NYU Langone Leads Clinical Trials to Investigate Next-Generation Transcatheter Aortic Valve Repair (TAVR) Technology
The Heart Valve Center at NYU Langone Medical Center last week became the first center in the world to implant a new heart valve for transcatheter aortic valve replacement (TAVR) in a patient with severe aortic stenosis. As a principal center in the new clinical trial for the Medtronic CoreValve™ Evolut™ PRO TAVR System, NYU Langone is leading the advancement of new technology to help patients suffering from aortic stenosis who are at high to extremely high surgical mortality risk. The technology is only available for investigational use in the United States.
Aortic stenosis is a serious condition that occurs when the heart’s aortic valve narrows, obstructing blood flow from the heart to the aorta, which can severely weaken the heart muscle. If left untreated, it can lead to heart failure and even death. Mathew R. Williams, MD, and a team of surgeons performed the first-ever TAVR procedure using the new investigational device on June 2, 2016 and the patient was discharged to her home the next day. Dr. Williams has performed more than 2,000 TAVR procedures to treat aortic stenosis, the most of any surgeon in the United States.
“This new technology represents an innovative advancement on an already-approved device that we hope with more study will become a new option for patients with severe aortic stenosis who are at extremely high risk for surgery,” says Dr. Williams, a cardiac surgeon in the Department of Cardiothoracic Surgery at NYU Langone, chief of Adult Cardiac Surgery, and director of Interventional Cardiology and Structural Heart. “As established leaders in the field of cardiac surgery and advancing the field through research and participation in cutting-edge clinical trials, we are uniquely qualified to treat patients who would otherwise have very limited options, and help them return to their normal lives within only weeks of surgery.”
NYU Langone previously led the clinical trials for the Evolut R device, which was approved by the U.S. Food and Drug Administration in June 2015, and was one of the top centers for Evolut R trial enrollment nationally.
The new system retains the key advantages of the Evolut R, as it is both recapturable and repositionable, so accuracy in placement and control during the procedure is increased. In addition to these advantages, the Evolut PRO TAVR System is designed with an added outer layer, a porcine pericardial skirt. The clinical study will evaluate the ability of the outer portion of the device to further improve paravalvular leakage around the implant. Because the procedure is not as invasive for the patient, physicians may be able to treat more complex patient cases, and many will leave the hospital more quickly.
“As pioneers in the field of cardiac surgery for several decades, NYU Langone’s national reputation for excellence only continues to grow as we strive to advance new minimally invasive treatments for patients,” says Aubrey C. Galloway, MD, the Seymour Cohn Professor of Cardiothoracic Surgery and chair of the Department of Cardiothoracic Surgery. “Treating aortic stenosis in patients who likely could not undergo open-heart surgery is one of our strongest areas of expertise, as our surgeons have done thousands of TAVR procedures. As one of the few medical centers enrolling patients in TAVR clinical trials, this research represents our dedication to bringing the newest, most advanced technologies to patients that will lead to the most successful outcomes.”
The Heart Valve Center has one of the most diverse and innovative programs in the country to treat aortic valve diseases, which include aortic valve stenosis and both acute and chronic aortic valve regurgitation. Our doctors have world-renowned expertise in valve repair, minimally invasive procedures, robotic-assisted surgery, and transcatheter treatments. With decades of experience in treating these conditions, our surgeons have pioneered many of the heart valve treatments that are the current standard of care. Our doctors work closely with each patient to help explain and simplify how each procedure works, and to determine the right course of care that will lead to the most successful outcomes.
The team at NYU Langone leading these clinical trials in addition to Dr. Williams includes Cezar Staniloae, MD, Peter Neuberger, MD, and Mohammed Saric, MD.