By Joe Rossiter
McClatchy-Tribune News Service
DETROIT — A pacemaker roughly the size of two stacked silver dollars that was implanted in the chest of Clarence Harm helped prolong his life after he had a heart attack in 1989 and underwent heart bypass surgery three years later. Today, that pacemaker is part of a worldwide effort to treat heart disease in underdeveloped countries.
After Harm died in June, his family donated the tiny piece of technology to Project My Heart-Your Heart, a University of Michigan research initiative aimed at reusing pacemakers among patients who live in countries where they aren’t available.
“It was a no-brainer as far as we were concerned,” said Harm’s daughter Sandy Adas, 57. “In many ways, it’s comparable to organ donation because you’re providing new life to someone who can truly use it.” Begun nearly 2½ years ago, Project My Heart-Your Heart relies on participating funeral homes to find consenting families who are willing to donate their loved ones’ pacemakers.
More than 4,000 pacemakers have been collected since the project was started. They’re stored at the University of Michigan Cardiovascular Center while researchers seek approval from the U.S. Food and Drug Administration to demonstrate that pacemaker reuse is safe and effective.
“We could go a long way to eradicate death due to slow heart rate throughout the world,” said Dr. Kim Eagle, director of the Cardiovascular Center and chief of clinical cardiology, and the person who started the research, along with Dr. Timir Baman. Eagle estimated that nearly 1 million people worldwide die each year due to lack of access to pacemakers.
If FDA permission is given, Eagle said future plans call for embarking on a large-scale clinical trial to study device implantation using hospitals in Vietnam, Pakistan, the Philippines and Nicaragua, where there is little access to extensive heart care. Because the FDA approves pacemakers for one use only in this country, its policy is that they cannot be recycled. FDA spokeswoman Karen Riley said pacemakers need to be capable of withstanding necessary cleaning, disinfection or sterilization without adverse effect to the devices while continuing to comply with applicable FDA requirements. Project researchers are working on a sterilization protocol now, said Dr. Thomas Crawford of the Cardiovascular Center.
Typically, pacemakers cost up to $5,000 and are implanted in patients to regulate an irregular or slow heartbeat by automatically shocking the heart back to a normal rhythm. During small humanitarian efforts in Canada and Europe, international medical teams did implant some recycled pacemakers, according to Eagle. Likewise, 12 patients in the Philippines were implanted with donated devices in 2008, and a close monitoring of their progress over the years by the Michigan team revealed that there were no medical complications, Eagle said.
“After learning about the project, we thought it was a great idea because pacemakers are so expensive,” said Michael Lope, co-owner of William Sullivan & Son Funeral Home, among more than 40 funeral homes in the state that participate. “We decided to begin a policy of asking the families if we can donate the pacemakers, and everyone has been more than willing to come aboard, which is great because it’s such an important program and so many people around the world can benefit.”