Pacemakers: Are They Really A Renewable Resource?

Reduce, reuse, recycle is one of the many catchphrases used in today’s society, with its increasing emphasis on being green. Is this novel way of thinking possible in the field of healthcare, especially for costly medical devices such as pacemakers? We think the answer is yes, and propose Project My Heart – Your Heart: A Joint Collaborative between Citizens, Physicians, and Funeral Directors of the State of Michigan, the University of Michigan Cardiovascular Center, and World Medical Relief, Inc. (WMR). The goal of this project is to determine if pacemaker reutilization is a safe and feasible method of delivering electrophysiological healthcare to those with no other means of obtaining a device. Is There a Need for Device Reuse? Cardiovascular disease (CVD) remains the leading cause of mortality world wide, accounting for 30% of all deaths worldwide.1 Innovations in the treatment and prevention of CVD have drastically reduced mortality rates in industrialized nations. Unfortunately, low- and middle-income countries (LMIC) have yet to experience this success. In 2015, about 80% of all CVD deaths will have occurred in LMIC.2 This healthcare disparity is even greater in the field of cardiac electrophysiology. As these nations develop, risk factors such as hyperlipidemia, hypertension, tobacco use, and obesity are becoming increasingly common. Furthermore, adding to the burden are infectious diseases native to LMIC, such as Chagas disease, which cause severe bradyarrhythmias in their hosts. Yet with a per capita income of US $9,200 in LMIC, it’s no wonder that electrophysiology treatment in these areas is almost nonexistent. For most in LMIC, a pacemaker is simply unaffordable. Up to one million lives are lost annually due to an inability to acquire bradyarrhythmia therapy. Project My Heart - Your Heart: A Proposed Initiative Project My Heart - Your Heart hopes to help alleviate the great disparities seen in healthcare between the industrialized and nonindustrialized world. The goal of the initiative is to create a reproducible model where funeral directors are given a framework to consent families of loved ones for pacemaker removal prior to burial or cremation. Pacemakers would then be sent to the University of Michigan and assessed for battery longevity and other quality control measures. If the device has a What Does the Public Think of Device Reuse? Recently, the University of Michigan surveyed patients with implantable devices, funeral directors, and the general public to elicit their thoughts on pacemaker reutilization. The results showed 84% of individuals with devices are in favor of reuse, and 71% of the general population would support such an initiative. In addition, 89% of funeral directors were willing to participate in a program to reuse devices for those in need in third world countries. Right now, crematory regulations state that all devices must be explanted prior to cremation due to the risk of explosion. This action, combined with the portion of individuals who want their device explanted before burial, results in approximately 40% of all patients having their devices explanted before burial/cremation in the surveyed areas of southeast Michigan. In 84% of funeral homes in southeastern Michigan, these explanted devices are either sitting in storage with no purpose or discarded as medical waste since funeral directors do not have any other viable options. These surveys clearly show that all members of our society would be in support of a reutilization program for pacemakers. Is Device Donation Feasible? From January to July of 2008, Dr. Al Romero and WMR collected 50 pacemakers from funeral homes in Michigan and tested them for device integrity and a battery life ≥70%. Twelve devices had an adequate battery life, met all quality control measures and were subsequently shipped to the University of Philippines-Philippine General Hospital (UP-PGH) for reutilization. Electrophysiology-trained physicians implanted the devices in patients with no financial means to obtain new pacemakers. There were no complications among the patients immediately after implantation and at four-month follow-up.3 Dr. Al Romero and WMR’s pilot program provides great hope for the future of Project My Heart – Your Heart and the one million patients hoping for a new life through the pacemaker implantation. What About Infection Rates? Understandably, many people worry that a reused pacemaker would put the recipient at a higher risk when compared to new device implantation. However, numerous studies in the literature (n=15) have shown that there is no increased risk of infection or mortality when comparing a reused pacemaker to a new device. It is important to note, though, that these studies had small sample sizes; there is a great need to study the safety and efficacy of device reuse on a large scale. A Success Story Ms. Olaya (name changed to protect her privacy) is a 65-year-old female living in the Philippines. After the bankruptcy of her corner store, her only financial support was her two children — a window installer and a housewife. One day Ms. Olaya fainted while sweeping her porch. She went to Philippine General Hospital in Manila where she could get charity care. The physician there told her she had third-degree heart block and would require a pacemaker. She was told that she would have to purchase this device and the charity hospital would implant it at no cost. However, Ms. Olaya had no money due to her store’s bankruptcy, and was currently fully reliant upon her family for daily expenses. So she checked out of the hospital and hoped for the best. A week later she fainted again. She was rushed to the hospital and was placed on transvenous pacing in the ICU. Meanwhile, a request was put in to international aid organizations for a donated new pacemaker. Until one could be found, she would have to wait in the ICU attached to the temporary pacemaker with no clear plan for device implantation. For two weeks, she waited in the ICU, not knowing if a device would ever arrive. On the 16th day of her stay, the pacemakers sent by Dr. Romero and WMR arrived at Philippine General Hospital. A refurbished pacemaker with 85% remaining battery life was implanted without complication and she was discharged in good health. At four-month follow-up, there were no complications. Ms Olaya once again became a functioning member of society after a simple act of generosity and ingenuity. Where is Project My Heart – Your Heart Right Now? Currently we are working with the Food and Drug Administration with hopes of creating a large-scale clinical trial in order to assess the safety and feasibility of pacemaker reutilization in third world countries. We believe that pacemaker reutilization is an ethical as well as socially responsible means of delivering cardiovascular healthcare to those less fortunate in our world. We hope that a regional, if not national, pacemaker reutilization program can be developed in the future to help the lives of many in impoverished nations.