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Presbyterian Hospital among first hospitals approved to perform transcatheter aortic valve replacement

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Thursday, November 03, 2011

Lifesaving procedure intended for patients not suited for surgery

Presbyterian Hospital is among the first hospitals in the country approved to offer transcatheter aortic valve replacement (TAVR) after it received FDA approval for commercial availability on November 3, 2011. TAVR is a non-surgical treatment option for valve replacement. The procedure is appropriate for people with severe aortic stenosis, or narrowing of the heart valve that causes a restriction in blood flow to the heart. Many patients with severe aortic stenosis cannot endure the traditional surgical approach of open-heart surgery for valve replacement due to age or coexisting health reasons.

“Transcatheter aortic valve replacement marks an important milestone in cardiovascular care,” said Yele Aluko, MD, Medical Director of the Presbyterian Cardiac Catheterization Lab. “This procedure provides a less invasive, lifesaving option to patients who previously could not be surgically treated without significantly high and often prohibitive risks.”

Together, an interventional cardiologist and cardiovascular surgeon create a small incision in the groin and feed a wire mesh valve through a catheter to the patient’s heart from the femoral artery in their leg. The procedure is performed while the heart is beating and eliminates the need for traditional open heart surgery, which requires a surgeon to cut through the breastbone, stop the heart and remove and replace the existing valve. Transcatheter valve procedures can frequently be completed within 90 minutes, while traditional open heart surgery takes about four to six hours. In addition, hospital admissions are usually shorter for patients who have TAVR.

Results from the PARTNER (Placement of AoRTIC traNscatherER valves) trial showed TAVR for patients that are too high risk for surgery is safe and effective. The one-year rate of death from those who participated in the trial was 20 percent lower than for those who received other treatment options such as optimal standard therapy, which includes watchful waiting, medications and balloon aortic valvulopasty. In addition, participants had fewer associated post-procedure symptoms. Results from the trial were published in the New England Journal of Medicine in June.

Cleveland Clinic was one of the 26 centers worldwide where the PARTNER trial was conducted. Presbyterian Hospital announced in September that it has affiliated with Cleveland Clinic for heart care.

The aortic valve replacement devices used in the study are manufactured by Edwards Life Sciences, which funded the study.

About 50,000 people nationwide have aortic valve replacement annually. About five percent of patients with severe aortic stenosis are at high risk for surgery and are candidates for TAVR.

The Valve Clinic at Presbyterian Hospital is now evaluating potential candidates. If you are a physician and would like to refer a patient, call 704-316-TAVR (8287) or toll-free at 1-855-590-TAVR.

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