TY  - BOOK
AU  - Asch, Federico M
AU  - Ben-Dor, Itsik
AU  - Craig, Paige
AU  - Garcia-Garcia, Hector M
AU  - Rogers, Toby
AU  - Ruiz, Daniel
AU  - Satler, Lowell F
AU  - Shults, Christian
AU  - Torguson, Rebecca
AU  - Waksman, Ron
AU  - Weissman, Gaby
AU  - Zhang, Cheng
TI  - Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis
SN  - 1936-8798
PY  - 2020///
KW  - *Aortic Valve Stenosis/su [Surgery]
KW  - *Aortic Valve/ab [Abnormalities]
KW  - *Heart Valve Diseases/co [Complications]
KW  - *Transcatheter Aortic Valve Replacement
KW  - Aged
KW  - Aortic Valve Stenosis/et [Etiology]
KW  - Aortic Valve Stenosis/mo [Mortality]
KW  - Aortic Valve Stenosis/pp [Physiopathology]
KW  - Aortic Valve/pp [Physiopathology]
KW  - Feasibility Studies
KW  - Female
KW  - Heart Valve Diseases/mo [Mortality]
KW  - Heart Valve Diseases/pp [Physiopathology]
KW  - Heart Valve Prosthesis
KW  - Hemodynamics
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Recovery of Function
KW  - Risk Assessment
KW  - Risk Factors
KW  - Severity of Illness Index
KW  - Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
KW  - Transcatheter Aortic Valve Replacement/is [Instrumentation]
KW  - Transcatheter Aortic Valve Replacement/mo [Mortality]
KW  - Treatment Outcome
KW  - United States
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online through MWHC library: 2008 - present
N2  - BACKGROUND: TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials; CONCLUSIONS: TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events. Copyright (c) 2020. Published by Elsevier Inc; METHODS: The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration-approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory; OBJECTIVES: The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS); RESULTS: Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days
UR  - https://dx.doi.org/10.1016/j.jcin.2020.02.008
UR  - https://dx.doi.org/10.1016/j.jcin.2020.02.008
ER  -