Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding defective medical devices.  A recent article in The New York Times cited a study published in The Journal of the American Medical Association that reviewed the experiences of patients who received defibrillators and heart devices.

    The researchers reviewed more than 1110,000 cases between January 2006 and June 2007, and analyzed how the patients did both during and following the procedure.
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Fewer complications from heart device specialists

Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding defective medical devices. A recent article in The New York Times cited a study published in The Journal of the American Medical Association that reviewed the experiences of patients who received defibrillators and heart devices.

The researchers reviewed more than 1110,000 cases between January 2006 and June 2007, and analyzed how the patients did both during and following the procedure.

The research, headed by Dr. Jeptha P. Curtis, a cardiologist at Yale University, found that the rate of serious complications was lowest, 1.7%, when the device was implanted by an electrophysiologist, a specialized cardiologist. About 70% of the procedures were performed by electrophysiologists. Some were done by other types of cardiologists, who had a rate of 2.5% serious complications.

The researchers then examined complication rates during implant procedures based both on the type of doctor involved and the type of device implanted. In recent years, the question of how much training doctors receive before they start implanting heart devices has taken on added importance because of the growing number of people getting defibrillators.

There has been an increase in the number of people getting defibrillators that send out electrical jolts to stop potentially fatal heart rhythms, so some defibrillator makers are teaching the implant procedures to doctors who are not electrophysiologists. A 2006 New York Times article detailed how one small heart device manufacturer, Biotronik, spent more than $50,000 to provide implant training to several South Carolina doctors, who then tended to use mainly Biotronik devices on their patients.

Electrophysiologists have claimed that physicians need to be highly trained to successfully implant heart devices. But other doctors have countered that the specialists are simply trying to protect their lucrative practices, and they have argued that there are too few specialists to meet patient demand, particularly in rural areas.

The research from the new study was based on records recorded in a national database set up in 2005 that was required by Medicare to approve payments for the procedure. Electrophysiologists are using this data to show that doctors need to be highly trained to successfully implant heart devices.

In another article in the medical journal, Dr. James Coromilas, a professor at the
University of Medicine and Dentistry of New Jersey in New Brunswick, said the new report suggested that patients requiring an implant should seek out an electrophysiologist. He also said that the study showed that many medical centers have both specialists and nonspecialists implanting heart devices so patients have access to an electrophysiologist if they want one.

While the study showed that the national database set up at Medicare’s behest has been useful in providing information about complications from defibrillator procedures, many experts say the database has not yielded much information about which types of patients are actually benefiting from the use of heart devices.










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