title: Direct transfemoral transcatheter aortic valve implantation without balloon pre-dilatation using the Edwards Sapien XT valve.
abstract: OBJECTIVE
  To evaluate the feasibility and safety of direct transcatheter aortic valve implantation (TAVI) by the transfemoral approach without balloon pre-dilatation using the Edwards SapienXT valve.
  
  
  BACKGROUND
  TAVI is established in selected high-risk patients with severe aortic stenosis. Balloon aortic valvuloplasty (BAV) is recommended prior to valve implantation, but may contribute to procedural risk. It is unknown whether this is necessary for successful passage and deployment of the device.
  
  
  METHODS
  81 patients (mean age 84 [95%CI:82-85.8], 62% male, median EuroScore 22.8% [95%CI:20.5-27]) undergoing transfemoral TAVI (35 by direct implantation [direct group]; 46 with balloon pre-dilatation [balloon group]) between 2010 and 2013 were analyzed for efficacy and safety endpoints.
  
  
  RESULTS
  Procedural success was 100%. Pre and post-procedural peak gradients in the direct group were 66mmHg (95%CI:59-72.8) and 14mmHg (95%CI:12-17.8)(P < 0.0001) compared to 76.5mmHg (95%CI:73.7-94.0) and 17mmHg (95%CI:16-19)(P < 0.0001) in the balloon group. Post-dilatation was performed in 4/35(11.4%) of the direct group and 3/46(6.5%) of the balloon group (P = 0.83). Post procedure moderate AR was present in 1/35(2.9%) in the direct group and none in the balloon group. In-hospital mortality (2.9% direct vs. 0% balloon group), stroke (2.9% vs. 4.4%), tamponade (2.9% vs. 2.2%), major vascular complications (2.9% vs. 8.7%) and new permanent pacing (2.2% vs. 0) were similar. Pacing time, inflations, radiation dose and contrast use were all significantly lower in the direct group.
  
  
  CONCLUSIONS
  Direct implantation of the Edwards SapienXT valve during TAVI by the transfemoral route appears safe, efficacious and feasible in those without extreme calcification. © 2016 Wiley Periodicals, Inc.
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Alykhan
authors.initials: A
authors.lastname: Bandali
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Gemma
authors.initials: G
authors.lastname: Parry-Williams
authors.affiliation: University of Calgary, Calgary, Canada.
authors.forename: Aliya
authors.initials: A
authors.lastname: Kassam
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Sonny
authors.initials: S
authors.lastname: Palmer
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Williams
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Mark A
authors.initials: MA
authors.lastname: de Belder
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Owens
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Goodwin
authors.affiliation: The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Douglas F
authors.initials: DF
authors.lastname: Muir
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D063126:Balloon Valvuloplasty; D006328:Cardiac Catheterization / Q000295:instrumentation*; D004452:Echocardiography; D005260:Female; D005263:Femoral Artery; D005471:Fluoroscopy; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: aortic stenosis; balloon aortic valvuloplasty; transcatheter aortic valve implantation