Tackling Heart Trouble in the Developing World
A new pilot study suggests that pacemakers can be safely reused
Valerie Ross • February 14, 2010
About a million people in the developing world die each year from a slow heart rate, a condition that in wealthy countries is often treated by a common procedure: pacemaker implantation. But pacemakers cost anywhere from $10,000 to $50,000 — much more than most people in poor countries earn in a year, or even a lifetime.
Meanwhile, when patients with pacemakers in the United States and other rich nations die, their still-functioning devices are removed and sit unused, mostly in funeral homes.
Funeral directors “have buckets of them, literally, just sitting in their offices,” said Dr. Timir Baman, a cardiologist at the University of Michigan Cardiovascular Center.
Baman and Dr. Kim Eagle, the center’s director, wondered whether pacemakers donated by deceased patients could be sterilized and reimplanted, potentially saving many lives in poorer countries.
Along with colleagues in Michigan and the Philippines, they conducted a small pilot study, implanting donated pacemakers in 12 patients at Philippine General Hospital in Manila. All 12 patients survived, without any complications from the devices. These preliminary results were so promising that the researchers are now working with the U.S. Food and Drug Administration to launch a much larger overseas trial.
The study, published in October in the Journal of the American College of Cardiology, “is simply a small feasibility study to show that we could do it,” said Eagle. “But we’re very excited. I think [pacemaker reuse] is possible, and I think it’s right.”
The cost of a pacemaker is usually covered by Medicare, Medicaid or private insurance in the U.S., says Baman. But in the developing world, not only is insurance coverage rare, the proportional cost of a pacemaker is much higher. Per capita income in the Philippines, for instance, was only $1,890 in 2008, according to World Bank estimates. That’s less than one-fifth the cost of even a low-end pacemaker.
“I did some work in Ghana,” Baman remembers, “and in one week I saw three patients who came in with heart rates in the thirties.” Arrhythmia is generally defined as a resting heart rate below 60 beats per minute. “There was no way that they could afford a device — and we simply sent them home.”
Pacemaker reuse is not a new idea. A number of pilot studies in Europe and Canada over the past 30 years have suggested that pacemaker reuse is safe and effective. Dr. Ulrika Birgersdotter-Green, head of the arrhythmia clinic at the University of California, San Diego, learned to reuse pacemakers as a medical student in Sweden twenty years ago. “It was done all the time, and there was never any question about it,” she said. But the practice petered out, Birgersdotter-Green said, due to liability issues.
Like any medical procedure, pacemaker implantation has risks. Even with a new pacemaker, there’s a small chance that the device won’t work or that the patient will get an infection. Some doctors worry these risks will be higher for reused pacemakers, because the devices will be more likely to fail or because they can’t be sterilized thoroughly enough. But so far, “there really aren’t any adverse consequences that have been found in reusing these devices,” said Dr. James Kirkpatrick, a medical ethicist at the University of Pennsylvania and one of the authors of the recent study.
There are ethical issues as well, Kirkpatrick said. “The biggest [ethical question] is … are we potentially doing more harm then good,” a question with any new medical procedure, he said. One way to ensure that patients are being helped is to closely track the patients’ health and how well the pacemakers are working.
Another ethical issue is informed consent, making it clear to patients what getting a donated pacemaker means. Patients must be made aware of the possible risks. “We have to make sure people understand they’re receiving a used device,” Kirkpatrick said. “We have to make sure they follow up and know the possible downsides.”
In the U.S., pacemaker reuse is only possible with explicit, case-by-case permission from the Food and Drug Administration. Any group wanting to reuse pacemakers will have to thoroughly sterilize the devices, show that they have adequate battery life, and measure the devices’ longevity. “FDA staff have discussed these issues with the sponsors of the University of Michigan study and will continue to provide assistance as they move through their work,” said Mary Long, a spokeswoman for the FDA, via e-mail.
To some, it may seem questionable to advocate pacemaker reuse abroad when it’s not done at home. But cardiologists generally agree that, as Birgersdotter-Green put it, “patients who need a pacemaker in the U.S. will get a pacemaker,” even if devices are not reused. In poorer countries, donated devices are often all that’s available or affordable, which means arrhythmia patients and their doctors may face a stark choice: a used pacemaker or none at all.
In their pilot study, Baman and Eagle worked to address concerns about pacemaker reuse. The researchers collected 12 pacemakers from Detroit-area funeral homes, checked their battery life — only devices with at least 70 percent battery power were used — and sterilized the devices.
Halfway around the world at Philippine General Hospital, Dr. Eric Sison and Dr. Ragelio Tangco were happy to accept the donated pacemakers. Both doctors had considerable experience implanting pacemakers, and, Tangco said via e-mail, as “a large charity hospital, we need all the help we can get.”
When the pacemakers arrived, Sison and Tango surgically implanted them in 12 arrhythmia patients. The patients returned to the hospital for follow-up exams after one week and then again two months later. By their second follow-up, none of the dozen patients had suffered from infection or device malfunction.
The Michigan team also found popular support back at home for reusing pacemakers. Seventy-eight of the 90 Detroit-area funeral directors surveyed said they would be willing to donate pacemakers to those in need, as did 87 of 100 patients with pacemakers surveyed. The patients’ families, too, responded positively. Many said that knowing the pacemaker was benefitting another person would help them cope with losing their loved one.
As part of a larger trial coordinated with the FDA, Baman said the Michigan team is considering partnerships with hospitals in Vietnam and Nicaragua as well as the Philippines. He hopes the next study will include between 200 and 500 patients receiving donated pacemakers; they would then have regular follow-ups for two to five years after surgery.
Although the larger trial is still years from completion, many cardiologists in poor countries are already asking for donated pacemakers. “We’re getting emails from all over the world,” Eagle said. “I got an e-mail today from a physician in India saying, ‘If you get sterilized devices, we have patients dying here.’”
Dear sir, I compliment for the thought and study, good work ,very useful should be inplemented will help many. Reason I approach you is to bring to your notice the undermentioned, facts ,that the benefit of this , would be very little, and will make room for more hanky panky,It will amount for more money for business people .Reasons why I say so :- 1) NO MEDICAL DEVICES LAW RXIST IN INDIA.2) NO REGULATORY BODY 3) Some how these Pacemakers will be pulled out in indian wards and packed without sterilisation &sold as new. 4) STERILISATION SYSTEMS IN INDIA ARE VERY POOR AND AT PLACES THOUGH DONE , BUT CORRECT STERILISATION PROCEDURES ARE NOT PUT IN PRACTICE—— I AM THE CHAIRMAN OF A GROUP CONSTITUTED BY GOVT OF INDIA TO STUDY THE EXISTING LACUNAE IN STERILISATION OF MEDICAL PRODUCTS AND CONSUMABLES
5) I have over 3 decades of experience in clinical practice in top city hospitals of delhi and i only can tell you pl do not give its distribution to govt agency , pharmaceutical units.Please have your systems ,and please see that the legal consent is taken form the patient and rlatives for use of reusable devices 6) many other factors can be also brought to your notice if needed. The fact that you are in the process of setting the policy so I thought, Ishould put in these words forthe benefit of mankind. In case you want a copy of the report please be in touch I will send it to you for academic reasons .