title: Favorable Clinical Outcomes of Transcatheter Aortic Valve Implantation in Japanese Patients　- First Report From the Post-Approval K-TAVI Registry.
abstract: Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.
  
  
  
  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.
  
  
  
  The K-TAVI registry data revealed that the early outcomes of TAVI using the SAPIEN XT were favorable in real-world Japanese patients.
authors.affiliation: Department of Cardiovascular Surgery, Graduate School of Medicine, Kyoto University.
authors.forename: Shinya
authors.initials: S
authors.lastname: Takimoto
authors.forename: Naritatsu
authors.initials: N
authors.lastname: Saito
authors.forename: Kenji
authors.initials: K
authors.lastname: Minakata
authors.forename: Shinichi
authors.initials: S
authors.lastname: Shirai
authors.forename: Akihiro
authors.initials: A
authors.lastname: Isotani
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Arai
authors.forename: Michiya
authors.initials: M
authors.lastname: Hanyu
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Komiya
authors.forename: Takeshi
authors.initials: T
authors.lastname: Shimamoto
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Goto
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Fuku
authors.forename: Natsuhiko
authors.initials: N
authors.lastname: Ehara
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Furukawa
authors.forename: Tadaaki
authors.initials: T
authors.lastname: Koyama
authors.forename: Atsuhi
authors.initials: A
authors.lastname: Nagasawa
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Tamura
authors.forename: Makoto
authors.initials: M
authors.lastname: Miyake
authors.forename: Kazuo
authors.initials: K
authors.lastname: Yamanaka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Koichiro
authors.initials: K
authors.lastname: Murata
authors.forename: Tomoya
authors.initials: T
authors.lastname: Onodera
authors.forename: Fumio
authors.initials: F
authors.lastname: Yamazaki
authors.forename: Masanao
authors.initials: M
authors.lastname: Nakai
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Taniguchi
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Sakata
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality* / Q000601:surgery*; D044466:Asian People; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D011446:Prospective Studies; D012042:Registries; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*