Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices. / Baggio, Sara; Pagnesi, Matteo; Kim, Won Keun; Scotti, Andrea; Barbanti, Marco; Costa, Giuliano; Adamo, Marianna; Kornowski, Ran; Vaknin-Assa, Hana; Estévez-Loureiro, Rodrigo; Cedeño, Robert Alarcón; De Marco, Federico; Casenghi, Matteo; Toggweiler, Stefan; Veulemans, Verena; Mylotte, Darren; Lunardi, Mattia; Regazzoli, Damiano; Reimers, Bernhard; Sondergaard, Lars; Vanhaverbeke, Maarten; Nuyens, Philippe; Maffeo, Diego; Buono, Andrea; Saccocci, Matteo; Giannini, Francesco; Di Ienno, Luca; Ferlini, Marco; Lanzillo, Giuseppe; Ielasi, Alfonso; Schofer, Joachim; Brinkmann, Christina; Van Der Heyden, Jan; Buysschaert, Ian; Eitan, Amnon; Wolf, Alexander; Adamaszek, Martin Marian; Colombo, Antonio; Latib, Azeem; Mangieri, Antonio.
I: EuroIntervention, Bind 18, Nr. 12, 2023, s. 977-986.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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
N1 - Publisher Copyright: © Europa Digital & Publishing 2023. All rights reserved.
PY - 2023
Y1 - 2023
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 - aortic stenosis
KW - atrio-ventricular block
KW - conduction abnormalities
KW - MSCT
KW - paravalvular leak
KW - TAVI
U2 - 10.4244/EIJ-D-22-00498
DO - 10.4244/EIJ-D-22-00498
M3 - Journal article
C2 - 36093795
AN - SCOPUS:85146324535
VL - 18
SP - 977
EP - 986
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 12
ER -
ID: 366498299