Pacemaker Reutilization for Those in Underserved Nations
Alhough the practicality of pacemaker reutilization may seem challenging, it has previously been demonstrated to be feasible in many countries. Many studies have examined the views of patients and funeral home directors, and the steps involved in device extraction and reuse.
In the USA alone, there are more than 225,000 pacemakers implanted each year. Brunner et al. found that median patient survival after pacemaker implantation was 8.5 years; however, only 65.6% of patients were still alive at 5 years after first implantation; they also noted an increase in the average age of patients at the time of implant. The cremation rate in North America is currently estimated to be 45% and is expected to increase to 57% in 2025. Therefore, it is reasonable to estimate that a majority of patients with pacemakers will wish to be cremated in the near future. Prior to cremation, pacemakers and defibrillators must be removed to prevent device explosion. Thus, their devices will be explanted per routine measures. This large number of available devices could prove to be a valuable source of reused pacemakers.
PMHYH has already started to acquire explanted pacemakers from funeral homes and crematories across the country. All devices are examined by a trained device nurse in order to assess structural integrity (specifically the integrity of device headers), as well as battery longevity. More than 10,000 devices have been donated to the program. Of these devices, 21% were found to have an adequate battery life for potential reutilization in a LMIC. The authors defined adequate battery life as ≥75% battery life or ≥4 years expected longevity. Moreover, a study of 328 implantable defibrillators, explanted for reasons other than reaching elective replacement interval, revealed that the majority had greater than 50% of battery life remaining.
As previously discussed, Nava et al. is the most recent large trial to examine the safety of device reutilization. In the reused-device cohort, the average device longevity was 6 years compared with 8 years longevity of a new device. Moreover, only 11 reused devices displayed signs of premature depletion. This study supports the current PMHYH definition of an adequate battery life to be >75%.
In a survey study carried out in the Chicago (IL, USA) area, Kirkpatrick et al. noted that, among 150 patients with implanted devices, 87% did not know how devices were handled after death. The majority of the patients (79%) were willing to have their devices returned to manufacturers after death. A total of 72% of device patients indicated they would sign a device advanced directive if asked and, of those, 92% were willing to have their devices removed and donated for use in developing countries. Similar findings were seen in a more recent survey performed at the University of Michigan that included 114 patients with devices and 1009 members of the general population; 87% of the patients with implantable devices and 71% of the general population supported pacemaker reutilization if given the opportunity (Figure 2). Therefore, it is logical to discuss with patients how to handle their devices upon death, similar to the concept of organ donation. This concept may be even more important than organ donation, as all device recipients can be potential donors.
(Enlarge Image)
Figure 2.
Percentage of patients with an implanted device who are willing to have their device explanted after death.
Despite recommendations by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines stating that funeral directors should notify the physician monitoring the device immediately and return the patient's device to the manufacturer after a patient's death, present studies show that most funeral directors do not perform this practice routinely. These guidelines also recommend that patients or family members should be asked to consent for post-mortem device evaluation, including interrogation and removal. Funeral home directors reported that 85% of patients are buried with their device. Retrieval of devices mainly occurred for reasons such as cremation or family request. Of those devices, 84% were discarded as waste or stored with no intended purpose. However, when asked, the majority of funeral home directors (89%) expressed willingness to donate the device to be used in underserved areas.
The current literature supports that pacemaker reutilization is a feasible practice with support from device patients, as well as members of the general public, including funeral directors.
PMHYH provides a framework for those interested in participating in a program to acquire, sterilize and redistribute devices to those in underserved nations. After identifying a device for potential reuse, signed consent must be obtained from the family in order to proceed with device removal. The majority of funeral directors have had experience and are comfortable with explanting devices, despite only a third of them undergoing prior formal training in device removal. This training is of utmost importance as reused-device malfunction was mainly due to set-screw abnormalities during the extraction process. The donated device should then be sent to a center of excellence for investigation, which includes interrogation to assure adequate battery life and other performance-testing specifications. Based on prior case series of pacemaker reuse, a cutoff of ≥70% of battery life was suggested by Baman et al. for proper reuse. Others have suggested the reuse of pacemakers implanted <3 years ago may possess an average longevity of 7 years. Devices that pass all quality-control measures would then undergo a process to erase all patient identifiers, followed by sterilization and suitable packing. The device should then be sent to nonprofit charitable organizations that specialize in delivering medical equipment for distribution to LMICs, where the device will be implanted with new unused leads.
Feasibility of Device Reutilization
Alhough the practicality of pacemaker reutilization may seem challenging, it has previously been demonstrated to be feasible in many countries. Many studies have examined the views of patients and funeral home directors, and the steps involved in device extraction and reuse.
Resources for Potential Device Acquisition
In the USA alone, there are more than 225,000 pacemakers implanted each year. Brunner et al. found that median patient survival after pacemaker implantation was 8.5 years; however, only 65.6% of patients were still alive at 5 years after first implantation; they also noted an increase in the average age of patients at the time of implant. The cremation rate in North America is currently estimated to be 45% and is expected to increase to 57% in 2025. Therefore, it is reasonable to estimate that a majority of patients with pacemakers will wish to be cremated in the near future. Prior to cremation, pacemakers and defibrillators must be removed to prevent device explosion. Thus, their devices will be explanted per routine measures. This large number of available devices could prove to be a valuable source of reused pacemakers.
PMHYH has already started to acquire explanted pacemakers from funeral homes and crematories across the country. All devices are examined by a trained device nurse in order to assess structural integrity (specifically the integrity of device headers), as well as battery longevity. More than 10,000 devices have been donated to the program. Of these devices, 21% were found to have an adequate battery life for potential reutilization in a LMIC. The authors defined adequate battery life as ≥75% battery life or ≥4 years expected longevity. Moreover, a study of 328 implantable defibrillators, explanted for reasons other than reaching elective replacement interval, revealed that the majority had greater than 50% of battery life remaining.
As previously discussed, Nava et al. is the most recent large trial to examine the safety of device reutilization. In the reused-device cohort, the average device longevity was 6 years compared with 8 years longevity of a new device. Moreover, only 11 reused devices displayed signs of premature depletion. This study supports the current PMHYH definition of an adequate battery life to be >75%.
Patients' Perspectives
In a survey study carried out in the Chicago (IL, USA) area, Kirkpatrick et al. noted that, among 150 patients with implanted devices, 87% did not know how devices were handled after death. The majority of the patients (79%) were willing to have their devices returned to manufacturers after death. A total of 72% of device patients indicated they would sign a device advanced directive if asked and, of those, 92% were willing to have their devices removed and donated for use in developing countries. Similar findings were seen in a more recent survey performed at the University of Michigan that included 114 patients with devices and 1009 members of the general population; 87% of the patients with implantable devices and 71% of the general population supported pacemaker reutilization if given the opportunity (Figure 2). Therefore, it is logical to discuss with patients how to handle their devices upon death, similar to the concept of organ donation. This concept may be even more important than organ donation, as all device recipients can be potential donors.
(Enlarge Image)
Figure 2.
Percentage of patients with an implanted device who are willing to have their device explanted after death.
Funeral Home Directors' Perspective
Despite recommendations by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines stating that funeral directors should notify the physician monitoring the device immediately and return the patient's device to the manufacturer after a patient's death, present studies show that most funeral directors do not perform this practice routinely. These guidelines also recommend that patients or family members should be asked to consent for post-mortem device evaluation, including interrogation and removal. Funeral home directors reported that 85% of patients are buried with their device. Retrieval of devices mainly occurred for reasons such as cremation or family request. Of those devices, 84% were discarded as waste or stored with no intended purpose. However, when asked, the majority of funeral home directors (89%) expressed willingness to donate the device to be used in underserved areas.
The current literature supports that pacemaker reutilization is a feasible practice with support from device patients, as well as members of the general public, including funeral directors.
Device Acquisition & Performance Measures
PMHYH provides a framework for those interested in participating in a program to acquire, sterilize and redistribute devices to those in underserved nations. After identifying a device for potential reuse, signed consent must be obtained from the family in order to proceed with device removal. The majority of funeral directors have had experience and are comfortable with explanting devices, despite only a third of them undergoing prior formal training in device removal. This training is of utmost importance as reused-device malfunction was mainly due to set-screw abnormalities during the extraction process. The donated device should then be sent to a center of excellence for investigation, which includes interrogation to assure adequate battery life and other performance-testing specifications. Based on prior case series of pacemaker reuse, a cutoff of ≥70% of battery life was suggested by Baman et al. for proper reuse. Others have suggested the reuse of pacemakers implanted <3 years ago may possess an average longevity of 7 years. Devices that pass all quality-control measures would then undergo a process to erase all patient identifiers, followed by sterilization and suitable packing. The device should then be sent to nonprofit charitable organizations that specialize in delivering medical equipment for distribution to LMICs, where the device will be implanted with new unused leads.