title: Collagen plug-based vascular closure devices do not decrease vascular and bleeding complications occurring after balloon aortic valvuloplasty.
abstract: BACKGROUND
  The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial.
  
  
  OBJECTIVE
  To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty.
  
  
  METHODS
  We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification≥3) and vascular access complications.
  
  
  RESULTS
  We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10-3.09; P=0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs.
  
  
  CONCLUSIONS
  Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France. Electronic address: f-leclercq@chu-montpellier.fr.
authors.forename: Florence
authors.initials: F
authors.lastname: Leclercq
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Delseny
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: Richard
authors.initials: R
authors.lastname: Gervasoni
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Lattuca
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: François
authors.initials: F
authors.lastname: Roubille
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cayla
authors.affiliation: Department of Cardiology, University of Montpellier, Montpellier, France.
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Macia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects* / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects* / Q000379:methods; D003094:Collagen; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005602:France; D006470:Hemorrhage / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011677:Punctures; D012307:Risk Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices / Q000009:adverse effects
chemical_list: D003094:Collagen
keywords: Balloon aortic valvuloplasty; Complications vasculaires; Fermeture vasculaire percutanée; Valvuloplastie aortique au ballon; Vascular closure devices; Vascular complications