Цель исследования-оценить влияние электрической стимуляции мышц или электромышечной стимуляции (ЭМС) голени на динамику резидуальной венозной обструкции (РВО) у пациентов с посттромботической болезнью (ПТБ) после завершения стандартного курса антикоагулянтной терапии. Материал и методы. Проведено проспективное сравнительное клиническое исследование с участием 60 пациентов (38 мужчин и 22 женщины) в возрасте от 40 до 86 лет (средний возраст 58,5 года), перенесших первый эпизод клинически неспровоцированного бедренно-подколенного венозного тромбоза, завершивших стандартный курс антикоагулянтной терапии, имеющих ультразвуковые признаки РВО, а также 5 баллов и более по шкале Villalta. Участники были разделены на две группы: основную и контрольную, по 30 человек в каждой. В обеих группах назначали ношение компрессионного гольфа (23-32 мм рт.ст.), курсовой прием флеботропных препаратов и дозированную ходьбу (не менее 5 тыс. шагов в сутки). В основной группе также использовали ежедневную ЭМС голени аппаратом. Срок наблюдения составил 12 мес с ежемесячной клинической и ультразвуковой оценкой. Оценивали частоту рецидива венозных тромбоэмболических осложнений, уменьшение степени РВО, уменьшение выраженности признаков ПТБ. Результаты. РВО была представлена стенозом общей бедренной вены в среднем на 48% у 12 пациентов, стенозом поверхностной бедренной вены в среднем на 53% у 16 больных и стенозом подколенной вены в среднем на 55%-у всех испытуемых. За период наблюдения эпизодов легочной эмболии не наблюдали. Рецидив венозного тромбоза был зарегистрирован у 7 пациентов контрольной группы и ни у одного из больных, применявших ЭМС: 23,3% против 0% (р=0,011). Уменьшение степени РВО было зарегистрировано в обеих группах. Разницу между группами наблюдали лишь в динамике РВО в подколенной вене: 60,8-55,1-28,8% в основной группе и 50,9-30,1-27,3% в контрольной группе (р<0,0001). Тяжесть ПТБ уменьшилась в обеих группах. Более выраженное снижение показателей наблюдали на фоне применения ЭМС (р<0,0001). Заключение. При наличии РВО после завершения стандартного курса антикоагулянтной терапии процесс реканализации пораженных вен не прекращается, а продолжается активным образом. Включение ЭМС в состав комплексной терапии ПТБ позволяет ускорить процесс реканализации и снизить частоту возникновения рецидива венозного тромбоза. Ключевые слова: венозный тромбоз, легочная эмболия, рецидив, посттромботическая болезнь, электромышечная стимуляция.
during the last 4 weeks. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (Qol) measured with the VascuQol questionnaire after 1 year follow-up. Analysis was performed according to the intention-to-treat principle. To take into account the repeated measurements structure of the data differences between MWD and VascuQol sumscore were assessed with a linear mixed model with a Toeplitz covariance structure. Results -Between November 2010 and May 2015, 114 patients were allocated to SET, 126 to PTA. Compliance to SET was poor; after 1 month 75/114 (66%) patients attended the program, declining to 68/114 (60%) and 57/114 (50%) after 3 and 6 months, respectively. Ten (8%) of the patients allocated to PTA did not receive the intervention, which was technically successful in 112/116 (97%) of the remaining patients. Five patients had a minor complication after PTA and 6 a major complication necessitating endovascular or surgical resolution. Some 90/114 (79%) patients allocated to SET completed one year follow-up, and 104/126 (83%) allocated to PTA. The mean MWD improved from 187 to 561 meters in the SET group and from 196 to 574 meters in the PTA group, (p¼0.693) The VascuQol sumscore improved from 4.24 in the SET group to 5.58, and from 4.28 in the PTA group to 5.88, (p¼0.048). Yet, in both groups the improvement in VascuQol sumscore was more than the minimally important clinical difference of 1.19 (derived from 100 participants of the SUPER study). Some 33/114 (29%) of patients allocated to SET had a PTA within one year, and 2/114 (2%) additional surgical revascularization (SR). Some 10/126 (8%) patients allocated to PTA had an additional PTA within one year and another 10/126 (8%) had SR. Conclusion -Both a strategy of immediate PTA, and SET with deferred PTA in case of SET failure improve MWD on a treadmill and disease specific Qol of patients with IC due to an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate. The cost-effectiveness analysis of this RCT will further define clinical decision making.
Aim. To assess the efficacy of electrical calf muscle stimulation (EMS) in patients with post-thrombotic syndrome (PTS) and residual venous obstruction (RVO) after cessation of a standard anticoagulation. Methods. This was a prospective comparative clinical trial with masked outcome assessor involving patients after the first episode of unprovoked femoro-popliteal DVT who have completed a standard 6-month course of anticoagulation and had signs of RVO in the affected veins and Villalta score of 5 and more. Totally were enrolled 60 patients in the age of 40-86 years (mean - 58,5 ± 11,4), 38 men and 22 women, divided into two groups of 30 participants. In both groups (main and control) PTS was treated by active walking (at least 5,000 steps per day controlled by an individual pedometer), below-knee graduated compression stockings (23-32 mm Hg) and micronized purified flavonoid fraction (2-month course twice a year). In the main group, EMS with «Veinoplus VI» device (3 procedures of 30 minutes every day) also was used. The main endpoint of the study was symptomatic or asymptomatic recurrent venous thrombosis confirmed by duplex ultrasound (DUS). The additional criteria of treatment efficacy were changes in the degree of current venous stenosis. The patients were followed up for 12 months with monthly DUS, aimed to reveal recurrent DVT, and 6-monthly DUS with evaluation of stenosis degree. Results. RVO was represented by an average of 48%-stenosis of the common femoral vein in 12 patients, 53%-stenosis of the superficial femoral vein in 16 cases and 55%-stenosis of the popliteal vein in all participants. Through 12-month follow up the degree of stenosis decreased in all affected veins in both groups (p<0,05). The most vivid dynamics was found in the popliteal vein: 60.8% - 55.1% - 28.8% in the main group and 50.9% - 30.1% - 27.3% in the control group (p<0,0001) with significant differences between the groups (p=0.004) Recurrence of venous thrombosis was found in 7 of 30 patients in the control group and in 0 of 30 patients in the main group (23.3% vs 0%, p=0.011). In 5 cases the recurrent DVT was silent and revealed by regular DUS and only in 2 cases it had a clinical manifestation. 4 of 5 silent cases were presented with re-occlusion of the early affected vein. Conclusions. There is an ongoing process of deep veins recanalization during 12 months after cessation of anticoagulation in patients with RVO and PTS. Using of EMS in complex treatment of PTS allows to reduce the rate of recurrent DVT and increase the speed of recanalization. Disclosures Lobastov: "Gemakor Labs" Ltd: Honoraria, Research Funding; "BEHO+" Ltd: Honoraria, Research Funding. Ryzhkin: "BEHO+" Ltd: Research Funding. Laberko: "Gemakor Labs" Ltd: Honoraria, Research Funding; "BEHO+" Ltd: Honoraria. Rodoman: "Gemakor Labs" Ltd: Research Funding.
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