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Poor Long-Term Survival in Patients With Moderate Aortic Stenosis Timing of intervention in asymptomatic patients with valvular heart disease Meta-Analysis of Effectiveness and Safety of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Low-to-Intermediate Surgical Risk Cohort Prevalence and clinical implications of valvular calcification on coronary computed tomography angiography Precision Medicine in TAVR: How to Select the Right Device for the Right Patient Association of Smoking Status With Long‐Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry Expert Recommendations on Cardiac Computed Tomography for Planning Transcatheter Left Atrial Appendage Occlusion Prognostic implications of baseline 6‐min walk test performance in intermediate risk patients undergoing transcatheter aortic valve replacement Comparison of safety and periprocedural complications of transfemoral aortic valve replacement under local anaesthesia: minimalist versus complete Heart Team 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
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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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