SAN FRANCISCO —
Millions of people have leaky heart valves. Each year, more than 100,000 people in the United States alone have surgery for them. A common one is the aortic valve, the heart’s main gate. It can stiffen and narrow, making the heart strain to push blood through it. Without a valve replacement operation, half of these patients die within two years, yet many are too weak to have one.
“Essentially, this was a death sentence,” said Dr. John Harold, a Los Angeles heart specialist who is president of the College of Cardiology.
That changed just over a year ago, when Edwards Lifesciences Corp. won approval to sell an artificial aortic valve flexible and small enough to fit into a catheter and wedged inside the bad one. At first it was just for inoperable patients. Last fall, use was expanded to include people able to have surgery but at high risk of complications.
Gary Verwer, 76, of Napa, Calif., had a bypass operation in 1988 that made surgery too risky when he later developed trouble with his aortic valve.
“It was getting worse every day. I couldn’t walk from my bed to my bathroom without having to sit down and rest,” he said. After getting a new valve through a catheter last April at Stanford University, “everything changed; it was almost immediate,” he said. “Now I can walk almost three miles a day and enjoy it. I’m not tired at all.”
“The chest cracking part is not the most fun,” he said of his earlier bypass surgery. “It was a great relief not to have to go through that recovery again.”
Catheter-based treatments for other valves also are in testing. One for the mitral valve — Abbott Laboratories’ MitraClip — had a mixed review by federal Food and Drug Administration advisers this week; whether it will win FDA approval is unclear. It is already sold in Europe.