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Monday, April 4, 2011

New heart valve holds promise and stroke risk

but as many as 30% of patients are too sick, or unwilling, to risk an operation than involves cracking open the breastbone, stopping the heart and putting patients on a heart-lung machine, said Ralph Brindis, president of the American College of Cardiology.

In the procedure, the new valve made of cow tissue encased in a springlike stent is guided into the heart and slipped into place in the heart by inflating a small balloon. The valve, made by the study's sponsor, Edwards Lifesciences, is awaiting approval by the Food and Drug Administration.

Half the patients in the new study got the experimental valve, and the rest underwent standard valve surgery, Smith reported at the annual scientific meeting of the American College of Cardiology here.

Death rates were similar, 24% for the new procedure and 27% for surgery, he said. Twenty patients who got the new valve suffered strokes, compared with 10 patients in the surgery group.

Some doctors said the stroke risk would deter many patients. "Some people say they'd rather be dead than live with a stroke," said Rita Redberg of the University of California-San Francisco.

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