FDA approval still pending; at least one doctor says it's not ready for widespread use
URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_110580.html(*this news item will not be available after 07/02/2011)
Sunday, April 3, 2011
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Heart Valve Diseases
SUNDAY, April 3 (HealthDay News) -- An experimental, minimally invasive procedure to place a new valve in a damaged heart is as good as conventional open-heart surgery, although it comes with a higher risk of stroke, researchers reported Sunday.
Transcatheter aortic valve implantation (TAVI) involves snaking a valve into position in the heart via an artery in the leg or directly through a tiny incision into the left ventricle of the heart, similar to a balloon angioplasty procedure to clear clogged arteries.
The collapsible heart valve, called the Edwards SAPIEN valve, is made by Edwards Lifesciences Corp., which sponsored the study.
According to Dr. Paul Teirstein, an interventional cardiologist with Scripps Health in San Diego and a study author, the full procedure could cost up to $50,000 -- about the same as traditional aortic valve replacement surgery.
The device is not yet approved by the U.S. Food and Drug Administration, although the new study results will no doubt be taken into account when the agency makes its decision.
The findings were presented at the annual meeting of the American College of Cardiology, in New Orleans.
Of the 200,000 people in the United States who need an aortic valve replacement, some 100,000 can't get one because their health is too frail to withstand traditional surgery, according to the study authors.
Previous results from the same study showed that TAVI actually bested standard medical therapy among patients who were too sick to undergo open-heart surgery. After one year, death rates went down 45 percent among those who underwent TAVI. Rates of patients needing to be hospitalized again also went down (22.3 percent in the TAVI group, vs. 44.1 percent in the open-heart surgery group).
In this new trial, TAVI went head-to-head with traditional surgical valve replacement. Nearly 700 patients with aortic stenosis (when the aortic valve, which opens to allow the aorta to transport blood out of the heart and into the rest of the body, does not fully open) were randomly chosen for one of the two treatment groups.
After one year, 24 percent of the patients undergoing TAVI had died, compared to 27 percent in the surgery group. Eight percent and 4 percent had strokes, respectively. The median age of the patients was 84.
Another portion of the trial was also presented Sunday at the cardiology conference. This found that among 358 patients, TAVI was more cost-effective at the end of one year than traditional surgery.
Findings presented at medical meetings should be viewed as preliminary because they typically do not undergo the same scrutiny as research published in peer-reviewed medical journals, scientists note.
"The buzz here is that this is a promising new approach," said Dr. Louis Teichholz, medical director of cardiac service at Hackensack University Medical Center in New Jersey. But it's not ready yet for widespread use, he added.
Teichholz pointed out a number of considerations, even beyond the stroke issue. Namely, this study involved very high-risk patients only.
"They had bad valves, a lot of symptoms, poor function in the heart," he said. "In the future, they [doctors] will be doing lower-risk patients so if this is going to have wide acceptance, it would have to be successful in less than the highest-risk patients."
The device is also quite large compared to second-generation devices already being developed in Europe, he said.
Another big question: When will the FDA actually approve the device. And the answer to that question, no one knows.
SOURCES: Louis Teichholz, M.D., medical director, cardiac service, and chief, complementary medicine, Hackensack University Medical Center, New Jersey; April 3, 2011, presentation, American College of Cardiology annual meeting, New Orleans
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Minimally Invasive Heart-Valve Procedure Shows Promise: Study: MedlinePlus
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