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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors: Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany.
authors: Christoph K
authors: CK
authors: Naber
authors: Stylianos A
authors: SA
authors: Pyxaras
authors: Hüseyin
authors: H
authors: Ince
authors: Azeem
authors: A
authors: Latib
authors: Peter
authors: P
authors: Frambach
authors: Peter
authors: P
authors: den Heijer
authors: Daniel
authors: D
authors: Wagner
authors: Christian
authors: C
authors: Butter
authors: Antonio
authors: A
authors: Colombo
authors: Stephan
authors: S
authors: Kische
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods; D016896:Treatment Outcome