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In the study, 184 people were assigned to get the clip and the procedure was successful in 136. Major complications occurred in 10 percent of people treated with the clip compared with 57 percent of 79 other patients treated with surgery. Two surgery patients died, two suffered major strokes, and four needed emergency heart surgery; none of the clip patients had those problems.
That made the device much safer than surgery, researchers said.
As for effectiveness, the study was only designed to see if the device was not substantially inferior to surgery and by that measure, it passed.
After one year, valve problems were sufficiently resolved in 72 percent of device patients and 88 percent of surgery patients.
Surgery is better, "but it's not so much better that patients, given the choice, want to undergo the open-heart procedure," especially given the difference in safety, Feldman said. "Part of what makes this attractive is that when the clip doesn't work, surgery remains an option," so the less drastic treatment could be tried first, he added.
The results are "very enticing and very exciting," although longer-term study is needed, said Dr. Robert Bonow, a former American Heart Association president and chief of cardiology at Northwestern University's Feinberg School of Medicine in Chicago.
"The surgeons would argue this is less good of a result. But from the patient's point of view, this might be exactly what you need" to turn a big problem into a mild one that does not need further treatment, Bonow said.
Dr. Donald Glower, a Duke University cardiac surgeon who co-led the study, agreed.
"This is part of the trade-off we have" with many treatments that avoid surgery. "It's probably not realistic" to expect it to be as good, he said.
No price for the device has been set in the U.S., but it sells for about $27,000 in Europe, plus whatever doctors and hospitals charge to implant it -- as yet unknown.
"You have to look at it always in comparison to the alternative" -- valve surgery costs $50,000 or more, including a longer hospital stay, said John Capek, executive vice president of Abbott's medical devices division.
On the Net:
Cardiology meeting: http://www.acc.org/
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