1-year outcomes with the evolut r ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
1-year outcomes with the evolut r self-expanding transcatheter aortic valve: from the international forward study
Author(s) :
Manoharan, Ganesh [Auteur]
Royal Victoria Hospital
Van Mieghem, Nicolas M. [Auteur]
Erasmus University Medical Center [Rotterdam] [Erasmus MC]
Windecker, Stephan [Auteur]
Bern University Hospital [Berne] [Inselspital]
Bosmans, Johan [Auteur]
Antwerp University Hospital [Edegem] [UZA]
Bleiziffer, Sabine [Auteur]
West German Heart Center
Modine, Thomas [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Linke, Axel [Auteur]
University Hospital Leipzig = Universitätsklinikum Leipzig
Scholtz, Werner [Auteur]
Chevalier, Bernard [Auteur]
Gooley, Robert [Auteur]
Zeng, Cathy [Auteur]
Oh, Jae K. [Auteur]
Mayo Clinic [Rochester]
Grube, Eberhard [Auteur]
Universität Bonn = University of Bonn
Royal Victoria Hospital
Van Mieghem, Nicolas M. [Auteur]
Erasmus University Medical Center [Rotterdam] [Erasmus MC]
Windecker, Stephan [Auteur]
Bern University Hospital [Berne] [Inselspital]
Bosmans, Johan [Auteur]
Antwerp University Hospital [Edegem] [UZA]
Bleiziffer, Sabine [Auteur]
West German Heart Center
Modine, Thomas [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Linke, Axel [Auteur]
University Hospital Leipzig = Universitätsklinikum Leipzig
Scholtz, Werner [Auteur]
Chevalier, Bernard [Auteur]
Gooley, Robert [Auteur]
Zeng, Cathy [Auteur]
Oh, Jae K. [Auteur]
Mayo Clinic [Rochester]
Grube, Eberhard [Auteur]
Universität Bonn = University of Bonn
Journal title :
JACC. Cardiovascular interventions
Abbreviated title :
JACC Cardiovasc Interv
Volume number :
11
Pages :
2326-2334
Publication date :
2018-11-26
ISSN :
1876-7605
English keyword(s) :
transcatheter aortic valve implantation
transfemoral
FORWARD
self-expanding valve
transcatheter aortic valve replacement
transfemoral
FORWARD
self-expanding valve
transcatheter aortic valve replacement
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, ...
Show more >This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).Show less >
Show more >This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
CNRS
Inserm
Université de Lille
CNRS
Inserm
Université de Lille
Collections :
Research team(s) :
Troubles cognitifs dégénératifs et vasculaires
Submission date :
2019-11-27T13:38:32Z
2020-03-02T17:04:00Z
2020-03-02T17:04:00Z