TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.
JACC Cardiovasc Interv
; 12(10): 901-907, 2019 05 27.
Article
em En
| MEDLINE
| ID: mdl-30860059
ABSTRACT
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.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.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.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).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.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Valva Aórtica
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Estenose da Valva Aórtica
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Substituição da Valva Aórtica Transcateter
Tipo de estudo:
Clinical_trials
/
Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article