Author + information
- Received September 30, 2018
- Revision received December 30, 2018
- Accepted January 11, 2019
- Published online April 1, 2019.
- Didier Tchétché, MDa,∗ (, )
- Stephan Windecker, MDb,
- A. Markus Kasel, MDc,
- Ulrich Schaefer, MDd,
- Stephen Worthley, MDe,
- Axel Linke, MDf,
- Mohamed Abdel-Wahab, MDg,
- Herve Le Breton, MDh,i,j,
- Lars Søndergaard, MD, MSck,
- Mark S. Spence, MDl,
- Sonia Petronio, MDm,
- Helmut Baumgartner, MD, PhDn,
- Tomas Hovorka, MSco,
- Philipp Blanke, MDp and
- Hermann Reichenspurner, MD, PhDq
- aGroupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France
- bDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- cDepartment of Cardiovascular Diseases, German Heart Center, Munich, Germany
- dDepartment of Cardiology, Marienkrankenhaus, Hamburg, Germany
- eDepartment of Cardiovascular Medicine, Royal Adelaide Hospital, Adelaide, Australia
- fDepartment of Internal Medicine and Cardiology, Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden, Dresden, Germany
- gCardiology Department, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany
- hService de Cardiologie, CHU Rennes, Rennes, France
- iU1099, INSERM, Rennes, France
- jLTSI, Université de Rennes 1, Rennes, France
- kCardiology Department, Rigshospitalet, Copenhagen, Denmark
- lCardiology Department, Royal Victoria Hospital, Belfast, United Kingdom
- mCardiothoracic and Vascular Department, Ospedale di Cisanelo, Pisa, Italy
- nDepartment of Cardiology III: Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Münster, Germany
- oStatistics Department, Edwards Lifesciences, Prague, Czech Republic
- pDepartment of Radiology, University of British Columbia, Vancouver, Canada
- qDepartment of Cardiovascular Surgery, University Heart Center, Hamburg, Germany
- ↵∗Address for correspondence:
Dr. Didier Tchétché, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, 45 Avenue de Lombez, 31076 Toulouse Cedex 3, France.
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)
- aortic stenosis
- CENTERA THV
- high-risk patients
- self-expanding valve
- transcatheter aortic valve implantation
The CENTERA-EU trial is sponsored by Edwards Lifesciences. Dr. Tchétché has served as a consultant for Edwards Lifesciences. Dr. Windecker has received research, educational, and travel grants to his institution from Amgen, Abbott, Bayer, Biotronik, Bristol-Myers Squibb, Medtronic, Edwards Lifesciences, St. Jude Medical, and Terumo. Dr. Kasel is a proctor and consultant for Edwards Lifesciences and Medtronic. Dr. Schäefer has received research funding, travel support, and speaker honoraria, and consultant has served as a proctor for Edwards Lifesciences. Dr. Worthley has received research grants from Abbott and Biotronik. Dr. Linke is a consultant to Edwards Lifesciences, Boston Scientific, Medtronic, Abbott, Claret Medical, Bayer, AstraZeneca, and Transverse Medical (TMI); has stock options with Claret Medical, TMI, and Emboline; and speaker honoraria with Edwards Lifesciences, Boston Scientific, Medtronic, Abbott, AstraZeneca, Bayer, Novartis, and Abio Med. Dr. Abdel-Wahab has served as a proctor for Boston Scientific; has received institutional research grants from St. Jude Medical and Biotronik; and has received speaker honoraria from Edwards Lifesciences and Medtronic. Dr. Le Breton has served as a board member for Abbott and received lecture fees from Edwards Lifesciences. Dr. Søndergaard has served as a proctor for and received institutional grants from Edwards Lifesciences. Dr. Spence has received research funding, travel support, and speaker honoraria from Edwards Lifesciences; has served as a consultant for Abbott; and has served as a proctor for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Petronio has served as a consultant for Abbott, Medtronic, and Boston Scientific. Dr. Baumgartner has received speaker honoraria and congress travel support from Edwards Lifesciences and Actelion. Dr. Hovorka is an employee of Edwards Lifesciences. Dr. Blanke has served as a consultant to Edwards Lifesciences, Circle Imaging, Neovasc, and Tendyne. Dr. Reichenspurner has received speaker support and travel honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 30, 2018.
- Revision received December 30, 2018.
- Accepted January 11, 2019.
- 2019 The Authors