Angio-Seal(TM) Evolution(TM) versus Manual Compression for Common Femoral Artery Puncture in Neurovascular Diagnostic Angiography : A Prospective, Non-Randomized Study

ABSTRACT

OBJECTIVE: This prospective, non-randomized study compared the safety and efficacy of the Angio-Seal(TM) Evolution(TM) to that of manual compression for common femoral artery punctures in neurovascular diagnostic angiography. METHODS: From June 2009 to September 2009, we performed 169 diagnostic trans-femoral cerebral angiographies, using either the Angio-Seal(TM) Evolution(TM) or manual compression to achieve hemostasis. We included 60 patients in this study, 30 in each group. We defined minor complications as those requiring no further treatment such as hematoma size less than 6 cm and bruise size less than 25 cm. Major complications were those requiring surgery of the femoral artery pseudoaneurysm and/or the second line increase of hospital stay even without further treatment. RESULTS: Mean time to hemostasis was 0.42+/-0.04 minutes for the angioseal and 15.83+/-1.63 minutes for manual compression (p<0.001). Overall complication rate did not differ between the 2 groups. After the patients were fully mobile, at 24 hours, the rate of onset of new complication differed significantly between the 2 groups (p=0.032). In the angioseal group, 5 (16.7%) of the 30 patients experienced the onset of a new complication after 24 hours, including 3 (60.0%) of the 5 who experienced major complications. CONCLUSION: The Angio-Seal(TM) Evolution(TM) is effective at decreasing mean time to hemostasis, like other closing devices. However, it may not be effective at producing early ambulation and discharge, compared to manual compression, because delayed complications may occur significantly after 24 hours.