LATE BREAKING CLINICAL TRIAL (JCS 2017) : Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis

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  • Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis

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<p>Background: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.</p><p>Methods and Results: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).</p><p>Conclusions: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.)</p>

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  • Circulation Journal

    Circulation Journal 81 (8), 1108-1115, 2017

    一般社団法人 日本循環器学会

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