Yale New Haven Hospital first in the United States to use Corevalve™ EVOLUT™ Pro transcatheter valve with advanced sealing

New Self-Expanding, Recapturable Heart Valve for high risk patients

NEW HAVEN, CT—April 3, 2017—The Heart and Vascular Center at Yale New Haven Hospital (YNHH) announced it is was first center in the United States to perform a commercial implant of the newly FDA approved CoreValve™ Evolut™ PRO transcatheter aortic valve (TAVR) for the treatment of severe aortic stenosis.  

Aortic stenosis is a condition in which the valve which controls the flow of blood from the heart to the aorta and rest of the body becomes narrowed.  This condition can result in heart failure and if not treated appropriately even death.  Over the past decade Yale New Haven Hospital has been nationally recognized as a leader in cardiovascular care and innovation. The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance.  

FDA approval for this new valve came after recent data presented at the American College of Cardiology (ACC) Meeting showed high survival, low rates of stroke, minimal paravalvular leak and excellent hemodynamics.  This data was presented by Dr. John K. Forrest who served as the national Principal Investigator for the study.  

“The Evolut Pro Valve represents the next step forward in transcatheter aortic valve replacement,” said Dr. John K. Forrest, Director of the Structural Heart Disease Program and Assistant Professor of Medicine at Yale.  “Over the past 10 years we have been able to refine and optimize these transcatheter valves to deliver a therapy that has now been shown to be advantageous treatment option for a patient with severe aortic stenosis.”    

The new system preserves and maintains the key advantages of the Evolut R, namely, being recapturable and repositionable, securing and safeguarding placement and control accuracy during the procedure. In addition to these advantages, the Evolut PRO TAVR System is designed with an added outer layer, a porcine pericardial skirt. The CoreValve™ Evolut™ PRO valve is a next evolution transcatheter aortic valve featuring an advanced design to help with valve sealing performance to address the occurrence of blood leaking through the sides of the valve. 
"The Outstanding work by Dr. Forrest and his colleagues in our Structural Heart Disease Program at Yale New Haven is illustrated by their leadership in this vital area of new technology assessment and the expansion of therapeutic options for patients with severe valvular disease,” said Keith Churchwell, MD, senior vice-president and executive director for cardiovascular services at Yale New Haven Health. “Our team within the Heart and Vascular Center are on the leading edge on how patients will be treated for severe aortic stenosis and this milestone is a tribute to their great vision and hard work."

Approved by the U.S. Food and Drug Administration in March 2017, the self-expanding device is intended to treat patients with severe aortic stenosis who are considered at high or extreme risk for open-heart surgery. The procedure is not as invasive for the patient, allowing physicians to possibly to treat more complex patient cases with many patients being discharged home sooner. The EnVeo R system features an InLine Sheath that makes it the lowest delivery platform currently on the market. It also provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. 

"Under Dr. Forrest's leadership our YNHH HVC valve program has become a national leader in the field providing our patients with state of the art care often before it is available elsewhere",” said Henry S. Cabin, MD, medical director, Yale New Haven Hospital Heart and Vascular Center and professor of medicine and Interim chief, cardiovascular medicine at the Yale University School of Medicine.