Background Large French (Fr) sheaths are commonly used to obtain optimum common femoral artery (CFA) access while performing acute stroke endovascular treatments. The StarClose Vascular Closure System (Abott Vascular) is currently indicated for the percutaneous closure of CFA access sheaths of 5 Fr or 6Fr procedural size. Limited data exists regarding off-label use of the StarClose device in patients who had 7–9 French CFA access.
Objectives To evaluate the safety and efficacy of the StarClose extravascular closure device in achieving post femoral artery catheterization hemostasis after placement of large Fr femoral sheath.
Methods Retrospective chart review was performed between 2009 and 2011 of 73 patients who underwent endovascular treatment for acute stroke who were closed with the StarClose device. The study included 39 females and 34 males with mean age 68.1 years. 86.4% (n=63) had hypertension, 26% (n=19) had diabetes mellitus, 75.34% (n=55) had dyslipidemia, 42.5% (n=31) had coronary artery disease, and 39.7% had (n=29) had atrial fibrillation. The primary endpoints were successful hemostasis and sheath related post procedure major and minor complication rates.
Results A 5Fr (1.4%) sheath was used in 1 patient, 6Fr sheaths in 37 (58.7%) patients, 7Fr sheaths in 2 (2.7%) patients, 8Fr sheaths in 14 (19%) patients, and 9Fr sheaths in 19 (26%) patients during acute stroke interventions. Overall, successful hemostasis was achieved in 72 (99%) cases. One (0.95%) minor complication was observed post procedure in the patient with a 6Fr access size. The patient had intermittent minor bleeding from the groin site and was found to have a CFA pseudoaneursym. No mortality or significant morbidity was observed associated with groin site closure in this study.
Conclusion The StarClose vascular closure device is safe and effective in achieving hemostasis during acute stroke endovascular interventions while using large French procedural access sheaths.
Competing interests None.