Signed: Noah Fromson
Newswise — Recycled pacemakers may work just as well as new devices, a University of Michigan-led study suggests.
These used and reconditioned devices have the potential to increase access to pacemaker therapy in low- and middle-income countries, where many patients cannot afford treatment.
Researchers at the UM Health Frankel Cardiovascular Center reported their findings as an updated abstract at the 2024 American Heart Association Scientific Sessions.
The international clinical trial involved nearly 300 participants in seven countries in Africa, North America, and South America.
It compared the function and safety of the refurbished pacemaker with the new device, with patients randomly assigned to receive one or the other.
The researchers found no significant differences in pacemaker function up to 90 days after the procedure.
Only five patients developed local pocket infections at the site where the pacemaker was implanted, three of whom were initially fitted with the new device.
There were three deaths in the reconditioned pacemaker group, but none were related to the implantation procedure, device infection, or malfunction.
“These early positive results are a sign of large-scale pacemaker delivery that could save lives around the world,” said lead investigator Thomas C. Crawford, M.D., a cardiac electrophysiologist at the Frankel Heart and Vascular Center. and brings us closer to the reality of realignment.”
“Unlike in the United States, people in low- and middle-income countries often don’t have access to or afford pacemaker treatment. Our program is determined to change that.”
It is estimated that hundreds of thousands of people die worldwide due to lack of pacemakers in countries with limited resources.
Implantation of recycled pacemakers is not legal in the United States, but the Food and Drug Administration allows export of remanufactured devices.
The “My Heart Your Heart” program began sending refurbished pacemakers overseas in 2010 for compassionate use when there are no other options for treating life-threatening heart conditions.
Refurbished devices are donated by someone who has passed away or who needs to upgrade their pacemaker to a device with more advanced features.
The UM team screens and examines recycled pacemakers and only reconditions pacemakers with a battery life of four years or more.
The devices will be reprocessed at a joint laboratory with World Medical Relief in Southfield, Michigan, and resterilized free of charge by Northeast Scientific in Connecticut.
Many of the pacemakers are provided by Implant Recycling, LLC, a Michigan environmental and recycling company serving the crematorium and cemetery industry.
The program receives donations from funeral homes in all 50 states.
The idea has been conceptualized for more than a decade, and each step has been carefully studied, said co-author Kim A. Eagle, MD, program founder and director of the Frankel Heart and Vascular Center.
“We started with the beliefs and attitudes of patients, families, physicians, and funeral directors. Proper extraction, functional analysis, sterilization, packaging, and final implantation and follow-up processes are rigorously pursued. We have created a public roadmap showing how other centers and partners around the world can join in this most worthy cause.”
The Michigan-led team plans to continue tracking participants to determine the long-term safety and effectiveness of the recycled pacemakers.
The lifespan of a new pacemaker depends on how often the patient uses it, but it typically exceeds 10 years.
“It is imperative that we move forward with this research to determine how best to reduce gaps in access to lifesaving pacemaker therapy,” Crawford said.
“Three-month results are encouraging, but six- and 12-month results are very important to understand whether reprocessed pacemakers can function as well as new, except for battery life. It’s important.”
This research is supported by the Frankel Heart and Vascular Center, grateful patients and donors, and numerous foundations. Please inquire about pacemaker donation.
Additional authors: Eric Purol, Eva Kline-Rogers, NP, Patricia Bruenger, Chih-Wen Pai, Ph.D., MSPH, Constantina Alexandris-Souphis, RN, BSN, AJ Hale, MBA, Ed Goldman, JD, Hakan Oral; M.D., all from the University of Michigan. External authors: Azorena Aponte, Vicente Finizola, MD, Maria Milagro Arends, MD, Eusevio Arends, MD, Hector Monasterios, MD, Emmanuel Edafe, MD, Adrian Ebner, MD, Ceci Martinez, MD, Oluwaseye Oladimeji, MD, Mahmoud Sani, Constantine Akwanaro, MD, Jorge Bahena, MD, Edgar Carrizales, MD, Albertino Damaseno, MD, James Russell, MD, Joel Dunning, MD, George Samson, MD, Noah Krugman, MD, Lane Powell, Dr. Sheldon Davis, MS, Marion Davis, Craig Allmendinger, Brad Wasserman.
Funding/Disclosure: Funding was provided by donations. Both hospital and physician resources were provided without compensation.
