Feasibility of transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis: Rationale and design of the Low Risk TAVR (LRT) study.

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Citation: American Heart Journal. 189:103-109, 2017 JulPMID: 28625366Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleYear: 2017Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006MH - AgedMH - Aortic Valve Stenosis/di [Diagnosis]MH - *Aortic Valve Stenosis/su [Surgery]MH - EchocardiographyMH - Feasibility StudiesMH - FemaleMH - Follow-Up StudiesMH - HumansMH - MaleMH - Prospective StudiesMH - Risk FactorsMH - Severity of Illness IndexMH - Tomography, X-Ray ComputedMH - *Transcatheter Aortic Valve Replacement/mt [Methods]MH - Treatment OutcomeISSN:
  • 0002-8703
Name of journal: American Heart JournalAbstract: BACKGROUND: Safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis have not yet been established.Copyright 2017. Published by Elsevier Inc.DESIGN: The LRT study is the first US Food and Drug Administration-approved Investigational Device Exemption prospective multicenter feasibility trial of TAVR in low-risk patients. Patients determined to be low risk by the Heart Team will be enrolled to undergo TAVR with a commercially available balloon-expandable or self-expandable device. A propensity score-matched, site-specific cohort of historical surgical aortic valve replacement patients will serve as a control group treated during the site's enrollment period or within the prior 3 years. Low-risk patients with symptomatic bicuspid aortic stenosis undergoing TAVR will be enrolled into a separate registry arm. All TAVR patients will undergo 4-dimensional contrast-enhanced cardiac computed tomography 4-6 weeks after implantation to assess for subclinical leaflet thrombosis and will be followed up clinically for 5 years with yearly echocardiography to monitor prosthesis function.HYPOTHESIS: Transcatheter aortic valve replacement is feasible in patients with symptomatic severe aortic stenosis and low risk for surgical aortic valve replacement.SUMMARY: The LRT study will test feasibility of TAVR in low-risk patients with symptomatic severe aortic stenosis in the United States with either tricuspid or bicuspid native aortic valves. Enrollment commenced in 2016 and results are expected in 2018.All authors: Bastian R, Corso P, Rogers T, Torguson R, Waksman RFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-06-22
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 28625366 Available 28625366

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006MH - AgedMH - Aortic Valve Stenosis/di [Diagnosis]MH - *Aortic Valve Stenosis/su [Surgery]MH - EchocardiographyMH - Feasibility StudiesMH - FemaleMH - Follow-Up StudiesMH - HumansMH - MaleMH - Prospective StudiesMH - Risk FactorsMH - Severity of Illness IndexMH - Tomography, X-Ray ComputedMH - *Transcatheter Aortic Valve Replacement/mt [Methods]MH - Treatment Outcome

BACKGROUND: Safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis have not yet been established.

Copyright 2017. Published by Elsevier Inc.

DESIGN: The LRT study is the first US Food and Drug Administration-approved Investigational Device Exemption prospective multicenter feasibility trial of TAVR in low-risk patients. Patients determined to be low risk by the Heart Team will be enrolled to undergo TAVR with a commercially available balloon-expandable or self-expandable device. A propensity score-matched, site-specific cohort of historical surgical aortic valve replacement patients will serve as a control group treated during the site's enrollment period or within the prior 3 years. Low-risk patients with symptomatic bicuspid aortic stenosis undergoing TAVR will be enrolled into a separate registry arm. All TAVR patients will undergo 4-dimensional contrast-enhanced cardiac computed tomography 4-6 weeks after implantation to assess for subclinical leaflet thrombosis and will be followed up clinically for 5 years with yearly echocardiography to monitor prosthesis function.

HYPOTHESIS: Transcatheter aortic valve replacement is feasible in patients with symptomatic severe aortic stenosis and low risk for surgical aortic valve replacement.

SUMMARY: The LRT study will test feasibility of TAVR in low-risk patients with symptomatic severe aortic stenosis in the United States with either tricuspid or bicuspid native aortic valves. Enrollment commenced in 2016 and results are expected in 2018.

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