Saving lives with re-used cardiac implantable electronic devices

Behzad Pavri (Thomas Jefferson University Hospital, Philadelphia, USA) is an advocate for re-use of cardiac implantable electronic devices (CIEDs) as life-saving medical technology for patients in low-income countries, which in most cases have limited access to them. For the past 25 years, Pavri and a small group of cardiologists and electrophysiologists have been collecting used devices and re-implanted for free in indigent patients. In this commentary, he discusses the rationale for this practice and the evidence suggesting its safety.

The past several decades have seen the advent of novel technologies designed to improve quality of life, prevent human suffering, and save lives. In terms of life-prolonging technology, few inventions can parallel the cardiac pacemaker and implantable cardioverter defibrillator (ICD), collectively referred to cardiac implantable electronic devices (CIEDs). CIEDs are battery-powered, and these batteries typically last from eight to 14 years. Many CIED recipients die from other causes well before their device battery is exhausted.

It is the sad truth that healthcare access is highly inequitable around the world, and patients in low-income countries have very limited access to such life-saving medical technology. Although disparities exist in many areas of healthcare, none are as glaringly evident as in the rates of CIED utilisation around the world. CIED implantation rates vary by orders of magnitude from <10 per million population to >430 per million between developed and developing nations.¹

The rates of CIED utilisation are increasing rapidly in developed countries,² and this disparity of utilisation rates is only likely to diverge further. These discrepancies are primarily related to the cost of such life-saving therapy, with available money being allocated to endeavours that deliver greater benefits (preventing and treating diarrhoea in children, providing clean drinking water, combating infectious diseases, etc) in countries with limited resources. It is estimated that >1 million patients die annually from bradycardia due to the lack of a pacemaker;³ some estimates put the number as high as three million.⁴ By comparison, it is estimated that an average of 29,916 (range 4,310 to 63,329) persons die annually from influenza.⁵Another comparison would be mortality from HIV/AIDS: according to the World Health Organization, an estimated 1.6 million people died of HIV/AIDS in 2012.⁶ Death from bradycardia, it must be remembered, is eminently preventable. There is now a substantial body of data from France, Sweden, Germany, Italy, Netherlands, Norway, Canada, United States, Nicaragua, Nigeria and India, and dating from 1976 to the current era ^7‒17 and all of which confirm that explanted CIEDs can be safely resterilised, as evidenced by very low (<2%) rates of complications after re-implantation. Many concerned physicians have, over the past three decades, proven that reuse of pacemakers and ICDs (taken from hospitalised patients at the time of device infection or upgrades or from funeral homes) is a safe and effective option for poorer patients who would otherwise have no other means of obtaining such devices. I have myself had the privilege of participating in a similar effort with a few other like-minded physicians for the past 25 years, and the results of our efforts have been published.¹⁸

Individual doctors can only provide a small number of such devices. A potential large resource could be after patient demise, as long as the pacemaker or ICD has more than five years of remaining battery life. After death, implanted CIEDs are routinely removed by morticians before cremation to prevent explosions; however, for burial, the majority of these devices are buried with the patient. This represents a travesty, with thousands of reusable devices being wasted while patients who cannot afford them die from lack of such devices. Studies also show that >90% of patients and their families are supportive of the idea of their device being removed after demise and being made available for reuse in poorer nations; the concept of a “Device Will” has been explored. 

Ultimately, the guiding consideration should be that access to a reused CIED is better than no access at all when faced with substantial mortality and morbidity from preventable causes such as heart block and ventricular fibrillation. Such considerations have led to calls for reappraisals of labelling CIEDs.¹⁹

Based on available data, mortality of “doing nothing” far exceeds any possible mortality associated with device reuse. This is borne out by the “appropriate use rate” of reused ICDs (>54% over 2.3 yrs), which far exceeds that in US populations. Individuals or groups of physicians will continue their independent efforts to send CIEDs overseas an important, but ultimately a very small effort. Systematic CIED reuse will require collaboration with patients, funeral homes/morticians, physicians, non-profit charitable organisations, and the FDA. Hopefully, robust data from prospective trials will become available, and free re-used devices from the “taint of the secondhand” while saving lives.²⁰

References:

1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a World Society of Arrhythmia’s Project. Pacing Clin Electrophysiol 2011;34:1013‒27
2. Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States From 1993 to 2009: Increasing complexity of patients and procedures.J Am Coll Cardiol 2012;60(16):1540‒1545
3. Mond HG, Mick W, Maniscalco BS. Heartbeat International: Making “Poor” Hearts Beat Better. HeartRhythm 2009;6:1538‒1540
4. https://www.heartbeatsaveslives.org/pdf/2009%20HBI%20Annual%20Report.pdf (last accessed on 8 July 2014)
5. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a1.htm (last accessed on 8 July 2014)
6. http://aids.gov/federal-resources/around-the-world/global-aids-overview/ (last accessed on 8 July 2014)
7. 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
8. Havia T, Schuller H. The re-use of previously implanted pacemakers. Scand J Thorac Cardiovasc Surg 1978;(suppl)22:33‒4
9. Amikam S, Feldman S, Boal B, Riss E, Neufeld H. Long-term follow-up of patients with re-used implanted pacemakers. In: Steinbach K, Glogan D, Laszkovics A, Scheibelhofer W, Weber H, eds. Cardiac Pacing. Proceedings of the Vllth World Symposium on Cardiac Pacing. Germany: Steinkopff-Verlag-Darmstadt, 1983:491‒3
10. Rosengarten MD, Portnoy D, Chiu RCJ, Peterson AK. Reuse of permanent cardiac pacemakers. Can Med Assoc J 1985;133:279‒283
11. Linde CL, Bocray A, Jonsson H, et al. Re-used pacemakers — as safe as new? A retrospective case-control study. European Heart Journal 1998;19:154–157
12. Namboodiri KKN, Sharma YP, Bali HK and Grover A. Re-use of Explanted DDD Pacemakers as VDD- Clinical Utility and Cost Effectiveness. Indian Pacing Electrophysiol 2004;4(1):3
13. Baman TS, Romero A, Kirkpatrick JN, et al. Safety and efficacy of pacemaker reuse in underdeveloped nations: A case series. J Am Coll Cardiol 2009;54:1557‒1558
14. Hasan R, Ghanbari H, Feldman D, et al. Safety, efficacy and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients. Pacing Clin Electrophysiol 2011;34:653–658
15. Kantharia BK, Patel SS, Kulkarni G, et al. Reuse of explanted permanent pacemakers donated by funeral homes.Am J Cardiol 2012;109:238–240
16. Pavri BB, Lokhandwala Y, Kulkarni GV, et al. Initial experience with re-use of explanted, resterilized implantable cardioverter-defibrillators.Ann Intern Med 2012;157:542‒548
17. Nava S, Morales JL, Márquez MF, et al.Reuse of pacemakers: Comparison of short and long-term performance. Circ 2013;127:1177‒1183
18. Pavri BB, Lokhandwala Y, Kulkarni GV, et al. Initial experience with re-use of explanted, resterilized implantable cardioverter-defibrillators.Ann Intern Med 2012;157:542‒548
19. Pantos I, Efstathopoulos EP, Katritsis DG. Reuse of devices in cardiology: Time for a reappraisal. Hellenic J Cardiol 2013;54:376‒381
    20. Farmer P. Bukhman G. Reuse of medical devices and global health equity. Ann Intern Med 2012;157:591‒592

Behzad Pavri is CCEP Fellowship director at Thomas Jefferson University Hospital, Philadelphia, USA. For more information on this initiative please contact him at [email protected]