1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve

Didier Tchétché (1) , Stephan Windecker (2) , Markus Kasel (3) , Ulrich Schaefer (4) , Stephen Worthley (5) , Axel Linke (6) , Mohamed Abdel-Wahab (7) , Hervé Le Breton (8, 9) , Lars Sondergaard (10) , Mark S. Spence (11) , Sonia Petronio (12) , Helmut Baumgartner (13) , Tomas Hovorka (14) , Philipp Blanke (15) , Hermann Reichenspurner (16)

1 Clinique Pasteur - Groupe Cardiovasculaire Interventionnel [Toulouse]
2 Inselspital - Bern University Hospital [Berne]
3 West German Heart Center
4 Department of Cardiology [Hamburg, Germany]
5 Royal Adelaide Hospital [Adelaide Australia]
6 TU Dresden - Technische Universität Dresden = Dresden University of Technology
7 Leipzig University / Universität Leipzig
8 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
9 LTSI - Laboratoire Traitement du Signal et de l'Image
10 Rigshospitalet [Copenhagen]
11 Royal Victoria Hospital [Belfast, UK]
12 Azienda Ospedaliero-Universitaria Pisana = Cisanello University Hospital [Pisa]
13 UKM - University Hospital Münster - Universitaetsklinikum Muenster [Germany]
14 Edwards Lifesciences [Prague, Czech Republic]
15 UBC - University of British Columbia
16 University Heart Center [Hamburg]

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 cm2, and no incidences of severe or moderate aortic regurgitation.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).

Mots clés: CENTERA THV; high-risk patients; transcatheter aortic valve implantation; self-expanding valve; aortic stenosis

Domaines: Ingénierie biomédicale

Didier Tchétché, Stephan Windecker, Markus Kasel, Ulrich Schaefer, Stephen Worthley, et al.. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC: Cardiovascular Interventions, 2019, 12 (7), pp.673-680. ⟨10.1016/j.jcin.2019.01.231⟩. ⟨hal-02115375⟩