After death, a new life for refurbished pacemakers in low-, middle-income countries
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Key takeaways:
- A University of Michigan program recycles pacemakers after death for reimplantation in low- and middle-income countries.
- The program provides pacemakers to people in need who would not otherwise receive one.
Most patients who receive a pacemaker are likely not thinking about its potential usefulness after their death; however, a viable, properly reconditioned device could help meet an overwhelming need outside of the United States.
Lack of access to pacemakers is a major challenge to the provision of CV health care in low- and middle-income countries; however, postmortem pacemaker utilization could offer an opportunity to deliver this needed care, according to Thomas Crawford, MD, an electrophysiologist and associate professor of internal medicine at University of Michigan Health and the medical director of My Heart Your Heart, a cardiac pacemaker reuse initiative at the University of Michigan Cardiovascular Center. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device, Crawford said.
Healio spoke with Crawford about the urgent need for pacemakers in under-resourced countries, how postmortem pacemaker utilization works and a clinical trial underway that may help formalize the process. Crawford is overseeing a team that is evaluating the concept of pacemaker reuse, its safety and efficacy and ethical and regulatory issues involved.
Healio: Can you describe the need for pacemakers across low- and middle-income countries?
Crawford: The need is great. Each year, somewhere between 1 million and 2 million people worldwide die due to a lack of access to pacemakers and defibrillators. There is literature reflecting this. When you query pacemaker implantation data for the United States, it is roughly 800 pacemakers per 1 million population. When you query countries like, for example, Nigeria, it says four pacemakers per million. Quite a difference.
Per capita gross domestic product is such that, in many countries, a pacemaker costs more than a person’s annual income. Outside of needing the pacemaker, you need testing to diagnose that a person needs it. You need a provider that knows how to implant pacemakers; you need an OR with a fluoroscopy machine. There are very few cardiologists practicing in some of these low- and middle-income countries. In some, there is not even a training program in cardiology. In the United States, if someone needs a pacemaker, they get it, regardless of their financial status. In the countries where I have traveled, there is no universal health insurance, but no private health insurance either. People pay out of pocket. People have to pay for health care before they get it. When I traveled to Sierra Leone to implant the first pacemakers in that country in 2018, one of the poorest countries in Africa, I spoke with the one cardiologist working in the country at the time. He did not have health insurance. Anyone in need of a pacemaker had to purchase it.
Slow heart rate is very treatable. You put the device in and it gives you the result you want.
Healio: What is the story behind the concept of refurbishing a pacemaker?
Crawford: We did not invent this concept. There is literature as far back as the 1970s from what were then low- and middle-income countries that demonstrated that refurbishing a pacemaker was possible.
The inception of the program here in Michigan was prompted by a man whose wife received a pacemaker before dying. She lived with that pacemaker for a few months. After she died, he brought the pacemaker to one of our trainees in the cardiovascular center. He said, “I hope you can reuse this; she only used it for 2 months and I was told this device could last for 12 years.” This is how it started: this man talking with one of our trainees, Timir Baman, MD.
We started by sending surveys to local funeral homes and crematories to find out what these businesses did with these devices. Turns out, only 4% reported returning these devices back to the manufacturer, which is technically what you are supposed to do. Through a company called Implant Recycling, we tapped into the broader funeral industry. The incidence of cremation is increasing — about 60% of people choose to be cremated. What many people do not realize is that the iodine battery inside the pacemaker, when exposed to the high 1,000°F heat during a cremation, could explode and damage the equipment. It must be removed prior to cremation.
Crematories and funeral homes always ask the family if the decedent has a device. If they do, they remove it by design. It is part of the consent process with cremation. This implant recycling company makes a business out of this, so some of the devices we receive come through that source. Many come directly to us, as people begin to hear about us and what we are doing. People say, “My mother just died and she was big on recycling.” There is a healing dimension to this. A death can become a way to help someone else.
We accept pacemakers from individuals, funeral homes, crematories. Sometimes when people need to get an upgraded device — a pacemaker to a defibrillator, for example — we receive them from hospitals. Our yield from funeral homes and crematories is about 20%, meaning about 20% of devices we receive have at least 4 years of battery life remaining.
Healio: What are the regulations around using a refurbished pacemaker?
Crawford: Pacemaker reuse is illegal in all jurisdictions. The FDA states that pacemaker reuse is an “objectionable practice.” We know we can do it, but we need to develop partnerships with other entities to give us credibility. One of those methods to do this is by engaging the government. FDA issues export permits for this type of activity. We created a protocol where we reprocess the device, working with Northeast Scientific, which provides the pacemaker cleaning and sterilization. We have received permission from the FDA to export them. We have to put a sticker on them saying “not for use in the United States.” We are doing this in countries in which governments will allow it. One of the limitations is needing a government letter from each of the recipient countries. We have about 12 countries now, and the collection of countries we are working with is purely accidental. It is not a normal methodological process. A lot of it is through contact with individuals and opportunities that arise.
Healio: You are leading a randomized controlled trial called Project My Heart Your Heart: Pacemaker Reuse. What is the study design, and what do you and your colleagues hope to learn?
Crawford: The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in low- and middle-income countries without resources. The target enrollment is 270 patients, all from outside the United States, who each have a class I indication for pacing and who attest that they do not have the ability to purchase a device on their own. They must consent to be randomly assigned to receive either a brand-new pacemaker, which we purchase, or a reprocessed pacemaker, for which we provide the leads and accessories. Donated devices are inspected according to specific protocols that evaluate physical and electrical suitability, including battery longevity, for future use. Devices deemed to be acceptable are shipped to a third-party vendor, Northeast Scientific, for disassembly, cleaning and re-sterilization. There will be about 130 participants in each arm. We will follow those patients and report any adverse events. The countries that have contributed patients include Kenya, Nigeria, Paraguay, Sierra Leone and Venezuela. We hope to soon begin enrolling patients in Mexico and Mozambique.
I have had clinicians outside the U.S. who tell me they removed a pacemaker device, cleaned it, reprocessed it and then implanted it in someone else — but the government does not know about it. This practice does happen and it is not regulated in any way; patients and physicians know about it and keep it quiet. The difference with what we are doing and these other efforts is we bring it to a much higher level, because that is what the FDA requires. All of this costs money. We are so grateful for the donations from people who support this program.
Healio: What are your hopes for the My Heart Your Heart program going forward?
Crawford: Because of working with FDA, we were told we could only focus on pacemakers, which are lower-complexity devices. Defibrillators are threefold or fourfold more expensive than pacemakers. In addition to delivering small impulses of electricity at appropriate rates, defibrillators can generate a voltage gradient of 800 V and shock the heart into normal rhythm. We are just starting to engage FDA to see how to expand this program to include devices that are even more out of reach, which are the defibrillators. We look forward to doing that in the next 2 years.
References:
- Donate a Pacemaker. https://www.myheartyourheart.org/donate-pacemaker.html. Accessed Feb. 22, 2024.
- Project My Heart Your Heart. https://www.myheartyourheart.org/. Accessed Feb. 22, 2024.
For more information:
Thomas Crawford, MD, can be reached at thomcraw@med.umich.edu.
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