Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)
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Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry). / Pagnesi, Matteo; Kim, Won-Keun; Conradi, Lenard; Barbanti, Marco; Stefanini, Giulio G; Schofer, Joachim; Hildick-Smith, David; Pilgrim, Thomas; Abizaid, Alexandre; Zweiker, David; Testa, Luca; Taramasso, Maurizio; Wolf, Alexander; Webb, John G; Sedaghat, Alexander; Van der Heyden, Jan A S; Ziviello, Francesca; MacCarthy, Philip; Hamm, Christian W; Bhadra, Oliver D; Schäfer, Ulrich; Costa, Giuliano; Tamburino, Corrado; Cannata, Francesco; Reimers, Bernhard; Eitan, Amnon; Alsanjari, Osama; Asami, Masahiko; Windecker, Stephan; Siqueira, Dimytri; Schmidt, Albrecht; Bianchi, Giovanni; Bedogni, Francesco; Saccocci, Matteo; Maisano, Francesco; Jensen, Christoph J; Naber, Christoph K; Alenezi, Abdullah; Wood, David A; Sinning, Jan-Malte; Brouwer, Jorn; Tzalamouras, Vasileios; Van Mieghem, Nicolas M; Colombo, Antonio; Latib, Azeem.
In: AM J CARDIOL, Vol. 125, No. 9, 01.05.2020, p. 1369-1377.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)
AU - Pagnesi, Matteo
AU - Kim, Won-Keun
AU - Conradi, Lenard
AU - Barbanti, Marco
AU - Stefanini, Giulio G
AU - Schofer, Joachim
AU - Hildick-Smith, David
AU - Pilgrim, Thomas
AU - Abizaid, Alexandre
AU - Zweiker, David
AU - Testa, Luca
AU - Taramasso, Maurizio
AU - Wolf, Alexander
AU - Webb, John G
AU - Sedaghat, Alexander
AU - Van der Heyden, Jan A S
AU - Ziviello, Francesca
AU - MacCarthy, Philip
AU - Hamm, Christian W
AU - Bhadra, Oliver D
AU - Schäfer, Ulrich
AU - Costa, Giuliano
AU - Tamburino, Corrado
AU - Cannata, Francesco
AU - Reimers, Bernhard
AU - Eitan, Amnon
AU - Alsanjari, Osama
AU - Asami, Masahiko
AU - Windecker, Stephan
AU - Siqueira, Dimytri
AU - Schmidt, Albrecht
AU - Bianchi, Giovanni
AU - Bedogni, Francesco
AU - Saccocci, Matteo
AU - Maisano, Francesco
AU - Jensen, Christoph J
AU - Naber, Christoph K
AU - Alenezi, Abdullah
AU - Wood, David A
AU - Sinning, Jan-Malte
AU - Brouwer, Jorn
AU - Tzalamouras, Vasileios
AU - Van Mieghem, Nicolas M
AU - Colombo, Antonio
AU - Latib, Azeem
N1 - Copyright © 2020 Elsevier Inc. All rights reserved.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.
AB - Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve Stenosis/surgery
KW - Balloon Valvuloplasty/instrumentation
KW - Dilatation/instrumentation
KW - Equipment Design
KW - Female
KW - Humans
KW - Male
KW - Preoperative Period
KW - Registries
KW - Retrospective Studies
KW - Transcatheter Aortic Valve Replacement/methods
U2 - 10.1016/j.amjcard.2020.02.003
DO - 10.1016/j.amjcard.2020.02.003
M3 - SCORING: Journal article
C2 - 32098656
VL - 125
SP - 1369
EP - 1377
JO - AM J CARDIOL
JF - AM J CARDIOL
SN - 0002-9149
IS - 9
ER -