TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial.

Aged Aortic Valve / diagnostic imaging Aortic Valve Stenosis / diagnostic imaging Feasibility Studies Female Hemodynamics Humans Male Postoperative Complications / etiology Prospective Studies Recovery of Function Risk Assessment Risk Factors Time Factors Transcatheter Aortic Valve Replacement / adverse effects Trauma Severity Indices Treatment Outcome United States

aortic stenosis hypoattenuated leaflet thickening low risk subclinical leaflet thrombosis transcatheter aortic valve replacement

Journal

JACC. Cardiovascular interventions

ISSN: 1876-7605

Titre abrégé: JACC Cardiovasc Interv

Pays: United States

ID NLM: 101467004

Informations de publication

Date de publication:
27 05 2019

Historique:

received: 31 01 2019

revised: 07 03 2019

accepted: 07 03 2019

pubmed: 13 3 2019

medline: 14 7 2020

entrez: 13 3 2019

Statut: ppublish

Résumé

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. 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. 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. 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). 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.

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.jcin.2019.03.002 PMID: 30860059

pubmed: 30860059

pii: S1936-8798(19)30656-9

doi: 10.1016/j.jcin.2019.03.002

pii:

doi:

Types de publication

Clinical Trial Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

901-907

Commentaires et corrections

Type : CommentIn