Researchers revealed this Sunday a new heart valve that can be implanted without surgery. The device may hold promise for tens of thousands of elderly patients who might not survive a standard valve-replacement operation.
The reports come in from a study of nearly 700 high-risk, elderly patients who underwent experimental valve procedure, done through a small incision in the groin. Results showed that it was as effective as open-heart surgery with a similar death rate. However the approach carries a big risk with participants having twice the number of major strokes as those who had surgery. Craig Smith, of New York-Presbyterian Hospital, one of the study's lead authors said, “Strokes were significantly more frequent.” Patients who had the new procedure also suffered more major damage to blood vessels, he said.
David Moliterno, chief of cardiology at the University of Kentucky welcomed this study saying, “This is an historic event… It will affect hundreds of thousands of people.” Nearly 10% of people older than 65 suffer from an ailment called aortic stenosis, narrowing of the valve that releases a big surge of blood into the heart's major artery, the aorta. Without a valve replacement, half the patients with severe disease die within two years. 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.
The new valve made of cow tissue encased in a spring-like stent made by the study's sponsor, Edwards Lifesciences, is guided into the heart and slipped into place in the heart by inflating a small balloon. It is awaiting approval by the Food and Drug Administration. Dr. Edward McNulty, a cardiologist at the UCSF, explained how it works. Through an artery in the groin or the chest, “a new heart valve is literally crimped on a balloon and advanced across the narrowed, older, diseased heart valve. The balloon is inflated and the new valve left in place.”
In the study half the patients got the experimental valve and the rest underwent standard valve surgery, Smith reported at the annual scientific meeting of the American College of Cardiology in New Orleans. 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.
Another trial will soon begin to test the procedure in younger, healthier patients.
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