Recovery of pacemakers and defibrillators for analysis and device advance directives: Electrophysiologists' perspectives

PACE - Pacing and Clinical Electrophysiology

Volumn 34, Issue 6, 2011, Pages 659-665

  Logani, Sachin ^a   Gottlieb, Maia ^b   Verdino, Ralph J ^b   Baman, Timir S ^c   Eagle, Kim A ^c   Kirkpatrick, James N ^b  

^a DREXEL UNIVERSITY COLLEGE OF MEDICINE   (United States)

^b HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF MICHIGAN   (United States)

Author keywords

advance directives; defibrillator; pacemaker; postmortem analysis; reuse

Indexed keywords

ADULT; AGED; ARTICLE; AUTOPSY; DEFIBRILLATOR; DEVICE REMOVAL; FEMALE; HEALTH SURVEY; HEART ELECTROPHYSIOLOGY; HUMAN; LIVING WILL; MAJOR CLINICAL STUDY; MALE; PACEMAKER; POSTMARKETING SURVEILLANCE; RECYCLING; WASTE DISPOSAL;

ADULT; AGED; AGED, 80 AND OVER; DEFIBRILLATORS, IMPLANTABLE; DEVICE REMOVAL; EQUIPMENT FAILURE ANALYSIS; FEMALE; HUMANS; MALE; MIDDLE AGED; PACEMAKER, ARTIFICIAL; PHYSICIAN'S PRACTICE PATTERNS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES;

EID: 79958139531     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2011.03032.x     Document Type: Article

References (30)

1. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM,. Recalls and safety alerts involving pacemakers and implantable cardioverterdefibrillator. JAMA 2001; 286: 793-799. (Pubitemid 33015572)
2. Carlson MD, Wilkoff BL, Maisel WH, Ellenbogen KA, Saxon LA, Prystowsky EN, Alpert JS, et al,. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACC) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 2006; 3: 1250-1273. (Pubitemid 44464165)
3. Kirkpatrick JN, Ghani SN, Burke MC, Knight BP,. Postmortem interrogation and retrieval of implantable pacemakers and defibrillators: A survey of morticians and patients. J Cardiovasc Electrophysiol 2007; 18: 478-482. (Pubitemid 46650335)
4. Coats AJ,. MADIT II, the Multi-center Autonomic Defibrillator Implantation Trial II stopped early for mortality reduction, has ICD therapy earned its evidence-based credentials? Int J Cardiol 2002; 82: 1-5. (Pubitemid 34084909)
5. Maisel WH,. Safety issues involving medical devices: Implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 2005; 294: 955-958. (Pubitemid 41215465)
6. Epstein AE, Miles WM, Benditt DG, Camm AJ, Darling EJ, Friedman PL, Garson A Jr, et al., Personal and public safety issues related to arrhythmias that may affect consciousness: Implications for regulation and physician recommendations: A medical/scientific statement from the American Heart Association and the North American Society of Pacing and Electrophysiology. Circulation 1996; 94: 1147-1166. (Pubitemid 26292881)
7. Maisel WH,. Medical device regulation: An introduction for the practicing physician. Ann Intern Med 2004; 140: 296-302. (Pubitemid 38200536)
8. Code of Professional Conduct. National Funeral Directors Association. http://www.nfda.org/files/CodeofConduct.pdf. (accessed 13 December 2006.)
9. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM,. Management of implantable cardioverter defibrillators in end of life care. Ann Intern Med 2004; 141: 835-838. (Pubitemid 39601176)
10. Pacemaker, Defibrillator, and Lead Explant and Return Guidelines. Boston Scientific Corporation. http://radiot.net/templatedata/imports/HTML/CRM/A- Closer-Look/pdfs/ACL-Product-Expl-Ret-Guidelines-102008.pdf. (accessed 2 July 2010.)
11. Cardiac Rhythm Management Product Returns. St. Jude Medical, Inc. http://www.sjmprofessional.com/Resources/communications/Cardiac-Rhythm- Management-Product-Returns.aspx. (accessed 6 July 2010.)
12. Mailer Kits Available for Returning Product. Medtronic, Inc. http://www.medtronic.com/crm/performance/introduction/mailer-kits.html. (accessed 6 July 2010.)
13. Medtronic connect. Medtronic, Inc. https://wwwp.medtronic.com/ mdtConnectPortal/registration/index.jsp. (accessed 10 September 2010.)
14. 2010 CPT Codes for Cardiac Device Monitoring. Medtronic, Inc. http://www.medtronic.com/crdm-code-lookup/93289.html. (accessed 2 September 2010.)
15. Product Performance Report. Medtronic, Inc. http://www.medtronic.com/crm/ performance/downloads/download.html. (accessed 6 July 2010.)
16. Product Performance Report. Boston Scientific Corporation. (accessed 6 July 2010.)
17. Product Performance Report. St. Jude Medical, Inc. http://www. sjmprofessional.com/Resources/reference-guides/Product-Performance-Report.aspx (accessed 31 October 2010.)
18. Product Performance Report. BIOTRONIK, Inc. http://www.biotronik.com/ portal/4608# (accessed 31 October 2010.)
19. Product Performance Report. Sorin CRM SAS http://www.sorincrm.com/sorin- elamedical/read/intl-about-us-sorin-group-crmour-performance (accessed 31 October 2010.)
20. Daley WR, Kaczmarek RG,. The epidemiology of cardiac pacemakers in the older US population. J Am Geriatr Soc 1998; 46: 1016-1019. (Pubitemid 28374084)
21. FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 23, 2008. http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/ucm111138.htm#proceedings. (accessed 25 August 2010.)
22. Baman TS, Romero A, Kirkpatrick JN, Romero J, Lange DC, Sison EO, Tangco RV, et al,. Safety and efficacy of pacemaker reuse in underdeveloped nations. J Am Coll Cardiol 2009; 54: 1557-1559.
23. Mendis S, Lindholm LH, Mancia G, Whitworth J, Alderman M, Lim S, Heagerty T,. World Health Organization (WHO) and International Society of Hypertension (ISH) risk prediction charts: Assessment of cardiovascular risk for prevention and control of cardiovascular disease in low and middle-income countries. J Hypertens 2007; 25: 1578-1582. (Pubitemid 47056562)
24. Oto A., Cardiac pacing and defibrillation in developing nations. Pacing Clin Electrophysiol 1995; 18: 1063-1064.
25. Linde CL, Bocray A, Jonsson M, Rosenqvist K, Radegran K, Ryden L,. Re-used pacemakers - as safe as new? A retrospective case-control study. Eur Heart J 1998; 19: 154-157. (Pubitemid 28112312)
26. Panja M, Sarkar CN, Kumar S, Kar AK, Mitra S, Sinha DP, Chatterjee A, et al,. Reuse of pacemaker. Indian Heart J 1996; 48: 677-680. (Pubitemid 127540881)
27. Mugica J, Duconge R, Henry L,. Survival and mortality in 3,701 pacemaker patients: Arguments in favor of pacemaker reuse. Pacing Clin Electrophysiol 1986; 9: 1282-1287. (Pubitemid 17206814)
28. Ryden L,. Re-use of devices in cardiology. Proceedings from a Policy Conference at the European Heart House, 5-6 February, 1998. Eur Heart J 1998; 19: 1628-1631. (Pubitemid 28524180)
29. Lampert R, Hayes DL, Annas GJ, Farley MA, Goldstein NE, Hamilton RM, Kay NG, et al,. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm 2010; 7: 1008-1026.
30. Danis M, Southerland LI, Garrett JM, Smith JL, Hielema F, Pickard CG, Egner DM, et al,. A prospective study of advance directives for life-sustaining care. New England J Med 1991; 324: 882-888.