Dr. Martin Leon and Dr. Craig Smith Lead Ongoing Multicenter Study of Heart Valve Replacement
Innovative Transcatheter Approach Offers Hope to Patients Considered High-Risk or Non-Operable for Traditional Open-Heart Surgery
Jul 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).
The Edwards SAPIEN transcatheter heart valve is manufactured by Edwards Lifesciences of Irvine, Calif., which is also funding the study.
Aortic Heart Valve Disease
The heart's four valves each have two or three strong tissue flaps, or leaflets, which open and close with each heartbeat, approximately once every second throughout a person's life. When working properly, heart valves ensure that blood flows in the right direction. But when damaged by congenital conditions or progressive disease, these valves can become defective and inhibit efficient blood flow to the body. The aortic valve in particular is prone to age-related stenosis, a narrowing and calcification of the valve opening that, over time, may inhibit adequate oxygenated blood flow to the circulatory system. Aortic valve stenosis may progress for years, with patients experiencing symptoms similar to those associated with aging such as increased fatigue and shortness of breath. As the condition deteriorates, patients also may experience angina (chest pain), light-headedness or fainting. Left untreated, aortic valve disease can ultimately lead to death. More than 5 million Americans have moderate to severe valve disease, where at least one valve does not work properly.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.