title: Trans-catheter aortic valve implantation with the direct flow medical prosthesis: Single center short-term clinical and echocardiographic outcomes.
abstract: OBJECTIVE
  To analyze our single center experience with the Direct Flow Medical (DFM).
  
  
  BACKGROUND
  The DFM has been recently introduced to the market and large real world experiences are lacking.
  
  
  METHODS
  A total of 126 patients with severe aortic valve stenosis (AVS) were treated by the same team from March 2013 to May 2015. Device success and procedural safety were classified, according to valve academic research consortium (VARC) criteria, for the entire cohort, including patients treated in the early phases of our learning curve.
  
  
  RESULTS
  Clinical and trans-thoracic echocardiography follow-up was performed (median duration 279 days; 36-761 days). Mean age was 80.9 ± 5.5 years and median logistic Euro-SCORE was 15.9 (5.5-84.2). Cardiovascular 30-day mortality was 4.8% (6/126), device success 89.6% (113/126), and early safety 85.7% (108/126). At discharge, no aortic regurgitation (AR) was present in 85.7% and mild AR in 14.3% of the patients. Estimated 1-year follow-up survival was 91%. At follow-up, no AR was present in 87.3%, mild AR in 10.9%, and moderate AR in 1.8%. Mean gradient of 15.1 ± 6.3 mm Hg and prosthesis effective orifice area of 1.6 ± 0.6 cm2were reported.
  
  
  CONCLUSIONS
  In this single center experience, the DFM valve showed satisfactory clinical and hemodynamic results. Short-term follow-up confirmed the consistent clinical results, with low rates of AR and acceptable trans-prosthetic gradients and prosthetic effective orifice area. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Rostock University Medical Center, Rostock, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Rostock University Medical Center, Rostock, Germany.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Ancona
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Rostock University Medical Center, Rostock, Germany.
authors.forename: Hüseyin U
authors.initials: HU
authors.lastname: Agma
authors.affiliation: Department of Cardiology, Heart Center, Vivantes Humboldt-Klinikum, Berlin, Germany.
authors.forename: Gihan
authors.initials: G
authors.lastname: El-Achkar
authors.affiliation: Department of Cardiology, Heart Center, Vivantes Humboldt-Klinikum, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dißmann
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Rostock University Medical Center, Rostock, Germany.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Ortak
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain und Am Urban, Berlin, Germany.|Rostock University Medical Center, Rostock, Germany.
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging* / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D004452:Echocardiography; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D059032:Learning Curve; D008297:Male; D018579:Patient Selection; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: direct flow medical; percutaneous; trans-catheter aortic valve implantation