St. Francis Hospital to be Part of Major Nationwide Study Using a Catheter-Based Aortic Valve Replacement

ROSLYN, N.Y., Jan. 11, 2011 /PRNewswire/ -- Newell Robinson, M.D., Chairman of the Department of Cardiothoracic & Vascular Surgery; George Petrossian, M.D., Director of Interventional Cardiovascular Procedures; Andrew Berke, M.D., interventional cardiologist; and Roberto Colangelo, M.D., cardiothoracic surgeon at St. Francis Hospital, The Heart Center® are part of the medical team that is testing a device that may offer new hope for patients with symptomatic, severe aortic stenosis.

St. Francis Hospital has been selected as one of 40 centers nationwide to assess the Medtronic CoreValve system for transcatheter aortic valve implantation (TAVI), which has recently received conditional approval from the FDA for clinical trials.  St. Francis is one of the first hospitals in the U.S. to be activated as a site, and cardiologists have begun the process of implanting it in patients who are at high risk, or are ineligible, for open heart surgery.

Approximately 300,000 people worldwide (100,000 in the U.S.) have been diagnosed with the condition, which prevents the valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body.  But about one third of these patients are deemed at too high a risk for open heart surgery,(i) the only therapy with significant clinical effect that is currently available in the United States.  Although the CoreValve system has been implanted in 12,000 patients worldwide, it has not been available to patients in the U.S. until now.

The new valve replacement procedure channels a tube called a catheter with a prosthetic valve through the femoral artery 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 native valve.

"This is the most revolutionary device I've seen in my more than 20 years of being a cardiologist.  Nothing that I have witnessed in the past can change the way we practice interventional cardiology in such a dramatic way," says Dr. Petrossian.

"CoreValve has been used extensively in Europe.  The expectation is that we will be able to treat patients that otherwise we could not have treated, and be able to improve their lifestyles so they can stay out of heart failure for a longer period of time even though they aren't a candidate for surgery," says Dr. Robinson.

The Hospital's Chairman of Cardiology, Richard Shlofmitz, M.D., was instrumental in bringing the study to St. Francis.  He sees a time in the future when the benefits of these innovative devices will be available to a broader segment of patients who are not a high risk for surgery.  "This new approach is likely to have the same impact on the treatment of valvular disease as stenting did on coronary artery disease."

For more information about the study, log on to www.clinicaltrials.gov.  For more information about enrolling in the study, call (516) 562-6790, or visit www.stfrancisheartcenter.com.

(i) Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2003;26:2714-2720.

SOURCE St. Francis Hospital