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Transcatheter valves, made by Edwards and competitor Medtronic, are threaded through a leg artery up to the heart -- and don't require removing the old valve. Instead, it's propped open and the new valve is wedged into that doorway.
In the new study, 358 patients deemed inoperable were randomly assigned to receive either the Edwards transcatheter valve or essentially comfort care. In the first month, 5 percent of the valve recipients died, compared with 2.8 percent of the control group, showing the risk of any procedure in these sickest-of-the-sick.
But a year later, half of the patients who didn't get a new valve had died of various causes, compared with just 30 percent of the valve recipients. Columbia's Leon said doctors saved a life for every five patients treated -- and most patients felt better and moved better, enjoying more quality of life.
That's a meaningful survival difference, said Dr. Andrew Wang of Duke University, who called the results exciting. Duke is among the centers soon to begin testing Medtronic's valve.
However, 5 percent of valve recipients suffered strokes, compared with 1 percent of the control group.
While the results are promising, the strokes are a worry, said Dr. James McClurken of Temple University in Philadelphia: "We don't want to have people stop having heart failure and be debilitated by having strokes."
Doctors had seen similar stroke rates in Europe and are working on smaller valves and better techniques to lower that risk.
Study patients will be tracked for five years, but how long these wedged-in valves will last is a huge question if they're ever to be used by lower-risk patients, cautioned Dr. John Conte of Johns Hopkins University, a spokesman for the Society of Thoracic Surgeons. He said potential patients should be evaluated by both an interventional cardiologist and a cardiac surgeon to decide if the new method or the old is the best option.
Standard heart valve replacement costs upward of $50,000, most from surgical and hospitalization fees. Transcatheter valves are anticipated to cost $20,000 to $30,000 but to bring lower hospital bills.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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