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Bioprosthetic valve oversizing is associated with increased risk of valve thrombosis following TAVR Chimney technique in a TAVR-in-TAVR procedure with high risk of left main artery ostium occlusion The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week Increased Risk of Valvular Heart Disease in Systemic Sclerosis: An Underrecognized Cardiac Complication Aortic Valve Stenosis Treatment Disparities in the Underserved JACC Council Perspectives Coronary Access After TAVR
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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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