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 < 0.0001). Device success was achieved in 102 (96%) patients. At 24 hours, a hematoma ≥ 5 cm was reported in 13 (12%) patients. No other vascular complications occurred. At a mean follow up of 9 ± 2.5 months, there was no clinical or Doppler evidence of arterial insufficiency or vascular complications.
Conclusion: The SC can be used for hemostasis after PCI in select cases where the arterial puncture site is located distal to the CFA bifurcation without adverse clinical outcomes.