[Clinical efficacy of electric stimulation of crural muscles in comprehensive treatment of post-thrombotic disease]. / Klinicheskaia éffektivnost' élektricheskoi stimuliatsii myshts goleni v kompleksnom lechenii posttromboticheskoi bolezni.

The purpose of the study was to evaluate clinical efficacy of electromyostimulation (EMS) of the crural muscles as part of comprehensive therapy for post-thrombotic disease in patients with residual venous obstruction in the femoropopliteal segment. We carried out a prospective comparative clinical study enrolling patients having endured a fist episode of clinically unprovoked venous thrombosis of the femoropopliteal segment and completed the standard 6-month course of anticoagulant therapy and presenting with ultrasonographic signs of complete recanalization of the proximal venous segments (stenosis of 20% and more from the vessel's initial diameter), as well as scoring 5 points and more by the Villalta scale. The study included a total of 60 patients (38 men and 22 women, mean age 58.5±11.4 years) subdivided into two groups consisting of 30 patients each. Patients of both the Study and Control Groups underwent comprehensive therapy including wearing a compression knee sock (23-32 mmHg), a course phlebotrophic drugs, and dosed walking (not less than 5,000 steps a day). The Study Group patients were additionally subjected to daily electrical stimulation of the crural muscles with the "Veinoplus VI" unit (three 30-minute sessions a day). The duration of the follow up amounted to 12 months. The criteria for assessing therapeutic efficacy were as follows: severity of the disease by the VCSS and Villalta scales, quality of life as assessed by the CIVIQ-20 questionnaire, and lack of relapses of the venous thrombus. Clinical and instrumental assessment of the patients' condition was carried out monthly, with the disease's severity and quality of life assesses each 6 months. Relapses of venous thrombosis were registered in 7 (23.3%) patients from the Control Group and were not observed in patients undergoing EMS (p=0.011). In 5 cases, thrombosis was asymptomatic and in 4 cases it was presented by reocclusion of the involved venous segments. Patients of the Study Group were found to have a decrease in the disease's severity, reflected in points: VCSS (9.9±1.6 - 7.8 ± 1.6 - 6.1±1.5 (p <0.0001)); Villalta scale (18.9±3.9 - 12.8±4.0 - 8.3±2.7 (p<0.0001)); CIVIQ-20 score (67.8±8.4 - 51.3±8.4 - 40.0±10.5 (p<0.001)). The Control Group patients showed a similar tendency for the disease's severity: 8.1±2.8 - 7.3±2.1 - 7.2±2.1 points by the VCSS (p=0.014); 12.7±6.7 - 10.9±5.6 - 10.2±5.4 points by the Villalta scale (p=0.002), but not for quality of life: 48.2±19.3 - 46.7±17.3 - 47.4±16.2 points by the CIVIQ-20 (p>0.05). On the background of using EMS, the alterations in the studied parameters were characterized by higher velocity and intensity (p<0.05). The use of electromyostimulation as part of comprehensive treatment for post-thrombotic disease makes it possible to efficiently eliminate both subjective and objective signs of venous insufficiency, improve patients' quality of life and decrease the risk for the development of relapsing venous thrombosis.

[Efficacy and safety of oral anticoagulant "Rivaroxaban" in patients after implantation of a cava filter]. / Éffektivnost' i bezopasnost' oral'nogo antikoagulianta «Rivaroksaban¼ u patsientov posle implantatsii kava-fil'tra.

OBJECTIVE: preliminary assessment of efficacy and safety of prolonged anticoagulant therapy with Rivaroxaban in patients after implantation of a cava filter. MATERIAL AND METHODS: this prospective clinical study included a total of 30 patients presenting with thrombosis of deep veins of lower limbs of proximal localization with signs of flotation of the thrombus and free apex more than 4 cm in length. The patients received a temporal cava filter later on not removed for various reasons. After implantation of the cava filter the patients were given therapeutic doses of low molecular weight heparins during 48 hours followed by switching to standard therapy with vitamin K antagonists or to an alternative regimen of treatment with new anticoagulant Rivaroxaban (15 mg twice daily for the first three weeks, then 20 mg once daily during the whole period of follow up). Rivaroxaban (Study Group) was given to 15 patients (8 men and 7 women aged from 35 to 87 years, mean age 65.5±16.2) having from one to six (averagely 2.9±1.4) individual risk factors for the development of venous thrombosis. Each of them had a matching patient included in the control group, receiving conventional therapy with vitamin K antagonists and corresponding by age (± 5 years), gender, and the total number of individual risk factors (± 1). The maximal duration of follow up amounted to 1 year. RESULTS: the cava filter according to the findings of ultrasound duplex scanning was patent during the whole follow-up period in 100% of patients in the both groups. No relapses of venous thromboembolic complications were registered in any patient. The cumulative frequency of the development of haemorrhagic complications amounted to 13% for the Study Group patients and to 20% for the Controls, with the differences being statistically significant. In the control group haemorrhagic complications were of more severe forms: one intracranial haemorrhage and two intracutaneous haemorrhages (in the Study group - one intracutaneous haemorrhage and one gingival haemorrhage). CONCLUSION: the study showed possibilities and safely of using new oral anticoagulant Rivaroxaban in patients with the implanted cava filter. The obtained pilot findings require further confirmation in randomized clinical studies.

[Treatment of acute deep vein thrombosis with new oral anticoagulant rivaroxaban: the first experience].

The aim of the study was to make a preliminary assessment of the efficacy and safety of acute deep vein thrombosis (DVT) prolonged treatment with new oral anticoagulant rivaroxaban. Materials and methods. It was a prospective observational study included patents with instrumentally verified DVT admitted to the Department of Vascular Surgery of the Clinical Hospital n.1 President's Administration of Russian Federation. All patients were administrated to the initial treatment with low-molecular weight heparins during first 24-48 hours followed by overlapped therapy with vitamin-K-antagonists. Patients who rejected a standard therapy were offered an alternative oral anticoagulant rivaroxaban: 15 mg bid during first 3 weeks followed by 20 mg qd. The duration of therapy varied from 3 to 12 month and more depend on localization and clinical provocation of the thrombosis. The dynamic control was performed on 3rd, 6th, 9th and 12th month. The endpoints of the study were recurrent DVT verified with duplex ultrasound or pulmonary embolism (PE) and hemorrhagic complications. In the study were enrolled 30 patients aged 27-87 years (mean age - 59.0±16.8), 13 men and 17 women who had from 0 to 6 individual risk factors (average - 2.4±1.6). In 33.3% cases DVT was clinically provoked and in 66.7% - unprovoked. Results. There were no recurrent DVT or PE observed. Cumulative rate of bleeding was 13.3% (95% CI: 1.2-25.5%): 6.65% (95% CI: 1.8-21.3%) - minor bleeding , that did not need drug withdrawal or extra visit to the doctor, and 6.65% (95% CI: 1.8-21.3%) - clinically significant bleeding, that needed an unscheduled visit to the doctor, the temporary interruption of the therapy or medical intervention. Major bleeding were not identified. Bleeding were presented as hematuria, petechial skin hemorrhages and epistaxis. Conclusion. The study demonstrates feasibility and safety of the new oral anticoagulant rivaroxaban application in the prolonged treatment of acute DVT.

[Role of compression bandage with elevated level of pressure in decreasing incidence of venous thrombosis in high-risk patients].

UNLABELLED: The study was aimed at assessing efficacy and safety of using graduated compression bandage with the level of pressure in the area of the middle ankle amounting to 20-40 mm Hg as compared to the conventional profile (10-20 mm Hg in the ankle area) in the composition of comprehensive prevention of postoperative venous thromboembolic complications (VTEC) in patients of a high-risk group. For this purpose we carried out a prospective randomized clinical study including a total of 100 surgical patients (general surgery, neurosurgery) from a group of high risk for the development of VTEC with the presence of 3 and more conditions predisposing to venous thrombosis. All patients were subdivided into two subgroups 50 patients each. Patients in both groups received anticoagulants in standard preventive doses from the first day after surgery or in the remote period. The Study group patients were treated by applying on the ankle a bandage of medium distensibility with the target pressure in the ankle area of 20-40 mm Hg measured by means of a portable manometer. The control group patients were treated by a similar bandage applied onto the ankle and femur with a pressure of 10-20 mm Hg. In all cases a special lining material was placed under the bandage. With the purpose of active screening of postoperative VTECs, prior to the beginning of the study and then each 3-5 days we performed ultrasound angioscanning and in case thrombosis was revealed we performed static perfusion scintigraphy of the lungs and/or echocardiography for verification of pulmonary embolism. The patients who died were subjected to post-mortem examination. We also assessed the frequency of correcting the bandage on the femur and crus. RESULTS: The incidence rate of postoperative venous thrombosis in the Study Group amounted to 16.0% (95% CI: 5.8-26.2%) and in the Control Group 36.0% (95% CI: 22.7-49.3%, p=0.039), with no significant differences in the incidence of proximal thrombosis or pulmonary embolism revealed. Maximal reduction of the development of venous thrombosis was revealed in patients with lower-limb paralysis amounting to 69.5%. The frequency of the development of cutaneous lesions under the bandage did not differ significantly between the subgroups, being 8% and 12%, respectively. The total number of corrections of the compression in the Control Group was significantly higher, amounting to 0.64±0.23 time a day versus 0.32±0.05 t/d (p<0.0001). CONCLUSION: The use of an elevated compression profile makes it possible to decrease the incidence of postoperative VTECs, especially in patients with palsy, not increasing the rate of cutaneous lesions under the bandages. Femoral compression provides no additional reduction of the incidence of thrombosis but creates an additional necessity of correcting the bandages.

[Caprini score as individual risk assessment model of postoperative venous thromboembolism in patients with high surgical risk].

The aim of this study was to estimate the role of Caprini model in forecasting of postoperative venous thromboembolism (VTE) in patients with high surgical risk and to determine patients with extremely high risk of venous thrombosis by using of this scale. It was performed prospective multicenter observational study involving 140 high risk patients who underwent large abdominal (48%) or neurosurgical (52%) intervention. All patients were assessed with the Caprini model and had a mean score of 9.5±2.7 (range: 5-15). Complex postoperative prevention of venous thromboembolic complications included elastic compression of low extremities and standard prophylactic doses of direct anticoagulants. Duplex ultrasonic scanning was performed during the first 12 hours after surgery and then every 3-5 days until discharge to assess the lower limbs venous system. If venous thrombosis was observed pulmonary embolism has been excluded by using of echocardiography, planar perfusion scintigraphy of the lungs, SPECT-imaging with computed tomography. Venous thrombosis was diagnosed in 39 (28%) patients. The incidence of VTE was 1.9% in the lowest tertile of the Caprini score (5-8); it was 26.1% in the middle tertile (score 9-11) and 65% in the upper tertile (score 12-15) (p<0.001). The area under ROC curve was 0.874 (95% CI 0.81 to 0.94) and Caprini score 11 was a cut-off point that provided the highest sensitivity and specificity. 2 (2.6%) of 77 patients with score less than 11 had venous thrombosis. In contrast, 37 (58.7%) of 63 patients with Caprini score 11 and more had venous thrombosis (p<0.001). There is significant correlation between Caprini scores and frequency of postoperative venous thromboembolism in patients with high surgical risk. Score 11 and more can identify patients with extremely high risk. These patients need for more effective prevention.

[Epidemiology of venous thromboembolias among the high risk surgical patients and the role of sural sinus in initiation of thrombus formation].

The prospective study of postoperative venous thromboembolism after standard prophylactic measures among high risk patients was performed. The ultrasound lower limb veins investigation registered postoperative venous thrombosis in 32.7% of these patients, the proximal thrombosis was in 9.1%. Half of the cases demonstrated the isolated sural sinus thrombus and the overall sural sinus involvement was 83.3%. 50% of all thromboses were diagnosed within the first week after the operation. 86.1% of all cases were registered within 2 weeks after the surgery. Terms of anticoagulative drugs prescription showed no influence on the thrombosis incidence aiming the researched patients. The study demonstrated the high true incidence of postoperative venous thromboembolism after standard prophylactic measures among high risk patients and the leading role of the sural sinus in its initiation.

[Haemodynamic and clinical efficacy of electric muscular stimulation of the venous outflow in prevention of postoperative venous thromboembolic complications].

The present clinical and experimental study was carried out in order to evaluate efficacy of electrical stimulation of the crural muscles with the purpose of preventing postoperative venous thromboembolic complications. At the first stage by means of ultrasonographic angioscanning in apparently healthy volunteers (n=21) we evaluated the linear velocity of blood flow on the popliteal vein on the background of using myostimulation and compression bandage with various levels of pressure applied either separately or in a combination with each other. It was revealed that electrical stimulation of the crural muscles led to a 2.8-4.5-fold increase in the peck velocity of blood flow, while the compression decreased the parameters of the venous outflow both at rest and during muscular contraction. By means of theoretical calculations it was determined that an optimal compression profile for a combination with electrical stimulation is a pressure under the bandage equalling 20-40 mm Hg, providing substantial acceleration of the venous outflow with the laminary blood flow preserved. At the second stage we assessed efficacy of comprehensive prevention of venous thromboembolism with the use of electromyostimulation, the respective compression bandage and direct anticoagulants in surgical-profile patients from a high-risk group (n=90) by means of ultrasound screening of the venous system during the whole postoperative period. When myostimulation was used in the regimen of 3-5 procedures a day, the frequency of venous thrombosis amounted to 40% (n=10) and did not significantly differ from that in patients not subjected to myostimulation (25%, n=40). When myostimulation was used in the regimen of 5-10 procedures per day, the frequency of venous thrombosis turned out to be considerably lower (2.5%, n=40). A conclusion was made on efficacy of using this method in the examined group of patients.

[Surgical technologies in the treatment of varicose veins of the lower extremities complicated with trophic ulcer].

Results of an open randomized study of staged treatment of 94 patients suffering from varicose veins of the lower extremities with open infected trophic ulcers of the shank were analyzed. All the patients were divided into 3 groups depending on the treatment variant. Based on this study, clinical efficacy of early correction of upper vertical venous-venous reflux is substantiated. Efficacy of CO(2) laser application for sanation of trophic venous ulcers and practical importance of their auto-venous plastic reconstruction are demonstrated. Thus, up-to-date technologies provide differential treatment in patients with trophic venous ulcers.