The University of Michigan is leading a clinical trial in low- and middle-income countries that is testing the impact of sending reconditioned pacemakers abroad for standard use. If successful, the trial could greatly increase access to pacemaker treatment for patients who otherwise would not receive it.
“I don’t believe that there’s any other effort on this scale in the world that’s trying to create a blueprint for how to safely recondition pacemakers and offer them to patients at no cost,” said the study’s principal investigator Thomas C. Crawford, MD, a cardiac electrophysiologist at the Frankel Cardiovascular Center and medical director of the program.
The process of servicing medical devices for reimplantation in life-threatening cases with no alternative, known as compassionate use, is not new. Pacemakers, however, are considered single-use devices in the U.S. and cannot be reimplanted in such situations.
Researchers and clinicians at the U-M Health Frankel Cardiovascular Center began sending reconditioned pacemakers to low- and middle-income countries for compassionate use cases in 2010 through the “My Heart Your Heart” program. The project offers the chance for American patients who are preparing to have their pacemaker removed for a new device, and the survivors of a person who died with a pacemaker in place, to consent to donate the device.
Surgeons have since reimplanted approximately 150 of these compassionate use devices in South America, Africa, Asia and Europe.
The international, randomized clinical trial of post-mortem pacemaker utilization, which is still enrolling patients, began in October of 2018, with sites in countries including Venezuela, Kenya and Nigeria.
“We’ve been met with a lot of enthusiasm from different countries,” Crawford said. “After overcoming the regulatory obstacles, we’ve been able to provide devices to physicians who really know what to do with them, and we’ve helped to train many of them.”
As a part of the clinical trial, patients are either given new pacemakers or those that have been reconditioned in the U.S. Pacemaker recipients are individuals who are unable to pay for a new device and for whom all other methods for acquiring one are exhausted.
The main method of determining if the reconditioned pacemakers are successful is whether recipients have infections related to the device implantation, as well as any software or hardware malfunctions.
Over 200 patients have already enrolled in the trial, with more than 100 coming from ASCARDIO in Venezuela.
“Proof of the safety of these devices would give us the opportunity to win time for even more of our patients,” said Vicente Finizola, MD, interventional cardiologist at ASCARDIO and board member of the Venezuelan Society of Cardiology.
Investigators have a goal of 260 patients and hope to complete it by October 2025.
“If the trial shows positive results, we could scale this up and create a self-sustaining operation to allow for large-scale pacemaker reconditioning and donations to low-income countries,” Crawford said.
