Thursday, December 1, 2011

Reusing Pacemakers from Deceased Donors Is Safe and Effective, Study Finds

Loyola physician co-authors study of devices donated to poor patients in India

MAYWOOD, Ill.  -- 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."

Dr. Gaurav Kulkarni of Loyola University Medical Center is a co-author of the 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.

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."

Kulkarni was born and raised in Mumbai, and at the time of the study, was a medical student at King Edward Memorial Hospital in Mumbai. He interviewed patients before and after they received pacemakers and collected data for the study. "There was a dramatic change in patients after they received their pacemakers," he said.

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.

Researchers reported that between January 2004 and January 2010, 121 pacemakers were removed and donated. (The devices were made 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.

There have been previous studies of reused pacemakers. But only one previous study involved the reuse of pacemakers donated by families in the United States. That study included 12 patients in the Philippines.

The authors conclude that reusing pacemakers could "alleviate the burden of symptomatic bradyarrhythmia (abnormally slow heart rate) in impoverished nations around the world."

Kulkarni now is a first-year resident in the Department of Surgery at Loyola University Chicago Stritch School of Medicine. Other co-authors are first author Bharat K. Kantharia, MD, of the University of Texas Health Science Center; Sandeep S. Patel, MD, of Louisiana State University; Arti N. Shah, MD, of Mount Sinai Medical School; Yash Lokhandwala, MD, of Holy Family Hospital; Erica Mascarenhas of Notre Dame of Bethlehem School; and Daniel A.N. Mascarenhas, MD, of Drexel University College of Medicine.

The authors expressed their gratitude to donors, family members, volunteers and others "who contributed to this charitable project and toward the welfare of poor and needy patients of India requiring cardiac permanent pacemakers."

About Loyola University Health System

Loyola University Health System (LUHS) is part of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. Loyola University Medical Center’s campus is conveniently located in Maywood, 13 miles west of Chicago’s Loop and 8 miles east of Oak Brook, Ill. At the heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children's Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as Loyola University Chicago Stritch School of Medicine, Loyola University Chicago Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

Trinity Health is a national Catholic health system with an enduring legacy and a steadfast mission to be a transforming and healing presence within the communities we serve. Trinity is committed to being a people-centered health care system that enables better health, better care and lower costs. Trinity Health has 88 hospitals and hundreds of continuing care facilities, home care agencies and outpatient centers in 21 states and 119,000 employees.