title: Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial.
abstract: OBJECTIVE
  Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN).
  
  
  METHODS
  Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification.
  
  
  RESULTS
  A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician's assessment was improved in 87.9 % of the patients.
  
  
  CONCLUSIONS
  We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.
authors.affiliation: Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-Oka, Suita, Osaka, 565-0871, Japan, sawa@surg1.med.osaka-u.ac.jp.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.forename: Morimasa
authors.initials: M
authors.lastname: Takayama
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Takanashi
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Komiya
authors.forename: Toru
authors.initials: T
authors.lastname: Kuratani
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Tobaru
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Goto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D012306:Risk; D012720:Severity of Illness Index; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome