Pacemaker Reutilization: Can “Going Green” Be a Safe Alternative for Those in Underserved Nations With No Access to Device Therapy?

Over the past 30 years, cardiac device implantation has significantly reduced the morbidity and mortality associated with brady- and tachyarrhythmias in the industrialized world. In the United States alone, 250,000 pacemakers and 100,000 implantable defibrillators are implanted every year.¹ These numbers are difficult to comprehend when countries such as Peru and Nepal report <15 new pacemakers per million people.² Moreover, approximately 1,000,000 individuals are dying every year in the world due to a lack of access to bradyarrhythmia therapy, with some reporting this number to be an underestimation.³ Novel methods of delivering pacemakers to those with the greatest need must be explored in order to alleviate this significant healthcare disparity seen in our world.

For decades, Heartbeat International³ has successfully distributed new devices close to expiration from a sterility standpoint to those in underserved nations with no access to pacemakers. Despite donating >10,000 devices, the supply of expired devices is simply unable to meet the rising demand witnessed in underserved nations.

We believe that the concept of pacemaker reutilization is a safe, feasible, and ethically responsible method of alleviating the suffering of those in underserved nations. Project My Heart Your Heart (MHYH) is a joint collaborative between citizens, physicians, funeral home and crematory directors, the University of Michigan Cardiovascular Center, and World Medical Relief, Inc.⁴ The premise of the program is to have funeral homes and crematories send devices that are currently being discarded as waste to the University of Michigan, where trained individuals will examine for battery life >70%. After undergoing validated cleaning, performance testing, and sterilization processes, devices would be sent to World Medical Relief, which specializes in delivery of medical equipment for distribution to hospitals and clinics in underserved nations. All funding for this program would be provided via philanthropy, and implanting hospitals would not be allowed to charge for the devices. The program is currently awaiting FDA approval prior to the distribution of devices.

However, there exists a significant amount of concern for device reutilization with regard to device safety — namely, infection and malfunction. Are we providing a safe and ethical treatment modality to those in society who are most desperate and willing to accept any form of medical therapy despite the risks? Is pacemaker reutilization safe, and should it be offered to those with no access to device therapy in underserved nations?

In an effort to promote cost savings as well as provide care to those with no other means of acquiring a device, a number of articles in a wide variety of international settings have been published in recent decades describing the safety and efficacy of pacemaker reutilization. Many of these studies were severely limited by sample size; therefore, safety remained a significant concern for those interested in device reuse. However, in the April 2011 issue of Circulation: Arrhythmia and Electrophysiology, a meta-analysis of pacemaker reutilization attempts to determine the risk of reusing these lifesaving devices.⁵

Eighteen studies were identified after an extensive literature search in which pacemakers were explanted after death from one patient and implanted into another. Of these, five studies had control groups receiving new pacemakers and the remaining 13 were case series without control groups. These 18 studies were performed over three decades with a total of 2,270 patients in 13 different countries. A meta-analysis was performed, which found an overall infection rate of 1.97% and malfunction rate of 0.68%. For the five studies that had control groups with new device implantation, there was no significant increased risk of infection between new and reused devices. However, a statistically significant increased risk of non-life-threatening device malfunction, when compared to new device implantation, was noted. One may attribute this higher rate of malfunction to mechanical abnormalities such as loose set screws, perhaps due to damage during device explantation.

Project MHYH will attempt to further examine the safety of device reutilization by requiring follow-up of all device recipients in an online database for at least 1–2 years. In this perspective, one must evaluate whether a higher rate of device malfunction outweighs the baseline risk of morbidity and mortality that patients with symptomatic bradycardia encounter on a daily basis. We submit that patients with symptomatic bradycardia will, on average, gladly accept such risk if this is the only opportunity to receive a device. 

A single story can convey the great need for device reutilization in underserved nations far better than any statistical analysis. Ms. DeGuzman (name changed to protect her privacy) is a 59-year-old woman living in the Philippines. She is a breast cancer survivor and has a 26-year-old son. Nine years ago she fell ill and was diagnosed with complete heart block. She and her family were able to scrape together enough money to buy a pacemaker and pay for its implantation. Early last year, her cardiologist told her that the device required replacement due to low battery and that she would need to purchase a new one. During those nine years, though, she had fallen on hard financial times, and a new device was many times her annual salary. She could no longer afford to buy her daily medication, let alone a new pacemaker. She went home and prepared to die as she knew of no way to get another device. World Medical Relief, a nonprofit in Detroit, Michigan, was contacted as a last resort for device donation. Due to the generous donation of an anonymous Detroit area funeral director, a device was sent to Ms. DeGuzman. It was implanted on October 22, 2010 by electrophysiologists at Philippine General Hospital.

Earlier this year she wrote a letter to World Medical Relief stating the following:

“Isa pong karangalan para sa aking dahil mga kagay ninyong maka-tao at maka-Dios ang nagging parte sa aking panibagong pag-asa para maipagpatuloy kong muli ang aking buhay. Sa totoo lang po mapakasaya ko ngayon sa aking buhay dahil sa ipinadama ninyong pagmamahal at pagdamay kahit hindi ninyo ako kilala.”
This translates to:
“I am blessed to be helped by your humanitarian and godly efforts which gave me hope and life. Truly I have a happy life because you made me feel loved even though you didn’t know me.”

Whenever possible, medical therapies should be offered to each and every individual who may derive benefit. Pacemaker reuse is an opportunity for our society to positively affect the lives of many in impoverished countries around the world.

For more information, please visit
www.myheartyourheart.org
www.worldmedicalrelief.com
www.heartbeatinternational.org

References

1. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports. JAMA 2006;295:1901–1906.
2. Mond HG, Irwin M, Ector H, Proclemer A. The world survey of cardiac pacing and cardioverter-defibrillators: Calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol 2008;31:1202–1212.
3. Heartbeat International (https://www.heartbeatintl.org/mission.htm). Accessed on March 6th, 2009. 
4. Baman TS, Kirkpatrick JN, Romero J, et al. Pacemaker reuse: An initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation 2010;122:1649–1656.
5. Baman TS, Meier P, Romero J, et al. Safety of pacemaker reutilization: A meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol 2011 Apr 14. [Epub ahead of print].