Prospective Randomized Study Comparing Ultrasound-Guided Thrombin Injection to Compression in the Treatment of Femoral Pseudoaneurysms

PURPOSE: To compare in a randomized prospective study the treatment of femoral pseudoaneurysms with ultrasound-guided thrombin injection versus ultrasound-guided compression. METHODS: Thirty consecutive patients (22 men; mean age 67+/-8 years, range 53-82) with iatrogenic femoral pseudoaneurysms were randomized to treatment with either ultrasound-guided compression (n=15) or injection of bovine thrombin (n=15). The primary outcome measure was thrombosis of the pseudoaneurysm within 24 hours. Secondary outcome measures were complications and hospitalization time (LOS). RESULTS: Thrombosis within 24 hours was achieved in 15 (100%) patients given thrombin versus 2 (13%) in the compression group (p<0.001). Of 13 pseudoaneurysms failing the initial compression treatment, 7 were retreated, 4 successfully. Thus, only 6 (40%) lesions were thrombosed within 48 hours after 1 or 2 compression sessions. The other 9 cases were successfully treated with thrombin injection. LOS was 2.8+/-1.5 days and 3.5+/-2.4 days in the thrombin and compression groups, respectively (p>0.05). No complications were noted in either group. CONCLUSIONS: Ultrasound-guided thrombin injection induces a fast, effective, and safe thrombosis of postcatheterization pseudoaneurysms. The technique is clearly superior to compression treatment and is recommended as the therapy of choice.