Safety and efficacy of StarClose SE Vascular Closure System in high-risk liver interventional oncology patients

PURPOSE: 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.