Clinical outcomes with a repositionable ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Clinical outcomes with a repositionable self-expanding transcatheter aortic valve prosthesis the international forward study
Author(s) :
Grube, Eberhard [Auteur]
Van Mieghem, Nicolas M. [Auteur]
Bleiziffer, Sabine [Auteur]
Modine, Thomas [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U1171
Bosmans, Johan [Auteur]
Manoharan, Ganesh [Auteur]
Linke, Axel [Auteur]
Scholtz, Werner [Auteur]
Tchetche, Didier [Auteur]
Finkelstein, Ariel [Auteur]
Trillo-Nouche, Ramiro [Auteur]
Fiorina, Claudia [Auteur]
Walton, Antony [Auteur]
Malkin, Christopher J. [Auteur]
Oh, Jae K. [Auteur]
Qiao, Hongyan [Auteur]
Windecker, Stephan [Auteur]
Van Mieghem, Nicolas M. [Auteur]
Bleiziffer, Sabine [Auteur]
Modine, Thomas [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U1171
Bosmans, Johan [Auteur]
Manoharan, Ganesh [Auteur]
Linke, Axel [Auteur]
Scholtz, Werner [Auteur]
Tchetche, Didier [Auteur]
Finkelstein, Ariel [Auteur]
Trillo-Nouche, Ramiro [Auteur]
Fiorina, Claudia [Auteur]
Walton, Antony [Auteur]
Malkin, Christopher J. [Auteur]
Oh, Jae K. [Auteur]
Qiao, Hongyan [Auteur]
Windecker, Stephan [Auteur]
Journal title :
Journal of the American College of Cardiology
Abbreviated title :
J. Am. Coll. Cardiol.
Volume number :
70
Pages :
845-853
Publication date :
2017-08-15
ISSN :
0735-1097
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
BACKGROUND: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.
OBJECTIVE: This study sought to document the clinical ...
Show more >BACKGROUND: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. OBJECTIVE: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. METHODS: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. CONCLUSIONS: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).Show less >
Show more >BACKGROUND: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. OBJECTIVE: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. METHODS: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. CONCLUSIONS: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (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 :
2019-11-27T14:29:05Z