Multicenter safety and efficacy analysis of assisted closure after antegrade arterial punctures using the StarClose device.

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of the StarClose device for closure of antegrade punctures following infrainguinal endovascular interventions. METHODS: A retrospective review was conducted of 221 consecutive patients treated with the StarClose device in a 12-month period at 5 centers (4 French and 1 British). Of these, 107 patients (69 men; median age 75 years, range 44-93) were from the UK cohort (111 closures), and 94 patients (75 men; median age 67 years, range 32-95) were from the French cohort (111 closures). Technical success, complication rates, demographic data, medical history, and procedural details were gathered for all patients. Residual bleeding and the requirement for additional manual compression were recorded when the device failed. Clinical evaluation was performed at discharge; color-coded duplex ultrasonography was done in a subset of French patients. RESULTS: The overall technical success rate was 94.6% (210/222; 95% CI 3.1%-9.2%). The results were similar in the 2 cohorts 95.5% (106/111; 95% CI 1.9%-10.1%) in the UK and 93.7% (104/111; 95% CI 3.1%-12.4%) in France. The 12 failures (5 UK and 7 France) were due to several mechanisms device failure (n=5), obesity (n=1), groin scarring (n=2), and unexplained (n=4). In 2 failed cases, open surgical closure of the arteriotomy was performed because pressure hemostasis failed. Two pseudoaneurysms were observed one after immediate failure was successfully treated by prolonged pressure; the other, after apparent success of the device, required surgical therapy. The incidence of serious vascular complication was 1.8% (4/222; 95% CI 0.7%-4.5%); 2 patients from each cohort. CONCLUSION: The StarClose device safely and effectively closes antegrade punctures after infrainguinal endovascular intervention, even in patients who would be considered to be at high risk for puncture-site bleeding. However, a randomized trial would be required to support any definitive recommendations.