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The valve's maker, Edwards Lifesciences Corp. of Irvine, Calif., paid for the study, and some researchers consult for the company. Edwards is seeking federal approval to sell the valve for inoperable patients now, and plans to ask the same for less ill patients like those in the new study in a few months.
The company plans to charge $30,000 for the valve, which is already used in Europe. Another study presented Sunday on the first group of patients treated with it -- those too sick for surgery -- put the total cost with doctor fees and hospitalizations at $73,563.
However, in those patients, it proved cost-effective -- costs were higher for hospitalizations of people who did not get new valves.
Doctors caution that these are only one-year results, and it will take at least five years of study to know whether these less invasive treatments will be as good as surgically implanted valves that typically last 20 years.
Having this option available for people too sick to have surgery would be great, but it's too soon to say if it should be used in less sick patients, said Dr. Elliott Antman, a Brigham and Women's Hospital cardiologist and American Heart Association spokesman.
Yet there is a big unmet need -- about 30 to 40 percent of people with very bad aortic valves are not being referred for surgery now, "and not all of them are patients that are inoperable," said Dr. Ralph Brindis, a California cardiologist who is president of the cardiology college.
Charles Cohen, who will be 90 in August, got an artery-placed valve two years ago at Cedars-Sinai Medical Center in Los Angeles, where he lives, as part of the study.
"I was a little bit leery" of either option, but was hoping for the catheter, he said. Before he had it, he could walk only a block or so before having to stop to rest. "Now I walk half a mile," he said.
NIH on heart valves:
Heart Association: http://tinyurl.com/5waq4mp
American College of Cardiology: http://www.acc.org/
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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