NYU Winthrop Hospital’s world-class cardiology program positioned the hospital as an ideal place to study a revolutionary heart procedure, transcatheter aortic valve replacement (TAVR), and now, thanks to its success, NYU Winthrop Hospital has entered the third phase of a study that could lead to a life-changing new alternative for low-risk patients with aortic valve stenosis.
NYU Winthrop began offering TAVR for high-risk cases of severe aortic stenosis—a subset of patients who previously had no other hope for curative therapy—in February 2012, following its approval by the U.S. Food and Drug Administration (FDA) in November 2011. Aortic valve stenosis is a chronic condition in which the aortic valve does not open properly, hindering the flow of blood from the heart to the rest of the body. Prior to TAVR, the traditional primary treatment for aortic valve stenosis was open heart surgery, in which the old valve was removed and replaced with a new valve.
TAVR employs a newly designed valve to take over for the diseased valve, which can be placed in the heart without standard open heart surgery. Out of thousands of hospitals around the country, only those hospitals with the highest level of cardiac care were selected to perform this new, lifesaving procedure, and NYU Winthrop was selected as one out of approximately 70 hospitals nationwide to receive the new TAVR technology. Since starting the program in 2012, NYU Winthrop has performed more than 800 minimally invasive TAVR procedures.
Thanks to NYU Winthrop’s success performing the procedure, the hospital has recently expanded its renowned TAVR program into the third phase of a prestigious research study called the PARTNER trials. These trials have demonstrated the safety and effectiveness of the Edwards Sapien valve, which led to the FDA approval in November 2011, for the use of the Edwards Sapien valve in inoperable patients. The ongoing trials are helping to determine its suitability for lower risk patients. Earlier this year, NYU Winthrop completed its participation as one of the research sites for the PARTNER 2 trial, which studied intermediate risk.
“Now that intermediate risk is approved for commercial use, the next step is to decide whether the TAVR procedure has similar results in low-risk patients,” said Scott L. Schubach, MD, chairman of the Department of Thoracic and Cardiovascular Surgery at NYU Winthrop and the PARTNER 3 Trial, which is a randomized study. “NYU Winthrop can now provide the option to people who are low risk and want this technologically advanced treatment and new alternative.”
Dr. Schubach credits part of the hospital’s TAVR program’s success to its excellent research team, who not only take great medical care of patients, but meticulously record data, complete the necessary follow up work and criteria to enter the studies, and strictly adhere to protocols. This team includes Elizabeth Rerisi, MS, RN, clinical research coordinator; Kimberly Stepinowski, MS, RN, clinical research coordinator; and Mary Tercynski, RN, TAVR clinical coordinator.