title: First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) may be a viable solution for inoperable or high-risk patients with aortic stenosis (AS), providing the benefit of valve replacement without the associated risks of surgery.
  
  
  RESULTS
  The prospective, multicenter MDT-2111 Japan Trial evaluated the efficacy and safety of a self-expandable TAV in patients with severe AS. A total of 55 patients were enrolled (October 2011 to October 2012). Mean age was 82.5±5.5 years; 30.9% male, 100% NYHA III/IV, and STS 8.0±4.2%. At 6 months, 91.7% of the iliofemoral patients had met the primary endpoint (an improvement of at least 1 NYHA class and an effective orifice area >1.2 cm(2) for iliofemoral patients). For all patients, freedom from all-cause mortality at 6 months was 90.8%. At 30 days, the Kaplan-Meier rate of major vascular complications was 10.9%, the rate of permanent pacemaker implantation was 22.2% and the rate of major stroke was 3.7%. The incidences of paravalvular regurgitation for all implanted patients at 6 months were: 38.3% (none), 25.5% (trace), 31.9% (mild), 4.3% (moderate), and 0.0% (severe).
  
  
  CONCLUSIONS
  This is the first study to evaluate a self-expandable TAV in a Japanese patient population. The data show successful achievement of the study's primary objective and demonstrate the functional and anatomical effectiveness of the MDT-2111 TAV system.
authors.affiliation: Osaka University Hospital.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Junjiro
authors.initials: J
authors.lastname: Kobayashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Niinami
authors.forename: Toru
authors.initials: T
authors.lastname: Kuratani
authors.forename: Koichi
authors.initials: K
authors.lastname: Maeda
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kanzaki
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Komiyama
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Adam
authors.initials: A
authors.lastname: Boyle
authors.forename: Angie
authors.initials: A
authors.lastname: Zhang
authors.forename: B Jane
authors.initials: BJ
authors.lastname: Moore
authors.forename: Ricardo
authors.initials: R
authors.lastname: de Medeiros
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000473:pathology / Q000601:surgery*; D044466:Asian People; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D007564:Japan; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods*