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Clinical Trial Establishes Catheter-Based Aortic Valve Replacement as New Standard of Care for Patients Who Cannot Undergo Surgery
Date:9/22/2010

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Aortic valves, which regulate blood flow from the heart into the aorta, can fall victim, typically with age and the onset of cardiovascular disease, to stenosis (failure to open) and insufficiency (which leads blood to flow in the wrong direction back into the heart). Aortic stenosis results in a poor quality of life and a high rate of death, approximately 50 percent, in the first two to three years after diagnosis without surgical intervention. Approximately 300,000 Americans suffer from severe aortic stenosis.

In clinical practice, at least 30 percent of patients with severe symptomatic aortic stenosis do not undergo surgery for replacement of the aortic valve because of advanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.

The replacement valve used in the PARTNER trial is made of pericardial tissue leaflets hand-sewn onto a metal frame and implanted via a catheter into the left ventricle. It is then positioned inside the patient's existing valve using a balloon to deploy the frame, which holds the valve replacement in place. The procedure is performed on a beating heart, without the need for cardiopulmonary bypass and its associated risks.

The transcatheter valve procedure takes about 90 minutes, compared with four to six hours for open-heart surgery. In open-heart surgery, the surgeon cuts through the breastbone, stops the heart, removes the valve, and replaces it. Open-heart surgery can require a two- to three-month recovery period, compared with only a few days for the transcatheter approach.

The multicenter PARTNER trial, which has more than 1,000 patients, began in 2007 and will be completed in 2014. The results reported today reflect only the cohort of patients who are not considered candidates for surgery. The other arm of the trial, which compares transcatheter valves with surgically implanted valves, is ongoing. The executive committee of the trial includes two academi
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SOURCE NewYork-Presbyterian Hospital/Columbia University Medical Center
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