Previously used pacemakers reconditioned with an U.S. Food and Drug Administration-approved protocol worked as well as new devices at 90 days, based on findings from the My Heart Your Heart (MHYH) trial presented at AHA 2024.

The study involved 298 adults from Sierra Leone, Venezuela, Nigeria, Kenya, Paraguay, Mexico and Mozambique who were candidates for pacemakers but had no financial means to acquire a new device. The average age in both groups was approximately 70 years and roughly half were men.

Participants were randomized 1:1 to either a reconditioned device or a new pacemaker and device safety and efficacy were assessed in-hospital at two weeks and then for up to 90 days in office visits.

At 90 days, five cases of device pocket infections requiring implant removal occurred in three patients with new pacemakers and two patients with reconditioned pacemakers, while lead dislodgement occurred in five patients in the new group compared with six patients in the reconditioned group. No device malfunctions were reported among patients in either group, and no deaths related to the device implantation occurred.

"Access to pacemakers is limited in many low- and middle-income countries due to the relatively high cost of the devices," said lead study author Thomas Crawford, MD, FACC. "Our study shows pacemaker recycling is green, good for the environment and can save the lives of people in other countries who can't afford a new device. However, longer-term follow-up will be necessary to confirm the safety and efficacy of reconditioned devices, including whether they continue to work as expected and whether the batteries depreciate at the expected rate."

The small sample size and short follow-up period of up to 90 days pose limitations to the study. Longer follow-up may reveal problems with reconditioned devices occurring later, especially premature battery depletion or late device malfunction, Crawford said.