Oct. 15, 2012 at 5:03 PM ET
For at least eight years, a Philadelphia heart specialist and his colleagues have been smuggling used cardiac devices in suitcases to India to help poor people who might die without them.
Now, Dr. Behzad B. Pavri, a cardiac electrophysiologist at Thomas Jefferson University Hospital, reports that recycled implantable cardioverter-defibrillators or ICDs -- devices that jolt a failing heart back into rhythm -- can be collected safely from U.S. patients and funeral homes, transported, sterilized and re-implanted in people who otherwise would not be able to afford them.
“The patients who are getting these devices are the sickest of the sick, the poorest of the poor,” Pavri said.
In a review of 81 patients who received recycled ICDs between 2004 and 2011, Pavri and his colleagues found no evidence of infection or malfunction of the ICDs. Nine of the patients died during follow-up, but the deaths didn’t appear related to the ICDs, the authors said.
Though there’s been growing evidence that heart pacemakers may be safely reused, this is one of the first published reports to suggest that the more sophisticated ICD device may also be recycled, Pavri said.
“The outcomes were what we expected and hoped for,” Pavri said of the study published in the latest issue of the Annals of Internal Medicine.
But the study also renews ongoing questions about the legality -- and ethics -- of reusing cardiac devices, a practice that is prohibited by federal regulators and device manufacturers in the U.S.
In an accompanying editorial, Harvard Medical School experts Dr. Paul Farmer and Dr. Gene Bukhman caution that such well-meaning efforts should be careful not to offer inferior treatment to the poor.
“Flagship projects must remain free of the taint of the secondhand, in part by making it clear when devices can safely be reused,” wrote those authors. Farmer is a renowned expert in global health disparities and one of the co-founders of Partners in Health, the international health and social justice organization.
The patients in Pavri’s study, conducted in cooperation with Holy Family Hospital in Mumbai, included 66 men and 15 women. They ranged in age from 27 to 79 and were all at highest risk for life-threatening irregular heart rhythms that could be treated with ICDs.
All told, the patients received 106 reused devices, including 22 who got a second device and three who received a third ICD during the course of the trial.
More than 40 percent of the patients got life-saving shocks from the ICDs, including one 27-year-old patient, Mohd Asif, who received more than 300 pacing charges or larger jolts during so-called ventricular tachycardia or ventricular fibrillation “storms,” in which the heart runs wildly out of rhythm.
He is “still very much alive,” said Dr. Yash Lokhandwala, a cardiologist at the Mumbai hospital who treated Asif and others.
The patients who got the ICDs were those who otherwise could not pay for them. In India, a new ICD might cost 3 lakhs, the equivalent of $6,000 U.S., far beyond the reach of ordinary Mumbai residents who earn about 1.41 lakhs a year. Those who can pay foot the bill themselves, but those who can’t are treated with other, often inferior methods, including drug therapies.
Cost is the chief barrier preventing use of cardiac devices such as ICDs and pacemakers in developing nations, Pavri said. Rates of new ICD implantation are about 1 per million in many Asian and South American nations, compared with 434 per million new ICD implantations per year in the U.S., according to the World Society of Arrhythmia.
At the same time, ICDs are removed every day from patients in the U.S. who get new devices or who die each year, Pavri said. Modern ICDs have a projected battery life of six to 10 years, and many used ICDs have three years or more of remaining charge when they’re explanted.
Funeral directors frequently remove ICDs from bodies to prevent explosions during cremation. Perhaps one-fifth to one-third of devices discarded by funeral homes may have sufficient battery life to save someone else.
“We don’t know exactly how many but it’s clearly in the thousands,” said Pavri.
For his study, Pavri and his colleagues collected the devices one by one over several years from consenting patients or from funeral homes. Shipping them by traditional methods was difficult because of the explanation involved, so the doctors packed them into checked luggage and transported them themselves.
Reusing ICDs is prohibited in the U.S. by the federal Food and Drug Administration, which classifies them as single-use devices. However, the FDA has no jurisdiction over the devices if they’re treated and implanted elsewhere and Lokhandwala said the Cardiological Society of India has authorized the practice.
The ICDs were collected, cleaned and sterilized during a multi-step process and then re-implanted into the new patients.
Researchers were able to follow up on 75 of the 81 patients; those who survived appeared to be doing well, Pavri said.
This study offers important new information about the apparent safety of reusing ICDs, but it also highlights obstacles, said Dr. Thomas Crawford, a cardiologist at the University of Michigan Health System in Ann Arbor who was not involved in the research.
Crawford is part of Project My Heart-Your Heart, a program that is collecting used pacemakers for future donation in developing countries. So far, they've amassed some 10,000 devices. However, researchers involved with that program have petitioned the FDA for permission to conduct a clinical trial to confirm the safety and efficacy of the reused devices in living people.
As it stands now, projects like Pavri’s aren’t officially sanctioned.
“It’s a very uncharted territory,” Crawford said. “It’s not exactly legal.”
Pavri acknowledged as much in the study, saying “any complications associated with such off-label use could be grounds for legal action.”
But, he added, such off-label research is necessary to bolster arguments that regulators and manufacturers should allow reuse of these devices on humanitarian grounds.
“It is worse practice, in my opinion, to not offer a patient anything,” Pavri said.
“A secondhand device is better than no device at all.”