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Cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators (ICDs) are mainstays in the treatment and prevention of bradyarrhythmias and tachyarrhythmias. Rates of CIED implantation in higher income countries (HIC) have been increasing alongside a rise in the incidence of cardiovascular disease. In 2009, Germany saw pacemaker implantation at a rate of 927 implantations per million population, and in the USA 434 ICDs were implanted per million. In contrast, annual CIED implantation in many low-income/middle-income countries (LMICs) in Central and South-East Asia and Africa has remained at <10 implantations per million.1 This disparity in CIED implantation rates is likely the result of a lack of access to CIEDs due to their high costs, which are up to $5000 for a pacemaker system and $50 000 for an ICD system.2 Conservative estimates set the unmet global pacemaker need to be around one million devices per year.3
Representing the Pan-African Society of Cardiology (PASCAR), Sani and Mayosi provide a review of pacemaker reuse and argue that sterilisation and reimplantation of used pacemakers and ICDs donated by developed nations are potentially a safe and effective solution to bridge the gap between CIED implantation rates in HIC and LMIC.4 To validate this approach, PASCAR plans to join with the University of Michigan’s My Heart Your Heart (MHYH) programme, World Medical Relief and Pace4Life in a randomised controlled trial (RCT) conducted in LMIC that randomises patients with class I indications for pacemaker implantation who are unable to afford a new device to either new or reused pacemaker implantation.
The normalisation of pacemaker reuse and the reuse RCT bring up a myriad of ethical issues: Does device reuse set a dangerous precedent of offering substandard therapies to patients in LMIC? Does it absolve more prosperous countries of efforts to promote equality of treatment? Is the proposed trial just another in a long line of exploitative clinical trials in LMIC? Is there true equipoise in offering used devices in place of new ones? Is the autonomy of poorly educated and financially and medically desperate patients threatened? How can the inevitable economic interests and disinterests for national health agencies, device companies and patients that will arise with device reuse be regulated?
Ethicist Peter Singer argues that, ‘If it is in our power to prevent something bad from happening, without thereby sacrificing anything of comparable moral importance, we ought, morally to do it.’5 This altruistic sentiment Singer echoes today can also be found in the sacred texts of nearly every major religion.6 When this principle is applied to the question, ‘Is it ethically permissible to perform a randomized controlled trial of reused pacemakers among patients in the developing world who would otherwise have no access to a CIED’, we contend that the answer is yes. As long as there is thoughtful trial design and accountability at every step of the device procurement, sterilisation, distribution and implantation process, we believe that this RCT and device reuse programme are ethically justified.
As Sani and Mayosi point out, multiple studies have shown no significant difference in rates of device infections, malfunction or earlier than expected battery depletion between reused pacemakers and ICDs and brand new devices. The largest cohort study by Nava et al 7 compared 307 patients receiving used devices with 296 patients receiving new devices between 2000 and 2010 and found used devices to be inferior only with regard to battery life. In Sweden, prior to European Common Market integration in 1994, used pacemakers accounted for 14% of all implantations.8
MHYH has obtained Food and Drug Administration (FDA) approval for export of devices sterilised in their rigorous protocol.9 The FDA’s approval of these devices for export but not domestic use could be seen to imply that used devices are unfit for American patients but acceptable for patients in LMIC. This raises critical concerns about injustice and biased moral evaluations. However, we believe this conclusion is unfounded for several reasons. First, the available data suggest that used devices are non-inferior to new devices. Second, unlike some prior clinical trials in LMIC which intended to establish an evidence base used to obtain approval for marketing in HIC, the social value of this trial will be realised in the very society in which the trial is being conducted. The prohibitions against device reuse in the European Common Market and the USA mean that the outcomes of the trial will have no impact in those countries, but will only inform practice in LMIC. It is doubly reassuring that PASCAR, which has no direct financial interest in the outcome, is the primary LMIC-based collaborator.
The primary ethical argument against device reuse is grounded in the belief that providing suboptimal care inhibits or disincentivises best practices. However, parallels can be drawn to other areas of healthcare in HIC where choosing ‘second best’ is standard. Few question whether a patient should be denied a life-saving, high-risk organ donation because the patient in queue before them received a lower risk organ. Even in LMICs, well-drilling in drought-afflicted villages is not opposed on the grounds that well water is not as pure as spring water. The principle of distributive justice recognises that if life-saving interventions and the research to support them are postponed until global justice is perfectly achieved, the cost, in the form of lives lost or subject to significant morbidity, cannot be morally justified. Of course, if the trial indicates that used devices are significantly inferior to new devices, continuing implantation of used devices will require careful re-examination.
Central to any device implantation is patient autonomy and informed consent. The concern that it is difficult to obtain truly informed consent in this RCT is legitimate. Patients in this trial may be poorly educated, possibly conditioned to healthcare systems in which medical personnel are not questioned, and may recognise that they have no means to obtain a CIED outside of this trial. Emanuel et al 10 provide five benchmarks for informed consent in LMIC research, which we believe should inform consent practices in this trial. These include local community involvement in study design, context-sensitive and collaborative disclosure of information, thoughtful consent that honours the familial and hierarchical structure of the specific culture and community, a culturally sensitive consent process, and specific attention to ensure that participants know they are free to refuse or withdraw from the study at any time.
If the trial demonstrates safety of device reuse and the practice scales up, competing interests will arise at every step of the donation, reprocessing and reimplantation cycle. Medical device companies request routine return of used devices for quality control purposes, and there is the potential to reduce the pool of devices available for analysis. However, since about 80% of devices extracted postmortem are currently discarded, initiatives to collect devices for reuse may paradoxically result in a higher number returned to companies for analysis, since all those with inadequate battery life can be returned to companies. Thousands of used devices reimplanted in the past have been sterilised and reimplanted without regulation. While protocols for sterilisation have been successfully employed in many countries, the practice may be variable. Moreover, some of these devices may have been diverted to patients who can afford new devices. Certification and regulation should solve these problems. Implantation facilities, physicians and follow-up plans should achieve a standard that promotes patient safety and guards against improper reuse. We believe facilities that receive, reprocess and implant used devices should be credentialled to guard against substandard reprocessing and reimplantation practices, a CIED black market and unfair allocation of used devices. PASCAR is instituting a Fellowship for Cardiac Pacing training programme for physicians and technologists from underserved areas, and these issues should become part of the training programme.
Hundreds of thousands, if not millions, of people around the world suffer from morbid and mortal arrhythmias for which CIEDs are the only durable therapy. Although we must be mindful of the ethical challenges to device reuse, we believe they can be overcome. The PASCAR/MHYH/WMR/Pace4 Life trial is a step in the right direction.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.