The use of the StarClose device for obtaining femoral artery hemostasis.

BACKGROUND: Following percutaneous intervention, obtaining femoral artery hemostasis quickly and reliably with few complications is of considerable importance. While the StarClose device has been studied in patients undergoing cardiac catheterization, its use in patients undergoing treatment for peripheral vascular disease has rarely been reported. It is the purpose of this report to determine whether the Starclose is able to deliver safe and effective femoral artery closure in this group of patients.

METHODS: The records of all patients undergoing StarClose closure of the femoral artery by or under the supervision of a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were noted. Times to mobilization and discharge were tabulated. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were recorded.

RESULTS: Between February 2006 and September 2009, 603 StarClose nitinol clip closure devices were deployed in 478 patients. In all, 97 procedures were diagnostic and 506 included therapeutic interventions. A total of 97 5F sheaths, 465 6F sheaths, and 41 7F sheaths were employed. Time to ambulation and discharge was 44.2 ± 13.2 minutes and 119.3 ± 22.6 minutes in patients in whom a 5F sheath was used, 112.5 ± 13.5 minutes and 157.5 ± 20.6 minutes when a 6F sheath was used, and 121.9+/-38.8 minutes and 160.2+/-43.2 minutes when a 7F sheath was employed. The clip could not be successfully deployed in 21 arteries (3.5%) and manual compression was successful in achieving hemostasis in 17 patients without complication. Three patients (0.5%) developed major hematomas requiring transfusion; 1 patient developed a pseudoaneurysm (0.17%) requiring thrombin injection. A single patient (0.17%) occluded his common femoral artery following StarClose deployment and 1 patient (0.17%) developed a femoral artery stenosis requiring balloon dilatation. No patient developed a groin infection.

CONCLUSIONS: The StarClose provides a safe and reliable method of achieving femoral artery closure following percutaneous intervention for peripheral arterial disease. When successfully deployed, it allows for early ambulation and discharge. Since it remains entirely extraluminal, it offers advantages over other closure devices and can be safely used in the vast majority of patients with peripheral vascular disease.