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However, complications were twice as common -- 8 percent in the device group and 4 percent on warfarin. Five strokes were triggered by implanting the device, and about 5 percent of device patients developed serious fluid buildup around the heart. Doctors were unable to implant the Watchman in 41 people assigned to get it.
These problems declined as the study went on, Holmes said.
Any new technology has "a learning curve" that improves with experience, said Dr. Ralph Brindis, a heart specialist at the California-based Kaiser Permanente health plan and spokesman for the college of cardiology.
The device's maker, Atritech Inc. of Plymouth, Minn., paid for the study, and Mayo may potentially receive future royalties from the device. Medicare paid $9,500 for the procedure, including $6,000 for the device itself, a company spokeswoman said. Hospitals typically charge two to three times the Medicare rate, she said.
Dr. Tristram Bahnson of Duke University said that if the device is approved, "patients and their physicians will have to decide whether assuming some increased risk up front is preferred to ongoing therapy with Coumadin, where there's a small risk of complications and the risk is cumulative."
For Kenneth Giunchedi, that was an easy choice. Giunchedi, 75, of suburban Chicago, had the device implanted last March by Dr. Bradley Knight of the University of Chicago Medical Center as part of the study. He had been on Coumadin for about two years.
Taking the drug was "a horrible experience for me," he said. "I was never easy to regulate -- I was always in trouble. They were constantly adjusting the dosage and I would go in for a blood draw sometimes as often as three times a week. I would have done anything to get off of the Coumadin."
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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