New technology helps heart condition patients

PALO ALTO, CA

At 86 John Grigsby still walks a mile and half every day with his wife Ginny. But last January, he could scarcely make it across the room.

"To get up and leave that chair and go into the family room, was a chore. I'd be huffing and puffing," says Grigsby.

He was suffering from severe aortic stenosis, a dangerous narrowing of the aortic valve in the heart.

"Not many patients live a year unless they're treated, and the only effective treatment, history has taught us is surgical aortic valve replacement -- open heart surgery," says Dr. Craig Miller.

Miller is professor of cardiothoracic surgery at Stanford and one of the investigators of an experimental treatment for older, high-risk patients like Grigsby.

Instead of open heart surgery, the new valve is delivered to the heart with a catheter -- a far less invasive treatment for high-risk patients.

Dr. Bill Fearon is part of the team and associate director of interventional cardiology at Stanford.

"Basically using a catheter with a balloon to inflate the valve inside the old one, without having to make any incisions in the chest," says Fearon.

The new device is a cow tissue valve crimped into a stent.

"Right now for the first time we have something to offer those here to for who were inoperable," says Miller.

Results in Wednesday's New England Journal of Medicine found a marked difference between two groups of patients ineligible for open heart surgery.

Only one group was given the new transcatheter aortic valve implantation. The procedure is typically an hour long and performed by a team of specialists.

At one year, half the patients in the standard care group had died, compared to 30 percent among those who had the transcatheter procedure.

"So we had absolute difference in death rate at one year of 20 percent," says Miller. "The best way to understand that is it took only five patients needed to be treated to save one life."

Miller acknowledges there is an increased risk of stroke among the transcatheter patients. And he says, "17 percent had serious vascular complications in the trial, just reported, due to the age and the disease in their arteries, so there is a price to be paid."

But he notes there is also a price paid if nothing is done. "And that price is paid in death," he says.

Grigsby is grateful for the less invasive approach. He received his new valve eight months ago and was happy to do his part for science.

"If you don't do some experiments, you're never going to know whether or not something works," says Grigsby.

So far, it's worked for Grigsby. He and Ginny celebrated their 60th wedding anniversary this summer.

The randomized clinical trial is over, but a limited number of patients who would have qualified for the research are still being offered the experimental device at Stanford under continued access by the FDA. More information can be found at the link above.

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