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Considerations for Optimal Device Selection in Transcatheter Aortic Valve Replacement: A Review Cardiovascular Magnetic Resonance as a complementary method to Transthoracic Echocardiography for Aortic Valve Area Estimation in patients with Aortic Stenosis: A systematic review and meta-analysis Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis Why and How to Measure Aortic Valve Calcification in Patients With Aortic Stenosis The Year in Cardiovascular Medicine 2020: Valvular Heart Disease: Discussing the Year in Cardiovascular Medicine for 2020 in the field of valvular heart disease is Professor Helmut Baumgartner and Dr Javier Bermejo. Mark Nicholls reports Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement Delirium After TAVR: Crosspassing the Limit of Resilience Transcatheter Aortic Valve Implantation Represents an Anti-Inflammatory Therapy Via Reduction of Shear Stress-Induced, Piezo-1-Mediated Monocyte Activation 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial Right ventricular function and outcome in patients undergoing transcatheter aortic valve replacement
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Review ArticleVolume 76, Issue 8, August 2020

JOURNAL：J Am Coll Cardiol. Article Link

Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week

S Kaul. Keywords: clinical trials; guidelines; evidence;TAVR; SAVR

ABSTRACT

On August 16, 2019, the U.S. Food and Drug Administration approved expanding the indication for transcatheter aortic valve replacement (TAVR) to low-risk patients with symptomatic severe aortic stenosis. The decision was based on the results of 2 pivotal trials that confirmed superiority (PARTNER [Placement of Aortic Transcatheter Valves] 3) or noninferiority (Evolut Low Risk [LR]) of TAVR as compared with SAVR at 1- and 2-year follow-up, respectively. As compared with intermediate-risk cohorts, the sample size in these trials was smaller and the total number of primary endpoint events was nearly 3 times as low (193 vs. 615). The total number of deaths from any cause or disabling stroke at 1 year in the low-risk cohorts was 62, which is substantially lower than the numbers in intermediate-, high-, and inoperable-risk cohorts. In Evolut LR, only 137 of 1,403 patients (9.8%) completed the 2-year follow-up, with 91.2% requiring model-based imputation. Thus, the quantum of evidence is insufficient for endorsing TAVR as the preferred intervention for these patients.
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