Patient Too Sick for Traditional Aortic Valve Surgery Receives Transcatheter Valve as Standard of Care
FDA Approval of SAPIEN Valve Follows Results of Multicenter PARTNER Clinical Trial Led by NewYork-Presbyterian/Columbia
Nov 4, 2011
NewYork-Presbyterian Hospital/Columbia University Medical Center today became the first in the United States to implant the SAPIEN transcatheter aortic heart valve as an FDA-approved standard of care. This major advance in patient care follows the FDA's decision on Nov. 2 to approve SAPIEN as a preferred treatment for patients too sick to undergo traditional aortic valve surgery.
The recent FDA approval was based on results of the 26-center Placement of AoRTic TraNscathetER Valve (PARTNER) clinical research trial co-led by Drs. Martin Leon, Jeffrey Moses and Craig Smith at NewYork-Presbyterian/Columbia. Since the start of FDA-approved clinical trials in 2005, the Medical Center has performed more than 300 valve procedures — the most in the country.
NewYork-Presbyterian/Columbia physicians Drs. Susheel Kodali and Mathew Williams will also lead a live demonstration of the procedure on Nov. 9 at the annual TCT meeting in San Francisco. Going forward, the Medical Center will be one of only four sites to train American physicians in the procedure.
"Approval of the SAPIEN transcatheter aortic heart valve is a monumental event on par with FDA approval of the bare metal stent in 1994. For patients too sick for open-heart surgery, this new treatment is the difference between life and death," says Dr. Leon, director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital/Columbia University Medical Center and professor of medicine at Columbia University College of Physicians and Surgeons. "It is a huge honor for our team to perform the first procedure as an FDA-approved preferred treatment."
"This achievement is born of an unprecedented collaboration between surgery and interventional cardiology. The aptly named PARTNER trial has not only demonstrated the benefits of the transcatheter aortic valve, but it has also presented a new model for research and clinical practice," says Dr. Smith, chairman of the Department of Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Johnson & Johnson Distinguished Professor and the Valentine Mott Professor of Surgery at Columbia University College of Physicians and Surgeons.
Drs. Leon and Smith were the lead authors of an article in the Oct. 21, 2010, New England Journal of Medicine presenting results of the PARTNER trial, showing the transcatheter aortic-valve implantation can improve survival and quality of life compared with standard therapy in patients with severely diseased aortic valves who were not candidates for standard open surgery.
The SAPIEN valve is made of bovine pericardial tissue leaflets hand-sewn onto a metal frame. It is inserted through a catheter and implanted within the patient's diseased aortic valve using a balloon to deploy the replacement valve and frame. The procedure is performed on a beating heart, without the need for cardiopulmonary bypass and its associated risks.
Results from a second arm of the PARTNER trial — cohort A — were submitted separately to the FDA and are still under review. Patients enrolled in this group are at high risk for needing traditional aortic valve surgery; by comparison, patients in cohort B (pertaining to the recent FDA decision) are too sick for the traditional surgery. Results of cohort A were reported in the June 9 New England Journal of Medicine by co-lead authors Drs. Smith and Leon.
Drs. Leon and Smith are also the principal investigators of a second clinical trial — PARTNER II — which is evaluating a next-generation smaller transcatheter aortic valve system called the SAPIEN XT.
The Edwards SAPIEN and SAPIEN XT transcatheter heart valves are manufactured by Edwards Lifesciences of Irvine, Calif., which funds the PARTNER and PARTNER II studies.
Along with Drs. Leon and Smith, members of the NewYork-Presbyterian/Columbia PARTNER physician team include Drs. Susheel Kodali, Jeffrey Moses and Mathew Williams, and Rebecca Hahn.
In addition to NewYork-Presbyterian/Columbia and other centers, the PARTNER trial was conducted 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 and the Philip Geier Professor of Cardiothoracic Surgery at Weill Cornell Medical College, and Dr. Shing-Chiu Wong, director of cardiac catheterization laboratories and professor of medicine at Weill Cornell Medical College.
Treatment of Aortic Stenosis
Aortic valves, which regulate blood flow from the heart into the aorta, are susceptible — typically with age and the onset of cardiovascular disease — to stenosis (failure to open) and insufficiency (which leads blood to flow in the wrong direction, back into the heart). Aortic stenosis results in a poor quality of life and a high rate of death, approximately 50 percent, in the first two to three years after diagnosis without surgical intervention. Approximately 300,000 Americans suffer from severe aortic stenosis. At least 30 percent of these patients do not undergo surgery for replacement of the aortic valve because of advanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.
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 & 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 and 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 2,409 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including 12,797 deliveries and 195,294 visits to its emergency departments. NewYork-Presbyterian's 6,144 affiliated physicians and 19,376 staff provide 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/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the 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.