The Utility of the StarClose Arterial Closure Device in Patients with Peripheral Arterial Disease Bruce H. Gray, Ryan Miller, Eugene M. Langan III, Charles S. Joels, Yousef Yasin, and Corey A. Kalbaugh, Greenville, South Carolina The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extralumi- nal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symp- tomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow ve- locities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all pa- tients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n ¼ 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requir- ing prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemo- stasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression. INTRODUCTION There is an increasing number of endovascular pro- cedures being performed, and many of these proce- dures are culminating with arterial closure devices (ACDs). ACDs range in design from the suture- based Perclose (Abbott Vascular, Redwood, CA) to the collagen-sealing AngioSeal (St. Jude Medical, St. Paul, MN) to the thrombus-inducing Duett (Vas- cular Solutions, Minneapolis, MN). The StarClose device (Abbott Vascular) uses a 4 mm diameter star-shaped extraluminal nitinol clip to provide closure. Hemostasis is achieved with thrombus formation outside of the extraluminal clip. ACDs decrease the time to hemostasis and ambulation. 1-8 Patients with peripheral arterial disease (PAD) are more likely to have common femoral artery (CFA) disease, frequent catheterizations, groin scarring from previous incisions, and compromised flow due to aortoiliac or infrainguinal disease. Patients treated in our endovascular program form the basis of this study to assess the use of the StarClose ACD. Academic Department of Surgery, Greenville Hospital System Uni- versity Medical Center, Greenville, SC. Correspondence to: Bruce H. Gray, DO, FSCAI, FSVM, FACOI, Ac- ademic Department of Surgery-Vascular Medicine, Greenville Hospital System University Medical Center, 701 Grove Road, Greenville, SC 29605, USA, E-mail: bhgray@ghs.org Ann Vasc Surg 2009; 23: 341-344 DOI: 10.1016/j.avsg.2008.07.009 Ó Annals of Vascular Surgery Inc. Published online: September 22, 2008 341