Study Shows Reused ICDs Can Be Successful

A study titled “Reuse of Explanted, Resterilized Implantable Cardioverter-Defibrillators,” published in the Annals of Internal Medicine, has found that reused, resterilized implantable cardioverter-defibrillators (ICDs) can safely be implanted in patients. The researchers looked at ICDs from the United States implanted in Indian patients who otherwise would be unable to afford a brand new device, and the results were positive.

“These devices did work well,” said lead researcher Behzad B. Pavri, M.D., of Thomas Jefferson University Hospital in Philadelphia, Pa. “They delivered appropriate shocks and saved lives.”

ICDs work by delivering electrical shocks to the heart in people who are at risk for cardiac arrest. However, pacemakers can cost up to $5,000 in the United States, and ICDs can run four times as much. Several studies already have shown that it is not possible to reuse pacemakers.

In the study detailed in the Annals of Internal Medicine, 81 consenting patients (average age of 52.6 years; 66 male and 15 female) received 106 explanted devices. Twenty-two patients received a second device and three patients received a third device after the prior one needed replacement voltage. The average time to ICD replacement was 1,287.4 days. Follow-up data were available for 75 of 81 patients (92.6 percent). The average follow-up duration for all devices was 824.9 days. No infectious complications occurred; one lead dislodgement and one lead fracture required repeated surgery. Appropriate therapy (shocks or antitachycardia pacing) was delivered by 64 of 106 devices (60.4 percent) in 44 of 81 patients (54.3 percent). Nine of 81 patients died (11.1 percent); the average time from implantation to death was 771.3 days.

The research was conducted on a relatively small group of patients, all at Holy Family Hospital in Mumbai. The research team hopes to conduct a much larger prospective study in which they would recruit patients specifically for the trial, and then follow them systematically over a long period of time. However, to conduct such a study in the United States, the U.S. Food and Drug Administration (FDA) would have to approve, and the agency currently does not allow the use of reused ICDs and pacemakers. For the study in India, Pavri and his colleagues brought the devices over from the United States packed in their personal luggage.

“We clearly need more data,” Pavri said. “Hopefully, these data will help in achieving a prospective trial.”

An estimated 1 million to 2 million people die annually due to lack of a pacemaker, but the number of deaths due to lack of an ICD is unknown. According to Pavri, ICDs are implanted in 434 per 1 million people in the United States; in India that rate is less than one per 1 million.

Discarding a used ICD that still has years of battery life in it is a “tremendous loss of potential,” Pavri told Reuters Health.

Aligning with the FDA, device manufacturers do not support the reuse of ICDs. Some companies, Medtronic Inc. and St. Jude Medical Inc. in particular, donate new devices to charities worldwide, though these donations do not meet current needs.

Thomas Crawford, M.D., a cardiologist at the University of Michigan School of Medicine in Ann Arbor, has applied for FDA approval of a trial to send reused, working cardiac devices abroad for use. Dubbed “Project My Heart Your Heart,” the project already has collected more than 1,800 pacemakers and ICDs that have at least four years of battery life left.

Crawford was pleased to see Pavri et al’s study in Annals, a widely read and respected journal. “This will probably spur some controversy and discussion,” he said.