Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis

Hermann Reichenspurner; Andreas Schaefer; Ulrich Schäfer; Didier Tchétché; Axel Linke; Mark S Spence; Lars Søndergaard; Hervé LeBreton; Gerhard Schymik; Mohamed Abdel-Wahab; Jonathon Leipsic; Darren L Walters; Stephen Worthley; Markus Kasel; Stephan Windecker

doi:10.1016/j.jacc.2017.10.060

Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis

Hermann Reichenspurner, Andreas Schaefer, Ulrich Schäfer, Didier Tchétché, Axel Linke, Mark S Spence, Lars Søndergaard, Hervé LeBreton, Gerhard Schymik, Mohamed Abdel-Wahab, Jonathon Leipsic, Darren L Walters, Stephen Worthley, Markus Kasel, Stephan Windecker

36 Citationer (Scopus)

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).

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	70
Udgave nummer	25
Sider (fra-til)	3127-3136
Antal sider	10
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2017.10.060
Status	Udgivet - 26 dec. 2017

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10.1016/j.jacc.2017.10.060

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Reichenspurner, H., Schaefer, A., Schäfer, U., Tchétché, D., Linke, A., Spence, M. S., Søndergaard, L., LeBreton, H., Schymik, G., Abdel-Wahab, M., Leipsic, J., Walters, D. L., Worthley, S., Kasel, M., & Windecker, S. (2017). Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. Journal of the American College of Cardiology, 70(25), 3127-3136. https://doi.org/10.1016/j.jacc.2017.10.060

Reichenspurner, H, Schaefer, A, Schäfer, U, Tchétché, D, Linke, A, Spence, MS, Søndergaard, L, LeBreton, H, Schymik, G, Abdel-Wahab, M, Leipsic, J, Walters, DL, Worthley, S, Kasel, M & Windecker, S 2017, 'Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis', Journal of the American College of Cardiology, bind 70, nr. 25, s. 3127-3136. https://doi.org/10.1016/j.jacc.2017.10.060

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title = "Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis",

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).",

keywords = "Journal Article",

author = "Hermann Reichenspurner and Andreas Schaefer and Ulrich Sch{\"a}fer and Didier Tch{\'e}tch{\'e} and Axel Linke and Spence, {Mark S} and Lars S{\o}ndergaard and Herv{\'e} LeBreton and Gerhard Schymik and Mohamed Abdel-Wahab and Jonathon Leipsic and Walters, {Darren L} and Stephen Worthley and Markus Kasel and Stephan Windecker",

year = "2017",

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doi = "10.1016/j.jacc.2017.10.060",

language = "English",

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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

PY - 2017/12/26

Y1 - 2017/12/26

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 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).

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 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).

KW - Journal Article

U2 - 10.1016/j.jacc.2017.10.060

DO - 10.1016/j.jacc.2017.10.060

M3 - Journal article

C2 - 29268926

SN - 0735-1097

VL - 70

SP - 3127

EP - 3136

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 25

ER -

Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis

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