Citation: American Heart Journal. 237:25-33, 2021 Mar 10..Journal: American heart journal.Published: ; 2021ISSN: 0002-8703.Full author list: Waksman R; Torguson R; Medranda GA; Shea C; Zhang C; Gordon P; Ehsan A; Wilson SR; Levitt R; Hahn C; Parikh P; Bilfinger T; Butzel D; Buchanan S; Hanna N; Buchbinder M; Asch F; Weissman G; Ben-Dor I; Shults C; Garcia-Garcia HM; Satler LF; Rogers T.UI/PMID: 33713618.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment(s): Advanced Cardiac Catheterization Research FellowshipActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1016/j.ahj.2021.03.006 (Click here)Abbreviated citation: Am Heart J. 237:25-33, 2021 Mar 10.Abstract: BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR.Abstract: METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR.Abstract: RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years.Abstract: CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure. Copyright (c) 2021 Elsevier Inc. All rights reserved.