The Impact of Electrical Calf Muscle Stimulation on the Residual Venous Obstruction and DVT Recurrence after Cessation of Standard Anticoagulation

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.