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Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study

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Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study. / Holzamer, Andreas; Doss, Mirko; Schramm, Rene; Diegeler, Anno; Conradi, Lenard; Strauch, Justus; Holzhey, David; Erlebach, Magdalena; Schröfel, Holger; Arsalan, Mani; Allocco, Dominic J; Hilker, Michael.

In: IJC HEART VASC, Vol. 36, 100862, 10.2021.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Holzamer, A, Doss, M, Schramm, R, Diegeler, A, Conradi, L, Strauch, J, Holzhey, D, Erlebach, M, Schröfel, H, Arsalan, M, Allocco, DJ & Hilker, M 2021, 'Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study', IJC HEART VASC, vol. 36, 100862. https://doi.org/10.1016/j.ijcha.2021.100862

APA

Holzamer, A., Doss, M., Schramm, R., Diegeler, A., Conradi, L., Strauch, J., Holzhey, D., Erlebach, M., Schröfel, H., Arsalan, M., Allocco, D. J., & Hilker, M. (2021). Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study. IJC HEART VASC, 36, [100862]. https://doi.org/10.1016/j.ijcha.2021.100862

Vancouver

Holzamer A, Doss M, Schramm R, Diegeler A, Conradi L, Strauch J et al. Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study. IJC HEART VASC. 2021 Oct;36. 100862. https://doi.org/10.1016/j.ijcha.2021.100862

Bibtex

@article{9a081647e23749519d0491a0c6dca74c,
title = "Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study",
abstract = "Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve.Methods and results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe).Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.",
author = "Andreas Holzamer and Mirko Doss and Rene Schramm and Anno Diegeler and Lenard Conradi and Justus Strauch and David Holzhey and Magdalena Erlebach and Holger Schr{\"o}fel and Mani Arsalan and Allocco, {Dominic J} and Michael Hilker",
note = "{\textcopyright} 2021 The Authors. Published by Elsevier B.V.",
year = "2021",
month = oct,
doi = "10.1016/j.ijcha.2021.100862",
language = "English",
volume = "36",
journal = "IJC HEART VASC",
issn = "2352-9067",
publisher = "Elsevier BV",

}

RIS

TY - JOUR

T1 - Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study

AU - Holzamer, Andreas

AU - Doss, Mirko

AU - Schramm, Rene

AU - Diegeler, Anno

AU - Conradi, Lenard

AU - Strauch, Justus

AU - Holzhey, David

AU - Erlebach, Magdalena

AU - Schröfel, Holger

AU - Arsalan, Mani

AU - Allocco, Dominic J

AU - Hilker, Michael

N1 - © 2021 The Authors. Published by Elsevier B.V.

PY - 2021/10

Y1 - 2021/10

N2 - Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve.Methods and results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe).Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

AB - Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve.Methods and results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe).Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

U2 - 10.1016/j.ijcha.2021.100862

DO - 10.1016/j.ijcha.2021.100862

M3 - SCORING: Journal article

C2 - 34504944

VL - 36

JO - IJC HEART VASC

JF - IJC HEART VASC

SN - 2352-9067

M1 - 100862

ER -