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Study supports heart valve procedure as surgery alternative

A bad aortic valve would be replaced with a new one inserted through a tube in an artery. Edwards Lifesciences seeks federal approval to sell the valve for inoperable patients. A bad aortic valve would be replaced with a new one inserted through a tube in an artery. Edwards Lifesciences seeks federal approval to sell the valve for inoperable patients. (Edwards Lifesciences Photos via Associated Press)
Associated Press / April 4, 2011

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NEW ORLEANS — A long-awaited study suggests that many people with a bad aortic valve, the heart’s main gate, can avoid open-heart surgery and have a new one placed through a tube in an artery instead.

There is a downside — a higher risk of stroke — and uncertainty about how long these valves will last.

Still, doctors predicted that if the new valve wins federal approval, patients would embrace it as they did balloon angioplasty, which has allowed millions to have clogged arteries fixed without an operation.

“The fact that it’s not open-heart surgery sells itself, and the rest gets lost in the mix,’’ said Dr. Craig Smith, heart surgery chief at Columbia University and New York-Presbyterian Hospital. He led the study and described the results yesterday at an American College of Cardiology conference in New Orleans.

Dr. Michael Crawford, chairman of the meeting and cardiology chief at the University of California, San Francisco, said the technique would dramatically change practice. “As good as surgery is, patients just don’t want it,’’ he said.

The aortic valve can stiffen and narrow with age, making the heart strain to push blood through it. Severe cases are treated with surgery to replace the valve, but that’s risky for many older people. Without an operation, half die within two years.

The study tested a way to wedge in a new valve without surgery, by using a balloon device inserted through an artery in the groin or the chest.

A test of this gentler approach in people too sick for surgery found it greatly improved survival, doctors reported last fall. The new study involved nearly 700 people eligible but at high risk for surgery.

Their median age was 84, and they were randomly assigned to get valves replaced through surgery or the new way.

In the end, both groups did very well. After one year, about 24 percent of the artery patients and 27 percent of the surgery patients had died — comparable results in a study this size and considerably fewer than researchers had predicted.

However, strokes and other neurological problems were twice as common in the artery-treated group — 8 percent versus 4 percent. Previous studies also found more strokes with the artery approach.

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, and plans to ask the same for less ill patients like those in the new study in a few months.

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