A prospective, randomized evaluation of nonsurgical closure of femoral pseudoaneurysm by compression device with or without ultrasound guidance.

Femoral artery pseudoaneurysm (PA) is a significant complication following diagnostic or therapeutic catheterization. The treatment of choice for femoral artery PA is freehand ultrasound-guided compression repair (UGCR). An alternative method is compression by mechanical devices. The study evaluated the mechanical compression device (FemoStop) with (G1) or without (G2) ultrasound guidance for initial placement in a randomized fashion. Thirty-eight patients (20 women, 18 men) age 40 to 85 (mean 54) years with clinical signs of PA underwent diagnostic color Doppler ultrasound. Randomization yielded 19 patients each for G1 and G2. PA occurred after 12 diagnostic cardiac catheterizations, 18 coronary stent implantations or balloon angioplasties, 2 electrophysiology procedures, and 6 peripheral percutaneous transluminal angioplasties. The G1 protocol was successful in 15 of 19 patients (79%), with a mean compression time of 28 min. The three other patients were treated successfully with UGCR. Only one patient needed vascular surgery. The G2 protocol was successful in 14 of 19 patients (74%) with a mean compression time of 33 min. The failed patients were treated successfully: three with UGCR and two with the same mechanical compression device now positioned under ultrasound control. Compression therapy with the compression device (FemoStop) for iatrogenic femoral pseudoaneurysm does not require ultrasound guidance for positioning. Cathet. Cardiovasc. Intervent. 47:304-309, 1999.