Indian patients `safely reusing` heart devices taken from Americans
Washington: Used heart devices of US patients can be safely fixed in seriously ill heart disease patients in the developing world, researchers say.
The devices, which are known as implantable cardioverter defibrillators (ICDs), automatically deliver potentially life-saving electrical shocks to the heart in people at high risk of cardiac arrest.
However, in the developing world few people have the money to afford the cost - about 5,000 dollars in the U.S. for pacemakers, and four times that for ICDs.
“These devices did work well. They delivered appropriate shocks and saved lives,” Fox News quoted lead researcher Dr. Behzad B. Pavri from Thomas Jefferson University Hospital in Philadelphia as saying.
A few studies have already shown that it is possible to reuse pacemakers - devices that use electrical pulses to the heart to keep a normal heartbeat.
According to researchers, one remedy 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.
The new study, reported in the Annals of Internal Medicine, is the first to look at reusing ICDs.
The researchers of the study 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.
Still, Pavra said, plenty of questions remain.
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. Hopefully, these data will help in achieving a prospective trial,” Pavri said.
However, 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.
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.
This was higher than what would be seen in U.S. patients, Pavri noted.
According to Pavri, the difference 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, Pavri concluded.
The study has been published in the Annals of Internal Medicine.
First Published: Wednesday, October 17, 2012, 11:19
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