New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation : Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF System

  • Maeda Koichi
    Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
  • Kuratani Toru
    Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
  • Torikai Kei
    Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
  • Mizote Isamu
    Department of Cardiology, Osaka University Graduate School of Medicine
  • Ichibori Yasuhiro
    Department of Cardiology, Osaka University Graduate School of Medicine
  • Onishi Toshinari
    Department of Cardiology, Osaka University Graduate School of Medicine
  • Nakatani Satoshi
    Department of Cardiology, Osaka University Graduate School of Medicine
  • Sakata Yasushi
    Department of Cardiology, Osaka University Graduate School of Medicine
  • Toda Koichi
    Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
  • Sawa Yoshiki
    Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

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  • New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation – Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF<sup>TM</sup> System –

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Background:Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TFTMself-expanding stent are reported.Methods and Results:The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P<0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm2(P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively.Conclusions:A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery. (Circ J 2015; 79: 1037–1043)

収録刊行物

  • Circulation Journal

    Circulation Journal 79 (5), 1037-1043, 2015

    一般社団法人 日本循環器学会

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