Catheter-Based Aortic Valve Replacement Recommended for High-Risk Patients

A new clinical trial has established transcatheter aortic-valve implantation (TAVI) as a new standard of care for patients with severe aortic stenosis who cannot undergo surgery.

Researchers at NewYork-Presbyterian Hospital/Columbia University Medical Center (NYP; USA) and other institutions reported the results of the Placement of AoRtic TraNscathetER valves (PARTNER) trial, a multicenter, randomized, clinical trial comparing TAVI with standard therapy in high-risk patients. A total of 358 patients with aortic stenosis who were considered to be unsuitable candidates for surgery underwent randomization at 21 centers, including 17 in the United States. The control patients randomized for standard therapy received a combination of watchful waiting, medications, and balloon aortic valvuloplasty. The primary end point was the rate of death from any cause over the duration of the study.

The results showed that at one year, patients who underwent TAVI showed a 45% reduction in the rate of death from any cause compared with patients who received standard therapy, and a 54% reduction in the combined end point of death from any cause or repeat hospitalization. Among 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% versus 58%). The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, held during September 2010 in Washington D.C. (USA).

"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 coprincipal researcher and study presenter Martin B. Leon, M.D., a professor of medicine at NYP.

The TAVI procedure takes about 90 minutes, compared with four to six hours for open-heart surgery. The replacement valve used 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.

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NewYork-Presbyterian Hospital/Columbia University Medical Center