TITLE: Radiotherapy for Cancer Patients with Cardiac Implantable Electronic Devices: Guidelines DATE: 25 April 2016 RESEARCH QUESTIONS 1. What are the evidence-based guidelines regarding screening and identification of cancer patients with cardiac implantable electronic devices who require radiotherapy? 2. What are the evidence-based guidelines regarding the use of radiotherapy for cancer patients with cardiac implantable electronic devices? 3. What are the evidence-based guidelines regarding the post-procedure monitoring and management of cancer patients with cardiac implantable electronic devices who have received radiotherapy? KEY FINDINGS Three evidence-based guidelines regarding the use of radiotherapy for cancer patients with cardiac implantable electronic devices were identified. METHODS A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, Canadian and major international health technology agencies, as well as a focused Internet search. Filters were applied to limit the retrieval to health technology assessments, systematic reviews and meta-analyses, and guidelines. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2011 and April 14, 2016. Internet links were provided, where available. Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic review s. The intent is to provide a list of sources of the best evidence on the topic that the Canadian Agency for Drugs and Technologies in Health (CADTH) could identify using all reasonable efforts within the time allow ed. Rapid responses should be considered along w ith other ty pes of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for w hich little information can be found, but w hich may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in w hich a third party ow ns copyright. This report m ay be used for the purposes of research or private study only. It may not be copied, posted on a w eb site, redistributed by email or stored on an electronic system w ithout the prior w ritten permission of CADTH or applicable copyrigh t ow ner. Links: This report may contain links to other information available on the w ebsites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the ow ners’ ow n terms and conditions. The summary of findings was prepared from the abstracts of the relevant information. Please note that data contained in abstracts may not always be an accurate reflection of the data contained within the full article. SELECTION CRITERIA One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Cancer patients (of any age) who have a cardiac implantable electronic device (CIED) (e.g., pacemaker [PPM], implantable cardioverter defibrillator [ICD], or cardiac resynchronization therapy [CRT] devices) Radiotherapy No comparator required Evidence-based guidelines regarding: Q1: Screening and identification of patients Q2: Use of radiotherapy (e.g., appropriate dose, duration of treatment) Q3: Post-procedure monitoring and management Evidence-based guidelines RESULTS Three evidence-based guidelines regarding the use of radiotherapy for cancer patients with cardiac implantable electronic devices were identified. Additional references of potential interest are provided in the appendix. OVERALL SUMMARY OF FINDINGS The recommendations indicate that radiotherapy can safely be used for patients with cardiac implantable electronic devices (CIEDs)2 with a few considerations. Radiotherapy can cause damage to CIEDs if the devices are too close to the field of radiation; 3 therefore, if CIEDs are too close to the focus of radiation, they should be covered with a lead shield 3 or surgically relocated.2 Patients with CIEDs receiving radiotherapy should be categorized according to their risk of device failure based on the radiation dose received by their device.1 The categories of risk are: low (less than two grays [Gy]), medium (two to 10 Gy), and high (greater than 10 Gy). 1 Radiotherapy for Cancer Patients with Cardiac Implantable Electronic Devices 2 REFERENCES SUMMARIZED Guidelines and Recommendations 1. Hurkmans CW, Knegjens JL, Oei BS, Maas AJ, Uiterwaal GJ, van der Borden AJ, et al. Management of radiation oncology patients with a pacemaker or ICD: a new comprehensive practical guideline in The Netherlands. Dutch Society of Radiotherapy and Oncology (NVRO). Radiat Oncol. 2012;7:198. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528416 PubMed: PM23176563 2. National Guideline Clearinghouse [Internet]. Rockville (MD): Agency for Healthcare and Research Quality (ARHQ); [1997] - . Guideline summary: Practice advisory for the perioperative management of patients with cardiac implantable electronic devices: pacemakers and implantable cardioverter-defibrillators. An updated report by the American Society of Anesthesiologists Task Force on perioperative management of patients with cardiac implantable electronic devices; 2011 [cited 2016 Apr 25]. NGC summary available: http://www.guideline.gov/content.aspx?id=34403&search=pacemaker+radiation See: F. Radiation Therapy 3. National Guideline Clearinghouse [Internet]. Rockville (MD): Agency for Healthcare and Research Quality (ARHQ); [1997] - . Guideline summary: Disease-specific approaches. In: II guidelines for perioperative evaluation; 2011 [cited 2016 Apr 25]. NGC summary available: http://www.guideline.gov/content.aspx?id=34055&search=pacemaker+radiation See: Potential Harms, Implanted Pacemakers and B. Intraoperative Period, Radiotherapy PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca Radiotherapy for Cancer Patients with Cardiac Implantable Electronic Devices 3 APPENDIX – FURTHER INFORMATION: Systematic Reviews and Meta-analyses 4. Munshi A, Agarwal JP, Pandey KC. Cancer patients with cardiac pacemakers needing radiation treatment: a systematic review. J Cancer Res Ther. 2013 Apr;9(2):193-8. PubMed: PM23771357 Clinical Practice Guidelines – Methodology Not Specified 5. Thomas H, Turley A, Plummer C, on behalf of BHRS council. BHRS Guidelines: British Heart Rhythm Society guidelines for the management of patients with cardiac implantable electronic devices (CIEDs) around the time of surgery [Internet]. Stratford upon Avon, Warwickshire (UK): BHRS; 2016 [cited 2016 Apr 25]. Available from: http://www.bhrs.com/files/files/Guidelines/160216-Guideline,%20Perioperative%20management%20of%20CIEDs.pdf See: Radiotherapy, page 7 6. Gauter-Fleckenstein B, Israel CW, Dorenkamp M, Dunst J, Roser M, Schimpf R, et al. DEGRO/DGK guideline for radiotherapy in patients with cardiac implantable electronic devices. Strahlenther Onkol. 2015 May;191(5):393-404. PubMed: PM25739476 7. The Society of Radiographers [Internet]. Management of cancer patients receiving radiotherapy with a cardiac implanted electronic device: a clinical guideline recommended for use by The Royal College of Radiologists, The Society and College of Radiographers and The Institute of Physics and Engineering in Medicine. London (UK): The Society of Radiographers (SoR); 2014 [cited 2016 Apr 25]. Available from: http://www.sor.org/sites/default/files/documentversions/mgmt_of_cancer_patients_with_cied_final_with_logos.pdf 8. Effects of therapeutic radiation on St. Jude Medical implantable cardiac rhythm devices. Sylmar (CA): St. Jude Medical; 2013. 9. Guidelines for managing radiotherapy patients with pacemakers or ICDs. Health Devices. 2013 Mar;42(3):100. PubMed: PM23593661 10. NHS Tayside. Management of patients with pacemakers/implantable cardiac defibrillators and undergoing invasive procedures including radiotherapy [Internet]. Tayside, England: NHS (National Health Service); 2012 [cited 2016 Apr 25]. Available from: http://blogs.cmdn.dundee.ac.uk/acutecareguide/files/2012/12/Management-of-devicepatients.pdf Radiotherapy for Cancer Patients with Cardiac Implantable Electronic Devices 4 11. Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, et al. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the Perioperative Management of Patients with Implantable Defibrillators, Pacemakers and Arrhythmia Monitors: Facilities and Patient Management. Heart Rhythm. 2011 Jul;8(7):1114-54. Available from: http://www.heartrhythmjournal.com/article/S15475271(10)01387-1/abstract PubMed: PM 21722856 See: 3.9.4 Therapeutic Radiation, page 1121 Additional References 12. Public Health England. Safer radiotherapy: radiotherapy newsletter of Public Health England [Internet]. London (UK): UK Government, Government Digital Service; May 2015 [cited 2016 Apr 25];1. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/430597/Saf er_RT_No16_StdQ.pdf See: Guest Editorial, page 4 13. Boston Scientific. Therapeutic radiation and implantable device systems: a closer look [Internet]. Marlborough (MA): Boston Scientific; 2012 [cited 2016 Apr 25]. Available from: https://www.bostonscientific.com/content/dam/bostonscientific/quality/educationresources/english/ACL_Therapeutic_Radiation_20120925.pdf Radiotherapy for Cancer Patients with Cardiac Implantable Electronic Devices 5