Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis.
Transcatheter aortic valve implantation (TAVI) is a viable alternative to surgical aortic valve replacement in high-risk or inoperable patients with aortic stenosis (AS). Here we report the midterm outcomes of high-risk Japanese patients with severe AS who underwent TAVI with a self-expandable TAV.



The CoreValve Japan Trial was a prospective, multicenter trial of the CoreValve System. A group of 55 patients (mean age 82.5±5.5 years, 30.9% male, 100% NYHA class III/IV, STS 8.0±4.2%) were enrolled in the 26-mm/29-mm CoreValve study, and 20 patients (mean age 81.0±6.6 years, 5.0% male, 100% NYHA class III/IV, STS 7.0±3.3%) were enrolled in the 23-mm CoreValve study, which started 1 year later. For the 26-mm/29-mm cohort, the 3-year all-cause mortality rate was 32.6%; major stroke was 15.4%. Mean pressure gradient (MPG), effective orifice area (EOA), and NYHA class showed sustained improvement. Paravalvular regurgitation (PVR) at 3 years was 28.6% (none), 25.7% (trace), 40.0% (mild), 5.7% (moderate), and 0.0% (severe). For the 23-mm cohort, the 2-year all-cause mortality rate was 5.0%; major stroke was 5.0%. MPG, EOA, and NYHA class showed sustained improvement. PVR at 2 years was 16.7% (none), 33.3% (trace), 44.4% (mild), 5.6% (moderate), and 0.0% (severe).



TAVI with the CoreValve System was associated with sustained clinical and functional cardiac improvement in high surgical risk Japanese patients with severe AS. (Clinicaltrials.gov Identifiers: NCT01437098 and NCT01634269.).
Osaka University Hospital.
Yoshiki
Y
Sawa
Osaka University Hospital.
Kei
K
Torikai
National Cerebral and Cardiovascular Center.
Junjiro
J
Kobayashi
Saitama Medical University International Medical Center.
Hiroshi
H
Niinami
Osaka University Hospital.
Toru
T
Kuratani
Osaka University Hospital.
Koichi
K
Maeda
National Cerebral and Cardiovascular Center.
Hideaki
H
Kanzaki
Saitama Medical University International Medical Center.
Nobuyuki
N
Komiyama
Shonan Kamakura General Hospital.
Yutaka
Y
Tanaka
Medtronic.
Angie
A
Zhang
Shonan Kamakura General Hospital.
Shigeru
S
Saito
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D044466:Asian People; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D007564:Japan; D008297:Male; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*
Aortic valve stenosis; Midterm follow-up; Transcatheter aortic valve implantation