Americans' heart devices reused safely in India
U.S. patients' used heart devices can be safely implanted in seriously ill heart disease patients in the developing world, a study out Monday suggests.
"These devices did work well. They delivered appropriate shocks and saved lives," said lead researcher Dr. Behzad B. Pavri, of Thomas Jefferson University Hospital in Philadelphia.
The devices, known as implantable cardioverter defibrillators (ICDs), automatically deliver potentially life-saving electrical shocks to the heart in people at high risk of cardiac arrest. But in the developing world, few people have the money to afford the cost - about $5,000 in the U.S. for pacemakers, and four times that for ICDs.
A few studies have already shown that it's possible to reuse pacemakers, devices that use electrical pulses to the heart to keep a normal heartbeat.
One remedy, some researchers say, would be for wealthy nations to donate used ICDs - taken from cadavers, or from patients who have their ICD removed because of an infection or to get an upgraded model. (See Reuters Health report of September 13, 2012: reut.rs/OsVHuu.)
The new study, reported in the Annals of Internal Medicine, is the first to look at reusing ICDs.
Researchers found that ICDs donated from the U.S. appeared to work safely for 75 impoverished patients in India. Over more than two years, there were no infections, and no evidence that the devices malfunctioned - the two biggest concerns with reused heart devices.
Regulations an obstacle
Still, plenty of questions remain, according to Pavri.
This study was small and reviewed the records of consecutive patients who got the donated ICDs at one center, Holy Family Hospital in Mumbai. It was not a "prospective" study, where researchers recruit patients then systematically follow them over time.
"We clearly need more data," Pavri said. "Hopefully, these data will help in achieving a prospective trial."
But even beginning a trial is far easier said than done. One of the biggest obstacles is U.S. regulation, Pavri noted. The Food and Drug Administration (FDA) allows ICDs and pacemakers to be used only once. For there to be any large-scale exportation of the devices from the U.S., the FDA would have to be on board with it.
The Indian patients in this study received their ICDs after Pavri and his colleagues flew to Mumbai themselves, carrying the devices in their baggage.
It's been estimated that between 1 million and 2 million people worldwide die each year because they don't have access to a pacemaker.
It's not clear how many lives are lost due to a lack of ICDs. But in the U.S., Pavri's team writes, ICDs are implanted at a rate of 434 per million people. In many developing countries, that rate is less than 1 per million.
"What we've done is just a drop in the bucket compared to the need," Pavri said.
He thinks that when ICDs with years of battery life left are simply discarded, it's a "tremendous loss of potential."
But regulatory hurdles are not the only obstacle. Both Pavri and Dr. Thomas Crawford, a cardiologist working on a separate project to collect donated devices for use in developing countries, said that following patients after the ICD is implanted is a major issue.
Patients from rural areas may live hours from any major hospital, and might use up the family savings just traveling to have the ICD implanted. It might be impossible for them to make regular return trips to have the ICD, and themselves, checked out.
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.