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 - Funding Information:
Dr. Kim is proctor for Symetis / Boston Scientific and Abbott Vascular and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Conradi and Prof. Schäfer are proctors for Symetis / Boston Scientific and Medtronic and have received lecture fees and travel support from both companies. Dr. Barbanti has served as a consultant for Edwards Lifesciences. Dr. Stefanini has received a research grant (to the Institution) from Boston Scientific, and speaker/consultant fees from B. Braun, Biosensors, and Boston Scientific. Dr. Hildick-Smith is an advisory and proctor for Boston Scientific, Symetis, and Medtronic. Dr. Pilgrim has received research grants (to the Institution) from Boston Scientific, Edwards Lifesciences, and Biotronik, as well as speaker fees from Boston Scientific and Biotronik. Dr. Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4tech, and CoreMedic, and has received speaker fees from Edwards Lifesciences. Dr. Wolf is proctor for Medtronic and Boston Scientific. Prof. Webb is a consultant for Abbott Vascular and Edwards Lifesciences. Dr. Sedaghat has received travel grants/support from Medtronic. Dr. Van Mieghem has received research grant support from Boston Scientific, Abbott Vascular, Medtronic, Claret, and Essential Medical. Dr. MacCarthy is proctor for Edwards Lifesciences. Prof. Hamm has served on the advisory boards of Medtronic. Prof. Tamburino has received speaker honoraria from Medtronic. Prof. Windecker has received grants from Abbott Vascular, Amgen, Bayer, BMS, Biotronik, Boston Scientific, CLS Behring, Edwards Lifesciences, Medtronic, Polares, and Sinomed. Dr. Siqueira is proctor for Medtronic, Symetis, and Edwards Lifesciences. Dr. Bedogni is proctor for Medtronic and Boston Scientific. Dr. Maisano has served as a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Valtech; and has received royalties from Edwards Lifesciences. Dr. Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular, and has served on the advisory boards of Boston Scientific and Abbott Vascular. Prof. Wood has received grant support from Boston Scientific and is a consultant for Medtronic. Prof. Sinning is proctor for Medtronic and Boston Scientific and has received speaker honoraria and research grants from Medtronic, Edwards Lifesciences and Boston Scientific. Dr. Latib has served on the advisory boards of Medtronic and Abbott Vascular. The other authors have no conflicts of interest to declare.
Publisher Copyright:
© 2020 Elsevier Inc.
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.
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U2 - 10.1016/j.amjcard.2020.02.003
DO - 10.1016/j.amjcard.2020.02.003
M3 - Article
C2 - 32098656
AN - SCOPUS:85080099041
VL - 125
SP - 1369
EP - 1377
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 9
ER -