The Core Value of Cost-Effectiveness Analyses.

O ver the past 4 years, transcatheter aortic valve replacement (TAVR) has transformed the cardiac care of patients in the United States with severe aortic stenosis (SAS). In September 2011, a balloon-expandable prosthesis (Sapien, Edwards Lifesciences, Irvine, California) received U.S. Food and Drug Administration (FDA) approval for the treatment of inoperable patients on the basis of a randomized trial showing improved 1-year mortality (50.7% vs. 30.7%) (1). This indication was extended in September 2012 to high-risk patients after another randomized trial showed similar 1-yearmortality in patients receiving TAVR and surgical aortic valve replacement (SAVR)—24.2% and 26.8%, respectively (2). This device has been enhanced, leading to a most recent FDA approval in June 2015 of the thirdgeneration balloon-expandable valve (3). In January 2014, the FDA also approved a self-expanding prosthesis (CoreValve, Medtronic, Dublin, Ireland) for TAVR on the basis of nonrandomized data in patients who were at prohibitive surgical risk (4).