NEW YORK (July 22, 2009) -- Over the last four years, heart specialists at NewYork-Presbyterian Hospital/Columbia University Medical Center have implanted an innovative aortic heart valve replacement using a catheter-based approach that does not require open-heart surgery in a total of 100 patients -- the most of any U.S. medical center to date.
Open-heart surgery can require a two- to three-month recovery period, compared to only a few days for the transcatheter approach.
The procedures were conducted as part of multiple clinical research studies of the Edwards SAPIEN transcatheter heart valve. Currently ongoing is the PARTNER (Placement of AoRTic traNscathetER valves) trial, a Phase 3 multicenter study led by national co-principal investigators Dr. Martin Leon and Dr. Craig Smith and focused on the treatment of patients who are at high risk or not suitable for open-heart valve replacement surgery.
The SAPIEN heart valve, made of bovine pericardial tissue leaflets hand-sewn onto a metal frame, is implanted via one of two catheter-based methods -- either navigated to the heart from the femoral artery in the patient's leg, or through a small incision between the ribs and 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. Both procedures are performed on a beating heart, without the need for cardiopulmonary bypass and its associated risks.
"This breakthrough technology could save the lives of thousands of patients with heart valve disease who have no other therapeutic options," says Dr. Leon, the study's national co-principal investigator, associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital and Columbia University Medical Center, and professor of medicine at Columbia University College of Physicians and Surgeons.
Annually, some 200,000 people in the U.S. need a new heart valve, but nearly half of them do not receive a new valve for a variety of reasons.
"This study may show that transcatheter valve replacement is a safe and effective alternative to open surgery, which remains the 'gold standard' for most patients," says Dr. Smith, study co-principal investigator, interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, and acting Chairman of the Department of Surgery and the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons.
The transcatheter valve procedures take about 90 minutes, compared with four to six hours for open-heart surgery. In open-heart surgery, the surgeon cuts through the breastbone, stops the heart, removes the valve and replaces it.
The PARTNER trial is a prospective randomized study with two separate treatment arms. In the surgical arm, patients are randomized to receive either the Edwards SAPIEN transcatheter heart valve or an Edwards surgical valve via open-heart surgery. In the non-surgical, medical management arm, patients considered to be non-operative are randomized to receive either the Edwards SAPIEN transcatheter heart valve or appropriate medical therapy.
The PARTNER trial is designed for patients with severe aortic stenosis -- a narrowing of the valve that restricts blood flow from the heart -- who are not good candidates for surgery due to age or other concurrent health factors. Interested patients may contact NewYork-Presbyterian/Columbia at (212) 305-6061.
The PARTNER trial is also available at NewYork-Presbyterian Hospital/Weill Cornell Medical Center's Ronald O. Perelman Heart Institute, led by Dr. Karl H. Krieger (vice chairman of cardiovascular surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and the Philip Geier Professor of Cardiothoracic Surgery at Weill Cornell Medical College) and Dr. Shing-Chiu Wong (director of cardiac catheterization laboratories at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and professor of medicine at Weill Cornell Medical College).
Source: New York- Presbyterian Hospital/Columbia University Medical Center