Reconditioned Pacemakers Expand Access

Reconditioned pacemakers are as safe as new ones, and work just as well, preliminary results from the My Heart Your Heart trial show, which could help more people receive lifesaving devices.

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

“In some high-income countries, as many as 1000 people per million population may receive a pacemaker annually. In low-income countries, it could be 3 per million population or fewer,” he said.

There are two potential solutions to this large disparity between rich and poor nations: design and produce a basic, low-cost pacemaker or create a system for the postmortem reuse of pacemakers. Because there has been 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 have at least 6 years of battery life remaining. Although the reuse of pacemakers is prohibited in the United States, and is not officially allowed in any other country, the team received approval from the US Food and Drug Administration to export their refurbished devices.

“We hope this will improve access to pacemaker therapy for patients who are unable to access it due to financial limitations,” he said.

Reusing Devices

About 300 patients in seven countries in Latin America and Africa took part in the My Heart Your Heart trial and randomly received a new or refurbished device. The ongoing trial’s primary endpoint is freedom from procedure-related infection at 12 months; a secondary endpoint is freedom from 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 just 1.5% of patients who received a refurbished device; that difference was not statistically significant. There were no malfunctions with any of the pacemakers, new or used.

“Refurbished pacemakers were noninferior to new ones in terms of infection up to 90 days after implantation,” Crawford reported.

The My Heart Your Heart trial should revive the idea of reusing devices such as pacemakers. “Reuse has been tried in the past but due to a number of regulatory issues — some valid, some less so — the programs were terminated over time,” explained Miguel Leal, MD, a cardiologist at Emory University in Atlanta, Georgia, who was not involved in the study. “We’ve needed more science and advocacy like this to show that it is not a taboo topic.”

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

“In an era when it is so difficult to promote equitable access, this is walking the walk, not just talking the talk,” Leal said.

It is not clear exactly how much cheaper a refurbished device will be, said Crawford; the devices in the current study were donated and much of the work was done by volunteers. However, he estimates that they should be able to provide refurbished devices for around $50 to $100 each, excluding the cost of new electrical leads. In contrast, a new low-end pacemaker costs around $2000 in low- and middle-income countries, and a new high-end device runs about $6500 in the United States.

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

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

“Delivering the pacemakers is just one slice of this work,” said Crawford. “I hope we can scale-up and expand the use of reconditioned pacemakers in the years to come.”