| 이종영, 박종필, 김경중, 김성환, 박덕우, 이승환, 김영학, 이철환, 홍명기, 박성욱, 박승정 |
Background: Percutaneous vascular closure devices (VCDs) decrease the time to ambulation, the time to discharge, and decrease complications undergoing invasive cardiovascular procedures via femoral artery access. Currently, the collagen-anchor-suture mediated device (Angioseal) and clip-mediated device (Starclose) were most commonly used. We compare the safety and efficacy of these two devices for patients receiving cardiac catheterization via femoral access.
Method: Patients undergoing coronary intervention via femoral approach were randomly assigned either AngioSeal or StarClose. Study end points were success of hemostasis and major vascular complication within 1 month. Success of hemostasis was defined as absence of pulsatile blood leakage directly after device placement. Major vascular complication was defined as puncture site bleeding necessary transfusion, distal device embolization, AVF, pseudoaneurysm and femoral artery compromise.
Results: Total 238 patients (Angioseal, N = 116 versus Starclose, N = 122) were enrolled from August 2007 through February 2008. There was no significant differences in baseline characteristics including antiplatelet medication, activated clotting time (ACT) level, platelet count, and sheath size (6~8Fr). Successful hemostasis was not achieved in 4 (3.2%) of Starclose group and not in Angioseal(p=0.12). The rate of oozing necessitating immediate manual compression was significantly high in Starclose group than in Angioseal group (37.4% vs. 20.0%, p=0.003). The incidence of early hematoma (≤12 hours) (13.8% vs. 11.3%, p=0.56) and bruising area (67 ± 70cm² vs 31 ± 29 cm², p=0.08) were not significantly different. However, late hematoma formation (≥12 hours) was significantly higher in Angioseal group. (8.7% vs. 0, p=0.001). There were no major vascular complication event in both the groups.
Conclusion: Two different VCD (AngioSeal and Starclose) are simialry safe and effective for percutaneous occlusion of femoral access without difference of major vascular complications. However, the rate of oozing with additive manual compression was significantly higher in Starclosure group than Angioseal group, whereas the incidence of late hematoma was vice versa.
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