Key result
The MDT-2111 self-expandable transcatheter heart valve successfully treated severe symptomatic aortic stenosis, achieving the primary composite endpoint of NYHA improvement and EOA >1.2 cm2 in 91.7% of patients at 6 months.
Why the study?
Does a self-expandable transcatheter heart valve improve clinical and echocardiographic outcomes in high-risk Japanese patients with severe aortic stenosis?
Population
55 Japanese patients with symptomatic severe aortic stenosis, mean age 82.5±5.5 years, 30.9% male, 100% NYHA…
Design
Cohort
Follow-up
6 months
Authors
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Supports MDT-2111 feasibility in high-risk Japanese AS patients; hypothesis-generating and requires randomized confirmation.
Does a self-expandable transcatheter heart valve improve clinical and echocardiographic outcomes in high-risk Japanese patients with severe aortic stenosis?
Absolute Event Rate: 91.7% vs 50%
p-value: p=<0.001
A self-expandable transcatheter heart valve demonstrated functional and anatomical effectiveness with acceptable safety in a high-risk Japanese population with severe aortic stenosis.
Sawa et al. (2014) studied Symptomatic Severe Aortic Stenosis (n=55). MDT-2111 self-expandable transcatheter heart valve vs. Conventional therapy (50% performance goal) was evaluated on Composite of improvement of at least 1 NYHA class and an effective orifice area >1.2 cm2 at 6 months (in iliofemoral access patients) (95% CI 77.5-98.2, p=<0.001). The MDT-2111 self-expandable transcatheter heart valve successfully treated severe symptomatic aortic stenosis, achieving the primary composite endpoint of NYHA improvement and EOA >1.2 cm2 in 91.7% of patients at 6 months.
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