title: Efficacy and safety of the nitinol clip-based vascular closure device (Starclose) for closure of common femoral arterial cannulation at or near the bifurcation: a propensity score-adjusted analysis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the nitinol clip-based closure device (Starclose®, Abbott Vascular, Santa Clara, California) in patients with femoral arterial cannulation at the common femoral artery bifurcation.
  
  
  BACKGROUND
  Femoral artery puncture at the bifurcation of common femoral artery is a relative contraindication for the use of vascular closure devices with intravascular components, and patients with bifurcation cannulation were excluded from the pivotal trials of these devices. The nitinol clip-based closure device (Starclose) is extravascular and is sometimes used in such patients; however, the efficacy and safety of this approach is unknown.
  
  
  METHODS
  We evaluated consecutive patients undergoing deployment of a Starclose device following a coronary procedure via the femoral artery approach. Quantitative femoral angiographic analyses were performed using a hand caliper. The distance of the artery puncture site from the bifurcation was recorded in each patient. Any arterial cannulation ≤ 3 mm from the bifurcation was categorized as a bifurcation cannulation (as the outer diameter of the nitinol clip of Starclose is 4 mm).
  
  
  RESULTS
  Among 1096 patients who underwent deployment of a Starclose device, 217 (20%) were within 3 mm of the bifurcation. Starclose deployment at the bifurcation was not associated with a significant increase in the risk of any (0.9% vs. 1.0%; p = 0.892) major (0.0% vs. 0.3%; p = 0.389) or minor vascular complications (0.9% vs. 0.7%; p = 0.711) compared to deployment for non-bifurcation cannulations (both for diagnostic and percutaneous coronary interventional procedures). The results were unchanged in both a regression model adjusted for a propensity score (41 baseline covariates) as well as a propensity score-matched cohort (217 bifurcation cannulations vs. 217 non-bifurcation cannulations).
  
  
  CONCLUSIONS
  In a select group of patients, vascular closure using a extravascular closure device (Starclose) appears to be safe for arterial cannulations at or near the bifurcation.
authors.affiliation: New York University School of Medicine, New York, USA.
authors.forename: Sripal
authors.initials: S
authors.lastname: Bangalore
authors.forename: Venkatesan D
authors.initials: VD
authors.lastname: Vidi
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Liu
authors.forename: Pinak B
authors.initials: PB
authors.lastname: Shah
authors.forename: Frederic S
authors.initials: FS
authors.lastname: Resnic
mesh_terms: D000368:Aged; D000497:Alloys; D000792:Angiography; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D016022:Case-Control Studies; D015331:Cohort Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D057216:Propensity Score; D012189:Retrospective Studies; D013525:Surgical Instruments; D016896:Treatment Outcome; D058106:Wound Closure Techniques / Q000009:adverse effects / Q000295:instrumentation*
chemical_list: D000497:Alloys; C013616:nitinol