NYU Winthrop is among an elite group of institutions nationwide that has been invited to participate in the third phase of a prestigious research study using a minimally invasive procedure to treat patients with severe aortic heart valve stenosis – 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. Called PARTNER 2/Sapien 3, the trial continues the work of the PARTNER trial, the pivotal study which demonstrated the safety and effectiveness of the Edwards Sapien valve to study transcatheter aortic valve replacement, or TAVR, a procedure that enables patients with a severe aortic stenosis to receive a new heart valve without undergoing open-heart surgery. Thanks to a smaller, improved valve, the third generation of the study opens the procedure up to an even larger part of the population who previously would not have been eligible.
“This new technology – with the lowest profile valve-stent, different valve sizes and a cuff to prevent leaks after implantation – offers some exciting new advancements. This will allow more patients who have suffered with severe aortic stenosis for years to be treated while reducing potential complications associated with TAVR,” said Richard Schwartz, DO, Interventional Cardiologist and Director of Cardiovascular Outreach at NYU Winthrop, who is part of the TAVR team of physicians at NYU Winthrop that includes Scott Schubach, MD, Chairman of the Department of Thoracic and Cardiovascular Surgery; Kevin Marzo, MD, Chief of the Division of Cardiology; and John A. Goncalves, MD, Chief of the Division of Cardiothoracic Surgery.
For sufferers of aortic valve stenosis, as the heart works harder to pump enough blood through the smaller valve opening, the heart weakens, which can cause chest pain, heart palpitations, fatigue and heart murmur, and may even lead to heart failure. Traditionally, the primary treatment for aortic stenosis has been open surgery. However, until recently, certain patients with severe stenosis were considered too sick for surgery, and their conditions considered hopeless.
Using the Edwards Sapien valve, a team of physicians at NYU Winthrop are able to replace a patient’s aortic valve without open-heart surgery by inserting the valve through an artery in the groin and advancing it into the heart using a catheter. The valve is then expanded with a balloon and immediately functions in place of the patient’s own valve. In the trial’s third phase, the sheath size of the catheter is significantly smaller and the improved valve possesses an extra flap of tissue to prevent leakage.
In early 2012, NYU Winthrop became one of only approximately 70 centers in the United States to offer this procedure (following FDA Approval in November 2011), and is one of the first 20 centers in the United States and Canada to be selected for Sapien 3. It is currently the only hospital on Long Island participating in the third trial. Since beginning its TAVR program, NYU Winthrop has completed a total of 175 procedures. The second phase closed in mid-October, and NYU Winthrop’s success with this procedure led to its selection for the third phase.
“The team at NYU Winthrop has been one of the national leaders in Transcatheter Valve Implantation and has been involved in pioneering new valve designs and broadening the criteria for the procedure. We are ranked in the top 20 hospitals nationwide for number of implants with excellent outcomes, and patients can feel comfortable coming to NYU Winthrop for this procedure knowing that our Hospital and team are the most experienced in the region,” said Dr. Schwartz.
To qualify for this study, patients need to be diagnosed with severe symptomatic aortic stenosis and must be considered high risk or considered inoperable for standard aortic valve replacement.
For additional information about the TAVR trial at NYU Winthrop, call 1-866-WINTHROP.