title: Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.
abstract: OBJECTIVE
  The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.
  
  
  RESULTS
  235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low.
  
  
  CONCLUSIONS
  In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02162069.
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Birgid
authors.initials: B
authors.lastname: Gonska
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Rodewald
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Seeger
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Dominik
authors.initials: D
authors.lastname: Scharnbeck
authors.affiliation: Department of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rottbauer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000601:surgery / Q000628:therapy; D001024:Aortic Valve Stenosis / Q000601:surgery* / Q000628:therapy*; D002140:California; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography / Q000379:methods; D011446:Prospective Studies; D011474:Prosthesis Design / Q000295:instrumentation / Q000379:methods; D012307:Risk Factors; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome