StarClose vascular closure device: safety and efficacy of deployment and reaccess in a neurointerventional radiology service.
OBJECTIVE
Obtaining safe and effective closure of the femoral access site following neurointerventional procedures can sometimes be challenging, especially in patients on anti-coagulation or anti-platelet therapy. The purpose of this study was to evaluate the safety and efficacy of a novel percutaneous closure device that employs a nitinol clip-mediated extravascular closure strategy following neurointerventional procedures.


METHODS
We performed a retrospective review of all patients who underwent neurointerventional procedures at our institution between January 1, 2006 and December 31, 2008. We evaluated the safety and efficacy of the StarClose device in patients undergoing first and repeat procedures. Groin complications were classified as self-limited hematoma, hematoma requiring transfusion, other/minor (pseudoaneurysm, infection), and other/major (vascular complication).


RESULTS
StarClose device use was attempted in 281 of 352 cases (79.8%) with success reported in 269 cases (95.7%). Minor and major complications occurred in 0.7% and 0.4% of patients, respectively. There was one major vascular complication. Repeat use was performed in 84 patients with 100% success and a 2.3% minor complication rate. Time to reaccess ranged from 1 to 1036 days (mean, 105 days).


CONCLUSIONS
The StarClose device achieves rapid and safe femoral arterial closure in patients, both for primary closure and after reaccess.
McTaggart
R A
RA
Department of Diagnostic Imaging, Alpert Medical School at Brown University, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA.
Raghavan
D
D
Haas
R A
RA
Jayaraman
M V
MV
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017541:Aneurysm, False / Q000209:etiology; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D016208:Databases, Factual; D004868:Equipment Failure; D005260:Female; D005263:Femoral Artery; D006406:Hematoma / Q000209:etiology; D006470:Hemorrhage / Q000209:etiology; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D007239:Infections / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009485:Neuroradiography / Q000295:instrumentation*; D012189:Retrospective Studies; D055815:Young Adult