A randomised trial comparing previously used and new pacemakers in patients with heart rhythm disorders has found reconditioned devices to be as safe and effective as their new counterparts, potentially offering affordable options for patients in low- and middle-income countries. This was the finding of a late-breaking study presented at the 2024 American Heart Association (AHA) Scientific Sessions (16–18 November, Chicago, USA).
While reusing pacemakers is prohibited in the USA, the US Food and Drug Administration (FDA) allows resterilised devices to be exported for reuse. In the present study, pacemakers were recovered from deceased patients and patients undergoing surgeries that required the removal of their existing devices. Pacemakers with at least six years of battery life and proper electrical function were sterilised for reuse.
The My Heart Your Heart (MHYH) study compared the function of refurbished pacemakers to new devices in a randomised trial of 298 adult patients across seven countries (Sierra Leone, Venezuela, Nigeria, Kenya, Paraguay, Mexico and Mozambique) from May 2022 to June 2024. These patients—all candidates for pacemakers who had no financial means to acquire a new device—were randomly assigned 1:1 to receive new pacemakers or reconditioned devices. Trial participants had a variety of heart rhythm disorders, including sick sinus syndrome.
“Access to pacemakers is limited in many low- and middle-income countries due to the relatively high cost of the devices,” explained lead study author Thomas Crawford (University of Michigan Medical School, Ann Arbor, USA). “In some high-income countries, as many as 1,000 people per million population may receive a pacemaker annually. In low-income countries, it could be three per million population or fewer who get pacemakers each year.”
Previous research has suggested that refurbished pacemakers can be safely implanted. However, as noted in an AHA press release, those studies were retrospective, reporting trends from previously collected information. In contrast, MHYH represents the first prospective, randomised study that included patient outcomes related to function and infection with reconditioned devices, with follow-up information collected up to 90 days after implantation.
“With reconditioned pacemakers, there is worry about whether the device will cause infection and whether it will function properly,” Crawford commented. “The 90-day endpoint of the My Heart Your Heart study addresses the most immediate concern of infection, because most of the infections related to the implantation procedure occur within that period.”
The trial assessed outcomes in patients evaluated in the hospital at two weeks after pacemakers were implanted, and for up to 90 days after this. A total of 280 patients completed at least one follow-up visit. Among participants receiving a new device, 48% were men and their average age was 70 years. Among those who received reconditioned pacemakers, 51% were men and their average age was 72 years.
Key findings from the researchers’ analysis include:
- Five cases of infection at the implant site (device pocket infections) required implant removal, three of which were among the patients who had received new devices compared to two patients in the group that had received reconditioned pacemakers
- A superficial skin infection responsive to antibiotics occurred in one patient with a new device; this device did not have to be removed, and the infection cleared
- Five patients with new pacemakers required surgery to move or replace the device’s leads after pacemaker implantation, compared to six patients with reconditioned devices
- No device malfunctions were reported among any patients
- Three deaths unrelated to the device implantation occurred in the reconditioned group versus zero in the new pacemaker group
The researchers concluded that reconditioned pacemakers were comparable to new pacemakers in terms of safety and effectiveness up to 90 days after implantation; however, they also believe that longer-term follow-up is necessary.
“Our study shows pacemaker recycling is green, good for the environment and can save the lives of people in other countries who can’t afford a new device,” Crawford said. “However, longer-term follow-up will be necessary to confirm the safety and efficacy of reconditioned devices, including whether they continue to work as expected and whether the batteries depreciate at the expected rate.”
The researchers add that a major limitation of the present study is its short follow-up period of up to 90 days. As alluded to by Crawford, longer follow-up may reveal problems with reconditioned devices that occur further down the line, such as premature battery depletion or late device malfunction. In addition, the study included a relatively small number of patients.
