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The Core Value of Cost-Effectiveness Analyses ∗

05 Jan 2016

Over 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-year mortality 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 third-generation 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).

Click here to view the full article which appeared in Journal of the American College of Cardiology Current Issue