title: Simplified Transapical Aortic Valve Implantation Using the SAPIEN 3 Valve Without Preballooning.
abstract: OBJECTIVE
  Preballooning (PB) of the stenotic aortic valve can be considered common standard during transcatheter aortic valve implantation (T-AVI). Transcatheter aortic valve implantation without preballooning (noPB) using the Edwards SAPIEN XT prosthesis has been described previously. The aim of this study was to evaluate the outcomes of next-generation SAPIEN 3 valve implantation without PB.
  
  
  METHODS
  Since January 2013, a total of 66 patients received SAPIEN 3 valve implantation at our center using the transapical approach. Patients were treated using the standard PB technique (n = 17 [25.8%]) or no PB (n = 49 [74.2%]).
  
  
  RESULTS
  Baseline characteristics of patient groups were comparable (38% women; mean age, 83 years; STS score, 8%, logistic EuroSCORE I and II, 30% and 8%, respectively). Patients in the PB group were exclusively treated in our earlier experience with this device. Overall 30-day mortality was 4.5% (6.1% for noPB vs. 0% PB; P = ns). Aortic regurgitation was grade 1 or less in 100% (PB) versus 93.9% (noPB); P = ns Median contrast use was 70 (60-95) mL (PB) versus 50 (40-50) mL (noPB); P < 0.001; and median radiation dose was 32.0 (17-57) Gy × cm (PB) versus 26.6 (16-36) Gy × cm (noPB); P < 0.001. Postdilatation was required in one patient only (noPB). The rate of new pacemaker implantations was 41.2% (PB) versus 12.2% (noPB); P = 0.03. Periprocedural stroke occurred in one patient in each group (6% PB vs 2.0% no-PB); P = ns.
  
  
  CONCLUSIONS
  Direct transapical SAPIEN 3 valve implantation without PB is feasible and safe. The no-PB technique leads to further simplification of the procedures.
authors.affiliation: From the *Department of Cardiac Surgery, and the †Department of Cardiology, Kerckhoff-Klinik, Bad Nauheim, Germany.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Van Linden
authors.forename: Won-Keun
authors.initials: WK
authors.lastname: Kim
authors.forename: Christoph
authors.initials: C
authors.lastname: Liebetrau
authors.forename: Mirko
authors.initials: M
authors.lastname: Doss
authors.forename: Florian
authors.initials: F
authors.lastname: Hecker
authors.forename: Mani
authors.initials: M
authors.lastname: Arsalan
authors.forename: Johannes
authors.initials: J
authors.lastname: Blumenstein
authors.forename: Helge
authors.initials: H
authors.lastname: Möllmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome