A recent study presented at the American Heart Association’s Scientific Sessions 2024 indicates that reconditioned pacemakers are as safe and effective as new devices for patients in low- and middle-income countries. The randomized trial, involving nearly 300 adults, offers a potential solution to the limited access to pacemakers due to high costs in these regions.
Study Design and Findings
The "My Heart Your Heart" (MHYH) study, conducted across seven countries, compared the performance of reconditioned pacemakers against new ones. Pacemakers, sourced from deceased patients or those undergoing device replacement, were re-sterilized following FDA-approved protocols, ensuring they had at least six years of battery life and proper electrical function. Participants were evaluated in-hospital at two weeks post-implantation and followed up for 90 days.
The results showed:
- Five cases of infection at the implant site: three in the new device group and two in the reconditioned group.
- One superficial skin infection in the new device group, which cleared with antibiotics.
- Five patients with new pacemakers required surgery to adjust device leads, compared to six in the reconditioned group.
- No device malfunctions were reported in either group.
- Three deaths, unrelated to the device, occurred in the reconditioned group, and none in the new pacemaker group.
Expert Commentary
"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 Dr. Thomas Crawford from the University of Michigan Medical School. He noted that while high-income countries may see 1,000 pacemaker implants per million people annually, low-income countries may see as few as 3 per million.
Dr. Crawford also addressed concerns about device safety: "With reconditioned pacemakers, there is worry about whether the device will cause infection and whether it will function properly. The 90-day endpoint of the My Heart Your Heart study addresses the most immediate concern of infection because most of the infections related to the implantation procedure occur within that period."
Implications and Future Research
The study suggests that reconditioned pacemakers could significantly improve access to cardiac care in underserved regions. "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," Dr. Crawford stated.
However, researchers emphasize the need for longer-term follow-up to assess the devices' long-term performance, including battery life and potential late malfunctions. The study's relatively short 90-day follow-up period is a limitation. Further research will be crucial to confirm the sustained safety and efficacy of reconditioned pacemakers.
Study Details
The study included 298 adults without the financial means to acquire a new pacemaker, with 149 receiving new devices and 149 receiving reconditioned ones. The trial took place in Sierra Leone, Venezuela, Nigeria, Kenya, Paraguay, Mexico, and Mozambique between May 2022 and June 2024. Funding was provided through donations to the MHYH program.
