title: First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.
abstract: OBJECTIVE
  Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure.
  
  
  RESULTS
  Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status.
  
  
  CONCLUSIONS
  For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.
authors.affiliation: San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Neil
authors.initials: N
authors.lastname: Ruparelia
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.forename: Fernando
authors.initials: F
authors.lastname: Gatto
authors.forename: Lorenz
authors.initials: L
authors.lastname: Hansen
authors.forename: Cem
authors.initials: C
authors.lastname: Ozbek
authors.forename: Peter
authors.initials: P
authors.lastname: Greilach
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.forename: Friedrich-Christian
authors.initials: FC
authors.lastname: Rieß
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D058386:Mitral Valve Annuloplasty / Q000295:instrumentation; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011474:Prosthesis Design; D016896:Treatment Outcome