Why the study?
Does reused pacemaker implantation provide a safe and effective alternative to new pacemaker implantation in patients with class I indications who cannot afford a new device in LMICs?
Does reused pacemaker implantation provide a safe and effective alternative to new pacemaker implantation in patients with class I indications who cannot afford a new device in LMICs?
This editorial discusses the ethical implications and potential benefits of a planned randomized controlled trial evaluating the safety and efficacy of reused pacemakers in low- and middle-income countries.
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 …
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Tandon et al. (2017) studied this question.
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