title: First-in-man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT valve.
abstract: OBJECTIVE
  To demonstrate the feasibility of transfemoral transcatheter aortic valve replacement (TAVR) with the 29 mm Edwards SAPIEN XT valve and Novaflex™ + delivery system through a 20F expandable sheath (eSheath™, Edwards Lifesciences, USA). In addition, to describe the use of the Novaflex + delivery system and expandable sheath.
  
  
  BACKGROUND
  TAVR has undergone significant advances in device technology resulting in smaller profile sheaths and delivery systems, allowing transfemoral delivery of a 29 mm valve.
  
  
  METHODS
  Twelve patients underwent transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath. Baseline clinical and procedural characteristics are evaluated. In-hospital and 30-day outcomes are reported according to Valve Academic Research Consortium criteria.
  
  
  RESULTS
  All patients were male with a mean aortic annulus diameter of 25.0 ± 1.1 mm and 25.9 ± 1.2 mm, on transesophageal echocardiography and multidetector computerized tomography, respectively. Mean iliofemoral minimal luminal diameter (MLD) was 8.0 ± 0.8 mm. Successful deployment of the valve occurred in 11 out of 12 patients. Valve embolization occurred in one patient. Aortic valve area increased from 0.7 ± 0.2 to 2.0 ± 0.5 cm(2) (P < 0.001). There were two major vascular complications; however, there were no in-hospital or 30-day neurological events, need for pacemaker insertion, or mortality.
  
  
  CONCLUSIONS
  Transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath was feasible with acceptable short-term outcomes.
authors: Department of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
authors: Melanie
authors: M
authors: Freeman
authors: Josep
authors: J
authors: Rodés-Cabau
authors: Marina
authors: M
authors: Urena
authors: Robert
authors: R
authors: DeLarochelliere
authors: Eric
authors: E
authors: Dumont
authors: Jean-Bernard
authors: JB
authors: Masson
authors: Alexander B
authors: AB
authors: Willson
authors: Ronald K
authors: RK
authors: Binder
authors: Stefan
authors: S
authors: Toggweiler
authors: Jonathon
authors: J
authors: Leipsic
authors: David A
authors: DA
authors: Wood
authors: John G
authors: JG
authors: Webb
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D001705:Bioprosthesis; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005240:Feasibility Studies; D005263:Femoral Artery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D018579:Patient Selection; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D016896:Treatment Outcome