Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial.

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Citation: American Heart Journal. 237:25-33, 2021 07.PMID: 33713618Institution: MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Advanced Cardiac Catheterization Research FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Aortic Valve/su [Surgery] | *Heart Valve Prosthesis | *Hemodynamics/ph [Physiology] | *Transcatheter Aortic Valve Replacement/mt [Methods] | Aged | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve Stenosis/pp [Physiopathology] | Aortic Valve/dg [Diagnostic Imaging] | Echocardiography | Feasibility Studies | Female | Fluoroscopy | Follow-Up Studies | Humans | Male | Prospective Studies | Prosthesis Design | Risk Factors | Severity of Illness Index | Time Factors | Treatment OutcomeYear: 2021ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR.CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure. Copyright (c) 2021 Elsevier Inc. All rights reserved.METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR.RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years.All authors: Asch F, Ben-Dor I, Bilfinger T, Buchanan S, Buchbinder M, Butzel D, Ehsan A, Garcia-Garcia HM, Gordon P, Hahn C, Hanna N, Levitt R, Medranda GA, Parikh P, Rogers T, Satler LF, Shea C, Shults C, Torguson R, Waksman R, Weissman G, Wilson SR, Zhang COriginally published: American Heart Journal. 237:25-33, 2021 Mar 10.Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: Date added to catalog: 2021-06-07
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Journal Article MedStar Authors Catalog Article 33713618 Available 33713618

BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR.

CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure. Copyright (c) 2021 Elsevier Inc. All rights reserved.

METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR.

RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years.

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