NEW YORK - Recycled pacemakers donated from U.S. funeral homes could offer a safe way to get the heart devices to poor people in the developing world, a small study suggests.
It's been estimated that between 1 million and 2 million people worldwide die each year because they have no access to a pacemaker — an implanted device that uses electrical pulses to the heart to maintain a normal heartbeat.
Pacemakers are used to treat certain long-term arrhythmias, disturbances in the heart's rate and rhythm. Arrhythmias can trigger symptoms like fatigue, breathlessness and fainting — or, if severe, prove fatal.
In India, where the used pacemakers ended up, the devices cost $2,200 to $6,600. That's more than many poor and middle-class Indians make in a year. And it doesn't even include doctor and hospital fees, or the cost of the wires connected to the pacemaker.
One potential, untapped source of pacemakers for the world's poor could be the significant number of Americans who die each year with a still-functioning implant.
A survey of Michigan and Illinois morticians, for example, found that 19 percent of the deceased had a pacemaker or other heart device. But the large majority of those devices are buried with the body. And if they are removed, they are usually thrown away as medical waste.
A small percentage, however, have been donated to developing nations as part of small-scale efforts by some charitable groups.
In the new study, U.S. researchers followed 53 heart patients in India who had received pacemakers donated from U.S. funeral homes.
They found that all of the patients survived the surgery and fared well immediately afterward. And there were no cases of infection or pacemaker malfunctions over an average follow-up of nearly two years.
A few patients did die over the study period, but none of the deaths was related to the pacemaker itself, the researchers report in the American Journal of Cardiology.
The new results bolster earlier data showing no increase in infections, malfunctioning or overall complications in hundreds of patients with reused pacemakers.
Recycled pacemakers "appear safe, provided you take precautions and follow the proper protocol," said lead researcher Dr. Bharat K. Kantharia, of the University of Texas Health Science Center in Houston.
The pacemakers in this study were collected over six years from U.S. funeral homes, with permission from the families of the deceased.
Of 122 pacemakers Kantharia's team collected, half had enough battery life left (more than 3 years) to be used again. They were partially sterilized, then sent to Holy Family Hospital in Mumbai, India. There, the devices underwent final sterilization and were implanted in 53 heart patients.
A quarter of the patients lived in remote areas, and could not be followed up after successfully having the pacemaker implanted -- a limitation of implanting the devices in poor people in the developing world, according to Kantharia.
"But the ones who were followed up were doing well," he said. Of those 40 patients, all but two reported "marked improvement" in their symptoms and quality of life, according to the researchers.
And while four died over the study period, their deaths were not linked to the pacemakers.
"All we are saying is, there are people who need a pacemaker and would not otherwise get one," Kantharia said. "And maybe this will help them live a normal life."
But there are still significant barriers to getting recycled pacemakers to the world's poor on any large scale.
One is that the safety needs further study. "This study is suggestive that it's safe," said Dr. Thomas Crawford, an assistant professor of cardiovascular medicine at the University of Michigan in Ann Arbor.
"But definitive data are not available yet," said Crawford, who was not involved in the study.
Crawford and his colleagues in Michigan are working on getting pacemakers to the developing world on a wider scale. In a study dubbed Project My Heart - Your Heart, the researchers have collected more than 4,000 pacemakers from funeral homes in the past three years.
The goal is to have a supply of pacemakers that have been inspected and sterilized under a "strict protocol," and can then be sent to medical centers in the developing world that have the expertise to do the implantation. Those patients can then be followed to better pin down the safety and effectiveness of reused pacemakers.
But first, there are legal questions. In the U.S., the Food and Drug Administration has approved pacemakers only for one-time use, meaning they cannot be recycled for U.S. patients. Pacemakers that are collected in the U.S. but sterilized overseas may not, however, fall under the FDA's jurisdiction.
The Michigan researchers are currently trying to get the FDA's OK to study their recycled pacemakers overseas as "investigational" devices.
"We want to try to prove that this is safe and efficacious," Crawford said.
Both Crawford and Kantharia said there are logistical issues as well, including getting pacemakers from the U.S. to those impoverished patients who need them.
And what happens when the battery dies is still an open question.
The Michigan researchers are working with a Detroit-based charity called World Medical Relief, which specializes in delivering used medical equipment to underdeveloped countries.