HALF OF PATIENTS GOT SHOCKS

In this study, 81 patients received ICDs, and the researchers were able to follow up with 75 - which is actually quite good in this context, according to Crawford, who was not involved in the work.

For 54 percent of the patients, the ICD delivered an appropriate shock at some point over two-plus years.

That’s higher than what would be seen in U.S. patients, Pavri noted. (Studies show that even after five years, the majority of Americans with ICDs have never had a shock from the device.)

The difference, according to Pavri, is that the patients in his study were higher-risk. They all had “class 1 indications” for an ICD. That includes people who’ve already suffered life-threatening heart arrhythmias or have significant damage to the heart muscle from a past heart attack.

Nine patients died, after an average of two years with the device.

A limit of the study, Pavri said, is that there was no information on how often the ICDs may have delivered inappropriate shocks - where the device mistakenly detects a dangerous heart arrhythmia and gives a needless (and painful) shock.

That’s a risk with any ICD, but it’s important to find out whether reused devices carry a particular risk. Future studies would need to look at that, according to Pavri.

DEVICE MAKERS OPPOSED

Device manufacturers do not support reuse, citing safety concerns. Two of those companies - Medtronic and St. Jude Medical Inc. - told Reuters Health last month that they donate new devices to charities around the world.

But those donations do not cover the need. “We’re not saying that (reused) devices are just as good as new ones,” said Crawford, who is part of a research group at the University of Michigan in Ann Arbor. But, he added, they could offer an additional way to get pacemakers and ICDs to people who need them.

Crawford’s group has applied for FDA approval to send recycled heart devices overseas for a clinical trial. Their program - dubbed Project My Heart Your Heart - has collected close to 1,800 pacemakers and ICDs that have at least four years of battery life left.

Crawford said he’s not surprised by the new findings.

“They support the smaller studies that have come out on pacemakers,” Crawford said.

He added that it was good to see the study published in a respected, widely read journal. “This will probably spur some controversy and discussion,” Crawford said.

SOURCE: Annals of Internal Medicine, October 15, 2012.