title: The use of vascular closure devices and impact on major bleeding and net adverse clinical events (NACEs) in balloon aortic valvuloplasty: a sub-analysis of the BRAVO study.
abstract: OBJECTIVE
  To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV).
  
  
  BACKGROUND
  Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding.
  
  
  METHODS
  The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10-13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use.
  
  
  RESULTS
  Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P < 0.001), a history of prior BAV (11.1% vs. 3.6%, P = 0.04) and peripheral vascular disease (30.7% vs. 19.7%, P = 0.01) was more common in those not undergoing preclosure (n = 159, 37%). Other clinical and demographic features were well balanced between groups. Vascular closure was associated with a significant reduction in NACE (24.5% vs. 10.0% P < 0.001). Results remained significant after adjusting for baseline differences and bivalirudin use (OR 0.38, 95% CI: 0.21-0.68; P = 0.001).
  
  
  CONCLUSIONS
  Our study suggests that suture-mediated vascular closure is associated with a substantial reduction in NACE after transfemoral BAV. Large randomized clinical trials should be conducted to confirm our results.
authors: Cardiovascular Division, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.
authors: Brian
authors: B
authors: O'Neill
authors: Vikas
authors: V
authors: Singh
authors: Annapoorna
authors: A
authors: Kini
authors: Roxana
authors: R
authors: Mehran
authors: Evan
authors: E
authors: Jacobs
authors: David
authors: D
authors: Knopf
authors: Carlos E
authors: CE
authors: Alfonso
authors: Claudia A
authors: CA
authors: Martinez
authors: Pedro
authors: P
authors: Martinezclark
authors: William
authors: W
authors: O'Neill
authors: Alan W
authors: AW
authors: Heldman
authors: Jennifer
authors: J
authors: Yu
authors: Usman
authors: U
authors: Baber
authors: Jason C
authors: JC
authors: Kovacic
authors: George
authors: G
authors: Dangas
authors: Samin
authors: S
authors: Sharma
authors: Samantha
authors: S
authors: Sartori
authors: Mauricio G
authors: MG
authors: Cohen
mesh_terms: D000046:Academic Medical Centers; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000627:therapeutic use; D001024:Aortic Valve Stenosis; D063126:Balloon Valvuloplasty / Q000009:adverse effects*; D016009:Chi-Square Distribution; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005431:Florida; D006470:Hemorrhage / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D061847:Hospitals, High-Volume; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D009519:New York City; D016017:Odds Ratio; D010446:Peptide Fragments / Q000627:therapeutic use; D011677:Punctures; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D013536:Suture Techniques / Q000295:instrumentation*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: aortic stenosis; balloon aortic valvuloplasty; bleeding; closure devices