Hermann Reichenspurner1, Andreas Schaefer2, Ulrich Schäfer2, Didier Tchétché3, Axel Linke4, Mark S Spence5, Lars Søndergaard6, Hervé LeBreton7, Gerhard Schymik8, Mohamed Abdel-Wahab9, Jonathon Leipsic10, Darren L Walters11, Stephen Worthley12, Markus Kasel13, Stephan Windecker14. 1. Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany. Electronic address: reichenspurner@uke.de. 2. Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany. 3. Cardiologie Générale et Interventionelle, Clinique Pasteur, Toulouse, France. 4. Department of Internal Medicine/Cardiology, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany. 5. Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom. 6. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. 7. Centre cardio-pneumologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France. 8. Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Karlsruhe, Germany. 9. Department of Cardiology, Heart Center Bad Segeberg, Bad Segeberg, Germany. 10. Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. 11. Department of Cardiology, The Prince Charles Hospital, Chermside, Queensland, Australia. 12. Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia. 13. Department of Cardiology, German Heart Center Munich, Munich, Germany. 14. Department of Cardiology, Bern University Hospital (Inselspital), Bern, Switzerland.
Abstract
BACKGROUND: The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability. OBJECTIVES: The pivotal study evaluated safety and efficacy of this THV in high-surgical-risk study patients with severe symptomatic aortic stenosis. METHODS: Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories. The primary endpoint was all-cause mortality at 30 days. RESULTS: Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the THV (4.9% for patients at risk). CONCLUSIONS: The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).
BACKGROUND: The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability. OBJECTIVES: The pivotal study evaluated safety and efficacy of this THV in high-surgical-risk study patients with severe symptomatic aortic stenosis. METHODS: Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories. The primary endpoint was all-cause mortality at 30 days. RESULTS: Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the THV (4.9% for patients at risk). CONCLUSIONS: The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).
Authors: Costanza Pellegrini; Tobias Rheude; Jonathan Michel; Hector A Alvarez-Covarrubias; Sarah Wünsch; N Patrick Mayr; Erion Xhepa; Adnan Kastrati; Heribert Schunkert; Michael Joner; Markus Kasel Journal: J Thorac Dis Date: 2020-11 Impact factor: 2.895
Authors: Antonio Mangieri; Claudio Montalto; Matteo Pagnesi; Giuseppe Lanzillo; Ozan Demir; Luca Testa; Antonio Colombo; Azeem Latib Journal: Front Cardiovasc Med Date: 2018-07-03