1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Australia
Bioprosthesis
Europe
Female
Heart Valve Prosthesis
Humans
Male
New Zealand
Postoperative Complications
/ mortality
Prospective Studies
Prosthesis Design
Recovery of Function
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
CENTERA THV
aortic stenosis
high-risk patients
self-expanding valve
transcatheter aortic valve implantation
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
08 04 2019
08 04 2019
Historique:
received:
30
09
2018
revised:
30
12
2018
accepted:
11
01
2019
entrez:
6
4
2019
pubmed:
6
4
2019
medline:
17
6
2020
Statut:
ppublish
Résumé
The purpose of this study is to report the 1-year results of the CENTERA-EU trial. The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve. Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee. Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).
Sections du résumé
OBJECTIVES
The purpose of this study is to report the 1-year results of the CENTERA-EU trial.
BACKGROUND
The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve.
METHODS
Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee.
RESULTS
Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm
CONCLUSIONS
The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).
Identifiants
pubmed: 30947942
pii: S1936-8798(19)30387-5
doi: 10.1016/j.jcin.2019.01.231
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02458560']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
673-680Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.