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

by Ali, Syed; Asch, Federico M; Bastian, Roshni; Ben-Dor, Itsik; Corso, Paul J; Craig, Paige E; Garcia-Garcia, Hector M; Kolm, Paul; Rogers, Toby; Satler, Lowell F; Shults, Christian; Torguson, Rebecca; Waksman, Ron; Weissman, Gaby; Zou, Quan.
Citation: ; Jacc: Cardiovascular Interventions. 12(10):901-907, 2019 05 27..Journal: JACC. Cardiovascular interventions.Published: ; 2019; ISSN: 1936-8798.Full author list: Ali S; Asch F; Bastian R; Ben-Dor I; Bilfinger T; Buchanan S; Buchbinder M; Butzel D; Corso PJ; Craig PE; Ehsan A; Garcia-Garcia HM; Garrett R; Goncalves J; Gordon P; Hahn C; Hanna N; Kolm P; Levitt R; Parikh P; Rogers T; Satler LF; Shults C; Torguson R; Waksman R; Weissman G; Wilson SR; Zou Q.UI/PMID: 30860059.Subject(s): Aged | United States | Treatment Outcome | Trauma Severity Indices | *Transcatheter Aortic Valve Replacement | Transcatheter Aortic Valve Replacement/mo [Mortality] | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | Time Factors | Risk Factors | Risk Assessment | Recovery of Function | Prospective Studies | Postoperative Complications/et [Etiology] | Male | Humans | Hemodynamics | Female | Feasibility Studies | *Aortic Valve Stenosis/su [Surgery] | Aortic Valve Stenosis/pp [Physiopathology] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve Stenosis/dg [Diagnostic Imaging] | *Aortic Valve/su [Surgery] | Aortic Valve/pp [Physiopathology] | Aortic Valve/dg [Diagnostic Imaging]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: (Click here) Abbreviated citation: ; JACC Cardiovasc Interv. 12(10):901-907, 2019 05 27.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: 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.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: 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: 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).

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