Procedure-related infection rates are similar between reconditioned and new pacemakers, potentially offering a “new hope” to patients in low- and middle-income countries (LMICs), according to late-breaking research presented at this year’s European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain).
“Patients in many LMICs still have very limited access to cardiac pacing despite its routine use in higher-income countries. Indeed, access to pacemaker implantation is around 200-fold lower in Africa than in Europe,” said Thomas Crawford (University of Michigan, Ann Arbor, USA). “To facilitate the use of reconditioned devices, Project My Heart Your Heart has developed a comprehensive protocol for cleaning, functional testing and sterilisation, and has gained US FDA [Food and Drug Administration] approval for their export to countries whose governments have provided express permission for pacemaker importation. We initiated a clinical trial to investigate the safety of implanting pacemakers reconditioned using our protocol compared with new devices in several LMICs.”
Project My Heart Your Heart led a randomised controlled trial conducted in Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone and Venezuela from May 2022 to June 2024. Adult patients with a life expectancy of at least two years, a class-one indication for pacemaker therapy and no financial means to acquire a new device were randomised 1:1 to receive a reconditioned pacemaker or a new pacemaker. The primary endpoint was procedure-related infection at 12 months. The trial included 306 patients who had a mean age of roughly 71 years, while approximately half were female. Follow-up data at 12 months were available for 259 patients (84.9%).
Over the course of 12 months, there were two pocket infections requiring explantation in the reconditioned pacemaker group and three in the new pacemaker group. There was one case of superficial cellulitis responsive to antibiotics in the new pacemaker group. Overall, the incidence of procedure-related infections at 12 months was 1.6% in patients in the reconditioned pacemaker group and 3.1% in the new pacemaker group. The upper bound of the 90% confidence interval for the difference in infection rates between the groups was 2.2%—which was within the researchers’ prespecified non-inferiority margin of 5%.
In addition, there were no device malfunctions in either group. Lead revisions occurred in nine patients in the reconditioned pacemaker group and five in the new pacemaker group. Unrelated to the implantation procedure, there were four deaths in the reconditioned pacemaker group and two in the new pacemaker group.
“Our trial demonstrates the safety of pacemakers reconditioned using a specific protocol, with non-inferior infection rates to new pacemakers and no malfunctions,” Crawford concluded. “The work of Project My Heart Your Heart serves as a blueprint that can be replicated by other organisations to enable wider pacemaker reuse. We would also like to expand into reconditioned implantable cardioverter-defibrillator devices, which are even more expensive and out of reach for many patients across the world.”
