Based on strong evidence from randomized clinical trials and large registries, transcatheter aortic valve replacement (TAVR) has been enthusiastically embraced as a lifesaving and life-changing therapy for older, frail patients with severe aortic stenosis who are either inoperable or at high risk for conventional surgical aortic valve replacement (SAVR). Currently more than 200,000 patients worldwide have received such a valve, including >50,000 patients in U.S. pivotal trials with 1 of the 3 valves commercially approved by the Food and Drug Administration (FDA). These valves, Sapien XT and Sapien 3 (Edwards Lifesciences, Irvine, California) and CoreValve Evolut R (Medtronic, Inc., Minneapolis, Minnesota), have shown no significant clinical signal of early structural valve deterioration or valve thrombosis with follow-up to 5 years (1,2).
Leggi l'articolo sul Journal of the American College of Cardiology