title: Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses.
abstract: BACKGROUND
  A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.
  
  
  OBJECTIVE
  To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis.
  
  
  METHODS
  Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used.
  
  
  RESULTS
  Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P<0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1±11.0% vs 27.3±11.1%; P<0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7±1.2 vs 8.5±1.3mm; P<0.0001). Device success was similar in both groups (95.5% for SAPIEN XT and 93.6% for SAPIEN), as was the 30-day combined safety endpoint (15.2% and 17.9%, respectively). At 30days, prosthesis performance was similar in both groups.
  
  
  CONCLUSIONS
  Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.
authors.affiliation: Department of Cardiology, Hospital Charles-Nicolle, University Hospital of Rouen, Rouen cedex, France. helene.eltchaninoff@chu-rouen.fr
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.forename: Eric
authors.initials: E
authors.lastname: Durand
authors.forename: Bogdan
authors.initials: B
authors.lastname: Borz
authors.forename: Matthieu
authors.initials: M
authors.lastname: Godin
authors.forename: Christophe
authors.initials: C
authors.lastname: Tron
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Litzler
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bessou
authors.forename: Karim
authors.initials: K
authors.lastname: Bejar
authors.forename: Chiara
authors.initials: C
authors.lastname: Fraccaro
authors.forename: Carlos
authors.initials: C
authors.lastname: Sanchez-Giron
authors.forename: Jean-Nicolas
authors.initials: JN
authors.lastname: Dacher
authors.forename: Fabrice
authors.initials: F
authors.lastname: Bauer
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods* / Q000592:standards; D017548:Echocardiography, Transesophageal; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome