April 21, 2011

VHVI to test novel treatment for aortic stenosis

VHVI to test novel treatment for aortic stenosis

Vanderbilt Heart & Vascular Institute will soon begin testing the safety of a novel, non-surgical approach to treating a common heart problem.

Vanderbilt will participate in the Medtronic CoreValve U.S. Clinical Trial, which will evaluate a non-surgical alternative to open-heart surgery for patients with severe aortic stenosis (narrowing).

The CoreValve System is designed to provide a minimally invasive option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open heart surgery. Worldwide, about 300,000 people have been diagnosed with this condition (100,000 in the United States), and about one-third of these patients are deemed too high a risk for open-heart surgery, the only therapy currently available in the United States.

The procedure channels a catheter (thin tube) with an artificial valve through the femoral artery in the groin to reach the heart. The CoreValve System is designed with self-expandable technology, deploying the new valve inside the diseased aortic valve without open-heart surgery or surgical removal of the patient's original valve.

“While traditional open aortic valve replacement will still have a major role in most low- and moderate-risk patients, trans-catheter valve therapy will probably be preferable in high-risk patients,” said David Zhao, M.D., director of the Cardiovascular Catheterization Lab and Interventional Cardiology.

The Medtronic trial will enroll more than 1,200 patients at 40 U.S. clinical sites, including Vanderbilt. Zhao and John G. Byrne, M.D., the William S. Stoney Professor and chair of the Department of Cardiac Surgery, are the co-principal investigators.

Other Vanderbilt physicians involved in the study include Joseph Fredi, M.D., Mark Robbins, M.D., Marshal Crenshaw, M.D., and Steven Ball, M.D.

“Medtronic chose Vanderbilt, in part, because of our integrated cardiovascular service line and high level of collaboration between Cardiology and Cardiac Surgery. Other probable factors were our extensive hybrid OR experience as well as our overall valve volume,” Byrne said. “We will be performing these procedures in our hybrid cath lab/OR, which is really the ideal setting.”

The trans-catheter approach takes 90 minutes vs. three to four hours for open heart surgery, Byrne said.

For more information about the Medtronic CoreValve U.S. Clinical trial, see www.aorticstenosistrial.com. Vanderbilt is currently enrolling patients in the trial. For more information about participating in this trial, call 343-9188.