Guideline Management Of Heart Failure 2013 ACC/AHA Updated Heart Failure Guidelines Dawn Lombardo DO, MS Associate Professor Medicine University of California, Irvine Medical Director Heart Failure Program and Echocardiography Lab AHA 2009 Population Group Total population Heart Failure Prevalence 5,000,000 Incidence 670,000 Mortality 57,218 Hospital Discharges 1,093,000 Cost $29.6 billion Despite advances in HF treatment the # of HF deaths continues to ↑: ↑’ing age of the population advanced cardiotherapeutic interventions HF is a “condition of the elderly” ≈ 80% ADHF hospitalizations are ≥ 65 y/o Most common hospital D/C DRG ↑’st Medicare $ spent www.acc.org/clinical/guidelines/failure//index.pdf Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. 1 Epidemic Proportions of HF US figures in millions/year 100 AHA 2009 37.2 Billion $ 50 ~15 10 ~6.5 ~5 5 1.0 1 0.5 0.3 0 Deaths Hosp. Hosp. Office Adm. Days Visits $ Susceptible Symptomatic Asymptomatic First DX Lindenfeld J, et al. HFSA 2010 Comprehensive www.acc.org/clinical/guidelines/failure//index.pdf Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Definition of Heart Failure Classification I. Heart Failure with Reduced Ejection Fraction (HFrEF) Ejection Fraction ≤40% Description Also referred to as systolic HF. Randomized clinical trials have mainly enrolled patients with HFrEF and it is only in these patients that efficacious therapies have been demonstrated to date. ≥50% Also referred to as diastolic HF. Several different criteria have been used to further define HFpEF. The diagnosis of HFpEF is challenging because it is largely one of excluding other potential noncardiac causes of symptoms suggestive of HF. To date, efficacious therapies have not been identified. a. HFpEF, Borderline 41% to 49% These patients fall into a borderline or intermediate group. Their characteristics, treatment patterns, and outcomes appear similar to those of patient with HFpEF. b. HFpEF, Improved >40% It has been recognized that a subset of patients with HFpEF previously had HFrEF. These patients with improvement or recovery in EF may be clinically distinct from those with persistently preserved or reduced EF. Further research is needed to better characterize these patients. II. Heart Failure with Preserved Ejection Fraction (HFpEF) 1 of 2 HFSA 2010 Practice Guideline Definition of Heart Failure A syndrome caused by cardiac dysfunction Leading to neurohormonal & circulatory abnormalities and characteristic symptoms: Fluid retention Shortness of breath Fatigue, especially on exertion Left untreated usually progressive. Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. 2 of 2 HFSA 2010 Practice Guideline Definition of Heart Failure Although HF is progressive and often fatal, patients can be stabilized and myocardial dysfunction and remodeling may improve, either spontaneously or as a consequence of therapy. In physiological terms, HF is a syndrome characterized by: Elevated cardiac filling pressure OR Inadequate peripheral oxygen delivery, at rest or during stress, caused by cardiac dysfunction. Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline HF with Preserved LVEF "HF with Preserved EF = HFPEF" Clinical syndrome characterized by S & S of HFpEF. Most commonly associated with a non-dilated LV chamber. May be the result of HTN, valvular disease, CAD, DM or other causes. Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Classification of HF ACC/AHA Guidelines 2009 D Refractory C Prior, current symptoms B Structural heart disease LVH, MI, low LVEF, dilatation, valvular disease A High-risk patients HF Prevention Hypertension, diabetes, coronary disease, family history, cardiotoxic drugs Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. ACC-AHA Guidelines 2009 Pre-HF Asymptomatic Symptomatic Advanced A NYHA Functional Class B C I II, III D IV Remodeling Reverse Remodeling Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Classification of Heart Failure A B C ACCF/AHA Stages of HF At high risk for HF but without structural heart disease or symptoms of HF. Structural heart disease but without signs or symptoms of HF. Structural heart disease with prior or current symptoms of HF. NYHA Functional Classification None I I II III IV D Refractory HF requiring specialized interventions. No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest. Treatment Objectives Decreased symptoms Decreased mortality Increased exercise capacity Increased quality of life Decreased neurohormonal changes/remodeling www.acc.org/clinical/guidelines/failure//index.pdf Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Stages, Phenotypes and Treatment of HF At Risk for Heart Failure Heart Failure STAGE A STAGE B STAGE C At high risk for HF but without structural heart disease or symptoms of HF Structural heart disease but without signs or symptoms of HF Structural heart disease with prior or current symptoms of HF e.g., Patients with: · HTN · Atherosclerotic disease · DM · Obesity · Metabolic syndrome or Patients · Using cardiotoxins · With family history of cardiomyopathy Structural heart disease e.g., Patients with: · Previous MI · LV remodeling including LVH and low EF · Asymptomatic valvular disease Development of symptoms of HF e.g., Patients with: · Known structural heart disease and · HF signs and symptoms HFpEF THERAPY Goals · Heart healthy lifestyle · Prevent vascular, coronary disease · Prevent LV structural abnormalities Drugs · ACEI or ARB in appropriate patients for vascular disease or DM · Statins as appropriate THERAPY Goals · Prevent HF symptoms · Prevent further cardiac remodeling Drugs · ACEI or ARB as appropriate · Beta blockers as appropriate In selected patients · ICD · Revascularization or valvular surgery as appropriate STAGE D Refractory HF THERAPY Goals · Control symptoms · Improve HRQOL · Prevent hospitalization · Prevent mortality Strategies · Identification of comorbidities Treatment · Diuresis to relieve symptoms of congestion · Follow guideline driven indications for comorbidities, e.g., HTN, AF, CAD, DM · Revascularization or valvular surgery as appropriate Refractory symptoms of HF at rest, despite GDMT e.g., Patients with: · Marked HF symptoms at rest · Recurrent hospitalizations despite GDMT HFrEF THERAPY Goals · Control symptoms · Patient education · Prevent hospitalization · Prevent mortality Drugs for routine use · Diuretics for fluid retention · ACEI or ARB · Beta blockers · Aldosterone antagonists Drugs for use in selected patients · Hydralazine/isosorbide dinitrate · ACEI and ARB · Digoxin In selected patients · CRT · ICD · Revascularization or valvular surgery as appropriate THERAPY Goals · Control symptoms · Improve HRQOL · Reduce hospital readmissions · Establish patient’s endof-life goals Options · Advanced care measures · Heart transplant · Chronic inotropes · Temporary or permanent MCS · Experimental surgery or drugs · Palliative care and hospice · ICD deactivation Initial and Serial Evaluation of the HF Patient History and Physical Examination History and Physical Examination I IIa IIb III A thorough history and physical examination should be obtained/performed in patients presenting with HF to identify cardiac and noncardiac disorders or behaviors that might cause or accelerate the development or progression of HF. I IIa IIb III In patients with idiopathic DCM, a 3-generational family history should be obtained to aid in establishing the diagnosis of familial DCM. I IIa IIb III Volume status and vital signs should be assessed at each patient encounter. This includes serial assessment of weight, as well as estimates of jugular venous pressure and the presence of peripheral edema or orthopnea. Initial and Serial Evaluation of the HF Patient Risk Scoring Risk Scoring I IIa IIb III Validated multivariable risk scores can be useful to estimate subsequent risk of mortality in ambulatory or hospitalized patients with HF. Risk Scores to Predict Outcomes in HF Risk Score Reference (from full-text guideline)/Link Chronic HF All patients with chronic HF Seattle Heart Failure Model (204) / http://SeattleHeartFailureModel.org Heart Failure Survival Score (200) / http://handheld.softpedia.com/get/Health/Calculator/HFSS-Calc37354.shtml CHARM Risk Score CORONA Risk Score Specific to chronic HFpEF I-PRESERVE Score (207) (208) (202) Acutely Decompensated HF ADHERE Classification and Regression Tree (CART) Model American Heart Association Get With the Guidelines Score (201) EFFECT Risk Score (203) / http://www.ccort.ca/Research/CHFRiskModel.aspx ESCAPE Risk Model and Discharge Score (215) OPTIMIZE HF Risk-Prediction Nomogram (216) (206) / http://www.heart.org/HEARTORG/HealthcareProfessional/GetWithTheGuidel inesHFStroke/GetWithTheGuidelinesHeartFailureHomePage/Get-With-TheGuidelines-Heart-Failure-Home- %20Page_UCM_306087_SubHomePage.jsp Initial and Serial Evaluation of the HF Patient Biomarkers Ambulatory/Outpatient Ambulatory/Outpatient I IIa IIb III In ambulatory patients with dyspnea, measurement of BNP or N-terminal pro-B-type natriuretic peptide (NTproBNP) is useful to support clinical decision making regarding the diagnosis of HF, especially in the setting of clinical uncertainty. I IIa IIb III Measurement of BNP or NT-proBNP is useful for establishing prognosis or disease severity in chronic HF. Ambulatory/Outpatient (cont.) I IIa IIb III BNP- or NT-proBNP guided HF therapy can be useful to achieve optimal dosing of GDMT in select clinically euvolemic patients followed in a well-structured HF disease management program. I IIa IIb III The usefulness of serial measurement of BNP or NTproBNP to reduce hospitalization or mortality in patients with HF is not well established. I IIa IIb III Measurement of other clinically available tests such as biomarkers of myocardial injury or fibrosis may be considered for additive risk stratification in patients with chronic HF. Initial and Serial Evaluation of the HF Patient Biomarkers Hospitalized/Acute Hospitalized/Acute I IIa IIb III Measurement of BNP or NT-proBNP is useful to support clinical judgment for the diagnosis of acutely decompensated HF, especially in the setting of uncertainty for the diagnosis. I IIa IIb III Measurement of BNP or NT-proBNP and/or cardiac troponin is useful for establishing prognosis or disease severity in acutely decompensated HF. Hospitalized/Acute (cont.) I IIa IIb III The usefulness of BNP- or NT-proBNP guided therapy for acutely decompensated HF is not well-established. I IIa IIb III Measurement of other clinically available tests such as biomarkers of myocardial injury or fibrosis may be considered for additive risk stratification in patients with acutely decompensated HF. Causes for Elevated Natriuretic Peptide Levels Cardiac · Heart failure, including RV syndromes · Acute coronary syndrome · Heart muscle disease, including LVH · Valvular heart disease · Pericardial disease · Atrial fibrillation · Myocarditis · Cardiac surgery · Cardioversion Noncardiac · Advancing age · Anemia · Renal failure · Pulmonary causes: obstructive sleep apnea, severe pneumonia, pulmonary hypertension · Critical illness · Bacterial sepsis · Severe burns · Toxic-metabolic insults, including cancer chemotherapy and envenomation Recommendations for Biomarkers in HF Biomarker, Application Setting COR LOE Diagnosis or exclusion of HF Ambulatory, Acute I A Prognosis of HF Ambulatory, Acute I A Ambulatory IIa B Acute IIb C Acute, Ambulatory I A IIb B IIb A Natriuretic peptides Achieve GDMT Guidance of acutely decompensated HF therapy Biomarkers of myocardial injury Additive risk stratification Biomarkers of myocardial fibrosis Ambulatory Additive risk stratification Acute Initial and Serial Evaluation of the HF Patient Noninvasive Cardiac Imaging Recommendations for Noninvasive Imaging Recommendation Patients with suspected, acute, or new-onset HF should undergo a chest xray A 2-dimensional echocardiogram with Doppler should be performed for initial evaluation of HF Repeat measurement of EF is useful in patients with HF who have had a significant change in clinical status or received treatment that might affect cardiac function, or for consideration of device therapy Noninvasive imaging to detect myocardial ischemia and viability is reasonable in HF and CAD Viability assessment is reasonable before revascularization in HF patients with CAD Radionuclide ventriculography or MRI can be useful to assess LVEF and volume MRI is reasonable when assessing myocardial infiltration or scar Routine repeat measurement of LV function assessment should not be performed COR LOE I C I C I C IIa C IIa B IIa C IIa B III: No Benefit B Initial and Serial Evaluation of the HF Patient Invasive Evaluation Recommendations for Invasive Evaluation Recommendation COR LOE I C Invasive hemodynamic monitoring can be useful for carefully selected patients with acute HF with persistent symptoms and/or when hemodynamics are uncertain IIa C When coronary ischemia may be contributing to HF, coronary arteriography is reasonable IIa C Endomyocardial biopsy can be useful in patients with HF when a specific diagnosis is suspected that would influence therapy IIa C Routine use of invasive hemodynamic monitoring is not recommended in normotensive patients with acute HF III: No Benefit B III: Harm C Monitoring with a pulmonary artery catheter should be performed in patients with respiratory distress or impaired systemic perfusion when clinical assessment is inadequate Endomyocardial biopsy should not be performed in the routine evaluation of HF Guideline for HF Treatment of Stages A to D Treatment of Stages A to D Stage A HFSA 2010 Practice Guideline (3.1) Heart Failure Prevention Stage A = “At Risk Population” A careful and thorough clinical assessment, with appropriate investigation for known or potential risk factors, is recommended in an effort to prevent development of LV remodeling, cardiac dysfunction, and HF. Strength of Evidence = A Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Stage A I IIa IIb III I IIa IIb III Hypertension and lipid disorders should be controlled in accordance with contemporary guidelines to lower the risk of HF. Other conditions that may lead to or contribute to HF, such as obesity, diabetes mellitus, tobacco use, and known cardiotoxic agents, should be controlled or avoided. HFSA 2010 Practice Guideline (3.2) HF Risk Factor Treatment Goals Risk Factor Goal Hypertension Generally < 130/80 Diabetes See ADA guidelines1 Hyperlipidemia See NCEP guidelines2 Inactivity 20-30 min. aerobic 3-5 x wk. Obesity Weight reduction < 30 BMI Alcohol Men ≤ 2 drinks/day, women ≤ 1 Smoking Cessation Dietary Sodium Maximum 2-3 g/day 1Diabetes 2JAMA Adapted from: Care 2006; 29: S4-S42 2001; 285:2486-97 Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Alcohol Equivalents One drink = 12-14 g alcohol = 1.5 oz 80-proof spirits = 12 oz beer = 5 oz wine Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Sodium Equivalents Salt Sodium Chloride Sodium ¼ tsp 1550 mg 600 mg ½ tsp 3100 mg 1200 mg ¾ tsp 4650 mg 1800 mg 1 tsp 6100 mg 2400 mg Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Treating Hypertension to Prevent HF Aggressive blood pressure control: Decreases risk of new HF by ~ 50% in DM2 Lancet 1991;338:1281-5 (STOP-Hypertension JAMA 1997;278:212-6 (SHEP) UKPDS Group. UKPDS 38. BMJ 1998;317:703-713 Aggressive BP control in patients with prior MI: Decreases risk of new HF by ~ 80% HFSA 2010 Practice Guideline (3.3-3.4) Prevention—ACEI and Beta Blockers ACE inhibitors are recommended for prevention of HF in patients at high risk for this syndrome, including those with: Coronary artery disease Peripheral vascular disease Stroke Diabetes and another major risk factor Strength of Evidence = A ACE inhibitors and beta blockers are recommended for all patients with prior MI. Strength of Evidence = A Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Management of Patients with Known Atherosclerotic Disease But No HF Treatment with ACE inhibitors decreases the risk of CV death, MI, stroke, or cardiac arrest. 16 14 12 % MI, 10 Stroke, 8 CV Death 6 4 2 0 Ramipril 22% rel. risk red. p < .001 0 1 2 3 4 Years 15 EUROPA 12 NEJM 2000;342:145-53 (HOPE) Lancet 2003;362:782-8 (EUROPA) Placebo HOPE Placebo % MI, CV Death, 9 Cardiac 6 Arrest Perindopril 3 20% rel. risk red. p = .0003 0 0 1 2 3 Years 4 5 Treatment of Stages A to D Stage B Recommendations for Treatment of Stage B HF Recommendations In patients with a history of MI and reduced EF, ACE inhibitors or ARBs should be used to prevent HF In patients with MI and reduced EF, evidence-based beta blockers should be used to prevent HF In patients with MI, statins should be used to prevent HF Blood pressure should be controlled to prevent symptomatic HF ACE inhibitors should be used in all patients with a reduced EF to prevent HF Beta blockers should be used in all patients with a reduced EF to prevent HF An ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 d post-MI, have an LVEF ≤30%, and on GDMT Nondihydropyridine calcium channel blockers may be harmful in patients with low LVEF COR LOE I A I B I A I A I A I C IIa B III: Harm C Treatment of Post-MI Patients with Asymptomatic LV Dysfunction (LVEF ≤ 40%) SAVE Study 0.3 Mortality Rate All-cause mortality ↓19% Placebo 0.2 Captopril CV mortality ↓21% 0.1 HF development ↓37% Recurrent MI ↓25% 19% rel. risk reduction p = 0.019 0 0 0.5 1 1.5 2 2.5 3 3.5 4 Years Pfeffer et al. NEJM 1992;327:669-77 ACE Inhibitors in Heart Failure: From Asymptomatic LVD to Severe HF SOLVD Prevention (Asymptomatic LVD) CONSENSUS (Severe Heart Failure) 20% death or HF hosp. 40% mortality at 6 mos. 29% death or new HF 31% mortality at 1 year 27% mortality at end of study SOLVD Treatment (Chronic Heart Failure) 16% mortality No difference in incidence of sudden cardiac death SOLVD Investigators. N Engl J Med 1992;327:685-91 SOLVD Investigators. N Engl J Med 1991;325:293-302 CONSENSUS Study Trial Group. N Engl J Med 1987;316:1429-35 The Additional Value of Beta Blockers Post-MI: CAPRICORN Carvedilol in post-MI pts, LVEF ≤ 40% on EBT: revascularization, anticoagulants, ASA, and ACEI: All-cause mortality reduced (HR=0.77; p=0.03) CV mortality reduced (HR=0.75; p=.024) Recurrent non-fatal MIs reduced (HR=.59; p =.014) Dargie HJ. Lancet 2001;357:1385-90 Treatment of Stages A to D Pharmacological Treatment for Stage C HFrEF Pharmacologic Treatment for Stage C HFrEF HFrEF Stage C NYHA Class I – IV Treatment: Class I, LOE A ACEI or ARB AND Beta Blocker For all volume overload, NYHA class II-IV patients For persistently symptomatic African Americans, NYHA class III-IV For NYHA class II-IV patients. Provided estimated creatinine >30 mL/min and K+ <5.0 mEq/dL Add Add Add Class I, LOE C Loop Diuretics Class I, LOE A Hydral-Nitrates Class I, LOE A Aldosterone Antagonist Drugs Commonly Used for HFrEF (Stage C HF) Drug ACE Inhibitors Captopril Enalapril Fosinopril Lisinopril Perindopril Quinapril Ramipril Trandolapril ARBs Candesartan Losartan Valsartan Aldosterone Antagonists Spironolactone Eplerenone Initial Daily Dose(s) Maximum Doses(s) Mean Doses Achieved in Clinical Trials 6.25 mg 3 times 2.5 mg twice 5 to 10 mg once 2.5 to 5 mg once 2 mg once 5 mg twice 1.25 to 2.5 mg once 1 mg once 50 mg 3 times 10 to 20 mg twice 40 mg once 20 to 40 mg once 8 to 16 mg once 20 mg twice 10 mg once 4 mg once 122.7 mg/d (421) 16.6 mg/d (412) --------32.5 to 35.0 mg/d (444) --------------------------------- 4 to 8 mg once 25 to 50 mg once 20 to 40 mg twice 32 mg once 50 to 150 mg once 160 mg twice 24 mg/d (419) 129 mg/d (420) 254 mg/d (109) 12.5 to 25 mg once 25 mg once 25 mg once or twice 50 mg once 26 mg/d (424) 42.6 mg/d (445) Drugs Commonly Used for HFrEF (Stage C HF) (cont.) Drug Initial Daily Dose(s) Beta Blockers Bisoprolol 1.25 mg once Carvedilol 3.125 mg twice Carvedilol CR 10 mg once Metoprolol succinate extended release 12.5 to 25 mg once (metoprolol CR/XL) Hydralazine & Isosorbide Dinitrate 37.5 mg hydralazine/ Fixed dose combination 20 mg isosorbide (423) dinitrate 3 times daily Hydralazine and Hydralazine: 25 to 50 isosorbide dinitrate (448) mg, 3 or 4 times daily and isorsorbide dinitrate: 20 to 30 mg 3 or 4 times daily Maximum Doses(s) Mean Doses Achieved in Clinical Trials 10 mg once 50 mg twice 80 mg once 8.6 mg/d (118) 37 mg/d (446) --------- 200 mg once 159 mg/d (447) 75 mg hydralazine/ 40 mg isosorbide dinitrate 3 times daily Hydralazine: 300 mg daily in divided doses and isosorbide dinitrate 120 mg daily in divided doses ~175 mg hydralazine/90 mg isosorbide dinitrate daily --------- Medical Therapy for Stage C HFrEF: Magnitude of Benefit Demonstrated in RCTs GDMT ACE inhibitor or ARB Beta blocker Aldosterone antagonist Hydralazine/nitrate (Standardized to 36 mo) RR Reduction in HF Hospitalizations 17% 26 31% 34% 9 41% 30% 6 35% 43% 7 33% RR Reduction in Mortality NNT for Mortality Reduction Pharmacological Therapy for Management of Stage C HFrEF Recommendations Diuretics Diuretics are recommended in patients with HFrEF with fluid retention ACE Inhibitors ACE inhibitors are recommended for all patients with HFrEF ARBs ARBs are recommended in patients with HFrEF who are ACE inhibitor intolerant ARBs are reasonable as alternatives to ACE inhibitor as first line therapy in HFrEF The addition of an ARB may be considered in persistently symptomatic patients with HFrEF on GDMT Routine combined use of an ACE inhibitor, ARB, and aldosterone antagonist is potentially harmful COR LOE I C I A I A IIa A IIb A III: Harm C Pharmacological Therapy for Management of Stage C HFrEF (cont.) Recommendations Beta Blockers Use of 1 of the 3 beta blockers proven to reduce mortality is recommended for all stable patients Aldosterone Antagonists Aldosterone receptor antagonists are recommended in patients with NYHA class II-IV HF who have LVEF ≤35% Aldosterone receptor antagonists are recommended in patients following an acute MI who have LVEF ≤40% with symptoms of HF or DM Inappropriate use of aldosterone receptor antagonists may be harmful Hydralazine and Isosorbide Dinitrate The combination of hydralazine and isosorbide dinitrate is recommended for African-Americans, with NYHA class III– IV HFrEF on GDMT A combination of hydralazine and isosorbide dinitrate can be useful in patients with HFrEF who cannot be given ACE inhibitors or ARBs COR LOE I A I A I B III: Harm B I A IIa B Pharmacologic Therapy for Management of Stage C HFrEF (cont.) Recommendations Digoxin Digoxin can be beneficial in patients with HFrEF Anticoagulation Patients with chronic HF with permanent/persistent/paroxysmal AF and an additional risk factor for cardioembolic stroke should receive chronic anticoagulant therapy* The selection of an anticoagulant agent should be individualized Chronic anticoagulation is reasonable for patients with chronic HF who have permanent/persistent/paroxysmal AF but without an additional risk factor for cardioembolic stroke* Anticoagulation is not recommended in patients with chronic HFrEF without AF, prior thromboembolic event, or a cardioembolic source Statins Statins are not beneficial as adjunctive therapy when prescribed solely for HF Omega-3 Fatty Acids Omega-3 PUFA supplementation is reasonable to use as adjunctive therapy in HFrEF or HFpEF patients COR LOE IIa B I A I C IIa B III: No Benefit B III: No Benefit A IIa B Pharmacological Therapy for Management of Stage C HFrEF (cont.) Recommendations Other Drugs Nutritional supplements as treatment for HF are not recommended in HFrEF Hormonal therapies other than to replete deficiencies are not recommended in HFrEF Drugs known to adversely affect the clinical status of patients with HFrEF are potentially harmful and should be avoided or withdrawn Long-term use of an infusion of a positive inotropic drug is not recommended and may be harmful except as palliation Calcium Channel Blockers Calcium channel blocking drugs are not recommended as routine in HFrEF COR III: No Benefit III: No Benefit LOE B C III: Harm B III: Harm C III: No Benefit A HFSA 2010 Practice Guideline (7.11) Pharmacologic Therapy: Beta Blockers SYMPTOMATIC EXACERBATION Continuation of beta blocker therapy is recommended in most patients experiencing a symptomatic exacerbation of HF during chronic maintenance treatment, unless they develop cardiogenic shock, refractory volume overload, or symptomatic bradycardia. Strength of Evidence = C Temporary dose reduction may be considered Avoid abrupt discontinuation Reinstate or gradually increase prior to discharge Titrate dose to previously tolerated dose as soon as possible Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. ACE Inhibitors in Heart Failure: From Asymptomatic LVD to Severe HF SOLVD Prevention (Asymptomatic LVD) CONSENSUS (Severe Heart Failure) 20% death or HF hosp. 40% mortality at 6 mos. 29% death or new HF 31% mortality at 1 year 27% mortality at end of study SOLVD Treatment (Chronic Heart Failure) 16% mortality No difference in incidence of sudden cardiac death SOLVD Investigators. N Engl J Med 1992;327:685-91 SOLVD Investigators. N Engl J Med 1991;325:293-302 CONSENSUS Study Trial Group. N Engl J Med 1987;316:1429-35 Effect of Beta Blockade on Outcome in Patients With HF and Post-MI LVD HF Severity Target Dose (mg) Outcome Study Drug US Carvedilol1 carvedilol mild/ moderate 6.2525 BID ↓48% disease progression (p= .007) CIBIS-II2 bisoprolol moderate/ severe 10 QD ↓34% mortality (p <.0001) MERIT-HF3 metoprolol succinate mild/ moderate 200 QD ↓34% mortality (p = .0062) COPERNICUS4 carvedilol severe 25 BID ↓35% mortality (p = .0014) CAPRICORN5 carvedilol post-MI LVD 25 BID ↓23% mortality (p =.031) 1Colucci WS et al. Circulation 1196;94:2800-6. 2CIBIS II Investigators. Lancet 1999;353:9-13. 3MERIT-HF Study Group. Lancet 1999;353:2001-7. 4Packer M et al. N Engl J Med 2001;344 1651-8. 5The CAPRICORN Investigators. Lancet 2001;357:1385-90. COPERNICUS: Death, Hospitalization, or Study Drug Withdrawal in High Risk Patients % of Patients With Event 30 HR = 0.67 (CI = 0.47-0.96) 20 Placebo 10 Carvedilol 0 0 2 4 6 Weeks After Randomization 8 Krum H et al. JAMA 2003;289:754-6 Krum et al. JAMA 2003;289 HFSA 2010 Practice Guideline Pharmacologic Therapy: Beta Blocker Overview* General considerations Initiate at low doses Up-titrate gradually, generally no sooner than at 2 week intervals Use target doses shown to be effective in clinical trials Aim to achieve target dose in 8-12 weeks Maintain at maximum tolerated dose If symptoms worsen or other side effects appear Adjust dose of diuretic or concomitant vasoactive med. If up-titration continues to be difficult Prolong titration interval Continue titration to target after symptoms return to baseline Reduce target dose Consider referral to a HF specialist *Consult language of specific recommendations Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline (7.3) Pharmacologic Therapy: Angiotensin Receptor Blockers ARBs are recommended for routine administration to symptomatic and asymptomatic patients with an LVEF ≤ 40% who are intolerant to ACE inhibitors for reasons other than hyperkalemia or renal insufficiency. Strength of Evidence = A Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. ARBS in Patients Not Taking ACE Inhibitors: Val-HeFT & CHARM-Alternative Val-HeFT CHARM-Alternative 50 CV Death or HF Hosp % Survival % 100 Valsartan 90 80 Placebo 70 Placebo 40 30 Candesartan 20 10 60 p = 0.017 HR 0.77, p = 0.0004 50 0 0 3 6 9 12 15 18 21 24 27 0 9 Months 18 27 Months Maggioni AP et al. JACC 2002;40:1422-4 Granger CB et al. Lancet 2003;362:772-6 36 Angiotensin Receptor Blockers Used in Clinical Trials Generic Name Trade Name Initial Daily Dose Target Dose Mean Dose in Clinical Trials Candesartan Atacand 4-8 mg qd 32 mg qd 24 mg/day Losartan Cozaar 12.5-25 mg qd 150 mg qd 129 mg/day Valsartan Diovan 40 mg bid 160 mg bid 254 mg/day Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline (7.14-7.15) Pharmacologic Therapy: Aldosterone Antagonists An aldosterone antagonist is recommended for patients on standard therapy, including diuretics, who have: NYHA class IV HF (or class III, previously class IV) HF from reduced LVEF (≤ 35%) One should be considered in patients post-MI with clinical HF or diabetes and an LVEF < 40% who are on standard therapy, including an ACE inhibitor (or ARB) and a beta blocker. Strength of Evidence = A Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Aldosterone Antagonists in HF EPHESUS (Post-MI) Probability of Survival RALES (Advanced HF) 1.00 1.00 0.90 0.90 0.80 Spironolactone 0.70 Eplerenone 0.80 Placebo 0.70 0.60 0.60 Placebo 0.50 0.50 RR = 0.70 P < 0.001 0.40 RR = 0.85 P < 0.008 0.40 0 3 6 9 12 15 18 21 24 27 30 33 36 0 3 6 9 12 15 18 21 24 27 30 33 36 Months Pitt B. N Engl J Med 1999;341:709-17 Pitt B. N Engl J Med 2003;348:1309-21 HFSA 2010 Practice Guideline (7.16-7.18) Aldosterone Antagonists and Renal Function Aldosterone antagonists are not recommended when: Creatinine > 2.5mg/dL (or clearance < 30 mL/min) Serum potassium> 5.0 mmol/L Therapy includes other potassium-sparing diuretics Strength of Evidence = A It is recommended that potassium be measured at baseline, then 1 week, 1 month, and every 3 months Strength of Evidence = A Supplemental potassium is not recommended unless potassium is < 4.0 mmol/L Strength of Evidence = A Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. after RALES: RX Juurlink et al. NEJM 2004;351:543 Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. after RALES::Death Juurlink et al. NEJM 2004;351:543 Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline (7.19) Pharmacologic Therapy: Hydralazine and Oral Nitrates A combination of hydralazine and isosorbide dinitrate is recommended as part of standard therapy, in addition to beta-blockers and ACE-inhibitors, for African Americans with HF and reduced LVEF: NYHA III or IV HF Strength of Evidence = A NYHA II HF Strength of Evidence = B Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. A-HeFT All-Cause Mortality 43% Decrease in Mortality 100 Survival % Fixed Dose ISDN/HDZN 95 90 Placebo P = 0.01 85 0 100 200 Days Since Baseline Visit 300 400 500 600 Taylor AL et al. N Engl J Med 2004;351:2049-57 Treatment of Stages A to D Treatment for Stage C HFpEF Treatment of HFpEF Recommendations Systolic and diastolic blood pressure should be controlled according to published clinical practice guidelines Diuretics should be used for relief of symptoms due to volume overload Coronary revascularization for patients with CAD in whom angina or demonstrable myocardial ischemia is present despite GDMT Management of AF according to published clinical practice guidelines for HFpEF to improve symptomatic HF Use of beta-blocking agents, ACE inhibitors, and ARBs for hypertension in HFpEF ARBs might be considered to decrease hospitalizations in HFpEF Nutritional supplementation is not recommended in HFpEF COR LOE I B I C IIa C IIa C IIa C IIb B III: No Benefit C Figure 11.3. Diagnostic Algorithm for HF with Preserved LVEF HF with Preserved LVEF Dilated LV Valvular disease AR, MR Non-dilated LV No valvular dis. High output HF Increased thickness Normal or increased QRS Hypertrophic dis. No aortic valve disease No hypertensive history of PE HCM, Fabry dis. Low QRS voltage Infiltrative myopathy Aortic valve dis. Aortic stenosis Hypertensive history of PE Hypertensive-HCM Some patients with RV dysfunction have LV dysfunction due to ventricular interaction. Normal Thickness Right vent. dysfunction No mitral obstruction Pericardial dis. Tamponade Constriction Pulmonary hypertension Isolated predominant RVMI No pericardial disease Inducible ischemia Intermittent/active ischemia Mitral obstruction MS, atrial myxoma No inducible ischemia, fibrotic, collagenVascular, RCM, cardinoid, diabetes, Radiation or chemotherapy induced heart disease, infiltrative disease, comorbid conditions, reconsider diagnosis of HF Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline (11.8, 15.2) Pharmacologic Therapy: Beta Blockers PRESERVED LVEF Beta blocker treatment is recommended in patients with HF and preserved LVEF who have: Prior MI Strength of Evidence = A Hypertension Strength of Evidence = B Atrial fib. requiring control of ventricular rate Strength of Evidence = B Strength of Evidence = C Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. The Hospitalized Patient Diuretics in Hospitalized Patients HFSA 2010 Practice Guideline (7.23) Pharmacologic Therapy: Diuretics Diuretic therapy is recommended to restore and maintain normal volume status in patients with clinical evidence of fluid overload, generally manifested by: Congestive symptoms Signs of elevated filling pressures Strength of Evidence = A Loop diuretics rather than thiazide-type diuretics are typically necessary to restore normal volume status in patients with HF. Strength of Evidence = B Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. HFSA 2010 Practice Guideline (7.24) Pharmacologic Therapy: Diuretics Restoration of normal volume status may require multiple adjustments. Once a diuretic effect is achieved with short-acting loop diuretics, increase frequency to 2-3 times a day if necessary, rather than increasing a single dose. Strength of Evidence = B Oral torsemide may be considered in patients exhibiting poor absorption of oral medication or erratic diuretic effect. Strength of Evidence = C IV administration of diuretics may be necessary. Strength of Evidence = A Diuretic refractoriness may represent patient nonadherence, a direct effect of diuretic use on the kidney, or progression of underlying dysfunction. Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Loop Diuretics Agent Initial Daily Dose Max Total Daily Dose Elimination: Duration of Renal – Met. Action Furosemide 20-40mg qd or bid 600 mg 65%R-35%M 4-6 hrs Bumetanide 0.5-1.0 mg qd or bid 10 mg 62%R/38%M 6-8 hrs Torsemide 10-20 mg qd 200 mg 20%R-80%M 12-16 hrs Ethacrynic acid 25-50 mg qd or bid 200 mg 67%R-33%M 6 hrs Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Potassium-Sparing Diuretics Agent Initial Daily Dose Max Total Daily Dose Elimination Duration of Action Spironolactone 12.5-25 mg qd 50 mg Metabolic 48-72 hrs Eplerenone 25-50 mg qd 100 mg Renal, Metabolic Unknown Amiloride 5 mg qd 20 mg Renal 24 hrs Triamterene 50-75 mg bid 200 mg Metabolic 7-9 hrs Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Therapies in the Hospitalized HF Patient Recommendation COR LOE HF patients hospitalized with fluid overload should be treated with intravenous diuretics I B HF patients receiving loop diuretic therapy, should receive an initial parenteral dose greater than or equal to their chronic oral daily dose, then should be serially adjusted I B HFrEF patients requiring HF hospitalization on GDMT should continue GDMT unless hemodynamic instability or contraindications I B Initiation of beta-blocker therapy at a low dose is recommended after optimization of volume status and discontinuation of intravenous agents I B Thrombosis/thromboembolism prophylaxis is recommended for patients hospitalized with HF I B Serum electrolytes, urea nitrogen, and creatinine should be measured during the titration of HF medications, including diuretics I C Therapies in the Hospitalized HF Patient (cont.) Recommendation COR LOE B When diuresis is inadequate, it is reasonable to a) Give higher doses of intravenous loop diuretics; or b) add a second diuretic (e.g., thiazide) IIa Low-dose dopamine infusion may be considered with loop diuretics to improve diuresis IIb B Ultrafiltration may be considered for patients with obvious volume overload IIb B Ultrafiltration may be considered for patients with refractory congestion IIb C Intravenous nitroglycerin, nitroprusside or nesiritide may be considered an adjuvant to diuretic therapy for stable patients with HF IIb B In patients hospitalized with volume overload and severe hyponatremia, vasopressin antagonists may be considered IIb B B HFSA 2010 Practice Guideline (12.25, Table 12.7) Discharge Criteria for Hospitalized ADHF Patients Recommended prior to discharge for all patients with HF: Exacerbating factors addressed Near optimum fluid status and pharmacologic therapy achieved Transition from IV to oral diuretic completed Patient education completed with clear discharge instructions Follow-up clinic visit scheduled, usually 7-10 days Should be considered prior to discharge for patients with advanced HF or a history of recurrent admissions: Oral regimen stable for 24 hours No IV inotrope or vasodilator for 24 hours Ambulation before discharge to assess functional capacity Plans for post-discharge management Referral for disease management, if available Strength of Evidence =C Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. Hospital Discharge Recommendation or Indication COR LOE Performance improvement systems in the hospital and early postdischarge outpatient setting to identify HF for GDMT I B Before hospital discharge, at the first postdischarge visit, and in subsequent follow-up visits, the following should be addressed: a) initiation of GDMT if not done or contraindicated; b) causes of HF, barriers to care, and limitations in support; c) assessment of volume status and blood pressure with adjustment of HF therapy; d) optimization of chronic oral HF therapy; e) renal function and electrolytes; f) management of comorbid conditions; g) HF education, self-care, emergency plans, and adherence; and h) palliative or hospice care. I B I B IIa B IIa B Multidisciplinary HF disease-management programs for patients at high risk for hospital readmission are recommended A follow-up visit within 7 to 14 days and/or a telephone follow-up within 3 days of hospital discharge is reasonable Use of clinical risk-prediction tools and/or biomarkers to identify higher-risk patients is reasonable HFSA 2010 Practice Guideline (8.1) Heart Failure Patient Education It is recommended that patients with HF and their family members or caregivers receive individualized education and counseling that emphasizes self-care. This education and counseling should be delivered by providers using a team approach. Referral to HF Disease Management Program Metrics to consider include the 6-minute walk test and NYHA functional class Strength of Evidence = B Adapted from: Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194. The Potential Impact of Effective Education on Patient Compliance Nonadherence rate when patients . . . Recall MD advice Don’t recall advice Medications 8.7% 66.7% Diet 23.6% 55.8% Activity 76.4% 84.5% Smoking 60.0% 90.4% Alcohol 60.0% 81.8% Kravitz et al. Arch Int Med 1993;153:1869-78 HF Disease Management and the Risk of Readmission 1.1 Risk Ratio Ekman 1 0.9 0.8 Jaarsma 0.7 Cline Lasater Stewart Rich Rauh Venner 0.6 Naylor Fonarow 0.5 Summary RR = 0.76 (95% CI .68-.87) Summary RR for randomized only = 0.75 (CI = .60-.95) Guideline for HF Quality Metrics/Performance Measures ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set Measure 1. LVEF assessment 2. LVEF assessment 3. Symptom and activity assessment Description* Care Level of Setting Measurement Percentage of patients aged ≥18 y with a diagnosis of HF for whom the Outpatient Individual quantitative or qualitative results of a recent or prior (any time in the practitioner past) LVEF assessment is documented within a 12 mo period Percentage of patients aged ≥18 y with a principal discharge diagnosis Inpatient · Individual of HF with documentation in the hospital record of the results of an practitioner LVEF assessment that was performed either before arrival or during · Facility hospitalization, OR documentation in the hospital record that LVEF assessment is planned for after discharge Percentage of patient visits for those patients aged ≥18 y with a Outpatien Individual diagnosis of HF with quantitative results of an evaluation of both t practitioner current level of activity and clinical symptoms documented *Please refer to the complete measures for comprehensive information, including measure exception. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:1812-32. ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure 4. Symptom management† 5. Patient selfcare education†‡ 6. Beta-blocker therapy for LVSD (outpatient and inpatient setting) Description* Percentage of patient visits for those patients aged ≥18 y with a diagnosis of HF and with quantitative results of an evaluation of both level of activity AND clinical symptoms documented in which patient symptoms have improved or remained consistent with treatment goals since last assessment OR patient symptoms have demonstrated clinically important deterioration since last assessment with a documented plan of care Percentage of patients aged ≥18 y with a diagnosis of HF who were provided with self-care education on ≥3 elements of education during ≥1 visits within a 12 mo period Percentage of patients aged ≥18 y with a diagnosis of HF with a current or prior LVEF <40% who were prescribed beta-blocker therapy with bisoprolol, carvedilol, or sustained release metoprolol succinate either within a 12 mo period when seen in the outpatient setting or at hospital discharge Care Setting Outpatient Level of Measurement Individual practitioner Outpatient Individual practitioner Inpatient Individual and practitioner Outpatient Facility *Please refer to the complete measures for comprehensive information, including measure exception. †Test measure designated for use in internal quality improvement programs only. These measures are not appropriate for any other purpose, e.g., pay for performance, physician ranking or public reporting programs. ‡New measure. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:1812-32. ACCF/AHA/AMA-PCPI 2011 HF Performance Measurement Set (cont.) Measure Description* Care Setting Level of Measurement Individual practitioner Facility 7. ACE Inhibitor or ARB Therapy for LVSD (outpatient and inpatient setting) 8. Counseling regarding ICD implantation for patients with LVSD on combination medical therapy†‡ 9. Post-discharge appointment for heart failure patients Percentage of patients aged ≥18 y with a diagnosis of HF with a current or prior LVEF <40% who were prescribed ACE inhibitor or ARB therapy either within a 12 mo period when seen in the outpatient setting or at hospital discharge Percentage of patients aged ≥18 y with a diagnosis of HF with current LVEF ≤35% despite ACE inhibitor/ARB and beta-blocker therapy for at least 3 mo who were counseled regarding ICD implantation as a treatment option for the prophylaxis of sudden death Inpatient and Outpatient Outpatient Individual practitioner Percentage of patients, regardless of age, discharged from an inpatient facility to ambulatory care or home health care with a principal discharge diagnosis of HF for whom a follow-up appointment was scheduled and documented including location, date and time for a follow-up office visit, or home health visit (as specified) Inpatient Facility *Please refer to the complete measures for comprehensive information, including measure exception. †Test measure designated for use in internal quality improvement programs only. These measures are not appropriate for any other purpose, e.g., pay for performance, physician ranking or public reporting programs. ‡New measure. Adapted from Bonow et al. J Am Coll Cardiol. 2012;59:1812-32. Thank You www.acc.org/clinical/guidelines/failure//index.pdf