ABSTRACT
Pseudoaneurysm has been an increasingly common complication of catheterization procedures during the past two decades, with the greatest incidence being in the femoral artery. Treatment of iatrogenic femoral artery pseudoaneurysm with the injection of thrombin is reported to be an efficacious and safe procedure. In this study, we evaluated the efficacy and success rate of percutaneous ultrasonographically-guided thrombin injection and compression method for the treatment of pseudoaneurysm and for studying of the effect of thrombin injection on systemic coagulation parameters. This cohort clinical trial was conducted on patients with femoral pseudoaneurysm after percutaneous intervention [PCI] in Shaheed Rajaie Cardiovascular Medical and Research Center. The patients were divided into two randomized groups and treated with either the compression method or the percutaneous ultrasonographically-guided thrombin injection method. Pseudoaneurysm size, pseudoaneurysm neck size, thrombin dose, thrombosis time, outcome of therapy, and complications were documented prospectively. Duplex sonographic follow-up examinations were performed at 0 and 24 hours afterwards. Partial thrombin time as well as the Quick test [prothrombin time] was monitored before and after the intervention. Thirty patients between 15 and 85 years of age with femoral pseudoaneurysm following catheterization were enrolled in this study. The average length and width of the pseudoaneurysms were respectively 2.45 +/- 1.15 cm and 2.06 +/- 1.07 cm. In total, 13 thrombin injections were administered. The mean thrombin dose was 500-2000 IU. The success rate of thrombin injection was %92.30 [12 of 13 patients], which was significantly higher than that of compression 82.35% [13 of 17 patients] [p value<0.05]. No thromboembolic, infectious, or allergic complications occurred. In this study, the percutaneous ultrasonographically-guided thrombin injection method was successful and safe in the management of femoral pseudoaneurysms. Changes in coagulating factors indicated the possibility of thrombin passage into the arterial circulation.