'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.


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.


CONCLUSIONS
The evaluated percutaneous vascular suture device is useful in clinical practice but limitations concerning patient selection seem to emerge in order to avoid complications.
Henk
Christine B
CB
Department of Radiology, Ludwig-Boltzmann Institute for Clinical and Experimental Radiology, University of Vienna, Währingergürtel 18-20, A-1090 Vienna, Austria. christine.henk@univie.ac.at
Grampp
Stephan
S
Heimberger
Karl
K
Czerny
Christian
C
Schindler
Erwin
E
Mostbeck
Gerhard H
GH
D000328:Adult; D000367:Age Factors; D000704:Analysis of Variance; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D002533:Cerebral Angiography / Q000379:methods*; D016009:Chi-Square Distribution; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006487:Hemostasis / Q000502:physiology; D006801:Humans; D020300:Intracranial Hemorrhages / Q000175:diagnosis; D008297:Male; D009339:Needles / Q000009:adverse effects / Q000706:statistics & numerical data; D011677:Punctures / Q000009:adverse effects / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012737:Sex Factors; D013536:Suture Techniques / Q000009:adverse effects* / Q000295:instrumentation* / Q000706:statistics & numerical data; D013537:Sutures / Q000009:adverse effects* / Q000706:statistics & numerical data; D016896:Treatment Outcome