The PARTNER 3 Trial at 2 Years: What We've Learned and What Time Will Tell
Based on data from large, industry-sponsored randomized prospective studies, the United States Food and Drug Administration (FDA) has approved both balloon-expandable and self-expanding transcatheter aortic valve replacement (TAVR) devices for use in aortic stenosis patients at low, intermediate and high-risk for surgical aortic valve replacement (SAVR).1-6 High-risk device approval was based on 1-year data, which was reasonable due to the actuarial life expectancies of the cohort.1, 2 Intermediate-risk approval for the balloon-expandable Sapien XT (Edwards Lifesciences, Irvine, California) system was largely based on data from the Placement of AoRTic TraNscathetER Valves (PARTNER) 2 trial, which reported a primary endpoint of death or disabling stroke at 2 years.
Source: Journal of Cardiothoracic and Vascular Anesthesia - Category: Anesthesiology Authors: Peter J. Neuburger, Kinjal M. Patel, Prakash A. Patel Source Type: research
More News: Anesthesia | Anesthesiology | Aortic Stenosis | Cardiology | Food and Drug Administration (FDA) | Heart | Heart Valve Surgery | Stroke | Study | USA Health