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Update: Clinical Trial Establishes Catheter-based Aortic Valve Replacement As New Standard of Care for Patients Who Cannot Undergo Surgery
Date:9/23/2010

survivors at one year, the rate of cardiac symptoms was significantly lower among patients who had undergone TAVI, as compared with those who had received standard therapy (25.2 percent vs. 58.0 percent).

"Based on the reduction in mortality during the first year of the study, balloon-expandable TAVI should be the new standard of care in patients who are not suitable candidates for surgery," said Martin B. Leon, M.D., professor of medicine and director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital and Columbia University Medical Center. Dr. Leon, founder and chairman emeritus of the Cardiovascular Research Foundation, is the co-principal investigator of the study.

At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0 percent vs. 1.1 percent) and major vascular complications (16.2 percent vs. 1.1 percent). In the year after TAVI, patients had no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.

"This study shows that transcatheter valve replacement is a safe and effective option for this life-threatening illness in patients unsuitable for surgical valve replacement," said Dr. Smith, study co-principal investigator and surgeon-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center. Dr. Smith is also the Valentine Mott Professor of Surgery, the Johnson & Johnson Distinguished Professor of Surgery, and chair of the Department of Surgery at Columbia University College of Physicians and Surgeons. "Additional studies are needed to examine the increased incidence of stroke following TAVI."

According to the study authors, research is already under way on the next generation of TAVI devices that researchers hope will address the vascular complications encountered in the trial.

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SOURCE NewYork-Presbyterian Hospital/Columbia University Medical Center
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