Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study

Won-Keun Kim; Corrado Tamburino; Helge Möllmann; Matteo Montorfano; Julia Ellert-Gregersen; Tanja K Rudolph; Nicolas M Van Mieghem; Michael Hilker; Ignacio J Amat-Santos; Christian Juhl Terkelsen; Anna Sonia Petronio; Pieter R Stella; Matthias Götberg; Andreas Rück; A Markus Kasel; Ramiro Trillo; Clare Appleby; Marco Barbanti; Philipp Blanke; Rodrigo Modolo; Dominic J Allocco; Lars Sondergaard

doi:10.4244/EIJ-D-22-00914

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study

Won-Keun Kim, Corrado Tamburino, Helge Möllmann, Matteo Montorfano, Julia Ellert-Gregersen, Tanja K Rudolph, Nicolas M Van Mieghem, Michael Hilker, Ignacio J Amat-Santos, Christian Juhl Terkelsen, Anna Sonia Petronio, Pieter R Stella, Matthias Götberg, Andreas Rück, A Markus Kasel, Ramiro Trillo, Clare Appleby, Marco Barbanti, Philipp Blanke, Rodrigo ModoloDominic J Allocco, Lars Sondergaard

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.

Originalsprog	Engelsk
Tidsskrift	EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Vol/bind	19
Nummer	1
Sider (fra-til)	83-92
Antal sider	10
ISSN	1774-024X
DOI	https://doi.org/10.4244/EIJ-D-22-00914
Status	Udgivet - maj 2023

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10.4244/EIJ-D-22-00914

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Kim, W.-K., Tamburino, C., Möllmann, H., Montorfano, M., Ellert-Gregersen, J., Rudolph, T. K., Van Mieghem, N. M., Hilker, M., Amat-Santos, I. J., Terkelsen, C. J., Petronio, A. S., Stella, P. R., Götberg, M., Rück, A., Kasel, A. M., Trillo, R., Appleby, C., Barbanti, M., Blanke, P., ... Sondergaard, L. (2023). Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 19(1), 83-92. https://doi.org/10.4244/EIJ-D-22-00914

Kim, Won-Keun ; Tamburino, Corrado ; Möllmann, Helge et al. / Clinical outcomes of the ACURATE neo2 transcatheter heart valve : a prospective, multicentre, observational, post-market surveillance study. I: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2023 ; Bind 19, Nr. 1. s. 83-92.

@article{31b76355bee1488788dde4655c146f21,

title = "Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study",

abstract = "Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.",

keywords = "MSCT, TAVI, aortic stenosis, femoral, transoesophageal echocardiogram",

author = "Won-Keun Kim and Corrado Tamburino and Helge M{\"o}llmann and Matteo Montorfano and Julia Ellert-Gregersen and Rudolph, {Tanja K} and {Van Mieghem}, {Nicolas M} and Michael Hilker and Amat-Santos, {Ignacio J} and Terkelsen, {Christian Juhl} and Petronio, {Anna Sonia} and Stella, {Pieter R} and Matthias G{\"o}tberg and Andreas R{\"u}ck and Kasel, {A Markus} and Ramiro Trillo and Clare Appleby and Marco Barbanti and Philipp Blanke and Rodrigo Modolo and Allocco, {Dominic J} and Lars Sondergaard",

year = "2023",

month = may,

doi = "10.4244/EIJ-D-22-00914",

language = "English",

volume = "19",

pages = "83--92",

journal = "EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "1",

}

Kim, W-K, Tamburino, C, Möllmann, H, Montorfano, M, Ellert-Gregersen, J, Rudolph, TK, Van Mieghem, NM, Hilker, M, Amat-Santos, IJ, Terkelsen, CJ, Petronio, AS, Stella, PR, Götberg, M, Rück, A, Kasel, AM, Trillo, R, Appleby, C, Barbanti, M, Blanke, P, Modolo, R, Allocco, DJ & Sondergaard, L 2023, 'Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study', EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, bind 19, nr. 1, s. 83-92. https://doi.org/10.4244/EIJ-D-22-00914

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study. / Kim, Won-Keun; Tamburino, Corrado; Möllmann, Helge et al.
I: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Bind 19, Nr. 1, 05.2023, s. 83-92.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Clinical outcomes of the ACURATE neo2 transcatheter heart valve

T2 - a prospective, multicentre, observational, post-market surveillance study

AU - Kim, Won-Keun

AU - Tamburino, Corrado

AU - Möllmann, Helge

AU - Montorfano, Matteo

AU - Ellert-Gregersen, Julia

AU - Rudolph, Tanja K

AU - Van Mieghem, Nicolas M

AU - Hilker, Michael

AU - Amat-Santos, Ignacio J

AU - Terkelsen, Christian Juhl

AU - Petronio, Anna Sonia

AU - Stella, Pieter R

AU - Götberg, Matthias

AU - Rück, Andreas

AU - Kasel, A Markus

AU - Trillo, Ramiro

AU - Appleby, Clare

AU - Barbanti, Marco

AU - Blanke, Philipp

AU - Modolo, Rodrigo

AU - Allocco, Dominic J

AU - Sondergaard, Lars

PY - 2023/5

Y1 - 2023/5

N2 - Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.

AB - Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.

KW - MSCT

KW - TAVI

KW - aortic stenosis

KW - femoral

KW - transoesophageal echocardiogram

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U2 - 10.4244/EIJ-D-22-00914

DO - 10.4244/EIJ-D-22-00914

M3 - Journal article

C2 - 36440588

SN - 1774-024X

VL - 19

SP - 83

EP - 92

JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

IS - 1

ER -

Kim WK, Tamburino C, Möllmann H, Montorfano M, Ellert-Gregersen J, Rudolph TK et al. Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2023 maj;19(1):83-92. Epub 2022 nov. 27. doi: 10.4244/EIJ-D-22-00914

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study

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