title: First experience without pre-ballooning in transapical aortic valve implantation: a propensity score-matched analysis.
abstract: OBJECTIVE
  Transapical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved into a routine procedure for selected high-risk elderly patients. The recently introduced SAPIEN™ delivery system (Ascendra II+™) with an added nose cone seems to facilitate direct valve implantation without prior balloon valvuloplasty (BAV). Here, we report our initial experience with this device.
  
  
  METHODS
  A total of 128 patients were enrolled in the study in 2012 and 2013 and were designated Cohort I. For a subset of 79 patients, exact cardio- computed tomography-based measurements were available; these patients were assigned to Cohort II. All patients received SAPIEN XT™ valves using the TA approach. TA-AVI without pre-ballooning was performed in 31.2% (Cohort I) and 31.6% (Cohort II) of patients. To adjust for baseline variables, propensity score (PS)-based pair matching was used.
  
  
  RESULTS
  All valves were implanted successfully. The use of PS matching resulted in bias reduction for both cohorts. For Cohort I, there were no significant differences in the primary end points, which were aortic valve incompetence≥2+, Pmean postimplantation, major stroke, transient ischaemic attack (TIA), requirement for post-dilatation and necessity for new pacemaker implantation. As expected, fluoroscopy time was significantly lower in no-BAV patients. In Cohort II, the 30-day TIA rate was lower in the no-BAV group.
  
  
  CONCLUSIONS
  Direct TA implantation of the SAPIEN valve without pre-ballooning is feasible, safe, does not seem to compromise functional outcomes and may be associated with fewer neurological events.
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany kempfertj@gmail.com.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Meyer
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany Department of Cardiology, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Won-Keun
authors.initials: WK
authors.lastname: Kim
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Arnaud
authors.initials: A
authors.lastname: van Linden
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Mani
authors.initials: M
authors.lastname: Arsalan
authors.affiliation: Department of Cardiology, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Blumenstein
authors.affiliation: Department of Cardiology, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Möllmann
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D016022:Case-Control Studies; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D057216:Propensity Score; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
keywords: Aortic valve implantation; Minimally invasive; Transapical