Pacemaker Reutilization for Those in Underserved Nations
Pacemaker Reutilization for Those in Underserved Nations
A great disparity exists in the utilization of pacemakers between the developed world and the low- and middle-income countries where healthcare resources are limited. Worldwide, it is estimated that more than 1 million individuals are in need of pacemakers to treat life-threatening bradyarrhythmias. Pacemaker reutilization is a promising solution to overcome the cost barrier of treating highly symptomatic bradyarrhythmias in these countries. Thus far, this initiative has gained the support of physicians, patients and funeral directors who have proven that a feasible model to deliver these devices to underserved nations is achievable. Many challenges still exist regarding pacemaker reutilization, however, Project My Heart Your Heart is working with the US FDA to overcome many of these obstacles with the goal of alleviating the associated morbidity and mortality of this otherwise treatable epidemic.
Cardiovascular disease is the leading cause of mortality worldwide, accounting for 30% of all deaths. In recent years, advances in technology have dramatically reduced the morbidity and mortality of this epidemic. This benefit is clearly evident in the developed world as opposed to low- and middle-income countries (LMICs) where resources are scarce or often nonexistent. Significant shortages of healthcare providers, as well as an inability to afford costly medical devices, partially account for the drastic disparities in healthcare between the developed world and LMICs.
In no other field is this great disparity more evident than in the field of cardiac electrophysiology – specifically pacemaker implantation. Between 1993 and 2009, 2.9 million patients in the USA received a permanent pacemaker, with an overall increase of 55% from the previous decade. This is in stark contrast to countries, such as India, where there are <18 new implants per million people. Moreover, in the industrialized world, the primary indication for pacemaker implantation is sinus node dysfunction, while in LMICs, complete heart block is the most common indication, thus leading to greater morbidity and mortality. An accurate understanding of the problem in LMICs is lacking; however, it is estimated that more than 1 million individuals globally are in need of pacemaker implantation annually. Currently, Heartbeat International (FL, USA), a not-for-profit organization, is trying to provide a solution by donating cardiac devices that are close to expiration. Devices close to expiration are those that are nearing the manufacturer shelf life in terms of guaranteed sterility. Typically, the period between the manufacturing date and the 'use before' date is 12–18 months. Although the achievements of Heartbeat International can be characterized as nothing less than extraordinary, the organization's impact is limited by the fact that they rely upon the limited number of devices that are near expiration. Other options must be explored in order to deliver care to those in great need.
In 2010, Project My Heart Your Heart (PMHYH) Pacemaker Reutilization Initiative was proposed with the intention to alleviate symptomatic bradycardia in LMICs. PMHYH is a joint collaboration between individuals, healthcare professionals and funeral directors, the University of Michigan Cardiovascular Center, and World Medical Relief, Inc. (both based in MI, USA). The goal of the initiative is to create a framework where pacemakers can be acquired from funeral homes, certified and safely resterilized by a third party reprocessing company, and ultimately sent to a LMIC for reimplantation in patients who would otherwise not be able to afford a device, all under the auspices of the US FDA. Recipient hospitals would be required to provide documentation of device implantation expertise, as well as follow-up capabilities. It is upon the hospitals and their social work departments to determine financial need of a patient in order for them to qualify for a donated device; the hospital is not allowed to charge for a device. All patients receiving devices would have their information entered into an online database. Moreover, follow-up data must be entered into this registry in order to assess for complications, as well as device malfunction. In case of device recall or malfunction, the recipient would immediately be contacted and the hospital sent a new refurbished device. With close monitoring and obligatory follow-up, the hope is to limit 'black market' sales of donated devices. The entire cost of the project is currently supported by private foundations, philanthropic individuals and university grants. This initiative has the potential to decrease morbidity and mortality for the millions of individuals who currently have no other option but to live with symptomatic bradycardia.
The concept of pacemaker reutilization is a logical solution to overcome the cost barrier of treating bradyarrhythmias in LMICs. In this review, we examine the safety and feasibility of pacemaker reutilization, as well as ethical issues surrounding this controversial practice.
Abstract and Introduction
Abstract
A great disparity exists in the utilization of pacemakers between the developed world and the low- and middle-income countries where healthcare resources are limited. Worldwide, it is estimated that more than 1 million individuals are in need of pacemakers to treat life-threatening bradyarrhythmias. Pacemaker reutilization is a promising solution to overcome the cost barrier of treating highly symptomatic bradyarrhythmias in these countries. Thus far, this initiative has gained the support of physicians, patients and funeral directors who have proven that a feasible model to deliver these devices to underserved nations is achievable. Many challenges still exist regarding pacemaker reutilization, however, Project My Heart Your Heart is working with the US FDA to overcome many of these obstacles with the goal of alleviating the associated morbidity and mortality of this otherwise treatable epidemic.
Introduction
Cardiovascular disease is the leading cause of mortality worldwide, accounting for 30% of all deaths. In recent years, advances in technology have dramatically reduced the morbidity and mortality of this epidemic. This benefit is clearly evident in the developed world as opposed to low- and middle-income countries (LMICs) where resources are scarce or often nonexistent. Significant shortages of healthcare providers, as well as an inability to afford costly medical devices, partially account for the drastic disparities in healthcare between the developed world and LMICs.
In no other field is this great disparity more evident than in the field of cardiac electrophysiology – specifically pacemaker implantation. Between 1993 and 2009, 2.9 million patients in the USA received a permanent pacemaker, with an overall increase of 55% from the previous decade. This is in stark contrast to countries, such as India, where there are <18 new implants per million people. Moreover, in the industrialized world, the primary indication for pacemaker implantation is sinus node dysfunction, while in LMICs, complete heart block is the most common indication, thus leading to greater morbidity and mortality. An accurate understanding of the problem in LMICs is lacking; however, it is estimated that more than 1 million individuals globally are in need of pacemaker implantation annually. Currently, Heartbeat International (FL, USA), a not-for-profit organization, is trying to provide a solution by donating cardiac devices that are close to expiration. Devices close to expiration are those that are nearing the manufacturer shelf life in terms of guaranteed sterility. Typically, the period between the manufacturing date and the 'use before' date is 12–18 months. Although the achievements of Heartbeat International can be characterized as nothing less than extraordinary, the organization's impact is limited by the fact that they rely upon the limited number of devices that are near expiration. Other options must be explored in order to deliver care to those in great need.
In 2010, Project My Heart Your Heart (PMHYH) Pacemaker Reutilization Initiative was proposed with the intention to alleviate symptomatic bradycardia in LMICs. PMHYH is a joint collaboration between individuals, healthcare professionals and funeral directors, the University of Michigan Cardiovascular Center, and World Medical Relief, Inc. (both based in MI, USA). The goal of the initiative is to create a framework where pacemakers can be acquired from funeral homes, certified and safely resterilized by a third party reprocessing company, and ultimately sent to a LMIC for reimplantation in patients who would otherwise not be able to afford a device, all under the auspices of the US FDA. Recipient hospitals would be required to provide documentation of device implantation expertise, as well as follow-up capabilities. It is upon the hospitals and their social work departments to determine financial need of a patient in order for them to qualify for a donated device; the hospital is not allowed to charge for a device. All patients receiving devices would have their information entered into an online database. Moreover, follow-up data must be entered into this registry in order to assess for complications, as well as device malfunction. In case of device recall or malfunction, the recipient would immediately be contacted and the hospital sent a new refurbished device. With close monitoring and obligatory follow-up, the hope is to limit 'black market' sales of donated devices. The entire cost of the project is currently supported by private foundations, philanthropic individuals and university grants. This initiative has the potential to decrease morbidity and mortality for the millions of individuals who currently have no other option but to live with symptomatic bradycardia.
The concept of pacemaker reutilization is a logical solution to overcome the cost barrier of treating bradyarrhythmias in LMICs. In this review, we examine the safety and feasibility of pacemaker reutilization, as well as ethical issues surrounding this controversial practice.
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