Prospective randomized study comparing ultrasound-guided thrombin injection to compression in the treatment of femoral pseudoaneurysms. A prospective, randomized evaluation of nonsurgical closure of femoral pseudoaneurysm by compression device with or without ultrasound guidance. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin.
To compare in a randomized prospective study the treatment of femoral pseudoaneurysms with ultrasound-guided thrombin injection versus ultrasound-guided compression.
                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).
                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.
                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. 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.
                Copyright 1999 Wiley-Liss, Inc. The purpose of this randomized controlled trial was to evaluate the benefits of compression and walking exercises in comparison with bed rest in the acute stage of proximal deep venous thrombosis (DVT).
                Forty-five patients with proximal DVT that was proved with compression ultrasound scan or phlebography were randomized into three groups. Group A consisted of 15 patients who received inelastic compression bandages (Unna boots on the lower leg, adhesive bandages on the thigh), and group B consisted of 15 patients who received thigh-length compression stockings, class II. Group C consisted of 15 patients who underwent bed rest and no compression. All patients received dalteparin, 200 IU/kg per body weight, subcutaneously every 24 hours. The clinical characteristics of the three groups were comparable. Primary end points were the reduction of pain assessed daily with the Visual Analogue Scale and the Lowenberg test, the reduction of leg circumference at the ankle and calf levels, and the improvement of clinical scores. The daily walking distance was measured with a pedometer. Safety parameters were ventilation-perfusion scans and duplex ultrasound scans performed on days 0 and 9.
                The daily walking distance was between 600 and 12,000 m in the compression groups and averaged 66 m in the bed rest group. The pain level showed a statistically significant reduction starting after the second day in the compression groups (A and B) and after 9 days in the bed rest group C (P <.05). The same was true for the measurement of leg circumference. Improvement of the clinical scores was significantly better in the compression groups compared with the bed rest group (P <.01). There was no significant difference concerning the occurrence of new pulmonary emboli and regression of thrombus diameter. Progression of thrombi in the femoral vein was greater and occurred more frequently in the bed rest group than in the other two groups (P = not significant).
                Mobile patients with acute proximal DVT treated with low molecular weight heparin should be encouraged to walk with compression bandages or medical compression stockings. The rate of resolution of pain and swelling is significantly faster when the patient ambulates with compression. The risk of pulmonary embolism is not significantly increased by this approach.
The limited evidence base appears to support the use of thrombin injection as an effective treatment for femoral pseudoaneurysm. A pragmatic approach may be to use compression (blind or ultrasound-guided) as first-line treatment, reserving thrombin injection for those in whom the compression procedure fails.