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The PARTNER 3 Trial at Two Years: What We Have Learned and What Time Will Tell
Based on data from large, industry-sponsored randomized prospective studies, the US 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 one-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, CA) system was based largely on data from the Placeme...
Source: Journal of Cardiothoracic and Vascular Anesthesia - May 28, 2021 Category: Anesthesiology Authors: Peter J. Neuburger, Kinjal M. Patel, Prakash A. Patel Tags: Editorial Source Type: research

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...
Source: Journal of Cardiothoracic and Vascular Anesthesia - May 28, 2021 Category: Anesthesiology Authors: Peter J. Neuburger, Kinjal M. Patel, Prakash A. Patel Source Type: research

Presentation on US Hospital Websites of Risks and Benefits of Transcatheter Aortic Valve Replacement Procedures
Adequate presentation of risks and benefits of medical therapies is essential to informed decision making by patients. Transcatheter aortic valve replacement (TAVR) has been recently approved by the US Food and Drug Administration for the treatment of severe aortic stenosis among carefully selected patients; recent randomized clinical trials have identified important positive and negative outcomes of TAVR in these populations, including twice the risk of stroke for patients undergoing TAVR vs those undergoing open aortic valve replacement. Since 78% of all adults in the United States seek out health information online, we ...
Source: JAMA Internal Medicine - January 12, 2015 Category: Internal Medicine Source Type: research