title: Safety and efficacy of StarClose SE Vascular Closure System in high-risk liver interventional oncology patients.
abstract: OBJECTIVE
  To assess the safety and efficacy of the StarClose SE Vascular Closure System (Abbott Vascular, Abbott Park IL, USA) in high-risk thrombocytopenic and coagulopathic interventional oncology (IO) patients.
  
  
  METHODS
  In this single institution retrospective study, 63 high-risk thrombocytopenic or coagulopathic IO patients (M:F=51:12, mean age 58 years, range 31-88 years) who underwent 83 common femoral arteriotomy closures using the StarClose device were identified among all IO patients (n=131) undergoing StarClose closure (n=177) between 2008-2011. High-risk thrombocytopenia and coagulopathy were defined as platelet count ≤100 10(3)/mL and international normalized ratio (INR) ≥1.5. Procedures included chemoembolization (n=67), radioembolization (n=8), and hepatic arterial mapping with technetium-99m macroaggrated albumin administration (n=8) for treatment of hepatocellular carcinoma (n=79) or liver metastases (n=4). Measured outcomes included technical success of arterial closure and closure-related adverse events, graded according to the Society of Interventional Radiology classification.
  
  
  RESULTS
  In all cases, 5 French common femoral arterial access was used. Platelet count was ≤100 10(3)/mL in 80/83 (96.4%) cases and INR was ≥1.5 in 35/83 (42.2%) cases. Mean pre-procedure platelet count was 71 (range 26-347) 10(3)/mL and mean INR was 1.4 (range 1.0-2.1). The StarClose device effectively sealed the arteriotomy in 83/83 (100%) cases, 60/83 (72.3%) cases were first-time closures, and 20/83 (24.1%) cases were repeat closures. Small groin hematomas, graded as class A minor complications, developed in 3/83 (3.6%) cases. No other complications were encountered.
  
  
  CONCLUSIONS
  The StarClose SE Vascular Closure System confers high technical success and safety in common femoral arteriotomy closure in high-risk IO patients.
authors.affiliation: Department of Radiology, Section in Interventional Radiology, University of Illinois Medical Center at Chicago, Chicago, IL 60612, USA. rgaba@uic.edu
authors.forename: Ron C
authors.initials: RC
authors.lastname: Gaba
authors.forename: Ahmad
authors.initials: A
authors.lastname: Parvinian
authors.forename: Estrellita M
authors.initials: EM
authors.lastname: Trinos
authors.forename: Suzanne V
authors.initials: SV
authors.lastname: Padayao
authors.forename: Rechel M
authors.initials: RM
authors.lastname: Francisco
authors.forename: Felix Y
authors.initials: FY
authors.lastname: Yap
authors.forename: M Grace
authors.initials: MG
authors.lastname: Knuttinen
authors.forename: Charles A
authors.initials: CA
authors.lastname: Owens
authors.forename: James T
authors.initials: JT
authors.lastname: Bui
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001778:Blood Coagulation Disorders / Q000097:blood / Q000209:etiology; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D002641:Chicago; D004621:Embolization, Therapeutic / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D019934:International Normalized Ratio; D008113:Liver Neoplasms / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D011677:Punctures; D011859:Radiography; D012189:Retrospective Studies; D012307:Risk Factors; D013921:Thrombocytopenia / Q000097:blood / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices