Placebo controlled efficacy of class 1 elastic stockings in chronic venous insufficiency of the lower limbs

OBJECTIVE: To compare, in a 4-week clinical trial, the efficacy of class 1 Elastic Compression Stockings (pressure at the ankle 10 to 15 mmHg) to that of Placebo Stockings (pressure at the ankle 3 to 6 mmHg) in women consulting in general practice for mild, symptomatic, chronic venous insufficiency of the lower limbs. PATIENTS AND METHODS: This was a 4-week multicentre, randomised, double-blind, placebo-controlled clinical trial conducted on two parallel groups of patients presenting with mild chronic venous insufficiency grade C(1-3S) E(p) A(S1-5) according to the CEAP classification. Treatment efficacy was assessed by the following criteria: global impairment as assessed at each visit on a visual analogue scale (primary efficacy parameter), Quality of Life measured by the CIVIQ questionnaire, symptoms index (sum of individual scores for pain, limb heaviness, paresthesias, cramps and evening limb oedema), limb volume measured by volumetry, and the evolution of global impairment during the course of the trial as assessed by repeated auto-evaluations on visual analogue scales. Compliance was assessed by the number of days patients wore the stockings for at least ten hours per day. Treatment tolerability was assessed by the record of the possible adverse events. RESULTS: Three hundred and forty one patients were included in total. Statistically significant differences were observed on global score of quality of life in favour of class 1 Elastic Compression Stockings group. In the subgroup of patients with evening limb oedema at inclusion, the decrease of limb volume noted with class 1 Elastic Compression Stockings was all the more marked that evening limb oedema was more pronounced at baseline. A good compliance was observed in 76% to 80% of patients according to the treatment group. Tolerability of class 1 Elastic Compression Stockings was comparable to that of the Placebo Stockings. CONCLUSIONS: After four weeks of treatment, compression with class 1 Elastic Compression Stockings allows a statistically significant improvement of Quality of Life and a decreasing of limb oedema in patients presenting with mild chronic venous insufficiency of the lower limbs. Moreover, the tolerability of class 1 Elastic Compression Stockings was confirmed by the high level of patient compliance.     

Expert assessment of chronic venous insufficiency

In the expertise of a chronic venous insufficiency kind and stage of the venous disease must be proved as objectively as possible. The diagnostic demands in the individual step programmes serve for the exact assessment of the remaining part of efficiency. The criteria of valuation are summarized, in which case we also deal with several possibilities of combination with other vascular diseases. The expert opinion of an accident is discussed. References to the inability to work, rating of nursing money, increased material benefit in impairments of health and to the acknowledgement of an identity card for injured persons supplement the statements.     

Microcirculation in chronic venous insufficiency.

In this review, the anatomy and physiology of the venous system and its pathophysiology are described. Theories regarding the possible causes of disturbances in venous microangiopathy are summarized. The theories concern the deoxygenation of red blood cells, arteriovenous shunts, fibrin cuffs, and the trapping of growth factors and/or white blood cells. Furthermore, microlymphatic, neurologic and hemorheologic disturbances in venous disease are outlined. Findings in venous microangiopathy obtained from histology, capillary microscopy, microlymphography, laser Doppler fluxmetry and transcutaneous oxygen partial pressure are detailed. Finally, the recently discovered pattern of perfusion in microcirculation within and around venous ulcers is discussed.     

Efficacy of Class 1 elastic compression stockings in the early stages of chronic venous disease. A comparative study.

AIM: The aim of this study was to compare the efficacy of Class 1 (10-15 mmHg at the ankle) compression stockings with that of reference stockings of identical appearance during the early stages of chronic venous disease (CVD). METHODS: A prospective multi-center randomized double blind crossover study was conducted on 2 groups of female patients presenting with CVD with a CEAP classification of C1-3SEp As1-5. The efficacy of Class 1 compression stockings was evaluated with respect to global painful discomfort (visual analog scale), each symptom of CVD, the daily behavior of the patient, changes in the volume of the legs, and the functioning of the venous pump (D-PPG). The compliance level of each patient was measured by the number of days that she wore the stockings for at least 6 hours, and tolerance was measured by the reporting of ensuing undesirable events. RESULTS: A total of 125 patients were included in the study and were analyzed for intent to treat. Highly significant differences favoring Class 1 compression stockings were noted with respect to both global painful discomfort and each symptom of CVD with the exception of paresthesia. The relief of symptoms that resulted from the use of the Class 1 compression stockings was twice that which resulted from the use of the reference stockings. Differences that favored the Class 1 compression stockings were also observed with respect to 2 quality-of-life factors (mood and daily work activity). Good compliance in the use of the stockings was reported for 95% of the patients, and tolerance was higher for the Class 1 compression stockings group than for the reference group. CONCLUSION: The regular wearing of Class 1 graduated elastic compression stockings during a 15-day period results in a significant improvement in the symptomatology of early-stage chronic venous disease, i.e., in the relief of global painful discomfort as well as in quality-of-life criteria. A high level of patient compliance in the wearing of the stockings was achieved in this study.     

Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial.

Elastic compression stockings are useful for preventing post-thrombotic syndrome after deep venous thrombosis (DVT). Less is known about their effects on thrombus recanalization and the optimal timing for starting compression. This study investigated whether compression applied early was more effective than when started 2 weeks after DVT. Seventy-three patients with DVT were randomly assigned to elastic compression hosiery starting either immediately after diagnosis or 2 weeks later. After 14 and 90 days the residual thrombus was measured by compression ultrasonography, and venous patency and any pathological reflux were recorded. There were significantly more recanalized venous segments in the group treated with early compression. Recanalization of popliteal DVT veins, expressed as the reduction of vein diameter, was also better in the early compression group than controls (day 14, 6.5 +/- 3 versus 5 +/- 2 mm, P = 0.035; day 90, 3.7 +/- 3 versus 2.1 +/- 1.7 mm; P = 0.014). On day 14 the mean score for popliteal patency was significantly better for the early compression patients (1.0 +/- 0.6 versus 1.5 +/- 0.5, P = 0.0015). In conclusion, elastic compression applied immediately at diagnosis of DVT was safe and effective on the surrogate end-points investigated in this study. Longer follow-up in larger series is needed to verify the patterns of recurrence of DVT and post-thrombotic syndrome.     

Air plethysmography in chronic venous insufficiency: clinical diagnosis and quantitative assessment.

To define the role of air plethysmography (APG) in the clinical diagnosis and quantitative assessment of chronic venous insufficiency (CVI), APG studies were performed on 582 limbs in 291 patients with signs and symptoms of CVI. One hundred and thirty-one limbs were classified into group I (no evidence of CVI), 291 into group II (mild CVI), and 160 into group III (advanced CVI). On APG, the mean venous filling index (VFI) was 1.45 mL/s, 3.90 mL/s, and 5.25 mL/s in groups I, II, and III respectively (p<0.05). The mean ejection fraction (EF) and mean residual volume fraction (RVF) also showed significant differences between the limbs with CVI and the contralateral normal limbs, but the values were similar for the different severities of CVI limbs. The amount of overlap in VFI, EF, and RVF values among the clinical groups was considerable. Discrimination analysis derived a VFI value of 2.67 mL/s as a cutoff point between normal limbs and limbs with CVI, with a positive predictive value of 96%. In conclusion, APG is a simple and noninvasive test for quantitative assessment of the different components of CVI, valvular reflux, and calf muscle pump function. However, only VFI correlated significantly with the severity of CVI. VFI, with its high positive predictive value, may be useful in diagnosis of CVI, and it may serve as an objective quantitative measurement for monitoring the effect of treatment.     

Treatment of chronic venous insufficiency

Opinion statement Chronic venous insufficiency (CVI) results from venous hypertension secondary to superficial or deep venous valvular reflux. Treatment modalities are aimed at reducing venous valvular reflux, thereby inhibiting the ensuing pathologic inflammatory process. Compression therapy using pumps, bandaging, and/or graded compression stockings is the mainstay of treatment for CVI. Compression therapy has been shown to be effective in reducing venous hypertension retarding the development of inflammation and pathologic skin changes. Pharmacologic agents such as diuretics and topical steroid creams reduce swelling and pain short term but offer no long-term treatment advantage. Herbal supplements may reduce the inflammatory response to venous hypertension, but are not licensed by the US Food and Drug Administration, and vary in their efficacy, quality, and safety. However, several randomized controlled trials using the herbal horse chestnut seed extract containing aescin have shown short-term improvement in signs and symptoms of CVI. Endovascular and surgical techniques aimed at treatment of primary and secondary venous valvular reflux have been shown to improve venous hemodynamics promoting healing of venous ulcers and improving quality of life. The newer endovascular treatments of varicose veins using laser, radiofrequency ablation, and chemical foam sclerotherapy show some promise.     

Immunohistochemical investigation of pericytes in chronic venous insufficiency.

Patients with chronic venous insufficiency show typical glomerulum like alterations of cutaneous capillaries. Objective of this study was to determine any changes of the alignment of pericytes around cutaneous capillaries in CVI patients. Skin biopsies from the area of the medial malleolus were taken from 42 patients with CVI, 5 healthy individuals and 11 cadavers without history of CVI. Sections were stained with HHF35, anti alpha and gamma muscle actin with the avidin-biotin-peroxidase method (ABC) and anti vimentin with the alkaline phosphatase anti-alkaline phosphatase technique (APAAP). The stage of stasis dermatosis was assessed and sections were examined for pericyte changes. Among the collective of 42 patients with CVI, 31 patients showed slight or severe pericyte changes, 11 patients were without changes. None of the sections from cadavers or healthy patients showed any pericyte changes. Pericytes are among other functions possibly involved in microvasculature regulation and wound healing. Thus destruction of the pericyte envelope might lead to microcirculatory dysfunction. This could be one of the causes that lead to leg ulcers in CVI.     

Restoration of muscle-pump function in chronic venous insufficiency.

The direct venous pressure profile was recorded before and after treatment in 15 patients suffering from chronic venous insufficiency. Patients were treated conservatively, first by tight elastic support and walking exercises, then by eliminating the points of blood shunting by sclerotherapy of the incompetent perforators. The average venous pressure drop during tiptoeing was increased from 31.6% to 50.9% (P less tan 0.01), and the time required for return to the resting venous pressure level increased from an average 6 seconds to 12.9 seconds (P = 0.01). These values indicate a significant improvement in the functioning of the muscle pump of the calf, and are paralleled by clinical and subjective improvement. Wr recommend this method of treatment in cases of chronic venous insufficiency. We also wish to point out the importance of repeated direct venous pressure profile recording as a means of assessing the effectiveness of treatment in cases of venous disorders.     

Circulating leucocyte adhesion molecules in chronic venous insufficiency.

BACKGROUND: Enzyme-linked immunosorbent assay (ELISA) techniques have detected the existence of circulating forms of intercellular adhesion molecule-1 (ICAM-1), vascular endothelial adhesion molecule-1 (VCAM-1) and E-selectin, all of which mediate leucocyte-endothelial adhesion. This study determined whether circulating cell adhesion molecules were increased in patients with chronic venous insufficiency (CVI) which causes venous stasis. PATIENTS AND METHODS: Before and after walking and upon recovery blood samples were drawn from the saphenous vein in 20 CVI patients: 10 with varicose veins (group 1), 10 with deep venous insufficiency (group 2). 10 healthy controls were enrolled. The total leucocyte count and the soluble levels of ICAM-1, VCAM-1 and E-selectin were determined. RESULTS: After walking, the total leucocyte count decreased significantly (p < 0.01) only in group 2 and sICAM-1 and sVCAM-1 increased significantly (p < 0.01). Upon recovery, these significant differences remained in group 2. No significant modification was observed at any stage of the study in group 1 or in the control group. CONCLUSIONS: These results suggest persistently high levels of circulating adhesion molecules may contribute to worsen microvascular perfusion, which leads to the onset of trophic damage in CVI.     

Acute and chronic venous insufficiency in the finger.

Venous hypertension with subsequent chronic venous insufficiency and its sequelae in the hand is reported as an uncommon complication of arteriovenous fistulae for hemodialysis.     

Profuse bleeding in patients with chronic venous insufficiency.

AIM: The aim of this retrospective study was to compare the healing rates of patients where the bleeding points were sutured (n=52) against those where the bleeding was controlled using compression sclerotherapy (n=72). The incidence of re-bleeding was also followed over a 12-month period. METHODS: During 1999-2003, we treated 124 patients (86 women and 38 men; mean age: 64 years, age range: 36-85 years) with profuse bleeding from varicose veins as emergency cases. Seventy-two patients (58%) were treated with compression sclerotherapy. In the suture group of 52 patients (42%) the bleeding points were treated in the emergency outpatients department. Usually a cross stitch was used and the same type of uninterrupted compression as in the sclerotherapy group was applied for 6 weeks afterwards. RESULTS: In the group of patients where compression sclerotherapy (Fegan's method) was used to control the bleeding (65 patients), the average time taken for the wound to heal completely was 7 days (5-13 days). There was no recurrence of bleeding in the subsequent 12 months. In the group of patients where a suture was used to control the bleeding, the average time of healing was 14 days (11-19 days) and re-bleeding occurred in 12 cases (23%). CONCLUSIONS: Using Fegan's technique of compression sclerotherapy with a low concentration of sclerosant (0.2% sodium tetradecyl sulfate), it is possible to treat bleeding varicose veins effectively with significantly faster healing of the wound.     

Prevention of edema,flight microangiopathy and venous thrombosis in long flights with elastic stockings. A randomized trial: The LONFLIT 4 Concorde Edema-SSL Study

The LONFLIT1/2 studies have established that in high-risk subjects after long (> 10 hours) flights the incidence of deep venous thrombosis (DVT) is between 4% and 6%. The LONFLIT4 study has been planned to evaluate the control of edema and DVT in low-medium-risk subjects. The aim of this study was to evaluate edema and its control with specific flight stockings, in long-haul flights. In the first part of the study 400 subjects at low-medium risk for DVT were contacted; 28 were excluded for several nonmedical problems; 372 were randomized into 2 groups to evaluate prophylaxis with stockings in 7-8-hour flights; the control group had no prophylaxis. Below-knee, Scholl, Flight Socks, producing 14-17 mm Hg of pressure at the ankle, were used in the treatment group. The occurrence of DVT was evaluated with high-resolution ultrasound scanning (femoral, popliteal, and tibial veins). Edema was assessed with a composite score based on parametric and nonparametric measurements. Part II: In this part of the study 285 subjects at low-medium risk for DVT were included and randomized into 2 groups to evaluate edema prophylaxis in 11-12-hour flights; the controls had no prophylaxis while the prevention group had below-knee, Scholl, Flight Socks (comparable to part I). RESULTS: Part 1: DVT evaluation. Of the 184 included subjects in the stockings group and 188 in the control group, 358 (96.2%) completed the study. Dropouts were due to compliance or connection problems. Age/sex distributions were comparable in the groups. Stockings Group: of 179 subjects (mean age 49; SD 7; M:F = 101:78), none had DVT or superficial thromboses. Control Group: of 179 subjects (mean age 48.4; SD 7.3; M:F = 98:81), 4 (2.2%) had a DVT. There were also 2 superficial thromboses. In total, 3.35% (6) subjects had a thrombotic event. The difference (p<0.002) is significant. Intention-to-treat analysis detects 15 failures in the control group (9 lost + 6 thromboses) out of 188 subjects (7.9%) versus 5 subjects (2.7%) in the stockings group (p <0.05). All thrombotic events were observed in passengers sitting in nonaisle seats. The tolerability of the stockings was very good and there were no complaints or side effects. Thrombotic events were asymptomatic. No difference was observed in the distribution of events between men and women. The 3 women who had a thrombotic event were taking low-dose, oral contraceptives. Edema evaluation: The level of edema at inclusion was comparable in the 2 groups. After the flight there was a score of 6.7 (3.1) in controls; in the stockings group the score was 2.9 times lower (p<0.05). The control of edema with stockings was clear considering both parametric (circumference, volume) and nonparametric (analogue scale lines) data. Part II: DVT evaluation. Of the 285 included subjects, 271 (95%) completed the study. Dropouts were due to low compliance or connection problems. Age/sex distributions were comparable in the groups. Stockings Group: of 142 subjects (mean age 48; SD 8; M:F = 89:53), none had DVT or superficial thromboses. Control Group: of 143 subjects (mean age 47; SD 8; M:F = 87:56), 3 had a popliteal DVT and 3 a superficial thrombosis. In total, 4.2% (6) subjects had a thrombotic event. The difference (p<0.02) between groups is significant. Intention-to-treat analysis detects 14 failures in the control group (8 lost + 6 thromboses = 9.7%) versus 6 (all lost = 4.2% in the stockings group) (p<0.05). Four of 6 events (3 DVT + 1 SVT) were observed in non-aisle seats. The tolerability of the stockings was very good. No difference was observed in the distribution of events between men and women. Edema evaluation: The level of edema at inclusion was comparable in the 2 groups. After the flight there was a score of 8.08 (2.9) in controls while in the stockings group the score was 2.56 (1.5) (p < 0.005). In conclusion. Scholl Flight Socks are very effective in controlling edema. Also this type of compression is effective in significantly reducing the incidence of DVT and thrombotic events in low-medium-risk subjects, in long-haul flights. CONCLUSIONS: Considering these observations, Flight Socks are effective in controlling edema and in reducing the incidence of DVT in low-medium-risk subjects, in long-haul flights (7-11 hours).     

弹力袜护理对冠状动脉旁路移植术后患者下肢深静脉血栓形成的影响

目的:探讨专业弹力袜护理对冠状动脉旁路移植术(CABG)后患者,下肢深静脉血栓形成的影响。方法:根据研究纳入排除标准,收集96例拟行单纯CABG术的患者进行随机分组,其中对照组46例,干预组50例,对照组患者接受常规心外科护理,干预组患者在常规心外科护理基础上接受护士对于术后医用弹力袜穿戴的一对一床旁宣教。结果:研究发现,专业弹力袜护理宣教可以减少接受CABG手术患者术后静脉血栓的发生,缩短患者住院时长[(6. 12±1. 10) vs.(7. 34±3. 92) d,P=0. 04]。结论:由护士进行的一对一弹力袜宣教可以减少患者术后下肢深静脉血栓的发生,减少术后住院天数。     

What complementary examinations to demand in chronic venous insufficiency?]

The diagnosis of chronic venous insufficiency (CVI) is first of all a clinical diagnosis. Subsequent investigations are useful to elucidate the underlying abnormalities in the venous system and to quantify their severity. Continuous wave doppler ultrasound is the basis test. Duplex scanning is useful for the study of popliteal and tibial veins reflux. The others non invasive techniques aim to investigate patients with severe CVI. But it seems necessary to be very careful with the methodologies used with these tests, and there is a need for a test of the whole calf venous pump function. Venographic studies are performed only if it is necessary to complete the non invasive tests data, before surgical treatment of a postthrombotic syndrome or of congenital deep venous reflux, or when a rare form of CVI is suspected. Venography remains the better test for the study of the anatomy of the venous system, but it is no longer the gold standard for the investigation of CVI.