title: Direct Flow Medical valve.
abstract: OBJECTIVE
  To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve.
  
  
  RESULTS
  The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days.
  
  
  CONCLUSIONS
  The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.
authors.affiliation: Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Reginald I
authors.initials: RI
authors.lastname: Low
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
mesh_terms: D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000517:prevention & control; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D019317:Evidence-Based Medicine; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D018579:Patient Selection; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome