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Transcatheter aortic-valve replacement with a self-expanding prosthesis Late kidney injury after transcatheter aortic valve replacement Frailty and Bleeding in Older Adults Undergoing TAVR or SAVR: Insights From the FRAILTY-AVR Study Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk Clinical Impact of Valvular Heart Disease in Elderly Patients Admitted for Acute Coronary Syndrome: Insights From the Elderly-ACS 2 Study
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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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