01:13pm Friday 24 November 2017

Pacemaker reuse cost-saving, effective option in poor countries: U-M study

ANN ARBOR, Mich. — Pacemaker reuse may be a safe, effective and ethical alternative to providing medical devices to people in Third World countries who couldn’t otherwise afford therapy, according to a study by the University of Michigan Cardiovascular Center.

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Researchers examined pacemaker reuse compared with new device implantation in four studies that included 603 people. They assessed complication rates, risk of infection, physiological complications and device malfunction.

Compared to new pacemaker implantation, reutilization of previously implanted devices was not associated with a significant increase in overall complications, according to study co-authors Kim A. Eagle, M.D., director of the U-M Cardiovascular Center and Timir S. Baman, M.D., U-M cardiology fellow.

The findings will be presented during the American Heart Association’s 11th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke in Washington, D.C. But large prospective clinical trials are necessary to truly understand the safety and efficacy of pacemaker reuse, authors say.

Experts at the University of Michigan Cardiovascular Center see an opportunity to collect pacemakers, after they are removed for burial or cremation, for sterilization and reuse across the globe. It’s a novel approach for treating cardiovascular disease, the world’s leading cause of death.

Pacemakers and other implantable cardiac devices are implanted to regulate an irregular or slow heartbeat, or act as an insurance policy by automatically shocking the heart back to a normal rhythm. They are usually implanted after a heart attack or if medications are unsuccessful, and they last 10-15 years.

But poor nations have not been able to afford the electrophysiology technology that has reduced cardiac deaths in industrialized nations, while unhealthy lifestyle, as well as infectious diseases, contribute to escalating rates of heart disease worldwide.

Each year 1 million to 2 million people worldwide die due to lack of access of pacemakers. Meanwhile 90 percent of those with pacemakers would donate their device to others in need if given the chance.

Growing evidence and support laid the groundwork for Project My Heart –Your Heart, a collaborative between citizens, physicians and funeral directors of Michigan, the U-M Cardiovascular Center and World Medical Relief, Inc., a Detroit-based non-profit organization that specializes in the delivery of used medical equipment.

Project My Heart – Your Heart hopes to establish a clinical trial with implantation centers in the Philippines and Vietnam to study device implantation in those who have no access to electrophysiological health care.

Through small humanitarian efforts, new and used pacemakers have been sent to underserved nations. In 2008, 50 pacemakers were donated by funeral homes to WMR. Of them, 12 with adequate battery life were implanted without complications in patients at University of Philippines–Philippine General Hospital in Manila.

Information about donating pacemakers to the U-M is available online at www.myheartyourheart.org. However, no devices will be shipped overseas, nor implanted into living persons until the FDA has approved a planned clinical trial.

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Additional authors: Joshua Romero, Pascal Meier, M.D., Lindsey Gakenheimer, James N. Kirkpatrick, M.D., Patricia Sovitch, R.N., and Hakan Oral, M.D., Director of the Cardiac Electrophysiology Service, all of the University of Michigan Health System.

Resources
Project My Heart – Your Heart
www.myheartyourheart.org

University of Michigan Cardiovascular Center
http://www.med.umich.edu/cvc/

American Heart Association QCOR 2010
http://www.americanheart.org/presenter.jhtml?identifier=3057695


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