Refurbished pacemakers are as safe as the new ones and work just as well, according to preliminary results from the My Heart Your Heart trial, which could help more people receive life-saving devices.

More than three-quarters of the 20 million deaths caused by cardiovascular disease worldwide each year occur in low- and middle-income countries, said Thomas Crawford, MD, a cardiologist at the University of Michigan School of Medicine in Ann Arbor, during his presentation here. to the American Heart Association (AHA) Scientific Sessions 2024.

“In some high-income countries, up to 1,000 people per million population may receive a pacemaker each year. In low-income countries, this figure could be 3 per million population or less,” he said. he declared.

There are two potential solutions to this large disparity between rich and poor countries: design and produce a low-cost basic pacemaker or create a system for post-mortem reuse of pacemakers. As there was little progress on the first option, Crawford decided to focus on the second.

Crawford and his team developed a protocol to sterilize and refurbish pacemakers recovered from people who have died or had their existing device replaced and whose battery life is at least 6 years. Although reuse of pacemakers is prohibited in the United States and officially permitted in no other country, the team received approval from the United States Food and Drug Administration to export their refurbished devices.

“We hope this will improve access to pacemaker treatment for patients who cannot access it due to financial limitations,” he said.

Reuse devices

About 300 patients across seven countries in Latin America and Africa participated in the My Heart Your Heart trial and randomly received a new or refurbished device. The primary endpoint of the current trial is freedom from procedure-related infection at 12 months; a secondary endpoint is the absence of device malfunction or unexplained death.

The preliminary results presented cover the first 90 days after implantation. Just under 3% of patients who received a new pacemaker developed an infection, as did only 1.5% of patients who received a refurbished device; this difference was not statistically significant. There were no malfunctions with any of the pacemakers, new or used.

“Refurbished pacemakers were not inferior to new ones in terms of infection up to 90 days after implantation,” Crawford reported.

The My Heart Your Heart trial is expected to reignite the idea of ​​reusing devices such as pacemakers. “Repurposing has been attempted in the past, but due to a number of regulatory issues – some valid, some less so – the programs have been discontinued over time,” explained Miguel Leal, MD, a cardiologist at Emory University in Atlanta, Georgia, which was not involved in the study. “We need more science and advocacy like this to show that this is not a taboo subject.”

Many new pacemakers now feature a battery life of 15 years or more, so many patients will die or experience an event that requires replacement long before the battery is exhausted. Normally, this device would simply be thrown away, but this study opens the door to a second life for these devices and could be a big step forward in improving health equity around the world.

“At a time when it is so difficult to promote equitable access, it’s about action, not just talk,” Leal said.

It’s unclear how much a cheaper refurbished device will cost, Crawford said; The devices in the present study were donated and much of the work was carried out by volunteers. However, he estimates they should be able to provide refurbished units for around $50 to $100 apiece, not including the cost of new electrical cables. In contrast, a new low-end pacemaker costs about $2,000 in low- and middle-income countries, and a new high-end device costs about $6,500 in the United States.

Crawford and Leal acknowledge that the study is limited by its short follow-up period and that much longer follow-up — 4 or 5 years, Leal said — will be needed to confirm safety and effectiveness.

Expanding the program will require partnerships with the funeral industry, academic medical centers and government regulators in the United States and abroad, and some sort of registry will be needed to coordinate the program. Destination countries will also need to have appropriate equipment, training, surgical facilities and access to follow-up care.

“Delivering the pacemakers is only part of this work,” Crawford said. “I hope we can increase and expand the use of remanufactured pacemakers in the years to come.”