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Edwards heart valve risk similar to surgery-study
March 26, 2012 / 1:00 PM / in 6 years

Edwards heart valve risk similar to surgery-study

CHICAGO, March 26 (Reuters) - Elderly patients who received a replacement heart valve through Edwards LifeSciences Corp’s less-invasive technique had similar death rates and risk of stroke at two years as those who got a new valve during open-heart surgery, a study showed.

Two years after implantation with Edwards’ heart valve, 33.9 percent of patients died compared with the 35 percent who underwent open-heart surgery in the study of very old and ill patients. The difference was not statistically significant.

The Edwards valve, called Sapien, is implanted via a catheter threaded to the heart through a leg artery or through a small incision between the ribs.

Patients who received the Edwards valve had nearly twice as many strokes within the first 30 days than those who had open-heart surgery for valve replacement.

But between the first and second year after the procedure, the risk of stroke diminished to 1.7 percent for both groups, said Dr. Susheel Kodali, co-director of the Heart Valve Center at Columbia University Medical Center/New York Presbyterian Hospital.

“There is clearly no late hazard with the transcatheter valve for stroke,” Kodali said in an interview.

The study, called Partner, which was funded by Edwards, looked at 699 patients who were at high risk for surgery and whose average age was 84 years. About 5 percent of people 75 and older have aortic stenosis, a narrowing of the valve that controls blood flow to the heart.

The U.S. Food and Drug Administration in November approved Edwards’ Sapien valve for patients deemed too sick to have open-heart surgery. The company is seeking a wider indication for the device.

The company’s Sapien valve competes with Medtronic Inc’s CoreValve device in Europe.

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