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

Christoph K. Naber, Stylianos A. Pyxaras, Hüseyin Ince, Azeem Latib, Peter Frambach, Peter Den Heijer, Daniel Wagner, Christian Butter, Antonio Colombo, Stephan Kische

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)e1314-e1320
JournalEuroIntervention
Volume11
Issue number11
DOIs
Publication statusPublished - Feb 1 2016

Keywords

  • Repositionability
  • Retrievability
  • Severe aortic stenosis
  • Transcatheter aortic valve implantation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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