title: Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR.
abstract: OBJECTIVE
  To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial.
  
  
  BACKGROUND
  Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications.
  
  
  METHODS
  From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre- and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified.
  
  
  RESULTS
  Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C = 4, P = 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound.
  
  
  CONCLUSIONS
  While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure.
authors.affiliation: Division of Cardiology, Medical City Hospital, Dallas, Texas.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Holper
authors.forename: Rebeca J
authors.initials: RJ
authors.lastname: Kim
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: William
authors.initials: W
authors.lastname: Brinkman
authors.forename: Morley
authors.initials: M
authors.lastname: Herbert
authors.forename: Wells
authors.initials: W
authors.lastname: Stewart
authors.forename: Kaitlyn
authors.initials: K
authors.lastname: Vance
authors.forename: Bruce
authors.initials: B
authors.lastname: Bowers
authors.forename: Todd
authors.initials: T
authors.lastname: Dewey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D001783:Blood Flow Velocity; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002406:Catheterization, Peripheral / Q000009:adverse effects; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011677:Punctures; D012039:Regional Blood Flow; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D018084:Ultrasonography, Interventional; D014656:Vascular Surgical Procedures / Q000009:adverse effects
keywords: valvular heart disease; vascular access complications