Efficacy and Long-Term Safety of StarClose™ for Hemostasis of Arterial Puncture Sites Distal to Common Femoral Artery Bifurcation After Percutaneous Coronary Interventions

ABSTRACT: Background. Currently approved vascular closure devices (VCDs) are not recommended for use in arterial puncture sites distal to the common femoral artery (CFA) bifurcation. The StarClose™ vascular system (SC) is a unique VCD that does not contain intravascular components, a feature that may allow safe use in smaller vessels. Objective. We sought to determine the efficacy and long-term safety of the SC for hemostasis of arterial punctures distal to the CFA bifurcation. Methods. Consecutive patients with arterial puncture sites located distal to the CFA bifurcation received SC after percutaneous coronary intervention (PCI). Patients were ambulated 4–6 hours later, and the presence of vascular complications was determined clinically before hospital discharge. Clinical and Doppler ultrasound examinations were performed at 8–9 months to assess long-term safety. Results. A total of 106 patients undergoing PCI were included in the study. Mean age was 66 ± 12 years and 63% were male. The arterial puncture site was located in the superficial femoral artery (SFA) in 76 (72%), the profunda femoris artery (PFA) in 22 (21%) and undetermined in 8 (7%) patients. The mean diameter of the CFA was significantly greater than the SFA or the PFA branch with the SC (6.2 ± 1.5 vs. 4.5 ± 1.0 mm for the CFA and branch with SC, respectively; p