title: Transfemoral aortic valve implantation of Edwards SAPIEN 3 without predilatation.
abstract: OBJECTIVE
  The purpose of the present study was to investigate whether transfemoral implantation of the balloon-expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible.
  
  
  BACKGROUND
  Transcatheter aortic valve implantation (TAVI) without predilatation may be advantageous and is feasible with various transcatheter heart valves.
  
  
  METHODS
  A total of 163 consecutive patients with severe aortic stenosis undergoing transfemoral TAVI were enrolled at two sites. We assessed whether the crossing of the native aortic valve with the prosthesis without prior pre-dilation was feasible and evaluated for procedural success according to VARC-2 criteria.
  
  
  RESULTS
  Direct implantation without pre-dilatation was feasible in 154 patients (94.5%), whereas in nine patients predilatation was required due to difficulties while crossing the native aortic valve. Procedural success was achieved in 85.6%. A large proportion of the procedural failures was mainly driven by increased post-procedural gradients ≥20 mm Hg, which almost exclusively concerned the smaller prostheses sizes (23-mm 10/39 (25.6%) vs. 26-mm 5/72 (6.9%) vs. 29-mm 1/52 (1.9%); P < 0.001). Patients in the pre-ballooning group had higher calcium scores of the aortic valve (5,335 [4,421-7,807] vs. 2,893 [1,879-3,993]), more advanced age, higher transvalvular gradients, and smaller aortic valve area.
  
  
  CONCLUSIONS
  The transfemoral implantation of the balloon-expandable SAPIEN 3 prosthesis without pre-dilatation is feasible in the majority of cases. In the presence of severe aortic valve calcification and critical aortic stenosis, however, predilatation may still be necessary. Furthermore, the significance of increased post-procedural gradients requires further verification. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.|Department of Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Won-Keun
authors.initials: WK
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Fabien
authors.initials: F
authors.lastname: Praz
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Blumenstein
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Liebetrau
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Luise
authors.initials: L
authors.lastname: Gaede
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Van Linden
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.|Department of Cardiology, Justus-Liebig University of Giessen, Giessen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Möllmann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013557:Switzerland; D016896:Treatment Outcome
keywords: TAVI; aortic stenosis; transvalvular gradient; valvuloplasty