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Winthrop Enters Phase II TAVR Trial for Patients with Severe Aortic Stenosis - Archived
April 25, 2013

Winthrop-University Hospital has been invited to participate in the second phase of a 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 the PARTNER II Trial, the trial is studying 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.

Using the Edwards Sapien valve, physicians are able to replace a patient’s aortic valve without open-heart surgery by inserting the aortic valve through an artery in the groin and advancing it into the heart using a catheter. Then the valve is expanded with a balloon and immediately functions in place of the patient’s own valve.

Winthrop-University Hospital is currently the only hospital on Long Island participating in the PARTNER II trial. The TAVR team at Winthrop is comprised of a multidisciplinary team of physicians, including Scott Schubach, MD, Chairman of the Department of Thoracic and Cardiovascular Surgery; Kevin Marzo, MD, Chief of the Division of Cardiology; John A. Goncalves, MD, Chief of the Division of Cardiothoracic Surgery; and Richard Schwartz, DO, Interventional Cardiologist and Director of Cardiovascular Outreach.

Since beginning its TAVR program, Winthrop has completed nearly 100 TAVR procedures and is currently one of the most experienced programs in the region, making it an excellent resource in the PARTNER II trial.

The PARTNER II trial is the follow-up trial to the PARTNER Trial, the pivotal study which demonstrated the safety and effectiveness of the Edwards Sapien valve in patients with severe aortic stenosis who were not candidates for open heart surgery. This led to FDA approval in November 2011 for the use of the Edwards Sapien valve in inoperable patients. Winthrop was selected by Edwards to be part of this FDA-approved program and began implanting the Edwards Sapien valve in February 2012.

The PARTNER II trial is designed to study the second generation valve, called the Sapien XT, and its delivery system, called NovaFlex. The Sapien XT has a smaller profile than the Sapien valve. The smaller profile may allow patients who were previously ineligible for the transfemoral approach to now be candidates for TAVR. In the PARTNER II trial, the Sapien XT valve and its delivery system are being compared to standard aortic valve replacement for intermediate-risk surgical patients. The Edwards Sapien valve is FDA approved for non-operative and/or high-risk surgical patients only.

To qualify for this study, patients must be diagnosed with severe, symptomatic aortic stenosis and must be considered intermediate risk or contraindicated for open heart surgery. The Heart and Vascular Institute at Winthrop has established a valve service where patients can be evaluated by a team of cardiologists and cardiothoracic and vascular surgeons. They are then followed collaboratively by both the Winthrop team and their regular physician. For more information, call 1-866-WINTHROP.

About Aortic Stenosis Aortic stenosis is a severe, 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. This causes the heart to work harder to push blood through the aortic valve and eventually the heart's muscles weaken, increasing the patient's risk of heart failure.

About TAVR TAVR is the name for a new, revolutionary procedure in cardiology and cardiac surgery that enables patients with a condition called severe aortic stenosis to receive a new heart valve without undergoing open-heart surgery. Traditionally, the primary treatment for aortic stenosis has been surgery. However, certain patients with severe stenosis were considered too sick for surgery. Therefore, their conditions were considered hopeless.

As a result of a pivotal new Partner Trial, the FDA has approved the use of the Edwards’ Transcatheter Heart Valve, which utilizes a minimally invasive procedure to implant a new valve using a method very similar to the implantation of a stent. Therefore, these patients can now receive a new valve without surgery and there is now hope for those whose conditions were previously thought to be untreatable.

Winthrop-University Hospital has been selected as only one of 70 hospitals nationwide to receive this new technology, and our skilled team of interventional cardiologists and cardio-thoracic surgeons is in place to offer this exciting new treatment to those for whom it is appropriate. Out of the thousands of hospitals around the country, only those hospitals with the highest level of cardiac care were selected to perform this new, life-saving procedure.

About Winthrop Founded in 1896 as Long Island’s first voluntary hospital, Winthrop-University Hospital is a major healthcare provider with a deep commitment to medical education and research. A regional healthcare resource committed to the dignity and well being of every patient, the Hospital has over a century of experience providing high quality, comprehensive healthcare services. The Hospital has received prestigious accreditations including its New York State (NYS) Regional Perinatal Center (RPC) and the NYS Department of Health-Designated Stroke Center. Additionally, Winthrop-University Hospital is a NYS-designated Regional Trauma Center and its cardiac care services have been consistently recognized by New York State for its quality outcomes.

Contact: Carolann Martines
Associate Writer
(516) 663-2234