title: Decrease of vascular and bleeding complications after balloon aortic valvuloplasty performed without heparin.
abstract: OBJECTIVE
  To determine whether vascular and bleeding complications may be reduced with balloon aortic valvuloplasty (BAV) performed without heparin.
  
  
  BACKGROUND
  Vascular and bleeding complications are currently the main adverse events occurring after BAV.
  
  
  METHODS
  This registry included 162 consecutive patients with severe aortic stenosis who underwent BAV by femoral approach in our center between 2008 and 2012. Eighty-five patients had unfractionated heparin (UH) 50 IU/kg bolus IV during the procedure, whereas 77 patients did not have heparin. Our primary combined endpoint included severe vascular or bleeding complications (BARC score ≥3), severe ischemic events (acute limb ischemia or systemic embolism) or death at 1-month follow-up.
  
  
  RESULTS
  The primary composite endpoint was achieved in 25 patients overall (15.4%) and was significantly lower in the heparin-free group (10.3% vs 20.0%; P=.03). Vascular, bleeding, or ischemic events were dramatically lower in the heparin-free group (6.5%) compared with the heparin group (18.8%; P=.01). UH use was associated with an increased risk of vascular and bleeding complications (relative risk, 2.92; 95% confidence interval, 1.35-7.94), but not with a decreased risk of ischemic events (relative risk, 1.81, 95% confidence interval, 0.34-9.61). After adjustment for patient and procedure characteristics, including the sheath size, heparin use was the only significant predictor of the primary endpoint (adjusted odds ratio, 2.94; 95% confidence interval, 1.75-14.74).
  
  
  CONCLUSIONS
  BAV performed without heparin is associated with a reduction of severe vascular events or death without increased ischemic risk. This marked difference is difficult to explain by confounding factors, but should be confirmed in a randomized controlled trial.
authors.affiliation: Department of Cardiology, Arnaud de Villeneuve University Hospital, 295 avenue du doyen Giraud, 34295 Montpellier cedex 5, France. f-leclercq@chu-montpellier.fr.
authors.forename: Florence
authors.initials: F
authors.lastname: Leclercq
authors.forename: Delphine
authors.initials: D
authors.lastname: Delseny
authors.forename: Erika
authors.initials: E
authors.lastname: Nogue
authors.forename: Valérie
authors.initials: V
authors.lastname: Macioce
authors.forename: Nicolas
authors.initials: N
authors.lastname: Nagot
authors.forename: Francois
authors.initials: F
authors.lastname: Roubille
authors.forename: Richard
authors.initials: R
authors.lastname: Gervasoni
authors.forename: Jean C
authors.initials: JC
authors.lastname: Macia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects* / Q000379:methods*; D004617:Embolism / Q000139:chemically induced* / Q000517:prevention & control*; D005121:Extremities / Q000098:blood supply; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000517:prevention & control*; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D007511:Ischemia / Q000139:chemically induced* / Q000517:prevention & control*; D008297:Male; D012042:Registries; D012306:Risk; D016896:Treatment Outcome
chemical_list: D006493:Heparin