Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)

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 -