Pacemaker reuse: an initiative to help those in underserved nations in need of life-saving device therapy

Keywords::

• medical device donation
• pacemaker reuse
• pacemaker recycling

Cardiac pacemakers have revolutionized the management of symptomatic bradyarrhythmia (slow heart rate) and are in part responsible for the dramatic reduction in morbidity and mortality from cardiovascular disease over the last several decades. However, despite reductions in the cost of pacemakers and near-ubiquitous access to them in wealthy nations, pacemakers are unaffordable and remain beyond reach for many patients in low- and middle-income countries (LMICs). At the same time, nearly 90% of patients with pacemakers state they would consider post-mortem donation of their device to assist others in underserved nations [1]. Despite challenging logistical and regulatory obstacles, post-mortem pacemaker reuse may be a feasible, safe and cost-effective strategy to provide life-saving therapy to patients in LMICs.

An unmet need for pacemakers

According to some estimates, one to three million people die every year as a result of lack of access to pacemakers [101]. In addition to the cardiovascular risk factors prevalent in both wealthy and disadvantaged nations, patients in some underdeveloped parts of the world face the specter of infectious disease resulting in heart failure or the need for pacing. Chagas’ disease, caused by the parasite Trypanosoma cruzi, is endemic to parts of Latin America, where it is a leading cause of heart disease [2]. Despite a large demand for pacemakers, the rate of pacemaker implantation in Peru – where Chagas’ disease is endemic – is significantly lower than in the USA (30 vs 767 implants per million people) [3]. This disparity results in significant morbidity and numerous preventable deaths each year.

Availability of post-mortem pacemakers

In the USA, there has been a steady rise in the number of pacemaker recipients, with 188,700 pacemaker implantations performed in 2009 [4]. With the median age at implant of 77 years, nearly 40% of patients die within 4 years after implantation [5]. The mean longevity of pacemakers in a recent registry was 11.2 ± 2.6 years [6]. Thus, a large number of potentially reusable pacemakers would be available for reuse. All deceased individuals undergoing cremation must have their devices removed, and as many as 5% of individuals choose to have their device removed before burial [7]. Importantly, patients and their families are willing to participate in pacemaker donation. In a survey of 114 device patients, 87% reported that they would be willing to have their devices removed post-mortem and donated for use in LMICs [8]. A survey of 152 funeral directors demonstrated that 89% of funeral directors would be willing to donate devices if given an appropriate framework [9].

One potential limitation to the supply of reusable pacemakers is device longevity, as each pacemaker must have a certain minimum amount of battery life to justify the risks associated with re-implantation. However, a significant proportion of donated devices are likely to have acceptable battery life. About 18% of pacemakers collected from funeral homes and crematories had at least 75% of the original battery life or >48 months of battery life remaining [10]. In another study of battery life involving 328 extracted implantable cardioverter-defibrillators (ICDs) of living patients, 74% of devices that had been removed for clinical reasons not related to battery life had a remaining expected longevity of at least 24 months (or 50% of battery life) [11].

Risks associated with pacemaker reuse

The major risks of pacemaker reuse include infection and malfunction. There is risk of transmission of an infectious agent from donor to recipient, as well as incomplete sterilization. Numerous small cohort studies suggest that this risk is small. A meta-analysis that pooled data from 2270 patients across 18 studies involving pacemaker reuse showed that the risk of infection was <2% [12]. Five of the studies in the analysis compared infection rates of re-implanted pacemakers and brand new implants, and found them to be not statistically different (odds ratio: 1.31, 95% CI: 0.50–3.40; p = 0.580). The risk of malfunction was sixfold greater with reused devices, although no deaths were associated with any of the events. Given the extremely high reliability of brand new devices, the relatively high rate of device malfunction does not appear large enough to negate the potentially huge benefits in terms of improved quality of life and mortality in patients who undergo pacemaker implantation.

My Heart Your Heart

Donated pacemaker implantation has been successful in many recent small-scale efforts in LMIC [13–16]. Yet, the effort has not been scaled up to match the large need. A highly organized system of device collection, evaluation and reprocessing must be developed before small charitable missions can transform this practice into a mainstream solution. The mission of Project My Heart Your Heart is to bridge the gap between the enormous need in LMIC and what is currently available. My Heart Your Heart is a joint collaborative between the University of Michigan Cardiovascular Center, World Medical Relief, Inc. (a non-profit organization that provides medical supplies and equipment to those in need) and the Michigan Funeral Directors Association. The goal of the initiative is to conduct the necessary evaluation to develop a blueprint for pacemaker reuse and to advocate for changes to the regulatory environment which would allow other charities the opportunity to collect, evaluate and re-process pacemakers in the USA. We have established collaboration with Pace4Life, a UK charity with the goal of advancing the concept of pacemaker reuse in Europe.

Challenges & obstacles

Although pacemaker donation and reuse has already been successful in small pilot projects, there remain significant regulatory and legal barriers to its wider adoption. One major regulatory hurdle stems from the US FDA position toward pacemaker reuse. Under current FDA regulations, pacemakers are classified as ‘single-use devices’ thus re-implantation is not allowed. The FDA compliance manual states that there is a ‘serious question whether pacemakers can be properly re-sterilized following initial implantation due to the possibility of body fluids entering the terminal leads of the pacemaker’, and refers to pacemaker reuse as an ‘objectionable practice’ [102]. Any organization that reprocesses single-use devices must comply with the same handling and product standards as the original manufacturer [17]. The FDA policy toward pacemaker reuse, especially outside of the USA, may change if a robust evaluation scheme for previously implanted pacemakers is developed. Until such regulatory change occurs, legal liability could limit the number of organizations able and willing to participate in wide-scale reuse.

Should reuse become a mainstream approach to delivering pacemakers to impoverished patients in LMIC, device ownership may become another ethical/legal issue to be resolved. It is not clear which party–the patient, the patient’s family members, the device manufacturer or payers–ultimately owns the device [17]. Living wills would likely help ensure that patients are able to dictate what happens to their devices after death. Further work to clarify ownership rights may help facilitate greater adoption of pacemaker reuse.

Another important consideration is ensuring pacemakers are distributed to patients who are most ‘deserving’. The distribution of this precious resource could become corrupt, resulting in the creation of a ‘black market’ for devices, particularly in LMICs with loose regulation and underdeveloped justice system [18]. It is essential that pacemaker distribution is done in a disciplined and transparent way with donors being able to audit delivery of this precious resource to those in greatest need.

Conclusion

Technological advances have enabled dramatic improvements in cardiovascular health around the world. It is a tragedy that so many individuals in LMICs remain unable to afford pacemakers. Pacemaker donation and reuse has been shown to be logistically feasible as well as safe. Despite regulatory and legal challenges, pacemaker reuse has the very real potential to help hundreds of thousands if not millions of patients who currently are denied this therapy due to its prohibitive cost. Large-scale prospective clinical studies to determine the clinical safety and efficacy of pacemaker reuse are needed. Further work is also needed to clarify the regulatory and legal framework in which reuse programs may operate.

Financial & competing interests disclosure

The My Heart Your Heart initiative is supported by grants from the Hewlett Foundation, the Mardigian Foundation, the University of Michigan Cardiovascular Center and a gift from Sheldon Davis. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.