Favorable Clinical Outcomes of Transcatheter Aortic Valve Implantation in Japanese Patients ― First Report From the Post-Approval K-TAVI Registry ―

  • Takimoto Shinya
    Department of Cardiovascular Surgery, Graduate School of Medicine, Kyoto University
  • Saito Naritatsu
    Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
  • Minakata Kenji
    Department of Cardiovascular Surgery, Graduate School of Medicine, Kyoto University
  • Shirai Shinichi
    Division of Cardiology, Kokura Memorial Hospital
  • Isotani Akihiro
    Division of Cardiology, Kokura Memorial Hospital
  • Arai Yoshio
    Division of Cardiovascular Surgery, Kokura Memorial Hospital
  • Hanyu Michiya
    Division of Cardiovascular Surgery, Kokura Memorial Hospital
  • Komiya Tatsuhiko
    Department of Cardiovascular Surgery, Kurashiki Central Hospital
  • Shimamoto Takeshi
    Department of Cardiovascular Surgery, Kurashiki Central Hospital
  • Goto Tsuyoshi
    Department of Cardiology, Kurashiki Central Hospital
  • Fuku Yasushi
    Department of Cardiology, Kurashiki Central Hospital
  • Ehara Natsuhiko
    Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital
  • Furukawa Yutaka
    Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital
  • Koyama Tadaaki
    Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital
  • Nagasawa Atsuhi
    Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital
  • Tamura Toshihiro
    Department of Cardiology, Tenri Hospital
  • Miyake Makoto
    Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital
  • Yamanaka Kazuo
    Department of Cardiovascular Surgery, Tenri Hospital
  • Sakaguchi Hisashi
    Department of Cardiovascular Surgery, Tenri Hospital
  • Murata Koichiro
    Department of Cardiology, Shizuoka City Shizuoka Hospital
  • Onodera Tomoya
    Department of Cardiology, Shizuoka City Shizuoka Hospital
  • Yamazaki Fumio
    Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital
  • Nakai Masanao
    Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital
  • Taniguchi Tomohiko
    Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
  • Sakata Ryuzo
    Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital
  • Kimura Takeshi
    Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University

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Abstract

<p>Background:Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.</p><p>Methods and Results:The Kyoto University-related hospital Transcatheter Aortic Valve Implantation (K-TAVI) registry includes prospectively collected data from 6 participating hospitals in Japan. We included 302 patients with severe aortic stenosis who underwent TAVI using the SAPIEN XT balloon-expandable valve via transfemoral (TF; n=203, 67%) or transapical (TA; n=99, 33%) approach between October 2013 and September 2015. Device success rate, based on the Valve Academic Research Consortium-2 criteria, was very high in the TF (97.0%) and TA (99.0%) groups. The 30-day mortality rates were 1.5% and 1.0% in the TF and TA groups, respectively. Major complications included stroke (transient or persistent: 2.3%), annulus rupture (1.0%), coronary intervention (1.0%), major vascular complications (1.7%), and permanent pacemaker implantation (5.4%). The procedure times of the post-proctoring period (n=210) were decreased compared with those of the proctoring period (n=89) without affecting the clinical outcomes. The survival rates at 6 and 12 months were 96.9% and 92.5% in the TF group, and 93.9% and 91.8% in the TA group, respectively.</p><p>Conclusions:The K-TAVI registry data revealed that the early outcomes of TAVI using the SAPIEN XT were favorable in real-world Japanese patients.</p>

Journal

  • Circulation Journal

    Circulation Journal 81 (1), 103-109, 2017

    The Japanese Circulation Society

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