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. Intermittent sequential pneumatic compression of the legs and thromboembolism-deterrent stockings in the prevention of postoperative deep venous thrombosis. Rapid-inflation intermittent pneumatic compression for prevention of deep venous thrombosis. A randomized comparison of sequential-gradient calf compression with intermittent plantar compression for prevention of venous thrombosis in orthopedic trauma patients: preliminary results. Cyclic sequential compression of the lower limb in prevention of deep venous thrombosis. Sequential mechanical and pharmacological thromboprophylaxis in the surgery of hip fractures. A pilot study. Prevention of deep-vein thrombosis after total hip and knee replacement. Low-molecular-weight heparin in combination with intermittent pneumatic compression.
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. One hundred fifty patients over the age of 30 who had undergone major abdominal operations were stratified according to the risk of deep venous thrombosis and randomized into three groups to receive different prophylactic regimens: group A, electrical calf stimulation; group B, low-dose subcutaneous heparin; group C, intermittent sequential compression and thromboembolism-deterrent (TED) stockings. All the patients were scanned with the 125I-fibrinogen test for the whole stay in hospital. The incidence of 125I-fibrinogen detected deep venous thrombi was 18% in group A, 9% in group B, and 4% in group C. The results indicate that the regimen of intermittent sequential compression and TED stockings is as effective as low-dose subcutaneous heparin. Electrical calf stimulation is less effective. Current treatment regimens that are designed to prevent deep venous thrombosis in patients undergoing orthopaedic procedures rely predominantly on drug prophylaxis alone. The purpose of this randomized clinical study was to evaluate the effectiveness of a mechanical adjunct to chemoprophylaxis that involves intermittent compression of the legs.
                During a twenty-two month period, 1803 patients undergoing a variety of orthopaedic procedures were prospectively randomized to receive either chemoprophylaxis alone or a combination of chemoprophylaxis and mechanical prophylaxis. Nine hundred and two patients were managed with low-molecular-weight heparin alone, and 901 were managed with low-molecular-weight heparin and intermittent pneumatic compression of the calves for varying time periods. Twenty-four percent of the patients underwent total hip or knee joint replacement. Screening for deep venous thrombosis was performed on the day of discharge with duplex-color-coded ultrasound.
                In the chemoprophylaxis-only group, fifteen patients (1.7%) were diagnosed with a deep venous thrombosis; three thromboses were symptomatic. In the chemoprophylaxis plus intermittent pneumatic compression group, four patients (0.4%) were diagnosed with deep venous thrombosis; one thrombosis was symptomatic. The difference between the groups with regard to the prevalence of deep venous thrombosis was significant (p = 0.007). In the chemoprophylaxis plus intermittent pneumatic compression group, no deep venous thromboses were found in patients who received more than six hours of intermittent pneumatic compression daily.
                Venous thrombosis prophylaxis with low-molecular-weight heparin augmented with a device that delivers rapid-inflation intermittent pneumatic compression to the calves was found to be significantly more effective for preventing deep venous thrombosis when compared with a treatment regimen that involved low-molecular-weight heparin alone. Trauma patients with fractures of the pelvis, acetabulum, or femur are at risk for deep venous thrombosis complicating the treatment of their injuries. This risk can be lessened with anticoagulant medications or with mechanical methods such as sequential pneumatic compression. However, many patients in this population group have contraindications to systemic anticoagulation and cannot use sequential limb compression devices because of leg injuries or appliances. Intermittent pneumatic compression of the plantar venous plexus is able to provide prophylaxis against deep venous thrombosis in many of these patients. We performed a prospective, randomized, controlled comparison between plantar compression and leg compression for prevention of deep venous thrombosis in an orthopedic trauma population of 124 patients. Patients were evaluated with duplex ultrasonagraphy at intervals after surgery. Both methods proved protective in comparison with reported rates in patients not given prophylaxis, and although the numbers were too small to give statistically meaningful results, we observed no significant difference in the thrombosis rate (4% for plantar compression versus 0% for leg compression). We conclude that foot pumps are an effective alternative to calf compression for prevention of deep venous thrombosis after a lower extremity fracture. Patients undergoing operations on the hip for either replacement or fracture were chosen for this study. Fifty-two subjects received cyclic sequential compression as well as elevation of the lower limb while another fifty-two patients were treated with only elevation of the lower limb. No other method of prophylaxis for deep venous thrombosis was employed during the study period. Support stockings were used after removal of the compression device. Doppler ultrasound, phleborheography, and, when possible, radioiodinated fibrinogen scanning were used for identification and location of thrombi. A deep-vein thrombosis developed in ten patients (19 per cent) in the control group and in only one patient (2 per cent) in the group that was treated with compression. This difference is statistically significant (p less than 0.05). Two hundred and thirty-eight patients with femoral neck fractures were entered into a randomised pilot study comparing the use of sequential treatment by 'Flowtron DVT' garments in the perioperative period followed by Enoxaparin (Clexane-Rhône-Poulenc Rorer), and Enoxaparin alone. One hundred and ninety-three patients were excluded indicating the difficulty of achieving pure comparisons in this population. The remaining 44 were randomised: 21 received Enoxaparin from the time of admission, and 23 had sequential treatment. There was no statistically significant difference in the incidence of thromboembolism. Patient preference did not indicate a favoured treatment subjectively. The operation field was drier in the sequential group, although this did not reach significance. Sequential treatment was not shown to be better or worse than treatment with Enoxaparin, but the trends favoured sequential treatment rather than drug treatment alone. The technique allows the operation to be carried out without the problems produced by low dose heparins and mobilisation is not hindered by compression garments. After total hip (THR) or knee replacement (TKR), there is still an appreciable risk of developing deep-vein thrombosis despite prophylaxis with low-molecular-weight heparin (LMWH). In a prospective, randomised study we examined the efficacy of LMWH in combination with intermittent pneumatic compression in patients undergoing primary unilateral THR or TKR. We administered 40 mg of enoxaparin daily to 131 patients combined with either the use of intermittent pneumatic compression or the wearing of graduated compression stockings. Compression ultrasonography showed no evidence of thrombosis after LMWH and intermittent pneumatic compression. In the group with LMWH and compression stockings the prevalence of thrombosis was 28.6% (40% after TKR, 14% after THR). This difference was significant (p < 0.0001). In the early post-operative phase after THR and TKR, combined prophylaxis with LMWH and intermittent pneumatic compression is more effective than LMWH used with graduated compression stockings.
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.