Soaring Pacemaker Demand Spurs Controversial New Approach

CHICAGO — When a female patient received a pacemaker at the Frankel Cardiovascular Center at the University of Michigan, Ann Arbor, Michigan, and died shortly after with the brand-new and fully functioning device still in her chest, her grieving husband wondered whether the expensive and barely used technology could be donated to help someone else.

But that’s not an option in the United States — or in any other country — not officially, at least. “Pacemakers are approved as single-use devices; it’s illegal to reimplant them,” said Thomas Crawford, MD, clinical professor of cardiac electrophysiology at the University of Michigan.

But that doesn’t mean it never happens.

The question inspired Timir Baman, MD, a fellow at the Frankel Cardiovascular Center at the time, and Kim Eagle, MD, the center’s director, to look into the idea, and they found that doctors in resource-poor countries, including India and the Philippines, have been quietly sterilizing and reusing pacemakers for decades.

A significant body of literature — mostly case series reports — has built up over the years showing that the practice is generally safe. And a meta-analysis by Baman found that the risk for infection was no different between new and used pacemakers, but the risk for malfunction was six times higher in the repurposed devices.

So, the Michigan team joined with the Detroit-based charity World Medical Relief and NEScientific in Connecticut to develop a process for sterilizing and reconditioning used pacemakers and create Project My Heart Your Heart to help facilitate the acquisition and delivery of used pacemakers to impoverished people around the world. It includes a randomized clinical trial led by Crawford to compare outcomes for both new and used pacemakers.

Growing Need

The burden of cardiovascular disease is high in lower-income countries, and many lack the resources to properly treat it. Around 80% of the estimated 20 million cardiovascular deaths worldwide occur in low- and middle-income countries, and as many as 1 million of them are due to a life-threatening slow heart rhythm and the lack of resources to get a pacemaker or an implantable defibrillator.

“In some high-income countries, as many as 1000 people per million population may receive a pacemaker annually. In low-income countries, it could be 3 per million population or fewer,” said Crawford.

Emmanuel Edafe, MD, a cardiologist in Port Harcourt, Nigeria, who is taking part in the new clinical trial, said the burden of heart disease is much higher in his country than in the developed world — almost 80% of his patients have complete heart block, compared with around 50% in western countries. But most of his patients who would benefit from a pacemaker cannot afford one, even though the devices offered in poorer countries are generally cheaper, lower-end models.

“In our healthcare system you often have to pay out of pocket. There is no insurance coverage for cardiac devices or surgery,” he said. “My patients usually come from villages or small cities and don’t have the funds.”

In Mexico, Jorge Bahena, MD, a cardiologist in Monterrey, said around 30% of the population either can’t afford the roughly $6000 required for the device and procedure or do not have insurance that will cover it. “I was surprised when I started as a professor at a university hospital that patients who needed a pacemaker, but could not afford it, were just released,” he said.

There are a couple of potential solutions for the lack of access to affordable pacemakers in lower-income countries. Bahena has been working with a charity called ForHearts that donates pacemakers for use in poorer countries — mostly new devices that have passed their sell-by date in the United States but still have more than 90% battery life remaining.

Donated New Devices

While Bahena has been implanting these donated pacemakers for more than 30 years, the supply is declining. “There used to be six pacemaker banks in Mexico, but now there are only three remaining,” he said. “Support is falling because of the economics.”

Researchers or companies could design and produce a basic low-cost device, though there has been little progress on this front. So creating a system for refurbishing and reusing pacemakers seems like the best option to help as many people as quickly as possible, said Crawford.

The earlier examples of informal pacemaker reuse the Project My Heart Your Heart team found did not take a standard approach to sterilizing or evaluating the devices, said Crawford. “There was no sophisticated electrical testing; they were cleaning devices in the sink in the hospital and putting them in ethylene oxide baths,” he said.

Crawford and his colleagues knew reprocessing devices in their own hospital, even for use outside the United States, would be legally dicey. So, they developed a stringent testing and sterilization protocol and approval from the governments of the destination countries to obtain export permits from the US Food and Drug Administration.

The refurbishment process is overseen by Eric Puroll, project manager for Project My Heart Your Heart. “It’s an extremely robust process, and we catalogue every step of the way, and we’re happy to share with any other centers to help as many people as we can,” he said.

Project My Heart Your Heart

Implant Recycling collects donated pacemakers from funeral homes and crematoriums across the country and sends them to World Medical Relief, which houses the Project My Heart Your Heart lab. There, a team of volunteers sorts the devices by type and manufacturer and tests how much battery life is remaining. Those with at least 4 years left are wiped of any previous owner’s health information, turned off, and shipped to NEScientific, a medical device reprocessor in Connecticut.

There they are cleaned and decontaminated with an enzymatic solution before being returned to Michigan for electrical testing with an oscilloscope and heart simulator to make sure the device is behaving as predicted. Once those tests are passed, the pacemaker is sent back to NEScientific one more time for a final sterilization and then is ready to be sent to its new recipient overseas.

Project My Heart Your Heart receives about 1000 eligible devices each year and processes them as needed. This year about 300 devices have been refurbished for use in other countries. In some cases, the battery life remaining in the high-end refurbished devices is longer than that of a brand new lower-end device.

Because the Project My Heart Your Heart devices are donated and much of the work is done by volunteers, it is not clear exactly how much cheaper a refurbished device will be, said Crawford. However, he estimates it would be around $50-$100, excluding the cost of new electrical leads, which cannot be reused. In contrast, a new low-end pacemaker costs around $2000 in low- and middle-income countries, and a new high-end device runs about $6500 in the United States.

Trial, No Error

The first reconditioned pacemaker in the My Heart Your Heart trial was implanted in a patient in Kenya in 2018. Since then, about 300 patients in seven countries in Africa and Latin America have received either a new or reconditioned device as part of the trial. And the results so far have been promising.

The preliminary results were presented at the American Heart Association (AHA) Scientific Sessions 2024 in November, covering the first 90 days after implantation. Just under 3% of patients who received a new pacemaker developed an infection, as did just 1.5% of patients who received a refurbished device; that difference was not statistically significant. There were no malfunctions with any of the pacemakers, new or used.

“We’re confident that while the refurbished devices may not be quite as good as new, they are pretty damn close,” said Crawford.

Longer-term results have not yet been released, and they will be needed to confirm the safety and efficacy of the recycled devices. But so far Edafe said he has seen no difference between the dozens of new and reconditioned devices he has implanted since he joined the trial in 2021.

Coming up with a way to safely recondition the pacemakers — and launching a trial to test the idea — was just one part of the process, said Crawford. The team also had to get ethical and regulatory approval from the destination countries and hospitals.

“Most of the effort went into not just developing the standards but finding government that would say, yes, you can bring these devices into our country for a study,” he said.

That wasn’t always easy. In many places doctors had already been bending the rules to give patients access to recycled pacemakers. “In virtually every country where we engaged, there was an under-the-surface movement to reprocess or reimplant devices,” he said. In Nigeria, for example, Edafe said he had never implanted a reconditioned device before but had replaced the leads on already implanted devices.

But not everyone was willing to take the risk of making the practice official. In South Africa, reconditioning devices for the indigent population is common, and results have been published in medical journals. But the doctors there declined to participate in the trial because they didn’t want to draw more attention from the government in case the answer was no.

There is also the question of whether a country has the capacity to perform the procedure. When a pacemaker was implanted in a patient in Sierra Leone as part of the My Heart Your Heart trial, it was the first time the procedure had been performed in that country, said Crawford.

“It’s not just access to pacemakers; it’s also do you have the physicians who can do it, do you have the right equipment in the OR, do you have the diagnostic tools?” he said. “We’re addressing the slice of needing the device and mostly working with countries where there is enough expertise gained from the paying customers so that the patients who don’t have the money can access it for free.”

Saving Lives

Should the longer-term results bear out the initial good news, Crawford says he hopes the trial will help to make the practice more common and save lives that might otherwise be lost to an easily treatable condition.

“It will take more than one randomized trial, but we are hoping to alter the trajectory so that this will become part of acceptable practice in the countries that have the need for it,” he said. “It’s the only way to make a significant change in the delivery of these devices.”

Crawford says he has no ethical qualms about providing recycled devices to poorer people overseas. “We’re providing something that would otherwise not be available, and the need is so enormous,” he said. “When we donate a pacemaker to someone, it allows them to return to work and take care of their family.”

Both Edafe and Bahena said that the patients taking part in the trial understand that they may receive a refurbished pacemaker, but most are willing, and even happy, to get one when the alternative is nothing at all. Edafe said when he discusses it with his patients, he likens a refurbished pacemaker to a kidney transplant — somebody else had used that kidney before, but it still has a lot of life left in it.

Edafe says he hopes that the positive results from the trial will encourage others to support and expand the project so that more disadvantaged people can benefit from a treatment that is considered commonplace in richer countries.

“There is a lot of inequality in the world,” he said. “If there is something that can be done to save these people, I think it is something that everybody should support so that you don’t leave somebody to die because they cannot afford a new device.”