'The Closer'-percutaneous vascular suture device: evaluation of safety and performance in neuroangiography

OBJECTIVE: To evaluate the use of the suture mediated vascular closure device concerning practicability and safety in clinical angiography practice. MATERIAL AND METHODS: One hundred and seventeen patients (59 female, 58 male, mean age 40.9+/-13.4) underwent percutaneous closure of common femoral arterial puncture sites following diagnostic neuroangiography using the suture device 'the Closer' (Perclose Inc., Redwood City, CA, USA). Primary success, early problems (within 24 h) and late complications were evaluated. Complications were graded as minor and severe with or without need of surgical intervention and categorized by type. Parameters such as age, gender, sheath size and number of previous arterial punctures were evaluated with respect to complications. RESULTS: Percutaneous closure was primary successful in 85% (100/117). The overall complication rate was 32% (28% mild n=35, 4% severe n=6, which needed surgical intervention). All but one problem occurred within the first 24 h after the suture. Additional manual compression was necessary in 32 cases (25%). There was no significant difference in age and gender between the groups with and without complications. Sheath size was significantly larger (P<0.01) and numbers of preceeding angiograms were significantly higher (P<0.01) in the complications group compared with uncomplicated cases. CONCLUSION: The evaluated percutaneous vascular suture device is useful in clinical practice but limitations concerning patient selection seem to emerge in order to avoid complications.