Madrid, Spain – 1 September 2025: Procedure-related infection rates were similar with reconditioned and new pacemakers, according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.1
Explaining the rationale for Project My Heart Your Heart, Doctor Thomas Crawford from the University of Michigan, Ann Arbor, USA, said: “Patients in many low- and middle-income countries (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.2 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 FDA approval for their export to countries whose governments have provided express permission for pacemaker importation.3 We initiated a clinical trial to investigate the safety of implanting pacemakers reconditioned using our protocol compared with new devices in several LMICs.”
A randomised controlled trial was conducted in Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone and Venezuela from May 2022 to June 2024. Adult patients with life expectancy of at least two years, a class I 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 around 71 years. Approximately half were female. Follow-up data at 12 months were available for 259 patients (84.9%).
Over 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 group. The upper bound of the 90% confidence interval for the difference in infection rates between the groups was 2.2%, which is within the pre-specified noninferiority margin of 5%.
There were no device malfunctions in either group. Lead revisions occurred in nine patients in the reconditioned pacemaker group and five in the new group. Unrelated to the implantation procedure, there were four deaths in the reconditioned pacemaker group and two in the new group.
Concluding, Doctor Crawford said: “Our trial demonstrates the safety of pacemakers reconditioned using a specific protocol, with noninferior infection rates to new pacemakers and no malfunctions. 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.”
Notes to editor
This press release accompanies a presentation at ESC Congress 2025.
It does not necessarily reflect the opinion of the European Society of Cardiology.
Funding: The project is funded by private philanthropic donations.
Disclosures: Doctor Crawford has no disclosures to report related to this trial.
References and notes:
1‘Project MHYH: One-Year Results’ presented during HOT LINE 9 on 1 September 2025 at 08:59 to 09:11 in Madrid (Main Auditorium).
2Bonny A, Ngantcha M, Jeilan M, et al. Statistics on the use of cardiac electronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces. Europace. 2018;20:1513–1526.
3Crawford TC, Allmendinger C, Snell J, et al. Cleaning and sterilization of used cardiac implantable electronic devices with process validation: the next hurdle in device recycling. JACC Clin Electrophysiol. 2017;3:623–631.
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