TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.
TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.
- 2019
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).
English
1936-8798
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Transcatheter Aortic Valve Replacement
Aged
Aortic Valve Stenosis/dg [Diagnostic Imaging]
Aortic Valve Stenosis/mo [Mortality]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Feasibility Studies
Female
Hemodynamics
Humans
Male
Postoperative Complications/et [Etiology]
Prospective Studies
Recovery of Function
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Trauma Severity Indices
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article
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).
English
1936-8798
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Transcatheter Aortic Valve Replacement
Aged
Aortic Valve Stenosis/dg [Diagnostic Imaging]
Aortic Valve Stenosis/mo [Mortality]
Aortic Valve Stenosis/pp [Physiopathology]
Aortic Valve/dg [Diagnostic Imaging]
Aortic Valve/pp [Physiopathology]
Feasibility Studies
Female
Hemodynamics
Humans
Male
Postoperative Complications/et [Etiology]
Prospective Studies
Recovery of Function
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/mo [Mortality]
Trauma Severity Indices
Treatment Outcome
United States
MedStar Heart & Vascular Institute
Journal Article