Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

Sara Baggio; Matteo Pagnesi; Won Keun Kim; Andrea Scotti; Marco Barbanti; Giuliano Costa; Marianna Adamo; Ran Kornowski; Hana Vaknin-Assa; Rodrigo Estévez-Loureiro; Robert Alarcón Cedeño; Federico De Marco; Matteo Casenghi; Stefan Toggweiler; Verena Veulemans; Darren Mylotte; Mattia Lunardi; Damiano Regazzoli; Bernhard Reimers; Lars Sondergaard; Maarten Vanhaverbeke; Philippe Nuyens; Diego Maffeo; Andrea Buono; Matteo Saccocci; Francesco Giannini; Luca Di Ienno; Marco Ferlini; Giuseppe Lanzillo; Alfonso Ielasi; Joachim Schofer; Christina Brinkmann; Jan Van Der Heyden; Ian Buysschaert; Amnon Eitan; Alexander Wolf; Martin Marian Adamaszek; Antonio Colombo; Azeem Latib; Antonio Mangieri

doi:10.4244/EIJ-D-22-00498

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

Sara Baggio, Matteo Pagnesi, Won Keun Kim, Andrea Scotti, Marco Barbanti, Giuliano Costa, Marianna Adamo, Ran Kornowski, Hana Vaknin-Assa, Rodrigo Estévez-Loureiro, Robert Alarcón Cedeño, Federico De Marco, Matteo Casenghi, Stefan Toggweiler, Verena Veulemans, Darren Mylotte, Mattia Lunardi, Damiano Regazzoli, Bernhard Reimers, Lars SondergaardMaarten Vanhaverbeke, Philippe Nuyens, Diego Maffeo, Andrea Buono, Matteo Saccocci, Francesco Giannini, Luca Di Ienno, Marco Ferlini, Giuseppe Lanzillo, Alfonso Ielasi, Joachim Schofer, Christina Brinkmann, Jan Van Der Heyden, Ian Buysschaert, Amnon Eitan, Alexander Wolf, Martin Marian Adamaszek, Antonio Colombo, Azeem Latib, Antonio Mangieri

Medicine

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

Original language	English (US)
Pages (from-to)	977-986
Number of pages	10
Journal	EuroIntervention
Volume	18
Issue number	12
DOIs	https://doi.org/10.4244/EIJ-D-22-00498
State	Published - Jan 2023

Keywords

MSCT
TAVI
aortic stenosis
atrio-ventricular block
conduction abnormalities
paravalvular leak

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.4244/EIJ-D-22-00498

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Baggio, S., Pagnesi, M., Kim, W. K., Scotti, A., Barbanti, M., Costa, G., Adamo, M., Kornowski, R., Vaknin-Assa, H., Estévez-Loureiro, R., Cedeño, R. A., De Marco, F., Casenghi, M., Toggweiler, S., Veulemans, V., Mylotte, D., Lunardi, M., Regazzoli, D., Reimers, B., ... Mangieri, A. (2023). Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices. EuroIntervention, 18(12), 977-986. https://doi.org/10.4244/EIJ-D-22-00498

Baggio, S, Pagnesi, M, Kim, WK, Scotti, A, Barbanti, M, Costa, G, Adamo, M, Kornowski, R, Vaknin-Assa, H, Estévez-Loureiro, R, Cedeño, RA, De Marco, F, Casenghi, M, Toggweiler, S, Veulemans, V, Mylotte, D, Lunardi, M, Regazzoli, D, Reimers, B, Sondergaard, L, Vanhaverbeke, M, Nuyens, P, Maffeo, D, Buono, A, Saccocci, M, Giannini, F, Di Ienno, L, Ferlini, M, Lanzillo, G, Ielasi, A, Schofer, J, Brinkmann, C, Van Der Heyden, J, Buysschaert, I, Eitan, A, Wolf, A, Adamaszek, MM, Colombo, A, Latib, A & Mangieri, A 2023, 'Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices', EuroIntervention, vol. 18, no. 12, pp. 977-986. https://doi.org/10.4244/EIJ-D-22-00498

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title = "Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices",

abstract = "Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.",

keywords = "MSCT, TAVI, aortic stenosis, atrio-ventricular block, conduction abnormalities, paravalvular leak",

author = "Sara Baggio and Matteo Pagnesi and Kim, {Won Keun} and Andrea Scotti and Marco Barbanti and Giuliano Costa and Marianna Adamo and Ran Kornowski and Hana Vaknin-Assa and Rodrigo Est{\'e}vez-Loureiro and Cede{\~n}o, {Robert Alarc{\'o}n} and {De Marco}, Federico and Matteo Casenghi and Stefan Toggweiler and Verena Veulemans and Darren Mylotte and Mattia Lunardi and Damiano Regazzoli and Bernhard Reimers and Lars Sondergaard and Maarten Vanhaverbeke and Philippe Nuyens and Diego Maffeo and Andrea Buono and Matteo Saccocci and Francesco Giannini and {Di Ienno}, Luca and Marco Ferlini and Giuseppe Lanzillo and Alfonso Ielasi and Joachim Schofer and Christina Brinkmann and {Van Der Heyden}, Jan and Ian Buysschaert and Amnon Eitan and Alexander Wolf and Adamaszek, {Martin Marian} and Antonio Colombo and Azeem Latib and Antonio Mangieri",

year = "2023",

month = jan,

doi = "10.4244/EIJ-D-22-00498",

language = "English (US)",

volume = "18",

pages = "977--986",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "EuroPCR",

number = "12",

}

TY - JOUR

T1 - Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

AU - Baggio, Sara

AU - Pagnesi, Matteo

AU - Kim, Won Keun

AU - Scotti, Andrea

AU - Barbanti, Marco

AU - Costa, Giuliano

AU - Adamo, Marianna

AU - Kornowski, Ran

AU - Vaknin-Assa, Hana

AU - Estévez-Loureiro, Rodrigo

AU - Cedeño, Robert Alarcón

AU - De Marco, Federico

AU - Casenghi, Matteo

AU - Toggweiler, Stefan

AU - Veulemans, Verena

AU - Mylotte, Darren

AU - Lunardi, Mattia

AU - Regazzoli, Damiano

AU - Reimers, Bernhard

AU - Sondergaard, Lars

AU - Vanhaverbeke, Maarten

AU - Nuyens, Philippe

AU - Maffeo, Diego

AU - Buono, Andrea

AU - Saccocci, Matteo

AU - Giannini, Francesco

AU - Di Ienno, Luca

AU - Ferlini, Marco

AU - Lanzillo, Giuseppe

AU - Ielasi, Alfonso

AU - Schofer, Joachim

AU - Brinkmann, Christina

AU - Van Der Heyden, Jan

AU - Buysschaert, Ian

AU - Eitan, Amnon

AU - Wolf, Alexander

AU - Adamaszek, Martin Marian

AU - Colombo, Antonio

AU - Latib, Azeem

AU - Mangieri, Antonio

PY - 2023/1

Y1 - 2023/1

N2 - Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

AB - Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

KW - MSCT

KW - TAVI

KW - aortic stenosis

KW - atrio-ventricular block

KW - conduction abnormalities

KW - paravalvular leak

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VL - 18

SP - 977

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JO - EuroIntervention

JF - EuroIntervention

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ER -

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

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