New life for used devices: Refurbished pacemakers address global disparities in access
Click Here to Manage Email Alerts
Key takeaways:
- The My Heart Your Heart study compared reconditioned pacemakers with that of new pacemakers among patients in low- and middle-income countries.
- Longer-term follow-up is needed.
CHICAGO — Reconditioned cardiac devices could help meet an overwhelming need outside of the United States.
In a new study presented at the American Heart Association Scientific Sessions, pacemakers that were reconditioned with an FDA-approved protocol were safe and worked as well as new devices among patients with an indication for a pacemaker living in Venezuela, Nigeria, Paraguay, Kenya, Mozambique and Mexico.
While more research is needed to determine long-term safety and effectiveness, “pacemaker reconditioning may improve access to pacemaker therapy for patients unable to acquire a new one due to personal financial limitations,” Thomas Crawford, MD, an electrophysiologist and associate professor of internal medicine at University of Michigan Health, said during a press conference. Crawford is medical director of My Heart Your Heart, a cardiac pacemaker reuse initiative at the University of Michigan Cardiovascular Center.
My Heart Your Heart
The My Heart Your Heart study compared the function of reconditioned pacemakers with that of new pacemakers. This is the first randomized study to report patient outcomes on function and infection with reconditioned devices, according to the researchers.
The study included 298 adults with a class I indication for a pacemaker but no financial means to acquire a new device, Crawford said. Each patient was randomly assigned to a reconditioned pacemaker (51% men; average age, 72 years) or a new pacemaker (48% men; average age, 70 years) from May 2022 to June 2024. Three-quarters of patients had complete heart block and about one-quarter had sinus node dysfunction.
The primary endpoint was freedom from procedure-related infection at 12 months. Crawford reported preliminary data from up to 90 days after implantation, as most infections related to implantation procedures occur within that period, he said.
The 90-day infection risk for new devices was 2.9% in the new-device group compared with 1.5% in the reconditioned-device group, according to Crawford. Infection leading to device removal occurred in 2.2% of those with new devices compared with 1.5% of those with reconditioned devices. One patient in the new-device group developed a superficial infection that was treated with antibiotics alone, Crawford said.
“Reconditioned pacemakers are noninferior to new pacemakers, in terms of infection rate up to 90 days of follow-up,” Crawford said.
The researchers observed no malfunctions or failures of the pulse generator with either new or reconditioned pacemakers, he said.
Three patients in the reconditioned group died. Crawford said no deaths were attributable to an issue with the pacemaker.
Global disparities
Significant disparities in CVD treatment access exist between industrialized nations and low- and middle-income countries, Crawford said. For one, cost is a major factor to access cardiac devices, including pacemakers, according to Crawford.
Crawford cited data that show the number of annual pacemaker implantations is substantially different around the world, from about 800 pacemaker implantations per million population every year in the U.S., to single-digits per million population in Kenya and Nigeria, he said.
“Our hope is that we can scale up device reprocessing and expand the use of reconditioned pacemakers in a registry for decades to come,” Crawford said of the My Heart Your Heart initiative. “Collaboration between centers of excellence in the U.S., charitable organizations and foreign entities may allow safe and effective large-scale pacemaker reconditioning.”
For the My Heart Your Heart study, pacemakers were recovered from deceased patients and patients undergoing procedures that required removal of existing devices, according to a press release from the AHA. Pacemakers with at least 6 years of battery life remaining were sterilized for reuse, Crawford said at the press conference. While reusing these devices is not permitted in the U.S., the FDA allows resterilized devices to be exported for reuse, according to information in the AHA release.
During a discussion at the press conference, Miguel Leal, MD, FACC, FHRS, associate professor at Emory University School of Medicine, acknowledged that devices today are lasting longer than previous iterations. Leal said the estimated longevity of a pacemaker has evolved over 2 decades from approximately 5 to 8 years, to the excess of 15 years.
“It is important to appreciate that [in this study] these were not devices that were selected because they were expired or outdated,” Leal said. He echoed the need for longer-term follow-up that reflects the lifespan of a pacemaker.
Leal also said looking at infection as the primary endpoint “is important because there is clearly a taboo ... around utilizing a device that once belonged to someone else.” However, he said, “this is not a taboo topic anymore.”
Click here to read a previous interview Healio conducted with Crawford about the My Heart Your Heart initiative.
Reference:
- Reconditioned pacemakers worked as well as new ones. https://newsroom.heart.org/news/reconditioned-pacemakers-worked-as-well-as-new-ones. Published Nov. 17, 2024. Accessed Nov. 17, 2024.
Perspective
Back to Top
Niraj Varma, MD, PhD
Implantable cardiac electronic devices such as pacemakers and defibrillators provide lifesaving therapy. Unfortunately, they are expensive and beyond the reach of many throughout the world. For decades, explanted devices with long battery life have been sterilized and donated to these areas, often by charity organizations. Although the experience has been positive, there has always been a concern in the medical and regulatory organizations that these reused devices pose risk. This study goes some way to redress that, showing noninferiority of reconditioned pacemakers to new devices in a randomized trial. The endpoint was freedom from infection at 90 days. While reassuring, longer-term outcomes, including device performance, need to be assessed. Also, optimal methods of repurposing devices and cost of leads need to be described. This work is likely to impact the lives of many who otherwise have no alternative options.
Collapse
Crawford T. LBS.05. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2024; Chicago.
Click Here to Manage Email Alerts