title: Direct transcatheter aortic valve implantation - one-year outcome of a case control study.
abstract: BACKGROUND
  Transaortic valve implantation (TAVI) has a well-established position in the treatment of high-risk and inoperable patients with severe aortic stenosis (AS). The TAVI protocol requires a pre-dilatation for native valve preparation.
  
  
  OBJECTIVE
  To assess the safety and feasibility of TAVI without pre-dilatation and to compare it with the procedure with pre-dilatation.
  
  
  METHODS
  Out of 101 TAVI patients, in 10 the procedure was performed without balloon predilatation, and 8 patients were included in the analysis. The procedural, echocardiographic, and clinical outcomes were compared with a case control matched cohort (1: 2 ratio). A 12-month follow-up was done in all cases.
  
  
  RESULTS
  The procedure was successfully completed in all patients in the study group (SG), but there was one procedural failure in the control group (CG). All patients received a CoreValve (Medtronic) bioprosthesis. There was a significant immediate decrease in transvalvular gradients (TG) in both study arms after the procedure (SG: mean TG: from 46.0 ±14.0 mm Hg to 10.0 ±4.8 mm Hg, p < 0.001; CG: mean TG: from 55.9 ±12.0 mm Hg to 9.9 ±2.9 mm Hg, p < 0.001). A marked increase in the effective orifice areas was observed in both cohorts (SG: 1.63 ±0.13 cm(2) and CG: 1.67 ±0.25 cm(2), p = 0.75). The periprocedural complication rate was equally distributed in both arms. The 12-month all-cause mortality was 12.5% in both groups.
  
  
  CONCLUSIONS
  The direct TAVI approach seams to be safe and feasible. The clinical and echocardiographic results are not different from those achieved in patients treated with standard TAVI protocol with pre-dilatation.
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Janusz
authors.initials: J
authors.lastname: Kochman
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Lukasz
authors.initials: L
authors.lastname: Kołtowski
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Zenon
authors.initials: Z
authors.lastname: Huczek
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Scisło
authors.affiliation: Department of Cardiac Surgery, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Leopold
authors.initials: L
authors.lastname: Bakoń
authors.affiliation: Department of Cardiac Surgery, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Radosław
authors.initials: R
authors.lastname: Wilimski
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Bartosz
authors.initials: B
authors.lastname: Rymuza
authors.affiliation: 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Opolski
keywords: aortic valve; balloon valvuloplasty; no pre-dilatation; pre-dilatation; transaortic valve implantation