Key result
Direct Flow Medical TAVI yields ~2% 30-day mortality in high-risk severe aortic stenosis.
Why the study?
The performance of the Direct Flow Medical repositionable and retrievable TAVI system in high-risk patients with severe aortic stenosis was not well established in a real-world multicentre setting.
Population
105 consecutive high-risk patients with severe aortic stenosis undergoing TAVI in six European centres
Comparison
No comparator; single-arm evaluation of the Direct Flow Medical TAVI system
Design
Real-world multicentre observational study
Follow-up
30 days
Authors
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Supports early safety of repositionable TAVI in high-risk aortic stenosis; leaves open randomized comparisons to established platforms.
Observational (n=105)
Yes
Naber et al. (2016) conducted an observational in Severe aortic stenosis (n=105). Direct Flow Medical (DFM) transcatheter aortic valve implantation system was evaluated on All-cause mortality at 30 days. The Direct Flow Medical repositionable and retrievable TAVI system demonstrated a low 30-day all-cause mortality rate of 1.9% in high-risk patients with severe aortic stenosis.
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