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

M. Pagnesi, W.-K. Kim, L. Conradi, M. Barbanti, G.G. Stefanini, J. Schofer, D. Hildick-Smith, T. Pilgrim, A. Abizaid, D. Zweiker, L. Testa, M. Taramasso, A. Wolf, J.G. Webb, A. Sedaghat, J.A.S. Van der Heyden, F. Ziviello, P. MacCarthy, C.W. Hamm, O.D. BhadraU. Schäfer, G. Costa, C. Tamburino, F. Cannata, B. Reimers, A. Eitan, O. Alsanjari, M. Asami, S. Windecker, D. Siqueira, A. Schmidt, G. Bianchi, F. Bedogni, M. Saccocci, F. Maisano, C.J. Jensen, C.K. Naber, A. Alenezi, D.A. Wood, J.-M. Sinning, J. Brouwer, V. Tzalamouras, N.M. Van Mieghem, A. Colombo, A. Latib

Research output: Contribution to journalArticlepeer-review

Abstract

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. © 2020 Elsevier Inc.
Original languageEnglish
Pages (from-to)1369-1377
Number of pages9
JournalAm. J. Cardiol.
Volume125
Issue number9
DOIs
Publication statusPublished - 2020

Keywords

  • aged
  • all cause mortality
  • aortic regurgitation
  • aortic valve calcification
  • Article
  • cerebrovascular accident
  • controlled study
  • diagnostic value
  • female
  • hospital discharge
  • human
  • major clinical study
  • male
  • multivariate analysis
  • observational study
  • pacemaker implantation
  • patient safety
  • priority journal
  • retrospective study
  • safety procedure
  • transcatheter aortic valve implantation
  • very elderly
  • aortic valve stenosis
  • clinical trial
  • devices
  • dilatation
  • equipment design
  • multicenter study
  • preoperative period
  • procedures
  • register
  • transluminal valvuloplasty
  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis
  • Balloon Valvuloplasty
  • Dilatation
  • Equipment Design
  • Female
  • Humans
  • Male
  • Preoperative Period
  • Registries
  • Retrospective Studies
  • Transcatheter Aortic Valve Replacement

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