TEE findings or to conventional management. Patients assigned to TEE were anticoagulated at therapeutic levels (typically with UFH intravenously for 24 hours or warfarin [INR ⫽ 2-3] for 5 days) prior to attempted cardioversion. If TEE showed no thrombus, the patient underwent cardioversion and continued on anticoagulant therapy for 4 weeks. If thrombus was detected, warfarin was given for 3 weeks, TEE was repeated, and if the thrombus had resolved, cardioversion was performed and warfarin continued for 4 weeks. If thrombus was still detected after 3 weeks of anticoagulation, no cardioversion was attempted, but warfarin was continued for 4 weeks further. The patients randomized to no TEE received warfarin for 3 weeks precardioversion and a further 4 weeks post-cardioversion. There was no significant difference between the TEE and the no-TEE groups in the rate of embolic events or prevalence of sinus rhythm. The TEE group had fewer total hemorrhagic events, most of them Cairns et al Stroke Prevention in Atrial Fibrillation 83 RECOMMENDATION We suggest that hemodynamically stable patients with AF or AFL of ⱖ48 hours or of unknown duration may undergo cardioversion guided by TEE (following the protocol from the Assessment of Cardioversion Utilizing Echocardiography trial as detailed in the text) (Conditional Recommendation, High-Quality Evidence). EM BA R G Coronary Artery Disease The clinician managing a patient with AF must often deal with concomitant coronary artery disease in the settings of primary prevention, stable coronary artery disease, an acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI). There is good evidence for the use of aspirin for primary prevention,74,75 for aspirin or clopidogrel for stable coronary artery disease,76 for aspirin supplemented by clopidogrel for up to 1 year following an ACS (with or without PCI77-86) and for PCI (both elective83,84 and post-ACS80). Warfarin alone or in combination with aspirin is less effective than aspirin plus clopidogrel for patients post-PCI.81,82 There is considerable evidence from randomized controlled trials, that for primary prevention among patients at high risk of coronary events, low-intensity warfarin (INR 1.5) is as effective as aspirin for the prevention of coronary events,87 and for secondary prevention following myocardial infarction, warfarin alone (INR 2.8-4.8)88 or warfarin (INR 2-2.5) plus aspirin (75-100 mg)89,90 is at least as efficacious as aspirin alone in reducing subsequent coronary events.91 There has been no rigourous comparison of warfarin vs the combination of aspirin and clopidogrel. The benefits of antithrombotic therapies for the primary prevention of coronary events must be balanced against the risks of major bleeding attributable to both aspirin and vitamin K antagonists. Although viewpoints vary, once the annual risk of a coronary event exceeds 1% to 1.5%, antithrombotic therapy is likely to confer more benefit than harm.75,92 Among patients with known coronary artery disease, ACS, or recent PCI, the benefits of appropriate antithrombotic therapy strongly outweigh the harms. Both aspirin and warfarin are appropriate for the primary prevention of coronary events in those patients at higher risk and for secondary prevention in most patients with known coronary artery disease. Accordingly, when such patients also have AF or AFL, it seems rea- sonable to choose the most appropriate antithrombotic therapy for the prevention of stroke with the expectation that the chosen therapy will also be protective against coronary events. For primary prevention of coronary events and for stable coronary artery disease, when the risk of stroke is very low (CHADS2 ⫽ 0), aspirin would be appropriate because of its lower bleeding risk and greater ease of administration. When the risk of stroke is higher (CHADS2 ⱖ1), warfarin would be appropriate, instead of aspirin. In the setting of elective PCI, aspirin plus clopidogrel are required for optimal prophylaxis against stent thrombosis. If the patient also has AF with a risk of stroke that is very low to low (CHADS2 ⱕ1), then aspirin plus clopidogrel would be appropriate for a minimum of 1 month for a bare metal stent, 3 months for a sirolimus drug-eluting stent, or 6 months for a paclitaxel drug-eluting stent; subsequently, CHADS2 ⫽ 0 patients might continue on aspirin alone, and CHADS2 ⫽ 1 patient might stay on aspirin plus clopidogrel or be switched to warfarin. If the risk of stroke is higher (CHADS2 ⱖ 2), OAC is required for adequate stroke prophylaxis. Hence, for optimal prophylaxis against both stroke and coronary events, a period of therapy with a combination of aspirin, clopidogrel, and OAC (“triple antithrombotic therapy”) may be required, even though the risk of bleeding is considerably increased by this combination.93 Whereas the optimal duration of dual antiplatelet therapy post-PCI for patients without AF is up to 12 months, the duration of triple therapy in patients with AF is uncertain and should be decided on the basis of balancing the likely risks of a stent-related event vs the risk of bleeding. Those patients at particularly high risk of bleeding should be considered for the use of a bare metal stent rather than a drug-eluting stent, with the triple therapy continued for only 1 month. Following an episode of ACS, aspirin plus clopidogrel appear optimal for up to 1 year. If the patient also has AF with a risk of stroke that is very low to low (CHADS2 ⱕ1), then aspirin plus clopidogrel would be appropriate for up to 1 year; subsequently, CHADS2 ⫽ 0 patients might continue on aspirin alone, and CHADS2 ⫽ 1 patients might stay on aspirin plus clopidogrel or be switched to warfarin. If the risk of stroke is higher (CHADS2 ⱖ2), warfarin is required for adequate stroke prophylaxis. Hence, for optimal prophylaxis against both stroke and coronary events, a period of therapy with combination aspirin, clopidogrel, and warfarin may be required, as for the patients with elective PCI. Whereas the optimal duration of dual antiplatelet therapy post-ACS for patients without AF is up to 12 months, the duration of triple therapy in patients with AF should be decided based on balancing the likely risks of a stent-related event vs the risk of bleeding. There are no randomized trials to guide the decisions, but it might be reasonable to prescribe 1 month of triple therapy, followed by up to 1 year of a combination of warfarin plus clopidogrel or warfarin plus aspirin, followed by warfarin alone as suggested in other guidelines.91 The issues regarding antithrombotic therapies for patients with coronary artery disease plus AF have been extensively evaluated in recent evidence-based guidelines.9,13,84,86,93 In the RE-LY trial, although the net clinical benefit outcome (a composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, death, or major bleeding) was in favour of dabigatran 150 mg (hazard ratio 0.91; 95% CI, 0.82-1.00; P ⫽ .04), there was a higher incidence of myocardial infarction with dabigatran (hazard O ED minor. Right or left heart thrombi were identified in 13.8% of patients who underwent TEE. Of those patients with thrombi detected, 88.2% had a thrombus in the left atrial appendage. Among those patients with atrial thrombi detected, the value of repeat TEE after the initial 3 weeks of anticoagulation is uncertain.72 The investigators subsequently reported the results of a small randomized controlled trial which found no difference in safety outcomes between UFH and enoxaparin for the acute anticoagulation phase.73 In centres where TEE is readily available and the interpretations reliable, a TEE-guided management strategy may safely shorten the time to cardioversion by comparison with standard anticoagulant regimens. The cost-effectiveness of such an approach depends very much on local and national patterns of practice and cost structures. 84 Canadian Journal of Cardiology Volume 27 2011 Anthromboc Management of AF/AFL in CAD Stable CAD Recent ACS PCI Choose anthromboc based on stroke risk Choose anthromboc based on balance of risks and benefits Choose anthromboc based on balance of risks and benefits CHADS2 = 0 CHADS2 ≥ 1 CHADS2 ≤1 CHADS2 ≥ 2 Aspirin OAC* monotherapy aspirin + clopidogrel Triple anthromboc Rx OAC 2 ≤1 CHADS aspirin + clopidogrel CHADS2 ≥ 2 Triple anthromboc Rx O ED * Warfarin is preferred OAC over dabigatran for paents at high risk of coronary events Figure 7. A summary of our recommendations for antithrombotic management in settings of coronary artery disease. ACS, acute coronary syndrome; CAD, coronary artery disease; CHADS2, see Table 1; OAC, oral anticoagulant; PCI, percutaneous coronary intervention. RECOMMENDATION We suggest that patients with AF or AFL who have stable coronary artery disease should receive antithrombotic therapy selected on the basis of their risk of stroke (aspirin for CHADS2 ⫽ 0 and OAC for CHADS2 ⱖ1). Warfarin is preferred over dabigatran for those at high risk of coronary events (Conditional Recommendation, Moderate-Quality Evidence). We suggest that patients with AF or AFL who have experienced ACS or who have undergone PCI should receive EM BA R G ratio 1.38; 95% CI, 1.00-1.91; P ⫽ .048). There has not yet been a trial of dabigatran to evaluate the agent for the primary or secondary prevention of coronary events. Given the known benefits of warfarin for the reduction of coronary events, which can be substantial in those patients at higher risk, when OAC is indicated to prevent stroke in those who have AF and are also at high risk of a coronary event (eg, those without evidence of coronary artery disease whose Framingham risk is ⱖ2% per year, those with stable coronary artery disease with high risk features, and those with or ACS in recent months), it seems prudent to recommend warfarin in preference to dabigatran. Paent With AF undergoing Surgical or Diagnosc Procedure With Major Bleeding Risk Very Low to Moderate Stroke Risk* High Stroke Risk** Low Bleeding Risk High Bleeding Risk Low Bleeding Risk High Bleeding Risk Connue anthromboc (INR < 3 if warfarin) Stop anthromboc preprocedure Reinstute when risk of bleeding reduced Connue OAC or stop OAC and bridge with UFH or LMWH perioperavely Stop OAC and bridge with UFH or LMWH ¶ perioperavely * CHADS2 ≤ 2 * * mechanical valve, recent stroke or TIA, rheumac valve disease, CHADS2 ≥3 ¶ stop 12 to 24 hours preprocedure, restart when hemostasis secure and bridge to therapeuc OAC Figure 8. A summary of our recommendations for management of antithrombotic therapies in patients undergoing surgical or diagnostic procedures with a risk of major bleeding. AF, atrial fibrillation; CHADS2, see Table 1; INR, international normalized ratio; LMWH, low molecular weight heparin; OAC, oral anticoagulant; TIA, transient ischemic attack; UFH, ultrafractionated heparin. Cairns et al Stroke Prevention in Atrial Fibrillation 85 Figure 7 is a flow chart outlining our recommendations for the management of antithrombotic therapy in the setting of coronary artery disease. EM BA R G Invasive Procedures When a patient receiving an OAC or antiplatelet agent is to undergo a surgical or diagnostic procedure that has a risk of major bleeding, the risk of a thromboembolic event occurring while the antithrombotic agent is reduced or stopped must be weighed against the goal of a reduced risk of major bleeding.94,95 We suggest that such patients be stratified as to their risk of stroke, which can range from ⬍1% to ⬎20% per year. If there is a very low to moderate risk of stroke (CHADS2 ⱕ 2), the antithrombotic agent should be discontinued before the procedure (aspirin or clopidogrel for 7-10 days, warfarin for 5 days if the INR was in the range of 2-3, and dabigatran for 2 days). Once postprocedure hemostasis is established (about 24 hours), the antithrombotic therapy should be reinstated. If the risk of bleeding from the procedure is low, the clinician might choose to continue the antithrombotic agent uninterrupted. On the other hand, if there is a particularly high risk of stroke (eg, prosthetic valve, recent stroke or TIA, rheumatic valve disease, CHADS2 ⱖ 3) or of other thromboembolism (eg, Fontan procedure), some form of antithrombotic therapy should be continued until as close to the time of the procedure as is judged to be safe in terms of the risk and consequences of procedural bleeding, and it should be reinstated as soon as hemostasis is established post-procedure. Consideration should be given to the risk of major bleeding from the procedure in determining the antithrombotic regimen. It is likely that most potentially hemorrhagic dental procedures, if undertaken with appropriate surgical skill and the use of hemostatic mouthwash, can be done without discontinuing warfarin, provided the preoperative INR is under 3.0.96 Cataract extraction and minor dermatologic procedures may also be done without interrupting warfarin.95 A randomized controlled trial is currently underway by a group of Canadian investigators who are comparing the strategies of uninterrupted warfarin vs bridging UFH or LMWH in the mangement of patients having a cardiac arrhythmia device implanted.97 surgical or diagnostic procedure carrying a risk of major bleeding be stratified by their risk of stroke: If there is a very low to moderate risk of stroke (CHADS2 ⱕ2), patients should have their antithrombotic agent discontinued before the procedure (aspirin or clopidogrel for 7-10 days, warfarin for 5 days if the INR was in the range of 2-3, and dabigatran for 2 days). Once postprocedure hemostasis is established (about 24 hours), the antithrombotic therapy should be reinstated (Conditional Recommendation, Low-Quality Evidence). If there is a particularly high risk of stroke (eg, mechanical valve, recent stroke or TIA, rheumatic valve disease, CHADS2 ⱖ3) or of other thromboembolism (eg, Fontan procedure), further consideration should be given to the risk of major bleeding from the procedure: If there is an acceptable perioperative bleeding risk (ie, risk of stroke outweighs risk of bleeding), patients should have OAC therapy continued perioperatively or have their OAC discontinued before the procedure and be bridged with LMWH or UFH perioperatively (Conditional Recommendation, Low-Quality Evidence). If there is a substantial risk of major and potentially problematic bleeding (ie, risk of bleeding and risk of stroke are both substantial), patients should have their OAC discontinued before the procedure, with LMWH or UFH bridging until 12 to 24 hours preprocedure. Once postprocedure hemostasis is established (about 24 hours), the OAC should be reinstated with LMWH or UFH bridging (Conditional Recommendation, LowQuality Evidence). O ED antithrombotic therapy selected on the basis of a balanced assessment of their risks of stroke, of recurrent coronary artery events, and of hemorrhage associated with the use of combinations of antithrombotic therapies, which in patients at higher risk of stroke may include aspirin plus clopidogrel plus OAC (Conditional Recommendation, LowQuality Evidence). RECOMMENDATION We suggest that patients with AF or AFL who are receiving aspirin, clopidogrel, or OAC and are scheduled for a Figure 8 is a flow chart outlining our recommendations for the management of antithrombotic therapy in patients undergoing invasive procedures. Stroke Management in Patients With AF Among AF patients experiencing a stroke, the high rate of recurrence suggested that there was some urgency in initiating anticoagulation after the occurrence of embolic stroke. The International Stroke Trial Collaborative Group randomized 18,451 patients with ischemic stroke within 24 hours of onset to subcutaneous unfractionated heparin (5000 IU twice a day or 12,500 IU twice a day), aspirin 300 mg per day, both, or neither and maintained for 14 days or until prior hospital discharge.24 CT scan was performed to exclude intracranial hemorrhage when possible and was mandatory in comatose patients. Among the 3169 patients with AF, both doses of heparin were significantly more effective for the prevention of recurrent stroke of ischemic or unknown type but resulted in significantly more symptomatic intracranial hemorrhage. There was no significant difference among the regimens in the rate of the composite outcome of recurrent stroke or symptomatic intracranial hemorrhage or in the rate of all-cause mortality. Patients with AF had a higher mortality than did patients without AF (16.9% vs 7.5%), probably because of greater mean age and larger cerebral infarcts. The rate of recurrence, within 14 days, of stroke of ischemic or unknown type was 3.9% among patients with AF, considerably lower than that reported in earlier studies but still higher than in patients with- 86 Canadian Journal of Cardiology Volume 27 2011 not life threatening and occurs with an INR in the therapeutic range, once pathology is ruled out and if the CHADS2 score is ⱖ2, it may be appropriate to reinstitute the OAC, attempting to maintain a therapeutic INR. RECOMMENDATION We suggest that patients with AF or AFL who experience hemorrhage while on OAC therapy be managed according to the practice guidelines of the American College of Chest Physicians103 (Conditional Recommendation, Low-Quality Evidence). O ED Pharmacogenomics Eventually, pharmacogenomic algorithms may allow more rapid and safe determinations of initial warfarin dosage, particularly among patients whose warfarin requirements are particularly low or high.104 For the present, routine genetic testing is not advised in the management of therapy with a vitamin K antagonist. Alternatives to Antithrombotic Therapies Rhythm control and stroke risk An overview105 of the 5 trials that compared the strategies of rhythm vs rate control in AF found a mortality of 13.0% with rate control vs 14.6% with rhythm control (odds ratio 0.87, P ⫽ .09). The rates of ischemic stroke and major hemorrhage were similar. The AFFIRM trial58 is by far the largest, mandated anticoagulation (INR 2.0-3.0) in the rate-control group (85% maintained warfarin) and strongly encouraged in the rhythm-control group, while allowing cessation at the physician’s discretion if sustained sinus rhythm was achieved (70% maintained warfarin). Ischemic stroke occurred at an annual rate of about 1% in each group, and in most instances the patient was either off warfarin or the INR was ⬍2.0. The authors concluded that continuous anticoagulation is warranted in all patients with AF and 1 or more risk factors for stroke, whether or not sinus rhythm appears to be restored and maintained, and this approach is recommended by consensus groups.9,13 Left atrial radiofrequency ablation is increasingly used as a rhythm control approach to treat AF, raising questions about the role of long-term OAC therapy in such patients.106 The issues are the risk of dislodgement of left atrium thrombus during the ablation procedure, bleeding in association with the invasive procedure, creation of thrombogenic areas of left atrium endothelial damage, and the risk of embolization during long-term follow-up. Recommendations are generally weak and based on evidence of low or very low quality.106 TEE is advised immediately preprocedure to ensure there is no important left atrium thrombus. In general, the procedure is performed with the patient adequately anticoagulated, either by sustaining the preprocedure warfarin (usually allowing the INR to fall to the lower end of the therapeutic range) or with use of bridging LMWH both before and after the procedure. In the latter case, UFH is given with access to the left atrium. The UFH or LMWH are discontinued at the completion of the procedure, and the sheath is removed when the ACT returns to RECOMMENDATION BA R G out AF in this study. The results indicate that heparin is not indicated in the acute management of embolic stroke among patients with AF. Published guidelines for the management of stroke in a patient with AF98-100 are based on extrapolations from clinical trials97,101 and include recommendations for the use of intravenous rtPA for selected patients within 3 hours of onset. Patients who receive rtPA should not receive any antiplatelet or anticoagulant therapy for at least 24 hours subsequently. If there is no evidence of hemorrhage on urgent CT scan, and yet the patient is not to receive fibrinolytic therapy, the patient should begin aspirin 325 mg per day immediately thereafter, with conversion to OAC after 14 days, or sooner if the infarct size is small and the patient is normotensive. If the clinical and computed tomography picture are consistent with a TIA, then immediate heparin therapy may be acceptable. If stroke occurs in a patient with AF or AFL who is already receiving anticoagulation, the drug should be stopped and intracranial hemorrhage should be excluded. If intracranial hemorrhage is present, the anticoagulation should be reversed, and subsequent decisions to resume anticoagulation should be made after reassessment of the risks of embolism and the risks of recurrent intracranial hemorrhage. For those without intracranial hemorrhage, it would be reasonable to start aspirin 325 mg per day when the INR falls below 1.5 and to restart the anticoagulant at day 14, or sooner if the infarct is small and the patient is normotensive.98,99 If warfarin is chosen as the anticoagulant, meticulous attention should be given to maintenance of the INR in the range of 2 to 3. A double-blind randomized trial102 of LMWH vs aspirin (160 mg/d) among patients with acute ischemic stroke and AF showed a trend to more recurrent ischemic stroke in the LMWH group (odds ratio 1.13; 95% CI, 0.57-2.24), supporting the strategy of early administration of aspirin to such patients in preference to heparin. EM We recommend that patients with AF or AFL who experience a stroke be managed acutely according to the published guidelines of the American Heart and American Stroke Associations100 (Strong Recommendation, Moderate-Quality Evidence). Hemorrhage on OAC Therapy The major determinants of OAC-induced bleeding are the INR, patient characteristics, and the concomitant use of drugs that interfere with hemostasis. The acute management of hemorrhage in a patient receiving OAC requires a graded response according to published guidelines,103 beginning with the immediate measurement of the INR, stopping the OAC, and assessment of the severity of hemorrhage. If there is major bleeding, vitamin K may be given intravenously, and if the bleeding is life threatening, vitamin K should be accompanied by fresh frozen plasma, prothrombin complex concentrate, or recombinant factor VIIa. If the INR is elevated and no explanatory pathology is found, it may be appropriate to restart the OAC, attempting to maintain the INR in the usual therapeutic range with intensified monitoring and attention to patient factors that can increase the INR in the setting of a given dose of OAC. If the bleeding is Cairns et al Stroke Prevention in Atrial Fibrillation 87 Left atrial appendage-directed interventions 5. Petersen P, Boysen G. Letter to editor. N Engl J Med 1990; 323:482. 6. Stroke Prevention in Atrial Fibrillation Investigators. Stroke Prevention in Atrial Fibrillation study: final results. Circulation 1991;84:527-39. 7. Atrial Fibrillation Investigators. Risk factors for stroke and efficiency of antithrombotic therapy in atrial fibrillation: analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994;154:1449-57. 8. Wolf PA, Dawber TR, Thomas E Jr, et al. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham Study. Neurology 1978;28:973-7. 9. Singer DE, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation. Chest 2008;133:546S-92S. 10. The Stroke Risk in Atrial Fibrillation Working Group. Independent predictors of stroke in patients with atrial fibrillation: a systematic review. Neurology 2007;69:546-54. 11. Stroke Prevention in Atrial Fibrillation Investigation. Prevention of thromboembolism in atrial fibrillation: I. Clinical features of patients at risk. Ann Intern Med 1992;116:1-5. 12. Stroke Prevention in Atrial Fibrillation Investigation. Prevention of thromboembolism in atrial fibrillation: II. Echocardiographic features of patients at risk. Ann Intern Med 1992;116:6-12. 13. Fuster V, Rydén LE, Cannon AS, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. Circulation 2006;114:257-354. EM BA R G A range of surgical procedures focused on curing AF have been developed and reported during the past 20 years.107 Left atrial appendage removal or occlusion may be done in an attempt to lower the risk of thromboembolism as part of a Cox Maze procedure or as an adjunct to another cardiac surgical procedure. Only case series are available in the literature, with levels of success very specific to individual centres and the indications uncertain. The long-term risk of stroke after such procedures appears to be low, but the requirement for long-term OAC is unclear, and advice should be provided by the expert centre conducting the arrhythmia surgery. A Canadian collaborative group is currently conducting a pilot study evaluating left atrial appendage occlusion in conjunction with various cardiac surgical procedures (clinicaltrials.gov, NCT00908700). (See detailed discussion in the accompanying article titled “Surgical Therapy for Atrial Fibrillation.”108) Percutaneous closure of the left atrial appendage was evaluated in a randomized, noninferiority comparison of conventional warfarin vs the Watchman occluding device and subsequent discontinuation of warfarin.109 The composite primary outcome (any stroke, cardiovascular or unexplained death, or systemic embolism) at a mean of 18 months was nonsignificantly less in the Watchman group (RR ⫽ 0.62; 95% CI, 0.35-1.25), and the device was concluded to be noninferior to conventional warfarin therapy. However, there were relatively few events, the follow-up was short, there are substantial learning curve considerations, and the antithrombotic regimen used with the device was complex and changing. Additional, adequately powered studies, particularly in patients at higher risk of stroke, are needed for adequate assessment of this new technique. 4. Petersen P, Boysen G, Godtfredsen J, et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: the Copenhagen AFASAK study. Lancet 1989;i:175-9. O ED a safe level. Parenteral anticoagulation is reinitiated within hours of the sheath removal and maintained until therapeutic anticoagulation is reestablished with warfarin or dabigatran, which is continued for at least 3 months. Long-term OAC should continue if AF recurs. In the presence of sustained normal sinus rhythm, OAC should be discontinued only if the long-term risk of stroke is low (CHADS2 score ⬍2). (See further details in the accompanying article titled “Catheter Ablation of Atrial Fibrillation and Flutter.”106) 14. Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285:2864-70. 15. Gage BF, van Walraven C, Pearce L, et al. Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation 2004;110:2287-92. 16. Stroke Risk in Atrial Fibrillation Working Group. Comparison of 12 risk stratification schemes to predict stroke in patients with nonvalvular atrial fibrillation. Stroke 2008;39:1901-10. Acknowledgements The authors are grateful to Grant Stotts, MD, FRCPC, for advice and liaison with the Canadian Stroke Network and to Marie-Josee Martin and Jody McCombe for final transcription of the manuscript. Administrative and technical support was provided by the Canadian Cardiovascular Society. 17. Camm AJ, Kirchof P, Lip GYH, et al. Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Guidelines for the management of atrial fibrillation. Eur Heart J 2010;31:2369-429. 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Limitations of transesophageal echocardiography in the risk assessment of patients before nonanticoagulated cardioversion from atrial fibrillation and flutter: an analysis of pooled trials. Am Heart J 1995;129:71-5. 73. Klein AL, Jasper SE, Katz JF, et al. The use of enoxaparin compared to unfractionated heparin for short-term antithrombotic therapy in atrial fibrillation patients undergoing transoesophageal echocardiographyguided cardioversion: Assessment of Cardioversion Using Transoesophageal Echocardiography (ACUTE) II randomized multicentre study. Eur Heart J 2006;27:2858-65. 74. Berger JS, Roncaglioni MC, Avanzini F, et al. Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials. JAMA 2006;295:306-13. 75. Sanmuganathan PS, Ghaharamani P, Jackson PR, et al. Aspirin for the primary prevention of coronary heart disease: safety and absolute benefit related to coronary risk derived from meta-analysis of randomised trials. Heart 2001;85:265-71. 76. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996;348:1329-39. 77. Yusuf S, Zhao F, Mehta S, et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001;345:494-502. R G 61. Seidel K, Ramekaen M, Drogemuller A, et al. Embolic events in patients with atrial fibrillation and effective anticoagulation: value of transesophageal echocardiography to guide direct-current cardioversion: final results of the Ludwigschafen Observational Cardioversion Study. J Am Coll Cardiol 2002;39:1436-42. 71. Elhendy A, Gentile F, Khandheria BK, et al. Thromboembolic complications after electrical cardioversion in patients with atrial flutter. 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Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 2005;352:1179-89. 79. Chen ZM, Jiang LX, Chen YP, et al. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebocontrolled trial. Lancet 2005;366:1607-21. 80. Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-tern therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001;358:527-33. 81. Rubboli A, Milandri M, Castelvetri C, et al. Meta-analysis of trials comparing oral anticoagulation and aspirin versus dual antiplatelet therapy after coronary stenting: clues for the management of patients with an indication for long-term anticoagulation undergoing coronary stenting. Cardiology 2005;104:101-6. 82. Leon MB, Baim DS, Popma JJ, et al. 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Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update. Stroke 2007;38:2001-23. 108. Pagé P, CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: surgical therapy. Can J Cardiol 2011;27:67-73. 109. Holmes DR, Reddy V, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial. Lancet 2009;374:534-42. Canadian Journal of Cardiology 27 (2011) 91–97 Society Guidelines Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Prevention and Treatment of Atrial Fibrillation Following Cardiac Surgery L. Brent Mitchell, MD, FRCPC,a and the CCS Atrial Fibrillation Guidelines Committeeb Libin Cardiovascular Institute of Alberta, Alberta Health Services and University of Calgary, Foothills Hospital, Calgary, Alberta, Canada b For a complete listing of committee members, see Gillis AM, Skanes AC. Canadian Cardiovascular Society Atrial Fibrillation Guidelines 2010: Implementing GRADE and achieving consensus. Can J Cardiol 2011;27:27-30. RÉSUMÉ Postoperative atrial fibrillation and atrial flutter (POAF) are the most common complications of cardiac surgery that require intervention or prolong intensive care unit and total hospital stay. For some patients, these tachyarrhythmias have important consequences including patient discomfort/anxiety, hemodynamic deterioration, cognitive impairment, thromboembolic events including stroke, exposure to the risks of antiarrhythmic treatments, longer hospital stay, and increased health care costs. We conclude that prevention of POAF is a worthwhile exercise and recommend that the dominant therapy for this purpose be -blocker therapy, especially the continuation of -blocker therapy that is already in place. When -blocker therapy is contraindicated, amiodarone prophylaxis is recommended. If both of these therapies are contraindicated, therapy with either intravenous magnesium or biatrial pacing is suggested. Patients at high risk of POAF may be considered for first-line amiodarone therapy, first-line sotalol therapy, or combination prophylactic therapy. The treatment of POAF may follow either a rate-control approach (with the dominant therapy being -blocking drugs) or a rhythm-control approach. Anticoagulation should be considered if persistent POAF lasts ⬎72 hours and at the La fibrillation auriculaire (FA) et le flutter auriculaire postopératoires sont les complications les plus courantes de la chirurgie cardiaque qui nécessitent une intervention et prolonge la durée de séjour de l’unité des soins intensifs ou hospitalier. Chez certains patients, ces tachyarythmies ont des conséquences importantes, citons entre autres l’inconfort et l’anxiété, la détérioration hémodynamique, les troubles cognitifs, les thromboembolies, l’accident vasculaire cérébral, l’exposition aux effets secondaires des traitements antiarythmiques, le séjour prolongé à l’hôpital et les coûts additionnels. Nous concluons que la prévention de la FA postopératoire est un exercice qui en vaut la peine et recommandons que le but premier du traitement soit le traitement par -bloquant, particulièrement la continuation des -bloquants déjà administrés en préopératoire. Lorsque le traitement par -bloquants est contre-indiqué, on recommande l’amiodarone en prophylaxie. Si ces deux traitements sont contre-indiqués, on suggère le traitement soit à l’aide de magnésium intraveineux ou la stimulation biauriculaire. Les patients à haut risque de FA postopératoire peuvent être considérés pour le traitement de première intention à l’amiodarone, le traitement de première ligne par sotalol ou la combinaison de Incidence of Postoperative Atrial Tachyarrhythmias Given that atrial fibrillation (AF) and atrial flutter are facilitated by atrial trauma, atrial stretch, atrial ischemia, epicardial inflammation, hypoxia, acidosis, electrolyte disturbances, and the refractoriness changes that accompany sympathetic nervous sys- tem discharge and given that all of these factors are frequently present immediately after cardiac surgical procedures, it is not surprising that AF and atrial flutter are frequent complications of these procedures. Indeed, atrial tachyarrhythmias are the most common postoperative complications of cardiac surgery that require intervention or prolonged intensive care unit and total hos- Received for publication November 11, 2010. Accepted November 12, 2010. consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgment in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case. EM R G BA ABSTRACT O ED a Corresponding author: L. Brent Mitchell, MD, FRCPC, Libin Cardiovascular Institute of Alberta, Alberta Health Services and University of Calgary, Foothills Hospital, 1403 29th St NW, Calgary, Alberta, Canada, T2N 2T9. Tel.: ⫹1-403-944-1683; fax: ⫹1-403-944-2906. E-mail: brent.mitchell@albertahealthservices.ca The disclosure information of the authors and reviewers is available from the CCS on the following Web sites: www.ccs.ca and www.ccsguidelineprograms.ca. This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the 0828-282X/$ – see front matter © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.cjca.2010.11.005 92 Canadian Journal of Cardiology Volume 27 2011 pital stay.1-10 The incidence of POAF after cardiac surgery ranges from ⬇30% for patients undergoing isolated coronary artery bypass graft (CABG) surgery to ⬇40% for patients undergoing valve replacement or repair to ⬇50% of patients undergoing both procedures.11 Furthermore, there is evidence that the incidence of POAF is increasing as older individuals with a higher prevalence of atrial tachyarrhythmia risk factors are more commonly undergoing these procedures.2,8 The peak incidence of these atrial tachyarrhythmias is between postoperative days 2 and 4. Of the patients who develop an atrial tachyarrhythmia, 70% do so before the end of the fourth postoperative day and 94% do so before the end of the sixth post hospital day.8 revealed a highly statistically significant heterogeneity assessment P-value of ⬍.001, indicating that differences between the trials preclude meaningful merging of their results. Much of the heterogeneity in the results of these trials was explained by the practice in some trials of permitting preoperative withdrawal of preexisting -blocker drug therapy in those patients randomized not to receive study -blocker drug therapy (-blocker therapy withdrawal–mandated trials) versus the practice in other trials of continuing preexisting -blocker drug therapy in those patients randomized not to receive study -blocker drug therapy (-blocker therapy withdrawal–not mandated trials). In the -blocker therapy withdrawal–mandated trials, study -blocker drug therapy was associated with a large reduction in the probability of postoperative AF (OR 0.30, 95% CI 0.22-0.40, P-value for effect ⬍.001, P-value for heterogeneity of .06). In the -blocker therapy withdrawal– not mandated trials, study -blocker drug therapy was associated with a smaller reduction in the probability of postoperative AF (OR 0.69, 95% CI 0.54-0.87, P-value for effect of .002, P-value for heterogeneity of .72). This observation may relate to preoperative -blocker therapy withdrawal increasing the control group probability of postoperative AF.26 The largest of the -blocker therapy withdrawal–not mandated trials, the Beta Blocker Length Of Stay (BLOS) trial,27 reported a post-hoc analysis28 indicating that, in patients receiving preoperative nonstudy -blocker drug therapy, study metoprolol therapy was associated with a decrease in postoperative AF (metoprolol group AF incidence 29.6%, placebo group AF incidence 40.1%, OR 0.63), while in patients not receiving preoperative nonstudy -blocker drug therapy, study metoprolol therapy was not associated with a decrease in postoperative AF (metoprolol group AF incidence 38.5%, placebo group AF incidence 35.0%, OR 1.16) (unadjusted P-value for interaction of .065). Furthermore, in patients not receiving preoperative nonstudy -blocker drug therapy, study metoprolol therapy was associated with greater acute reduction in heart rate (unadjusted P-value for interaction of .002), greater acute reduction in cardiac index (unadjusted P-value for interaction of .002), and an increase in total hospital stay (unadjusted P-value for interaction of .002). Current evidence suggests that the standard -blocker drugs are equivalent with regard to their efficacy in the prevention of postoperative AF after cardiac surgery. Nevertheless, one small, nonrandomized, retrospective comparison of carvedilol versus other -blocker drugs (mostly metoprolol or atenolol) suggested that carvedilol prevented postoperative AF better than did the others (relative risk 0.24, 95% CI 0.11-0.51, P ⬍ .05).26 This possibility will need to be assessed in a comparative clinical trial. Thus, the evidence for continuing preoperative -blocker drug therapy after cardiac surgery for the prevention of postoperative AF is very strong. However, initiating -blocker drug therapy just before or after cardiac surgery in patients BA R G Risk Factors for Postoperative Atrial Tachyarrhythmias Independent patient characteristics that predict the occurrence of atrial tachyarrhythmias after cardiac surgery include prior AF episodes, older age, male gender, history of hypertension, requirement for an intraoperative balloon pump, requirement for prolonged ventilation (⬎24 hours), and withdrawal of -blocker therapy.2-8,12,13 As in the general population,14 age has the highest predictive value. Operative variables reported to be atrial tachyarrhythmia risk factors include the procedure performed (isolated CABG, valve repair/replacement, or both), the number of bypass grafts, the duration of surgery, and the duration of aortic cross-clamp time.2,15-17 traitements prophylactiques. Le traitement d’une FA postopératoire peut suivre soit une méthode de ralentissement de la fréquence ventriculaire (avec les -bloquants) ou une méthode de stabilisation du rythme. Les anticoagulants devraient être considérés si la FA postopératoire dure plus de 72 heures et si elle est encore présente au moment de prendre congé de l’hôpital. Le besoin continu de traitement d’une FA postopératoire (notamment l’anticoagulation) devra être reconsidéré pour 6 à 12 semaines suivant la procédure chirurgicale. O ED point of hospital discharge. The ongoing need for any POAF treatment (including anticoagulation) should be reconsidered 6-12 weeks after the surgical procedure. EM Consequences of Postoperative Atrial Tachyarrhythmias Post cardiac surgery atrial tachyarrhythmias may be transient and cause little morbidity. However, for some patients these tachyarrhythmias have important consequences including patient discomfort/anxiety, hemodynamic deterioration, cognitive impairment, thromboembolic events including stroke, exposure to the risks of arrhythmia treatments, longer hospital stay, and increased health care costs.2,4,8,9,18-23 Linear regression models indicate that postoperative atrial tachyarrhythmias are independently associated with an increase in the duration of hospitalization and in health care costs.8,24 Prophylaxis of Postoperative Atrial Tachyarrhythmias Standard -blocker drug therapy A recent meta-analysis of randomized controlled clinical trials (RCTs) evaluating standard -blocker drug therapy (Table 1) for the prevention of postoperative AF after cardiac surgery examined 31 RCTs involving 4452 patients.25 -Blocker drug therapy was associated with a reduction in the probability of postoperative AF with an odds ratio (OR) of 0.36, a 95% confidence interval (95% CI) for this point estimate of 0.28-0.47, and a statistical significance level (P-value) of .001. Nevertheless, this meta-analysis also Postoperative Atrial Fibrillation Mitchell et al. 93 Table 1. Prophylactic therapies for the prevention of postoperative atrial tachyarrhythmias Dosage* Odds ratio† Any in usual therapeutic dose (ie, metoprolol 50 mg PO q12h or q8h for at least 2 preoperative d, d of surgery, and at least 6 postoperative d) 10 mg/kg/d (rounded to nearest 100 mg) divided into 2 daily PO dosages for 6 preoperative d, d of surgery, and 6 postoperative d44 0.39 (0.28-0.52) Reactive airways disease, decompensated CHF Sinus bradycardia AV block Hypotension Bronchospasm 0.61 (0.50-0.74) Postoperative amiodarone 900-1200 mg IV over 24 h beginning within 6 h of surgery, then 400 mg PO tid each of the next 4 d37 0.53 (0.39-0.71) Magnesium sulfate 1.5 g IV over 4 h first preoperative d, immediately postoperatively, and next 4 postoperative d.45 Other trials have omitted the preoperative dosage Right, left, or biatrial pacing for 3-4 d postoperatively.46 Rate set to overdrive sinus rate either manually or using sensing algorithms 0.83 (0.65-1.06) 30%-50% reduction in the dosages of other drugs with antiarrhythmic or sinus/AV nodal effects and warfarin will be required 30%-50% reduction in the dosages of other drugs with antiarrhythmic or sinus/AV nodal effects and warfarin will be required Renal failure Sinus bradycardia AV block Hypotension Torsade de pointes VT (rare) Pulmonary toxicity (rare) Sinus bradycardia AV block Hypotension Torsades de pointes VT (rare) Pulmonary toxicity (rare) Hypotension (rare) Sedation (very rare) Respiratory depression (very rare) Diaphragmatic stimulation, Increased myocardial oxygen requirements, ? Increased infection rate Preoperative -blocker Preoperative amiodarone Atrial pacing Cautions 0.67 (0.54-0.84) May increase atrial tachyarrhythmias if pacing continues in setting of sensing malfunction O ED Therapy Adverse effects R G AV, atrioventricular; CHF, congestive heart failure; VT, ventricular tachycardia. * Dosages used in the randomized studies vary widely and the optimal dosages for this indication have not been established. The dosages provided are those used in the largest positive trial of that therapy and are referenced to that study. † The odds ratios provided are from meta-analyses of the studies of each prophylactic approach (not for the single study referenced for dosage). Comparisons of the efficacies of various prophylactic approaches require randomized trials, which, for the most part, have not been performed. Accordingly, comparisons of the odds ratios provided in the table should be avoided. RECOMMENDATION BA who were not receiving preoperative -blocker drug therapy for the purpose of preventing postoperative AF has less compelling support. EM We recommend that patients who have been receiving a -blocker before cardiac surgery have that therapy continued through the operative procedure in the absence of the development of a new contraindication (Strong Recommendation, High-Quality Evidence). We suggest that patients who have not been receiving a -blocker before cardiac surgery have -blocker therapy initiated just before or immediately after the operative procedure in the absence of a contraindication (Conditional Recommendation, Low-Quality Evidence). Values and preferences. These recommendations place a high value on reducing postoperative AF and a lower value on adverse hemodynamic effects of -blockade during or after cardiac surgery. It is also noted that inherent to a strategy of prophylaxis, a number of patients will receive -blocker therapy without personal benefit. 0.50, 95% CI 0.43-0.59, P ⬍ .0001). This meta-analysis reported that amiodarone therapy for the prevention of postoperative AF was also associated with a reduction in postoperative ventricular tachyarrhythmias (OR 0.39, 95% CI 0.26-0.58, P ⬍ .001), a reduction in postoperative neurologic events (OR 0.53, 95% CI 0.30-0.92, P ⫽ .02), a reduction in the postsurgery hospital length of stay (0.6 days: 95% CI 0.4-0.8 days, P ⬍ .0001), and a reduction in hospital costs (–$2527, 95% CI –$500 to –$5815, P ⫽ .1). Another meta-analysis that included adverse events noted that amiodarone therapy in this setting is also associated with an increase in postoperative bradycardia (OR 1.66, 95% CI 1.732.47).25 A meta-analytic comparison of the effects of amiodarone therapy initiated preoperatively (6 studies, OR 0.50, 95% CI 0.30-0.63) versus that initiated intraoperatively or postoperatively (8 studies, OR 0.48, 95% CI 0.37-0.63) showed no statistically significant difference in the prevention of postoperative AF (P ⫽ .86).30 In a small, direct-comparison RCT, amiodarone was reported to be more effective for the prevention of postoperative AF after cardiac surgery than standard -blockade (propranolol) (RR 0.53, 95% CI 0.37-0.93, P ⫽ .05).31 Similarly, amiodarone therapy was suggested to be more effective than sotalol therapy for this purpose, but the difference was not statistically significant in a small trial of 160 patients (RR 0.77, 95% CI 0.54-1.12, P ⫽ .21).32 RECOMMENDATION Amiodarone therapy A recent meta-analysis of RCTs evaluating amiodarone therapy (Table 1) for the prevention of postoperative AF after cardiac surgery examined 19 placebo-controlled RCTs involving 3295 patients.29 Compared to placebo, amiodarone therapy was associated with a reduction in the probability of postoperative AF (OR We recommend that patients who have a contraindication to -blocker therapy before or after cardiac surgery be considered for prophylactic therapy with amiodarone to prevent postoperative AF (Strong Recommendation, HighQuality Evidence). 94 Canadian Journal of Cardiology Volume 27 2011 Sotalol therapy Overdrive atrial pacing Trials of overdrive atrial pacing (Table 1) for the prevention of postoperative AF have used multiple pacing configurations: right atrial pacing, left atrial pacing, biatrial pacing, and Bachmann’s bundle pacing. Overall, a meta-analysis of 14 RCTs involving 1885 patients showed that overdrive atrial pacing was associated with a reduction in the incidence of postoperative AF from 35.3% to 17.7% (OR 0.60, 95% CI 0.47-0.77, P ⬍ .001).25 Although the P-value for heterogeneity was not statistically significant, there was a trend to heterogeneity (P ⫽ .13) and the majority of the benefit was seen in 10 trials involving 754 patients wherein biatrial pacing was associated with a statistically significant reduction in the incidence of postoperative AF (OR 0.44, 95% CI 0.31-0.64, P ⬍ .001). Individual assessment of right atrial and of left atrial or Bachmann’s bundle overdrive atrial pacing did not show a statistically significant result. The Atrial Fibrillation Suppression Trial II (AFIST-II) compared overdrive atrial septal pacing to amiodarone therapy for the prevention of postoperative AF and reported that amiodarone therapy prevented AF better than did overdrive atrial pacing (RR 0.50, 95% CI 0.30-0.82, P ⬍ .05).37 Accordingly, the quality of evidence to recommend overdrive atrial pacing, in the absence of other prophylactic therapy, for the prevention of postoperative AF after cardiac surgery is low but, when used, the evidence favours biatrial overdrive pacing. Intravenous magnesium therapy BA R G A recent meta-analysis of RCT evaluating sotalol therapy for the prevention of postoperative AF after cardiac surgery examined 9 placebo-controlled RCTs involving 1382 patients.25 Compared to placebo, sotalol therapy was associated with a reduction in the probability of postoperative AF (OR 0.34, 95% CI 0.26 – 0.45, P-value ⬍.001). More patients receiving sotalol had their therapy withdrawn because of adverse effects than did patients receiving placebo (6.0% versus 1.9%, respectively, P ⫽ .004). The same meta-analysis of RCTs evaluating sotalol therapy for the prevention of postoperative AF after cardiac surgery examined 7 RCTs involving 1240 patients comparing sotalol therapy to standard -blocker drug therapy.25 Compared to standard -blocker drug therapy, sotalol therapy was associated with a reduction in the probability of postoperative AF (OR 0.42, 95% CI 0.26-0.65, P-value ⬍.001). More patients receiving sotalol had their therapy withdrawn because of adverse effects than did patients receiving standard -blocker drug therapy but this difference was not statistically significant (7.2% versus 4.8%, respectively, P ⫽ .25). Thus, sotalol therapy for the prevention of postoperative AF after cardiac surgery has been less well studied than has standard -blocker drug therapy. Nevertheless, it appears that sotalol therapy has greater efficacy for this purpose than does standard -blocker drug therapy but may also have a greater adverse effect profile in this setting. postoperative AF than was intravenous magnesium (RR 0.53, 95% CI 0.36-0.80, P ⫽ .01). Another small trial of 105 patients found no significant difference in the efficacy of intravenous magnesium therapy versus sotalol therapy for this purpose (RR 0.87, 95% CI 0.48-1.55).36 Thus, there is moderate evidence that intravenous magnesium therapy, particularly lower-dose therapy initiated before cardiac surgery, will reduce the postoperative incidence of AF after cardiac surgery. The major advantage of this approach is that the therapy has a very low probability of being associated with adverse effects in patients without renal dysfunction. O ED Values and preferences. This recommendation places a high value on minimizing the patient population exposed to the potential adverse effects of amiodarone and a lower value on data suggesting that amiodarone is more effective than -blockers for this purpose. EM A recent meta-analysis of 7 RTCs involving 1234 patients evaluating intravenous magnesium therapy (Table 1) for the prevention of postoperative AF after cardiac surgery reported that intravenous magnesium therapy was associated with a reduction in the incidence of postoperative AF from 26.7% to 20.0% (OR 0.66, 95% CI 0.51-0.87, P ⫽ .003) and with a reduction of the postoperative length of hospital stay in 6 trials involving 1136 patients by 0.29 days (95% CI 0.05-0.54 days, P ⫽ .02).33 However, this meta-analysis also found significant heterogeneity among the intravenous magnesium trials (P ⫽ .02) with patients receiving preoperative intravenous magnesium (as opposed to intraoperative or postoperative therapy initiation) and patients receiving lower dosages of intravenous magnesium (as opposed to moderate or higher dosages of magnesium) apparently receiving all of the benefit of therapy with respect to a reduction in the postoperative incidence of AF. Most intravenous magnesium trials report no evident adverse effects of magnesium therapy in properly selected patients. Nevertheless, one trial reported a higher probability of postoperative hypotension with combination intravenous magnesium and propranolol therapy than with propranolol therapy alone.34 Intravenous magnesium therapy has been compared to a standard -blocker (propranolol) in a trial involving 134 patients.35 Propranolol was more effective for the prevention of RECOMMENDATION We suggest that patients who have a contraindication to -blocker therapy and to amiodarone therapy before or after cardiac surgery be considered for prophylactic therapy to prevent postoperative AF with intravenous magnesium (Conditional Recommendation, Moderate-Quality Evidence) or with biatrial pacing (Conditional Recommendation, Low-Quality Evidence). Values and preferences. This recommendation places a high value on preventing postoperative AF using more novel therapies that are supported by lower quality data. A high value is placed on the low probability of adverse effects from magnesium. The use of biatrial pacing needs to be individualized by patient and institution, as the potential for adverse effects may outweigh potential benefit based on local expertise. Other interventions Meta-analyses have not shown a potential role for the use of digoxin (OR 0.97, 0.62-1.49, P ⫽ .88), calcium channel blocker drugs (OR 0.73, 95% CI 0.48-1.12, P ⫽ .15), Postoperative Atrial Fibrillation Mitchell et al. 95 Combination therapy RECOMMENDATION We suggest that consideration be given to anticoagulation therapy if postoperative continuous AF persists for ⬎72 hours. This consideration will include individualized assessment of the risks of a thromboembolic event and the risk of postoperative bleeding (Conditional Recommendation, Low-Quality Evidence). EM BA R G Two small trials36,37 directly compared 2 apparently effective treatments for the prevention of POAF after cardiac surgery using a 2 ⫻ 2 factorial trial design to evaluate the utility of combination prophylactic therapy. Forlani et al36 randomized 207 patients to receive prophylactic sotalol, prophylactic intravenous magnesium, both therapies, or neither therapy. The incidence of postoperative AF was statistically significantly reduced from 38.0% in the neither-therapy group to 14.8% in the magnesium therapy–alone group and to 11.8% in the sotalol therapy– alone group. The incidence of postoperative AF was statistically significantly reduced even further by combined magnesium and sotalol to an astonishing 1.9%. The AFIST-II37 randomized 160 patients to receive prophylactic atrial septal pacing, prophylactic amiodarone, both therapies, or neither therapy. The incidence of postoperative AF was 37.5% in the neither-therapy group. The incidence of postoperative AF was not reduced by atrial septal pacing (40.0%). The incidence of postoperative AF was reduced to 28.5% in the amiodarone-treated group but this difference was not statistically significant (RR 0.79, 95% CI 0.48-1.29). Although the incidence of postoperative AF was further reduced by combined amiodarone and atrial septal pacing to 15.8%, this difference was not statistically significant relative to that achieved with amiodarone therapy alone (RR 0.77, 95% CI, 0.49-1.22). These suggestions of no difference are, of course, power-limited. cardiac surgery is dominated by self-terminating but frequently recurrent atrial tachyarrhythmia episodes and resolution of this propensity in 6-12 weeks regardless of the therapy used.38-40 Furthermore, the adrenergic discharge state after cardiac surgery lessens the effectiveness of therapies that do not include -blockade. There is an association between POAF and postoperative cerebrovascular events2,3,8,20,21 and cognitive impairment19 after cardiac surgery. On the other hand, early anticoagulation therapy in this setting may predispose the postoperative patient to delayed pericardial bleeding and cardiac tamponade.41 In recognition of this risk and in the absence of controlled trials of the optimum timing for the initiation of anticoagulation therapy for patients with AF after cardiac surgery, anticoagulation is recommended for patients with prolonged (⬎72 hours) AF. Once initiated, anticoagulation is usually continued for ⱖ6 weeks. O ED propafenone (OR 0.73, 0.39-1.38, P ⫽ .97), or procainamide (OR 0.51, 95% CI 0.25-1.04, P ⫽ .07) for the prevention of postoperative AF after cardiac surgery.25 Newer interventions with promising preliminary results not yet tested in larger patient populations include glucose/ insulin/potassium, preservation of the anterior cardiac fat pad, N-3 fatty acids, HMG CoA reductase inhibitors, and systemic steroids. RECOMMENDATION We suggest that patients at high risk of postoperative AF receive prophylactic therapy to prevent postoperative AF such as sotalol or combination therapy including ⱖ2 of a -blocker, amiodarone, intravenous magnesium, or biatrial pacing (Conditional Recommendation, Low- to Moderate-Quality Evidence). Values and preferences. This recommendation recognizes that data confirming the superiority of combinations of prophylactic therapies are sparse. Treatment of postoperative atrial fibrillation The treatment goals for AF and flutter that occur after cardiac surgery are identical to those of AF and atrial flutter that occur in other settings. These goals include prevention of thromboembolic events, slowing of the ventricular response rate, and consideration of conversion to and maintenance of sinus rhythm. Nevertheless, postoperative physiology does have features that favour some therapeutic strategies over others. The natural history of POAF after Values and preferences. This recommendation places a higher value on minimizing the risk of thromboembolic events and a lower value on the potential for postoperative bleeding. Because the risk of postoperative bleeding decreases with time, the benefit-to-risk ratio favours a longer period without anticoagulation in the postoperative setting than that suggested in other settings. Therapy for ventricular rate control for atrial tachyarrhythmias is usually required for patients who experience AF after cardiac surgery. Nevertheless, cardiac surgery may also predispose such patients to bradyarrhythmias after conversion of AF or atrial flutter secondary to sinus nodal, AV nodal, or His-Purkinje system dysfunction. Accordingly, the availability of back-up ventricular pacing is important. As the postsurgical state includes adrenergic discharge, -blocker therapy is often very effective for slowing of the ventricular response rate to AF and flutter. Other therapeutic alternatives, used when -blocker therapy is ineffective, poorly-tolerated, or contra-indicated, include a non-dihydropyridine calcium antagonist (diltiazem, verapamil) or amiodarone. In this setting, therapy with digoxin is usually insufficient. RECOMMENDATION We recommend that temporary ventricular epicardial pacing electrode wires be placed at the time of cardiac surgery to allow for backup ventricular pacing as necessary (Strong Recommendation, Low-Quality Evidence). 96 Canadian Journal of Cardiology Volume 27 2011 RECOMMENDATION We recommend that postoperative AF with a rapid ventricular response be treated with a -blocker, a non– dihydropyridine calcium antagonist, or amiodarone to establish ventricular rate control. In the absence of a specific contraindication, the order of choice is as listed (Strong Recommendation, High-Quality Evidence). Values and preferences. This recommendation places a high value on the randomized controlled trials investigating rate control as an alternative to rhythm control for AF, recognizing that these trials did not specifically address the postoperative period. We suggest that postoperative AF may be appropriately treated with either a ventricular response rate-control strategy or a rhythm-control strategy (Conditional Recommendation, Low-Quality Evidence). Values and preferences. This recommendation places a high value on the randomized controlled trials investigating rate control as an alternative to rhythm control for AF, recognizing that these trials did not specifically address the postoperative period. RECOMMENDATION We recommend that, when anticoagulation therapy, rate-control therapy, and/or rhythm-control therapy has been prescribed for postoperative AF, formal reconsideration of the ongoing need for such therapy should be undertaken 6-12 weeks later (Strong Recommendation, Moderate-Quality Evidence). Values and preferences. This recommendation reflects the high probability that postoperative AF will be a selflimiting process that does not require long-term therapy. EM BA R G Considerations related to the advantages, disadvantages, and risks of conversion to and maintenance of sinus rhythm for patients with sustained atrial tachyarrhythmias after cardiac surgery are similar to those in other settings. Nevertheless, because early recurrence of the atrial tachyarrhythmia is common, ongoing antiarrhythmic drug therapy to prevent atrial tachyarrhythmia recurrences is preferred over isolated DC cardioversion provided that the patient is sufficiently stable to proceed. Although intravenous ibutilide has been proposed as a rapid-acting approach to pharmacologic cardioversion of atrial tachyarrhythmias after cardiac surgery, this intervention was effective in ⬍50% of patients (with the highest success rates in patients with atrial flutter) and was associated with the precipitation of Torsades de pointes ventricular tachycardia in ⬇2%-5% of postoperative patients.42 In addition, the short half-life of this agent also translates into the absence of ongoing therapy to prevent atrial tachyarrhythmia recurrences. The overwhelming majority of patients with postoperative atrial tachyarrhythmias will no longer be susceptible to atrial tachyarrhythmia recurrences within 6-12 weeks after cardiac surgery. Accordingly, a rate-control strategy, as opposed to a rhythmcontrol strategy, has the advantage of not exposing the patient, who by definition has structural heart disease, to the risks of Class I or Class III antiarrhythmic drugs. No large randomized clinical trial has evaluated the advantages, disadvantages, and risks of the rate-control strategy versus the rhythm-control strategy for POAF. One small randomized pilot study39 reported a statistically significant reduction in the duration of the postsurgical hospital stay in patients developing postoperative AF who were assigned to a rhythm-control approach versus a rate-control approach to treatment. Nevertheless, a retrospective evaluation43 suggested a statistically significant reduction in the duration of postsurgical hospital stay in patients discharged in AF (after ventricular response rate control and anticoagulation) compared to patients discharged in sinus rhythm. Accordingly, the preferred approach remains unknown. Regardless of the approach chosen, therapy provided for POAF can usually be withdrawn 6-12 weeks later. RECOMMENDATION O ED Values and preferences. 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Kowey PR, Stebbins D, Igidbashian L, et al. Clinical outcome of patients who develop PAF after CABG surgery. PACE 2001;24:191-3. 39. Lee JK, Klein GJ, Krahn AD, et al. Rate-control versus conversion strategy in postoperative atrial fibrillation: a prospective, randomized pilot study. Am Heart J 2000;140:871-7. 40. Danias PG, Caulfield TA, Weigner MJ, et al. Likelihood of spontaneous conversion of AF to sinus rhythm. J Am Coll Cardiol 1998;31:588-92. 41. Meurin P, Weber H, Renaud N, et al. Evolution of the postoperative pericardial effusion after day 15: the problem of late tamponade. Chest 2004;125:2182-7. 42. VanderLugt JT, Mattioni T, Denker S, et al. Efficacy and safety of ibutilide fumarate for the conversion of atrial arrhythmias after cardiac surgery. Circulation 1999;100:369-75. 43. Solomon AF, Kouretas PC, Hopkins RA, et al. Early discharge of patients with new-onset atrial fibrillation after cardiovascular surgery. Am Heart J 1998;135:557-63. 44. Mitchell LB, Exner DV, Wyse DG, et al. Prophylactic oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, valve replacement, or repair (PAPABEAR): a randomized clinical trial. JAMA 2005;294:3093-100. 45. Toramen F, Karabulut EH, Alhan HC, Dağdelen S, Tarcan S. Magnesium infusion dramatically decreases the incidence of atrial fibrillation after coronary artery bypass surgery. Ann Thorac Surg 2001;72,1256-62. 46. Greenberg MD, Katz NM, Iuliano S, Tempestra BJ, Solomon AJ. Atrial pacing for the prevention of atrial fibrillation after cardiovascular surgery. J Am Coll Cardiol 2000;35:1416-22.