Real-world multicentre experience with the Direct Flow Medical(R) repositionable and retrievable transcatheter aortic valve implantation system for the treatment of high-risk patients with severe aortic stenosis.

  • Cardiovascular Research Unit
February 12, 2016 By:
  • Naber CK
  • Pyxaras SA
  • Ince H
  • Latib A
  • Frambach P
  • den Heijer P
  • Wagner D
  • Butter C
  • Colombo A
  • Kische S.

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.

2016 Feb. EuroIntervention.11(11):e1314-20.
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