TY - BOOK AU - Ali, Syed AU - Asch, Federico M AU - Bastian, Roshni AU - Ben-Dor, Itsik AU - Corso, Paul J AU - Craig, Paige E AU - Garcia-Garcia, Hector M AU - Kolm, Paul AU - Rogers, Toby AU - Satler, Lowell F AU - Shults, Christian AU - Torguson, Rebecca AU - Waksman, Ron AU - Weissman, Gaby AU - Zou, Quan TI - TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial SN - 1936-8798 PY - 2019/// KW - *Aortic Valve Stenosis/su [Surgery] KW - *Aortic Valve/su [Surgery] KW - *Transcatheter Aortic Valve Replacement KW - Aged KW - Aortic Valve Stenosis/dg [Diagnostic Imaging] KW - Aortic Valve Stenosis/mo [Mortality] KW - Aortic Valve Stenosis/pp [Physiopathology] KW - Aortic Valve/dg [Diagnostic Imaging] KW - Aortic Valve/pp [Physiopathology] KW - Feasibility Studies KW - Female KW - Hemodynamics KW - Humans KW - Male KW - Postoperative Complications/et [Etiology] KW - Prospective Studies KW - Recovery of Function KW - Risk Assessment KW - Risk Factors KW - Time Factors KW - Transcatheter Aortic Valve Replacement/ae [Adverse Effects] KW - Transcatheter Aortic Valve Replacement/mo [Mortality] KW - Trauma Severity Indices KW - Treatment Outcome KW - United States KW - MedStar Heart & Vascular Institute KW - Journal Article N2 - 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; 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; Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved; 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; 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; 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) UR - https://dx.doi.org/10.1016/j.jcin.2019.03.002 ER -