Abstract
Many heart patients in India are too poor to afford pacemakers. But a study has found that removing pacemakers from deceased Americans, resterilizing the devices and implanting them in Indian patients “is very safe and effective.” A press release from Loyola University Medical Center can be found here.
Background
Dr. Gaurav Kulkarni of Loyola University Medical Center, Illinois is a co-author of this study, published online ahead of print in the American Journal of Cardiology. Kulkarni helped conduct the research before coming to Loyola while he was a medical student in India.
In India a pacemaker costs $2,200 to $6,600, which is well beyond the means of many patients. Consequently pacemaker donation had begun as a philanthropic exercise. Physicians then decided to undertake a formal study of the safety and effectiveness of the donated devices, an important step if the practice was to become more widespread as both safety and control would need to be established.
The Study
Fifty-three “poor” patients in Mumbai received pacemakers that had been donated by the families of deceased Americans.
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.
Between January 2004 and January 2010, 121 pacemakers were removed and donated. (Devices were manufactured by Medtronic, St. Jude Medical and Boston Scientific.) Sixty pacemakers were selected because they had a battery life greater than three years, but seven were discarded due to further decay in battery life. The remaining 53 pacemakers were rigorously cleaned and sterilized. They were sent to Holy Family Hospital in Mumbai, which serves all patients, regardless of income.
At every step of the study, patients gave informed consent and after receiving the reused pacemakers, they were followed for an average of nearly two years.
Results
Following operations to reimplant the devices, all Indian patients were reportedly alive and doing well. 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.
Investigator comments
“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 authors conclude that reusing pacemakers could “alleviate the burden of symptomatic bradyarrhythmia (abnormally slow heart rate) in impoverished nations around the world.”
Regulatory Status
The Food and Drug Administration prohibits reusing pacemakers in the United States. But there is no prohibition against donating and reusing pacemakers in other countries.
Medlatest comments
It certainly appears that this work could provide adequate reassurance that charitable efforts to recycle pacemakers could be worthwhile and effective. There would no doubt need to be significant control exerted over the exercise however in order to ensure that donor pacemakers were “quality checked” as thoroughly as they were in this study. We’ve all heard of charitable donations of spectacles, where the risk of malfunction is somewhat lower, but given the right safeguards we remain very encouraged that this work could change people’s lives and even provide comfort for donor families.
Source: Loyola University Health System
published: December 7, 2011 in: Cardio, Clinical Studies/Trials, Regulatory, USA