First Clinical Trial of a Self-Expandable Transcatheter Heart Valve in Japan in Patients With Symptomatic Severe Aortic Stenosis

New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation – Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF^TM System –

“…Moreover, it was easy to handle the delivery system, even in cases of moderate tortuosity/angulation of the aorta. The procedural time (iliofemoral series: 96±35 min) was similar to that in previous initial reports of the SAPIEN (iliofemoral series: 109±28 min) 9 or CoreValve TM (iliofemoral series: 81±44 min) 10 in Japan.…”

Transcatheter aortic valve implantation in Asia

“…The PREVAIL Japan trial was performed as a prospective, multicentre, non-randomized and pivotal clinical trial in Japan using the Edwards Lifescience balloon expandable Sapien XT (Edwards Lifescience) valve (15). The MDT-2111 Japan trial on the other hand, was a relatively similar trial that used the Medtronic self-expanding CoreValve (Medtronic) (16). Results from both these Japanese trials were pivotal for product registration and commercialization in Japan.…”

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

“…The study's design has been previously reported. 4 Briefly, key patient inclusion criteria were severe symptomatic AS with a mean gradient >40 mmHg and an aortic valve area ≤0.8 cm 2 . Primary anatomical exclusion criteria were: a native aortic annulus size <20 mm or >27 mm for the 26-mm/29-mm cohort and <18 mm or >20 mm for the 23-mm cohort; a pre-existing prosthetic heart valve in any position; mixed AV disease with predominant aortic regurgitation (AR); moderate to severe mitral or tricuspid valve regurgitation; an ascending aorta diameter >40 mm for the 26-mm/29-mm cohort and >34 mm for the 23-mm cohort; bicuspid or unicuspid valve; or femoral or iliac arterial diameter <6 mm (unable to accommodate an 18Fr sheath).…”