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  • Title: Real-world multicentre experience with the Direct Flow Medical repositionable and retrievable transcatheter aortic valve implantation system for the treatment of high-risk patients with severe aortic stenosis.
    Author: Naber CK, Pyxaras SA, Ince H, Latib A, Frambach P, den Heijer P, Wagner D, Butter C, Colombo A, Kische S.
    Journal: EuroIntervention; 2016 Feb; 11(11):e1314-20. PubMed ID: 26865450.
    Abstract:
    AIMS: Our aim was to assess the performance of the Direct Flow Medical (DFM) repositionable and retrievable transcatheter aortic valve implantation (TAVI) system in high-risk patients with severe aortic stenosis. METHODS AND RESULTS: One hundred and five consecutive high-risk patients with severe aortic stenosis undergoing TAVI with the DFM prosthesis were enrolled in six high-volume TAVI centres in Germany, Italy, The Netherlands, Belgium, and Luxembourg. The "inner curve" technique was systematically used in all patients. The primary endpoint was all-cause mortality at 30 days of clinical follow-up. Secondary endpoints for the same time frame were: (i) VARC-2-defined patient safety; and (ii) VARC-2-defined device success. The primary endpoint of all-cause mortality at 30 days was met in 1.9% (two patients). The VARC-2-defined device success rate was 98.1%. The combined patient safety endpoint was met in 88.6%. Residual moderate aortic regurgitation was observed in 1.9% (two patients). Permanent pacemaker implantation due to post-procedural persistent advanced atrioventricular block was performed in 9.5% (10 patients). CONCLUSIONS: In a multicentre, real-world clinical setting of high-risk patients with severe aortic stenosis, a repositionable and retrievable TAVI system was effective and safe in the short-term follow-up.
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