• Didier Tchétché, Stephan Windecker, A Markus Kasel, Ulrich Schaefer, Stephen Worthley, Axel Linke, Mohamed Abdel-Wahab, Herve Le Breton, Lars Søndergaard, Mark S Spence, Sonia Petronio, Helmut Baumgartner, Tomas Hovorka, Philipp Blanke, and Hermann Reichenspurner.
• Groupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France. Electronic address: d.tchetche@clinique-pasteur.com.
• JACC Cardiovasc Interv. 2019 Apr 8; 12 (7): 673-680.

ObjectivesThe purpose of this study is to report the 1-year results of the CENTERA-EU trial.BackgroundThe 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.MethodsImplantations 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.ResultsBetween 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.ConclusionsThe 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).Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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