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 Corporation, 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 new 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, versus 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 w
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