title: One-year outcomes after direct transcatheter aortic valve implantation with a self-expanding bioprosthesis. A two-center international experience.
abstract: BACKGROUND
  Balloon aortic valvuloplasty (BAV) is considered to be an essential part of the transcatheter aortic valve implantation (TAVI) procedure and is being performed routinely. At present there is insufficient long-term data as to the benefits of routine BAV prior to TAVI.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the safety of direct TAVI and the mortality rate at 1-year in patients undergoing TAVI with or without BAV with a self-expanding bioprosthesis.
  
  
  METHODS
  Between January 2008 and September 2013 consecutive patients undergoing TAVI with the Medtronic CoreValve in two experienced centers in Athens, Greece and in Siegburg, Germany were studied. All data were prospectively collected and retrospectively analyzed. Primary endpoint was mortality at 1 year. Procedural data and clinical data (bleeding, vascular complications and echocardiographic parameters) were analyzed.
  
  
  RESULTS
  A total of 210 patients undergoing TAVI were evaluated (non-direct=120 patients, direct=90 patients). All-cause mortality at 30 days and at 1 year was similar in both groups (4% in non-direct versus 2% in direct, p=0.6 and 15% in non-direct versus 11% in direct, p=0.5, respectively). Device success rate was similar in both groups (77% in non-direct versus 83% in direct, p=0.2). Major vascular complications were comparable for both groups (5% in non-direct versus 3% in direct, p=0.5). The direct group had less moderate/severe paravalvular leakage than the non-direct group after the device implantation (7% versus 33%, p<0.01).
  
  
  CONCLUSIONS
  Performing direct TAVI with the self-expanding bioprosthesis is safe and feasible showing similar mortality rates compared to patients undergoing non-direct TAVI at 30 days and at 1-year.
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece. Electronic address: ktoutouz@gmail.com.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Toutouzas
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Latsios
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Stathogiannis
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Maria
authors.initials: M
authors.lastname: Drakopoulou
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Andreas
authors.initials: A
authors.lastname: Synetos
authors.affiliation: Cardiology Department, Laikon Hospital, Athens, Greece.
authors.forename: Elias
authors.initials: E
authors.lastname: Sanidas
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Antonios
authors.initials: A
authors.lastname: Mastrokostopoulos
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Trantalis
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Odysseas
authors.initials: O
authors.lastname: Kaitozis
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Lazaros
authors.affiliation: Gemeinschaftskrankenhaus Bonn, Germany.
authors.forename: Seyrani
authors.initials: S
authors.lastname: Yuecel
authors.affiliation: Gemeinschaftskrankenhaus Bonn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.affiliation: University Hospital, Dept of Medicine II, Bonn, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Tousoulis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000379:methods*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000379:methods*; D004452:Echocardiography / Q000379:methods; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006470:Hemorrhage / Q000150:complications / Q000209:etiology; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: Balloon aortic valvuloplasty; CoreValve; Direct; Mortality; TAVI