Treatment for valvular heart disease has changed dramatically in recent years — more than almost any other area of cardiovascular medicine. In 2017 the number of minimally invasive, transcatheter aortic valve replacement (TAVR) procedures performed in the U.S. surpassed the number of surgical interventions for the first time. Led by researchers at Yale, emerging evidence published last month in JACC: Cardiovascular Interventions evaluates the safety and efficacy of TAVR in patients with bicuspid aortic valve stenosis.
In support of these findings, the U.S. Food & Drug Administration (FDA) approved revised commercial labeling for TAVR medical devices. The updated guidelines offer the potential for a less-invasive treatment for thousands of patients across the U.S.
Located on the left side of the heart, the aortic valve acts as a portal between the left ventricle and the aorta. Bicuspid aortic stenosis (AS) is an abnormality that develops before birth, resulting in the patient having two valve leaflets instead of three. Patients with bicuspid aortic valves are more likely to develop problems with their valve as compared to patients with a trileaflet aortic valve. Until recently it was felt that the best option for patients with bicuspid aortic valve stenosis was surgical aortic valve replacement (SAVR).
Led by John Forrest, MD, the Yale Structural Heart Program has been at the forefront of clinical research in the areas of valvular heart disease leading international transcatheter structural studies. As the program director for both the Interventional Cardiology and the Structural Heart Disease Programs at Yale, Forrest has led work to advance patient care and treatment options in the area of structural heart disease interventions. These new advancements have the potential to improve patient outcomes while decreasing procedural risks and hospital length of stay for patients.
A landmark study in JACC: Cardiovascular Interventions explored data from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, focusing on patients with severe AS and bicuspid aortic valve disease who underwent TAVR. A related press release highlights recent data from this patient population. “Clinical outcomes generated to date through the TVT Registry and the Low Risk Bicuspid Trial have shown that the Evolut TAVR system achieves favorable early results for patients with bicuspid aortic valve disease,” said Forrest, who served as the principal investigator.
One of these studies compared outcomes in patients with bicuspid valve disease from July 2015 to September 2018. One year after the TAVR procedure, bicuspid and tricuspid patients had similar mortality rates. “The updated labeling is indicative of the progress that has been made to find minimally invasive treatment options for this particular group of patients with severe AS and should be part of the decision process made by heart teams evaluating patients with bicuspid aortic stenosis,” said Forrest.
The second study, co-authored by Abeel Mangi MD, MBA, FACS, FACC, evaluated the safety of repositioning with Medtronic’s self-expanding valves in patients implanted with TAVR between June 2016 and November 2018. The Evolut R and Evolut PRO therapeutic devices can be recaptured if needed. Procedures with valve repositioning and those without were divided into groups. The results of the comparison showed no difference in mortality, stroke, and other complications after 30 days and one year. However, researchers said longer-term data is needed to further evaluate the safety measures. The effect of repositioning in lower-risk patients is also unknown.
TAVR at Yale
Non-invasive catheter-based interventions have rapidly evolved. In ten years, the Yale Structural Heart Program has risen as a national leader TAVR procedures. Today, Yale performs more transcatheter structural procedures than any center in New England. The program relies on a shared-decision making process between patients and a multidisciplinary clinical team that includes experts in heart failure specialists, interventional cardiologists, echocardiographers, and cardiac surgeons to tailor patient-specific interventions.