Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. / Reichenspurner, Hermann; Schaefer, Andreas; Schäfer, Ulrich; Tchétché, Didier; Linke, Axel; Spence, Mark S; Søndergaard, Lars; LeBreton, Hervé; Schymik, Gerhard; Abdel-Wahab, Mohamed; Leipsic, Jonathon; Walters, Darren L; Worthley, Stephen; Kasel, Markus; Windecker, Stephan.
I: Journal of the American College of Cardiology, Bind 70, Nr. 25, 2017, s. 3127-3136.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis
AU - Reichenspurner, Hermann
AU - Schaefer, Andreas
AU - Schäfer, Ulrich
AU - Tchétché, Didier
AU - Linke, Axel
AU - Spence, Mark S
AU - Søndergaard, Lars
AU - LeBreton, Hervé
AU - Schymik, Gerhard
AU - Abdel-Wahab, Mohamed
AU - Leipsic, Jonathon
AU - Walters, Darren L
AU - Worthley, Stephen
AU - Kasel, Markus
AU - Windecker, Stephan
N1 - Copyright © 2017 American College of Cardiology Foundation. All rights reserved.
PY - 2017
Y1 - 2017
N2 - 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 cm2to 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).
AB - 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 cm2to 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).
U2 - 10.1016/j.jacc.2017.10.060
DO - 10.1016/j.jacc.2017.10.060
M3 - Journal article
C2 - 29268926
VL - 70
SP - 3127
EP - 3136
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 25
ER -
ID: 194906572