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Transcatheter Aortic Valve Replacement

Abstract

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Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study Prognostic implications of baseline 6‐min walk test performance in intermediate risk patients undergoing transcatheter aortic valve replacement 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 Low Transvalvular Flow Rate Predicts Mortality in Patients With Low-Gradient Aortic Stenosis Following Aortic Valve Intervention Comparison of Safety and Periprocedural Complications of Transfemoral Aortic Valve Replacement Under Local Anaesthesia: Minimalist Versus Complete Heart Team Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Implantation
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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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