Portal de Periódicos da CAPES

Pacemaker Reuse

2010; Lippincott Williams & Wilkins; Volume: 122; Issue: 16 Linguagem: Holandês

10.1161/circulationaha.110.970483

1524-4539

Timir S. Baman, James N. Kirkpatrick, Joshua Romero, Lindsey Gakenheimer, Al Romero, David Lange, Rachel Nosowsky, Kay Fuller, Eric Oliver D Sison, Rogelio V. Tangco, Nelson S. Abelardo, George Samson, Patricia Sovitch, Christian Machado, Stephen R. Kemp, Kara Morgenstern, Edward B. Goldman, Hakan Oral, Kim A. Eagle,

Cardiac electrophysiology and arrhythmias

HomeCirculationVol. 122, No. 16Pacemaker Reuse Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBPacemaker ReuseAn Initiative to Alleviate the Burden of Symptomatic Bradyarrhythmia in Impoverished Nations Around the World Timir S. Baman, James N. Kirkpatrick, Joshua Romero, Lindsey Gakenheimer, Al Romero, David C. Lange, Rachel Nosowsky, Kay Fuller, Eric O. Sison, Rogelio V. Tangco, Nelson S. Abelardo, George Samson, Patricia Sovitch, Christian E. Machado, Stephen R. Kemp, Kara Morgenstern, Edward B. Goldman, Hakan Oral and Kim A. Eagle Timir S. BamanTimir S. Baman From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , James N. KirkpatrickJames N. Kirkpatrick From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Joshua RomeroJoshua Romero From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Lindsey GakenheimerLindsey Gakenheimer From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Al RomeroAl Romero From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , David C. LangeDavid C. Lange From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Rachel NosowskyRachel Nosowsky From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Kay FullerKay Fuller From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Eric O. SisonEric O. Sison From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Rogelio V. TangcoRogelio V. Tangco From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Nelson S. AbelardoNelson S. Abelardo From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , George SamsonGeorge Samson From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Patricia SovitchPatricia Sovitch From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Christian E. MachadoChristian E. Machado From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Stephen R. KempStephen R. Kemp From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Kara MorgensternKara Morgenstern From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Edward B. GoldmanEdward B. Goldman From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). , Hakan OralHakan Oral From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). and Kim A. EagleKim A. Eagle From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (T.S.B., J.R., L.G., D.C.L., R.N., K.F., P.S., K.M., E.B.G., H.O., K.A.E.); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia (J.N.K.); Wixom Health Center, Wixom, Mich (A.R.); Division of Cardiovascular Medicine, University of Philippines–Philippine General Hospital, Manila (E.O.S., R.V.T., N.S.A.); World Medical Relief, Detroit, Mich (G.S.); Division of Cardiovascular Medicine, St John/Providence Hospital, Southfield, Mich (C.E.M.); and Michigan Funeral Directors Association, Okemos (S.R.K.). Originally published19 Oct 2010https://doi.org/10.1161/CIRCULATIONAHA.110.970483Circulation. 2010;122:1649–1656Health of body and mind is so fundamental to the good life that if we believe men have any personal rights at all as human beings, they have an absolute right to such a measure of good health as society and society alone is able to give them.—Aristotle, 330 bcFor most of the industrialized world, the morbidity and mortality attributed to cardiovascular disease have declined in recent decades as a result of improvements in technology and a greater emphasis on primary and secondary preventative strategies.1 Unfortunately, this dramatic improvement in disease burden has not been witnessed in low- and middle-income countries (LMICs), defined by the World Bank as generating a gross national income per capita lower than US $9200.2 Currently, cardiovascular disease is the primary cause of mortality worldwide, accounting for 30% of all global deaths,3 and it has twice the mortality rate of HIV/AIDS, malaria, and tuberculosis combined.4 Secondary treatments are often limited because of a paucity of skilled healthcare providers and, more important, the inability of the patient to afford costly medical procedures.5This great disparity in medical health care is clearly evident in the field of cardiac electrophysiology, specifically pacemaker implantation; this specialty is either severely underdeveloped or entirely nonexistent in many LMICs.6 As a result, many individuals with symptomatic bradycardia experience a decreased quality of life and/or decreased life expectancy because of a lack of resources (personal correspondence, University of Philippines–Philippine General Hospital [UP-PGH], November 15, 2008). As the epidemic of cardiovascular disease continues to alter the demographics of disease in LMICs, healthcare providers with access to medical technology must investigate novel methods of easing the burden of those less fortunate. The purpose of this article is to address the concept of postmortem pacemaker use for those in LMICs who otherwise would not have access to bradyarrhythmia therapy. We believe that postmortem pacemaker reuse can be shown to be a safe, feasible, and ethically responsible means of delivering electrophysiological healthcare to those in great need.Scope of the EpidemicTo help alleviate the overall burden of untreated symptomatic bradycardia, we must understand differences in pathogenesis of cardiac dysrhythmias and their intersection with device implantation. In the United States, the primary indication for pacemaker implantation is sinus node dysfunction7; however, in many LMICs, complete heart block is the most common indication, with sinus node dysfunction accounting for only 5%.8,9 Part of this difference may be due to infectious diseases leading to severe bradyarrhythmias in Latin American countries. Clinical Chagas disease, caused by an infection of Trypanosomiasis cruzi, may affect up to 20 million individuals.10 One study reported that 72% of pacemaker recipients in a Brazilian cohort displayed seropositivity for T cruzi.11 Seropositivity as high as 25% has been reported in Bolivian children 5 to 13 years of age.12Understanding the true prevalence of untreated symptomatic bradycardia can be difficult because of a paucity of clinical data. However, Mond et al6 elegantly surveyed 43 countries to determine rates of pacemaker implantation. Countries in Europe reported an average of 475 new implantations per million as compared with 191 new implantations per million in the Americas (excluding Canada and United States). Sixty percent of pacemaker implantation in the Americas was due to high-degree atrioventricular block compared with 27% in Europe, although this may represent an allocation of limited resources to those in greatest need.Expanding Access to PacemakersNovel methods of healthcare delivery in the field of electrophysiology must be explored to alleviate the morbidity of those currently unable to acquire pacemakers because of a lack of affordability. However, understanding the scope of the epidemic can be difficult because there are no clinical studies to address prevalence of untreated bradyarrhythmias. Heartbeat International, a nonprofit organization specializing in the delivery of expired devices to third-world countries, estimates that >1 million individuals die annually as a result of a lack of access to pacemakers.13We propose a joint collaboration between patients, funeral directors, physicians, and nonprofit charitable organizations to meet this need (Figure 1). Previous data have shown that patients with pacemakers have overwhelmingly expressed an interest in donating their device postmortem.14 Moreover, funeral directors have voiced interest in participating in a pacemaker donation initiative if given the proper framework.15 Finally, a review of the literature shows that the feasibility of this practice has been demonstrated in numerous settings worldwide.Download figureDownload PowerPointFigure 1. Proposed initiative for delivery of electrophysiological devices to LIMCs.The views and opinions of private citizens encompass a pivotal aspect of any pacemaker reuse initiative. A survey of pacemaker and defibrillator patients by Kirkpatrick et al14 showed that 91% of patients willing to sign an advanced directive dictating device handling after death would donate their device to a medically underserved nation. A recent survey of 210 patients with pacemakers and implantable defibrillators (ICDs) at the University of Michigan and University of Pennsylvania found that 84% would donate their device for reuse. In a survey of 1009 members of the general population, 71% reaffirmed the desire to donate postmortem devices to those less fortunate (Figure 2).16 These results strongly suggest that a great majority of the patient population with devices and the general public is willing to consent to cardiac device removal for philanthropic reuse in underserved nations.Download figureDownload PowerPointFigure 2. Views of general population and patient population with pacemakers and implantable defibrillators relative to device reuse.The goal of our proposed initiative is to create a reproducible model in which funeral directors are given a framework to obtain consent from families of loved ones for pacemaker removal before burial or cremation. Under current regulations, all pacemakers and ICDs must be explanted before cremation because of the risk of device explosion.17 The Cremation Association of North America predicts a cremation rate of 39% in 2010 and 59% for 2025.18 Therefore, a majority of the nearly 2 million individuals with pacemakers and ICDs expected to be cremated in 2025 will have their device explanted per routine protocol. Our survey found that currently an estimated 45% of the deceased with pacemakers and ICDs will have their device explanted before burial (Figure 3) and that 84% of devices in southeastern Michigan funeral homes were discarded in medical waste or stored with no intended purpose.15 These results are consistent with a previous study demonstrating that explanted devices are rarely returned to the manufacturer.19 This practice conflicts with guidelines from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines recommending that funeral directors notify all physicians of patients with cardiac devices and routinely return the device to the manufacturer after proper consent is obtained from the family.20Download figureDownload PowerPointFigure 3. Current rate of device extraction in southeastern Michigan funeral homes.A University of Michigan survey of 152 funeral directors reaffirmed the previous findings in the literature.15 This study showed that 69% of funeral directors lacked the knowledge of how to or found it difficult to return devices to the original manufacturer, and 81% supported a central independent organization to regulate device distribution. A large majority (89%) of funeral directors were willing to donate devices to charitable organizations if given the opportunity (Table 1). Based on estimates from survey responses, a total of 166 postmortem pacemakers and ICDs are currently stored in southeastern Michigan funeral homes with no purpose.15 These data illustrate that an overwhelming majority of funeral directors have the desire and ability to perform postmortem cardiac device removal for humanitarian reuse in underserved nations if given the opportunity and proper framework.Table 1. Current Use of Explanted Devices by Funeral Directors and Views Relative to Device ReuseSurvey QuestionsPercentage of Funeral Directors (n=90)Discard pacemakers in waste or store with no intended purpose84Return pacemakers to device manufacturer4Support a central independent organization to regulate device distribution back to manufacturers81Willing to donate the devices to charitable organizations if given the opportunity89Have previously donated a device for reuse in third-world countries10We propose that the Project My Heart–Your Heart Pacemaker Reutilization Initiative may provide a model for treating those with symptomatic bradycardia in underserved nations. Project My Heart–Your Heart is a joint collaborative between the citizens, physicians, and funeral directors of the State of Michigan, the University of Michigan Cardiovascular Center, and World Medical Relief, Inc. Through collaboration with the Michigan Funeral Directors Association, 1057 funeral directors in the state of Michigan would receive a flyer describing the pacemaker reuse initiative and a referral to http://www.myheartyourheart.org, from which a proper legal consent could be downloaded. Funeral directors may request a free postage-paid envelope with instructions for device removal. All funding for this program would be provided by philanthropic donation and grants. Funeral directors would be assured that no devices would be implanted without the express approval from the Food and Drug Administration (FDA).Battery life and other performance testing specifications would be the initial criteria to determine whether a device is sent to underserved nations or returned to the manufacturer to evaluate for malfunction or unusual wear. We suggest a cutoff of ≥70% battery life for further consideration to reuse. Previous studies have reused pacemakers implanted 50% of devices removed for reasons other than elective replacement interval had an adequate battery life (defined as ≥24 months' longevity for Medtronic devices or >50% battery life remaining for Boston Scientific/Guidant devices). Specifically, biventricular upgrade and heart transplantation were strong predictors of devices with adequate battery life.22Pacemakers would be closely inspected and rejected if there was evidence of exterior loss of integrity or damage, with extra attention paid to the set screws and header connections. All patient-identifying information would be erased from the device to preserve the privacy of the donor. After undergoing validated cleaning, performance testing, and sterilization processes, devices would be sent to nonprofit charitable organizations specializing in delivery of medical equipment for distribution to hospitals and clinics in underserved nations. These hospitals would be required to provide documentation of technical expertise and training with regard to pacemaker implantation and follow-up. All patients considered for charitable device implantation would have to show proof of financial insufficiency. Hospitals would not be able to charge for the donated device. Project My Heart–Your Heart has established relationships with UP-PGH in Manila and the Vietnam Heart Institute in Hanoi as potential implanting centers. Both academic institutions have been visited by members of Project My Heart–Your Heart to confirm adequate facilities and technical expertise. Moreover, the Ministries of Health in the Philippines and Vietnam are aware of a potential clinical trial and have deemed that importation and reuse of previously implanted pacemakers do not violate governmental policies. Finally, all patients would require follow-up for proper monitoring for pacemaker infection and device malfunction. An online registry would be created to track and monitor patients with reused devices. The hope is that this system would limit unauthorized sale or bartering of reused devices and would provide the ability to effectively communicate to the patients and implanting physicians in case of device recall.When examining the concept of postmortem pacemaker reutilization, we must examine not only the technological aspects of device reuse but also the degree of cost savings associated with such an endeavor. Linde et al21 performed a cost-benefit analysis in 1994 and ascertained that 317 reused devices had an estimated national savings of $919 300. However, this number denotes only the cost of sterilizing the device itself and does not take into account physician or hospitalization fees. Using these previous factors and intangible factors such as product liability insurance, pacemaker availability, and the effects on hospital procedures, Myers23 concluded that the savings associated with pacemaker reuse is generally negligible. In addition, low-cost manufacturers around the world have decreased the cost of a device to around $800 plus the cost of leads and implantation.We believe that pacemaker reuse can be a cost-effective measure if performed in the appropriate clinical setting. Despite the substantial cost reduction from foreign device manufacturers, a new pacemaker is often more than the annual income of the average citizen in underdeveloped nations. Project My Heart–Your Heart estimates that sterilization and shipping of reused devices to global implantation centers would cost approximately $75 to $100, with private donations and grants providing the devices to patients at no charge. In areas such as the Philippines and Vietnam, government-owned medical facilities can provide hospitalization and physician services at no charge to the patient. Moreover, these physicians would provide follow-up services because device companies would likely not be involved owing to liability concerns. The patient would be responsible for obtaining a new lead ($200); however, we believe this is a reasonable expense for most patients and their families (personal correspondence, UP-PGH, November 15, 2008, and Vietnam Heart Institute, February 10, 2010). Namboodiri et al24 showed that dual-chamber pacemaker generators can be effectively implanted as single-VDD-lead devices, resulting in a significant cost savings compared with the purchase of 2 new leads with no difference in quality-of-life scores. Therefore, if performed in the appropriate clinical setting, pacemaker reuse may be a cost-effective means of providing health care to those who are unable to obtain a new device.Establishing the Feasibility of the Proposed InitiativeA review of the literature (Table 2) shows that the feasibility of this practice has been demonstrated in numerous settings worldwide.21,24–42 Furthermore, a joint collaboration with the ultimate goal of delivering pacemakers to those less fortunate has already been established in the State of Michigan. World Medical Relief is a nonprofit charitable organization with with a mission of improving the well-being of medically impoverished individuals on an international scale through the distribution of donated medical commodities.43 Several funeral directors in southeast Michigan have obtained consent for pacemaker donation and subsequently delivered these devices to World Medical Relief. Trained physicians then inspected the integrity of the device, and if battery life was ≥70%, the pacemaker was cleaned, sterilized with ethylene oxide, and packaged for shipping. World Medical Relief has established a relationship for pacemaker donation with UP-PGH in Manila. Before device implantation, a social work assessment of the financial status of the patient was obtained to validate financial need. All patients receiving charitable devices were documented and monitored for follow-up.Table 2. Review of the Literature Relative to Pacemaker ReuseStudyDuration of StudyCountryPacemakers Reused, nFollow-UpComplications Related to InfectionComplications Related to Device Failure Caused by ReuseCommentsBalachander et al271983–1999India45317 y……Average battery life of refurbished device=8.3 yBalachander286 yIndia1406 y20Pescariu et al401993–2001Romania36535±21 mo60No statistical difference in infection