JACC: Refurbished pacemakers work just as well
Patients who received refurbished pacemakers donated from Detroit area funeral homes survived without complications from the devices, according to a study that appears online ahead of print in the Oct. 13 issue of the Journal of the American College of Cardiology.
The pacemakers were implanted in 12 patients at the University of Philippines-Philippine General Hospital in Manila, Philippines, who could not afford advanced cardiac care and were confined to their beds as they waited for a permanent pacemaker.
All donated pacemakers functioned normally at six months, and most importantly there were no device complications such as infections, according to the authors.
The argument for pacemaker reuse has been debated for decades. However, the researchers reported that the idea is gaining ground as promising results of providing donated pacemakers to underserved nations become available.
"In light of the widening healthcare disparity seen between the industrialized world and developing nations, we feel that pacemaker reuse is an ethical obligation to address the medical needs of those who could not afford therapy otherwise," said co-author Timir Baman, MD, cardiology fellow at the University of Michigan (U-M) Cardiovascular Center.
Based on surveys showing a majority of heart patients were interested in donating their pacemakers after death, U-M has launched Project My Heart Your Heart. The project is a joint collaboration between the U-M Cardiovascular Center, Michigan funeral homes and World Medical Relief (WMR), a Detroit-based non-profit organization focused on the delivery of used medical equipment.
"Many of these countries lack the financial resources to address this epidemic of cardiovascular disease," said co-author Hakan Oral, MD, director of electrophysiology at the U-M Cardiovascular Center. "As a result, resources are often directed away from high-cost treatment strategies, such as implantable cardiac rhythm management devices."
Pacemakers and other implantable cardiac devices are implanted to regulate an irregular or slow heart beat, usually last up to 10 years and cost $10,000 to $50,000.
The researchers included only pacemakers with 70 percent battery life in the study and informed consent was obtained from all patients' families in order to remove and donate the pacemakers after death. A total of 50 pacemakers were donated by funeral homes to WMR. Of them, 12 with adequate battery life were implanted in poor patients at Philippine General.
U-M is exploring partnerships with the Philippine General, Vietnam Heart Institute in Hanoi, Vietnam, and Komfo Medical Center in Ghana, which is in the process of developing an arrhythmia therapy program, for allocation of used pacemakers.
“Ongoing research is needed to evaluate the feasibility of regional and potentially nationwide pacemaker donation programs," said co-author Kim Eagle, MD, director of the U-M Cardiovascular Center.
In the next phase, U-M said will seek approval from the FDA to embark on a large scale clinical trial to show that pacemaker reuse is safe and effective.
The pacemakers were implanted in 12 patients at the University of Philippines-Philippine General Hospital in Manila, Philippines, who could not afford advanced cardiac care and were confined to their beds as they waited for a permanent pacemaker.
All donated pacemakers functioned normally at six months, and most importantly there were no device complications such as infections, according to the authors.
The argument for pacemaker reuse has been debated for decades. However, the researchers reported that the idea is gaining ground as promising results of providing donated pacemakers to underserved nations become available.
"In light of the widening healthcare disparity seen between the industrialized world and developing nations, we feel that pacemaker reuse is an ethical obligation to address the medical needs of those who could not afford therapy otherwise," said co-author Timir Baman, MD, cardiology fellow at the University of Michigan (U-M) Cardiovascular Center.
Based on surveys showing a majority of heart patients were interested in donating their pacemakers after death, U-M has launched Project My Heart Your Heart. The project is a joint collaboration between the U-M Cardiovascular Center, Michigan funeral homes and World Medical Relief (WMR), a Detroit-based non-profit organization focused on the delivery of used medical equipment.
"Many of these countries lack the financial resources to address this epidemic of cardiovascular disease," said co-author Hakan Oral, MD, director of electrophysiology at the U-M Cardiovascular Center. "As a result, resources are often directed away from high-cost treatment strategies, such as implantable cardiac rhythm management devices."
Pacemakers and other implantable cardiac devices are implanted to regulate an irregular or slow heart beat, usually last up to 10 years and cost $10,000 to $50,000.
The researchers included only pacemakers with 70 percent battery life in the study and informed consent was obtained from all patients' families in order to remove and donate the pacemakers after death. A total of 50 pacemakers were donated by funeral homes to WMR. Of them, 12 with adequate battery life were implanted in poor patients at Philippine General.
U-M is exploring partnerships with the Philippine General, Vietnam Heart Institute in Hanoi, Vietnam, and Komfo Medical Center in Ghana, which is in the process of developing an arrhythmia therapy program, for allocation of used pacemakers.
“Ongoing research is needed to evaluate the feasibility of regional and potentially nationwide pacemaker donation programs," said co-author Kim Eagle, MD, director of the U-M Cardiovascular Center.
In the next phase, U-M said will seek approval from the FDA to embark on a large scale clinical trial to show that pacemaker reuse is safe and effective.