Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes.

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Citation: Circulation: Cardiovascular Interventions. 16(5):e012655, 2023 May.PMID: 37192308Institution: MedStar Health Research Institute | MedStar Heart & Vascular Institute | MedStar Washington Hospital CenterDepartment: Interventional Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter StudySubject headings: *Aortic Valve Stenosis | *Heart Valve Prosthesis | *Stroke | *Thrombosis | *Transcatheter Aortic Valve Replacement | Aortic Valve Stenosis/co [Complications] | Aortic Valve Stenosis/dg [Diagnostic Imaging] | Aortic Valve Stenosis/su [Surgery] | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Heart Valve Prosthesis/ae [Adverse Effects] | Hemodynamics | Humans | Prospective Studies | Risk Factors | Stroke/et [Etiology] | Stroke/su [Surgery] | Thrombosis/et [Etiology] | Treatment Outcome | Year: 2023Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-7640
Name of journal: Circulation. Cardiovascular interventionsAbstract: BACKGROUND: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years.CLINICALTRIALS: gov; Unique identifier: NCT02628899.CONCLUSIONS: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years.METHODS: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years.REGISTRATION: URL: https://www.RESULTS: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56+/-5.54 mm Hg and aortic valve area 1.69+/-0.52 cm2) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94+/-5.01 mm Hg versus 12.3+/-5.57 mm Hg; P=0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years.All authors: Ali S, Asch FM, Ben-Dor I, Bhogal S, Bilfinger T, Buchbinder M, Ehsan A, Garcia-Garcia HM, Gordon P, Hanna N, Kim FY, Levitt R, Parikh P, Rogers T, Satler LF, Shea C, Shults CC, Sutton JA, Waksman R, Weissman G, Wilson SR, Zhang CFiscal year: FY2023Digital Object Identifier: Date added to catalog: 06/01/2023
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Available online from MWHC library: 2008 - present

BACKGROUND: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years.

CLINICALTRIALS: gov; Unique identifier: NCT02628899.

CONCLUSIONS: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years.

METHODS: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years.

REGISTRATION: URL: https://www.

RESULTS: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56+/-5.54 mm Hg and aortic valve area 1.69+/-0.52 cm2) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94+/-5.01 mm Hg versus 12.3+/-5.57 mm Hg; P=0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years.

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