Recycled pacemakers safe and effective
Many heart patients in India are too poor to afford pacemakers. However, a study 1 has found that removing pacemakers from deceased Americans, resterilizing the devices, and implanting them in Indian patients "is very safe and effective."
Gaurav Kulkarni, PhD, of Loyola University Medical Center, is a co-author of the study, published in the American Journal of Cardiology. Kulkarni helped conduct the research before coming to Loyola while he was a medical student in India.
Fifty-three poor patients in Mumbai received pacemakers that had been donated by the families of deceased Americans. Following operations to reimplant the devices, all Indian patients were alive and doing well, researchers reported.
The Indian patients had severe heart rhythm disorders called complete heart block and sick sinus syndrome. Typically, the slightest physical exertion would leave them gasping for breath and exhausted. Without pacemakers, they likely would have died within weeks or months. But in India, a pacemaker costs $2,200 to $6,600, which is well beyond the means of many patients.
The pacemaker donations began as a philanthropic project. Physicians later decided to make a formal study of the safety and effectiveness of the donated devices. At every step of the study, patients gave informed consent. After receiving the reused pacemakers, they were followed for an average of nearly two years. There were no infections or other significant complications and no device failures. All but two patients reported marked improvement in their symptoms.
Of four patients who were previously employed, all were able to return to their manual jobs. Twenty-seven women said their symptoms had improved enough so they could resume household chores. "Implantation of donated permanent pacemakers can not only save lives, but also improve quality of life of needy poor patients," researchers wrote.
Kulkarni added: "Without pacemakers, these patients would pretty much be forced to remain on confined rest, due to cardiac fatigue."
The Food and Drug Administration (FDA) prohibits reusing pacemakers in the United States. However, there is no prohibition against donating and reusing pacemakers in other countries.
The authors conclude that reusing pacemakers could "alleviate the burden of symptomatic bradyarrhythmia (abnormally slow heart rate) in impoverished nations around the world."
- Bharat K, Patel S, Kulkarni G. Reuse of explanted permanent pacemakers donated by funeral homes. Amer J Cardiology 2011; published online Oct. 14, 2011. http://www.ajconline.org/article/S0002-9149(11)02752-4/abstract.