Journal article
Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis.
- Reichenspurner H Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany. Electronic address: reichenspurner@uke.de.
- Schaefer A Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany.
- Schäfer U Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany.
- Tchétché D Cardiologie Générale et Interventionelle, Clinique Pasteur, Toulouse, France.
- Linke A Department of Internal Medicine/Cardiology, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.
- Spence MS Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom.
- Søndergaard L Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
- LeBreton H Centre cardio-pneumologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France.
- Schymik G Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Karlsruhe, Germany.
- Abdel-Wahab M Department of Cardiology, Heart Center Bad Segeberg, Bad Segeberg, Germany.
- Leipsic J Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
- Walters DL Department of Cardiology, The Prince Charles Hospital, Chermside, Queensland, Australia.
- Worthley S Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
- Kasel M Department of Cardiology, German Heart Center Munich, Munich, Germany.
- Windecker S Department of Cardiology, Bern University Hospital (Inselspital), Bern, Switzerland.
- 2017-12-23
Published in:
- Journal of the American College of Cardiology. - 2017
high-risk patients
self-expanding valve
transcatheter aortic valve replacement
Aged
Aged, 80 and over
Alloys
Aortic Valve
Aortic Valve Stenosis
Cause of Death
Echocardiography
Equipment Design
Europe
Female
Follow-Up Studies
Humans
Male
Prospective Studies
Prosthesis Design
Severity of Illness Index
Time Factors
Tomography, X-Ray Computed
Transcatheter Aortic Valve Replacement
Treatment Outcome
English
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).
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2017.10.060
- PMID 29268926
- Persistent URL
- https://sonar.ch/global/documents/247324
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