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  • Favorable Clinical Outcomes...
    Takimoto, Shinya; Saito, Naritatsu; Minakata, Kenji; Shirai, Shinichi; Isotani, Akihiro; Arai, Yoshio; Hanyu, Michiya; Komiya, Tatsuhiko; Shimamoto, Takeshi; Goto, Tsuyoshi; Fuku, Yasushi; Ehara, Natsuhiko; Furukawa, Yutaka; Koyama, Tadaaki; Nagasawa, Atsuhi; Tamura, Toshihiro; Miyake, Makoto; Yamanaka, Kazuo; Sakaguchi, Hisashi; Murata, Koichiro; Onodera, Tomoya; Yamazaki, Fumio; Nakai, Masanao; Taniguchi, Tomohiko; Sakata, Ryuzo; Kimura, Takeshi

    Circulation Journal, 01/2017, Letnik: 81, Številka: 1
    Journal Article

    Background:Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.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.Conclusions:The K-TAVI registry data revealed that the early outcomes of TAVI using the SAPIEN XT were favorable in real-world Japanese patients.