Key Points:
- Many patients in low- and middle-Income countries are unable to obtain new pacemaker devices. It is unknown if reconditioned pacemakers are as effective as new pacemakers.
- In this randomized clinical trial, 298 patients who had class I indications for a pacemaker but no financial means to obtain one were given either a reconditioned pacemaker or a new pacemaker at implant.
- Reconditioned pacemakers was found to be non-inferior to new pacemakers for infection and lead complications at 90 days.
Many patients in low- and middle-Income countries are unable to obtain new pacemaker devices due to poor healthcare infrastructure and high costs. As a result, many patients in low- and middle-income countries are unable to receive pacemakers for their bradyarrhythmia. It is unknown if reconditioned pacemakers may be as effective as new pacemakers in filling this disparity gap.
The My Heart Your Heart trial was a multi-center, single-blind, non-inferiority clinical trial performed at 7 sites in 6 countries (Venezuela, Nigeria, Paraguay, Kenya, Mozambique, and Mexico). The study randomized participants who had class I indications for a permanent pacemaker and no financial means to acquire a new device to receiving either reconditioned pacemakers (149 participants) or new pacemakers (149 participants). The primary outcome was infection with other complications of lead dislodgement, pacemaker removal, and death also assessed. The results presented were for 90-day follow-up with the full study intending for 1-year follow-up.
The results of the trial were presented as a late breaking clinical trial at the American Heart Association on November 17, 2024. Among the 298 participants who underwent randomization, 280 (94.3%) had at least 1 follow-up completed, the average age was 70 years, and 52% were women. The researchers found that reconditioned pacemakers were non-inferior to new pacemakers for infection with 2 cases of pocket infections requiring removal in the reconditioned arm and 3 cases in the new pacemaker arm. Lead dislodgement requiring removal was also similar between the two groups with 6 patients in the reconditioned arm and 5 in the new pacemaker arm. No device malfunctions were reported.
Limitations of the trial include the short follow-up period, single-blind study, and lower number of participants. Future research may be better as assessing premature battery depletion or late device malfunctions.
In the late breaking presentation at the American Heart Association Scientific Sessions, Dr. Crawford concluded that “reconditioned pacemakers are noninferior to new pacemakers in terms of infection rate up to 90 days of follow-up and pacemaker reconditioning may improve access to pacemaker therapy for patients unable to acquire a new one due to financial obstacles.”