The safety and efficacy of a suture-based closure device designed to achieve hemostasis at the femoral access site post catheterization procedures was compared to manual compression in a 600 patients randomized trial (data available for 590 patients). The patients were randomized to percutaneous vascular surgery (PVS) or manual compression after diagnostic (401 patients) and interventional (189 patients) procedures. Two types of PVS devices were used delivering 1 or 2 sutures at the arterial access site. The overall results as well as the results by procedure type demonstrated a significant reduction in time of hemostasis (7.8 +/- 4.8 min vs 19.6 +/- 13.2 min, p < 0.01) and time to ambulation (4.5 +/- 6.5 hours vs 17.8 +/- 5.0 hours, p < 0.01) with the use of the PVS device. The safety results showed no significant differences in the incidence of vascular complications (5.7% for PVS vs 11.3% for compression) in the overall population or in the interventional patients subset (8.4% for PVS vs 9.6% for compression). However, the PVS device demonstrated a significant reduction in the incidence of vascular complications post diagnostic catheterization procedures (4.4 for PVS vs 12.1% for compression, p < 0.05). The incidence of vascular complications and the time of hemostasis was similar in an American multicenter study (STAND II).
Conclusion: Percutaneous vascular surgery is a safe and effective method to achieve hemostasis post catheterization procedure providing faster hemostasis and ambulation without increasing the rate of complication.