[Risk of post-thrombotic syndrome following direct oral anticoagulant intake: a systematic review and meta-analysis]. / Risk razvitiya posttromboticheskoi bolezni pri ispol'zovanii pryamykh oral'nykh antikoagulyantov: sistematicheskii obzor literatury i metaanaliz.

OBJECTIVE: To perform a systematic review and meta-analysis of data devoted to the risk of post-thrombotic syndrome (PTS) following direct oral anticoagulant (DOAC) intake. MATERIAL AND METHODS: A systematic review and meta-analysis of trials available in the PubMed database were performed in March 2021. Analysis included the reports with known Villalta score for PTS in patients receiving DOACs or alternative anticoagulation. We analyzed the incidence and risk of any form of PTS. RESULTS: We found 10 comparative studies comprising 3161 patients. Incidence of PTS under DOAC therapy was 30.8% (95% confidence interval (CI) 22.2-39.3%), severe PTS - 2.2% (95% CI 1.0-3.4%). DOACs were associated with significantly less risk of any form of PTS (odds ratio (OR) 0.57; 95% CI 0.48-0.68; p<0.001) and severe PTS (OR 0.56; 95% CI 0.36-0.87; p=0.010) compared to vitamin K antagonists. Among various DOACs, specified data were available only for rivaroxaban (OR 0.54, 95% CI 0.42-0.71, p<0.001 for any PTS; OR 0.49, 95% CI 0.27-0.89, p=0.019 for severe PTS). The use of flavonoids in adjunction to rivaroxaban was associated with additional risk reduction for PTS (OR 0.14; 95% CI 0.06-0.31; p<0.001). CONCLUSION: Moderate quality evidence suggests that DOACs are associated with significant less risk of any PTS and severe PTS compared to VKA in patients with deep vein thrombosis. Among all DOACs, only rivaroxaban has clear data confirming PTS risk reduction. The use of flavonoids in adjunction to rivaroxaban can further improve treatment outcomes.

[Peculiarities of the treatment of venous thromboembolism with direct oral anticoagulants in challenging patients: senile age, renal failure, fragility]. / Osobennosti terapii venoznykh tromboembolicheskikh oslozhnenii pryamymi oral'nymi antikoagulyantami u oslablennykh patsientov: starcheskii vozrast, pochechnaya nedostatochnost', khrupkost'.

The paper is a narrative review of the literature on the use of direct oral anticoagulants (DOACs) for the VTE treatment in challenging patients: senile age (≥75 years), impaired renal function (estimated glomerular filtration rate ≤50 ml/min), fragility (one of the previous characteristics and/or bodyweight ≤50 kg). The paper discusses the studies of EINSTEIN DVT and PE (rivaroxaban), AMPLIFY (apixaban), HOKUSAI-VTE (edoxaban), RE-COVER I and II (dabigatran) in the focus of the secondary analysis in the pre-specified patient's subgroups, as well as their pooled analyzes and meta-analyzes. Based on the results of this review, it was concluded that in a subgroup of senile age patients, dabigatran increases the risk of major bleeding by 4.8 times and has no advantages over vitamin K antagonists (VKA); rivaroxaban and apixaban retain superiority over VKA on the safety outcomes and reduce the risk of major bleeding by 73% and 77%. In the subgroup of patients with impaired renal function, the use of apixaban and dabigatran is associated with an increase in the risk of major bleeding by 6.5 and 7.3 times, and these DOACs do not have advantages over VKA; rivaroxaban retains its superiority over VKA and reduces the risk of major bleeding by 78%. For fragile patients, a secondary analysis is available only for rivaroxaban, which remains superior to VKA on safety endpoints and reduces the risk of major bleeding by 73%. In the absence of direct comparisons between the available DOACs, the presented data can be used as a rational approach for the choice of appropriate treatment for VTE in challenging patients.

[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.

[The clinical and experimental substantiation of the laparotomic access choice].

The experimental model was constructed to choose the optimal surgical access for the treatment of postoperative ventral hernias. The experimental results were compared with the clinical study, devoted to the long-term follow-up results assessment in 508 patients. The experiment demonstrated the higher durability of the paramedian access in comparison with median and oblique assess. Its clinical use allowed to the postoperative herniation to 4.84%.

[The role of surgical access in postoperative ventral hernia development].

Long-term follow-up of 508 patients after various surgical procedures has been conducted. Of the 351 patients were operated on using a paramedian incision, 109 had an upper median laparotomy and the rest 48 had an oblique subcostal incision. Post-operative ventral hernias were registered in 45 (8.86%) patients. The upper median laparotomy herniated in 18 (16.51%) patients, paramedian incision - in 17 (4.84%), and the oblique subcostal incision herniated in 10 (20.83%). Hernia was noticed by the patient within 12 months after the initial operation in 46.67%, of them in 85.71% - within first 6 months. 53,33% of patients were diagnosed with postoperative hernia only after thorough examination. Thus, paramedian incision is considered to be the most preferable access. Postoperative hernias develop within the first 6-12 months postoperatively, later hernia registration is a result of poor examination.

[One-row continuous suture in abdominal surgery]. / Odnoriadnyi nepreryvnyi shov v abdominal'noi khirurgii.

One-row continuous suture (OCS) was used in 3605 patients while placing anastomoses in different parts of the digestive tract, extrahepatic bile ducts and pancreas as well as suturing after gastrostomy and choledochotomy. Two techniques of OCS were used. In 526 patients OCS was used for biliary tract surgery with complications rate 1.3%. In surgery of the stomach and small intestine OCS was used in 2606 patients; the insufficiency rate of stomach and small intestine anastomoses was equal (0.04%). In surgery of colon and rectum OCS was used in 405 patients; insufficiency rate was 1.5%. In surgery of the pancreas this suture was used in 70 patients without complications after surgery. Analysis of the data shows high reliability of OCS for anastomoses in abdominal surgery and allows to recommend its wider use in clinical practice.