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January 17, 2011

UVA offers elderly patients new approach to aortic valve replacement

A team of heart specialists at the University of Virginia Health System last week performed a leading-edge procedure in which an 74-year-old man, whose risk factors made him ineligible for traditional surgery, received a new aortic valve. Two days later, he was well enough to go home.

The patient, who was the first to be treated as part of a new clinical trial at UVA, underwent a minimally-invasive procedure during which doctors made a small incision in his leg and inserted a catheter into his artery to replace the valve. Instead of stitches, the new valve is held in place by an expandable frame.

“We are extremely pleased with this patient’s outcome and look forward to monitoring his progress during the months ahead,” reports Scott Lim, M.D., a UVA interventional cardiologist who served as lead physician for the procedure.

The patient was suffering from severe aortic stenosis, a build-up of calcium that prevents the aortic valve from working effectively. Aortic stenosis impairs the flow of blood from the heart’s lower left chamber (ventricle) to the arteries and, when severe, can be life-threatening. The condition is associated with aging and affects three times more men than women. Symptoms include breathlessness, chest pain, weakness and dizziness.

Conventional treatments for stenosis range from medication when symptoms are mild to open-heart surgery when the aortic valve is severely damaged. Recovering from surgery can require a four to 10-day hospital stay and take three months or longer.

“Unfortunately, conventional valve replacement surgery may be too rigorous and too risky for a lot of elderly patients, leaving them with no viable options,” observes Irving L. Kron, M.D., chair of the Department of Surgery who participated in the procedure. “We’re excited to offer this promising new treatment to these patients.”

“Being able to help patients who have been considered untreatable is really important and exciting to us,” adds Michael Ragosta, M.D., UVA’s director of Cardiac Catheterization Laboratories.

The transcatheter procedure is available at UVA as part of the PARTNER Trial, a large, randomized, controlled, multi-center study. PARTNER sites are evaluating the safety and effectiveness of a transcatheter aortic valve and of two catheter-based delivery approaches developed by Edward Lifesciences. To qualify for study participation, patients must have severe aortic stenosis and be classified as either a high surgical risk or not a candidate for surgery.  Lim and Kron are UVA’s principal investigators for the trial and expect to enroll 40 or more patients this year.

“It’s an honor for the UVA Health System to be selected as a site for this important trial,” says Brian Annex, M.D., chair of the Department of Cardiology. “We consider it to be an acknowledgement of the close and highly effective partnership that exists between our cardiologists and cardiac surgeons.”

According to Annex, the partnership has enabled the UVA Heart and Vascular Center to become one of the few places in the U.S. that offers minimally-invasive transcatheter techniques to replace both aortic and mitral valves. “This is a tremendous benefit to our patients, especially to those in high-risk groups,” he says.

In addition to Lim, Kron and Ragosta, cardiac surgeons John Kern, M.D. and Gorav Ailawadi, M.D. were part of the specialist team that performed last week’s procedure.

“As a team, everybody functioned at a brilliantly high level,” says Lim. “These new devices are opening up a new frontier for us. They are changing how we look at and treat patients with valvular heart disease.”

More information about the PARTNER Trial at UVA can be obtained by calling Sandra Burks at 434-243-0315 or by emailing sgb2c@virginia.edu.

Related link:

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

http://clinicaltrials.gov/ct2/show/NCT00530894

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