Immediate sealing of arterial puncture site following femoropopliteal angioplasty: a prospective randomized trial.

PURPOSE: A new hemostatic puncture closure device (HPCD) was evaluated following femoropopliteal angioplasty. Efficacy in hemostasis and complications were compared between manual compression and the new system.

METHODS: One hundred patients undergoing percutaneous interventional procedures were randomly assigned to receive either manual compression or HPCD. The time to complete hemostasis (when a compression bandage was applied) was noted as well as complications such as hematoma or arterial stenosis at the puncture site. Follow-up was by clinical examination and color-coded duplex sonography (CCDS).

RESULTS: With the HPCD, immediate hemostasis was achieved in 22 patients (44%). Discrete oozing without the necessity of external compression or further consequences was observed in 11 patients. Mean manual compression time was 25 (+/- 20) min including application of the pressure bandage. Eleven patients needed additional manual compression and technical failures were observed in 6 patients (12%). The compression time in these 17 cases was 27 (+/- 12) min. Subcutaneous hematomata with a diameter of more than 5 cm developed in 15 of 48 patients in the HPCD group and in 14 of 48 patients in the manual compression group. No surgical or percutaneous intervention was necessary. The complication rate was comparably low in the experimental and control groups.

CONCLUSION: Compared with manual compression HPCD is faster and more accurate for sealing the arterial puncture defect following angioplasty. After an initial learning curve, it is easy to handle and time-saving as well as convenient for the patient. Furthermore, immediate and full anticoagulation is possible and arterial inflow is not compromised. A drawback is the necessity of an 8 Fr sheath. Nevertheless, the complication rate is comparably low for both methods.