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TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.

by Waksman, Ron; Corso, Paul J; Torguson, Rebecca; Asch, Federico M; Weissman, Gaby; Ben-Dor, Itsik; Shults, Christian; Bastian, Roshni; Craig, Paige E; Ali, Syed; Garcia-Garcia, Hector M; Kolm, Paul; Zou, Quan; Satler, Lowell F; Rogers, Toby.
Citation: Jacc: Cardiovascular Interventions. 12(10):901-907, 2019 May 27..Journal: JACC. Cardiovascular interventions.Published: ; 2019ISSN: 1936-8798.Full author list: Waksman R; Corso PJ; Torguson R; Gordon P; Ehsan A; Wilson SR; Goncalves J; Levitt R; Hahn C; Parikh P; Bilfinger T; Butzel D; Buchanan S; Hanna N; Garrett R; Buchbinder M; Asch F; Weissman G; Ben-Dor I; Shults C; Bastian R; Craig PE; Ali S; Garcia-Garcia HM; Kolm P; Zou Q; Satler LF; Rogers T.UI/PMID: 30860059.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.jcin.2019.03.002 (Click here) Abbreviated citation: JACC Cardiovasc Interv. 12(10):901-907, 2019 May 27.Abstract: OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients.Abstract: BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement.Abstract: METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.Abstract: RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53).Abstract: CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.Abstract: Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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