In vivo biological effects of foam sclerotherapy.

OBJECTIVES: This study aims to assess by biological markers the in vivo consequences of foam sclerotherapy (FS) of saphenous veins. The secondary objective of this randomised controlled trial (RCT) is to compare results of two randomised groups: with or without post-treatment compression. PATIENTS AND METHODS: Forty patients with incompetent great or small saphenous veins underwent ultrasound-guided FS. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings and the other (WCG) without compression. A laboratory work-up was done on days 0 (before sclerotherapy), 1, 7, 14 and 28. The studied markers were: fibrinogen, factor VIII, thrombomodulin, thrombin-antithrombin complex, D-dimers, platelet factor 4 and troponin. RESULTS: General data repartition was homogenous for CG and WCG. Twenty patients were included in each group (females 90%; mean age 58 years). On day 28 (D28), the occlusion rate of the veins was 100% in both groups. In all the samples (D0-D28), apart from a moderate D-dimers' increase at D1-D14, no significant biological change was observed in either the WCG or the CG groups. CONCLUSION: In terms of inflammation and coagulation, FS seems to have a minimal effect on peripheral blood, either with or without post-treatment compression and does not appear to have an effect on the myocardial risk.

Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.

OBJECTIVES: This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings. DESIGN: This is a prospective open randomised controlled trial conducted in two centres. PATIENTS AND METHODS: Sixty patients with incompetent great (GSV) or small saphenous veins (SSV) underwent ultrasound-guided foam sclerotherapy. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings (15-20 mmHg worn during the day, for 3 weeks) and the other (WCG) without compression. Efficacy of sclerotherapy and all of the side effects were assessed, including side effects in the treated region. On days 14 and 28, clinical and duplex ultrasound (DUS) assessments were performed by independent experts. Patients also completed quality of life (QOL), symptom questionnaires and provided satisfaction scores. RESULTS: Five men and 55 women ranging in age from 32 to 78 (mean 57 years) years were included: 29 in the WCG and 31 in the CG group. On day 28, abolition of venous reflux and occlusion of the vein was obtained in 100% of the cases in both groups. The length of the occluded vein was the same in both groups (mean 36 cm for the GSV and 30 cm for the SSV) as was the mean diameter of the occluded vein (5 mm). Symptoms and QOL questionnaires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessments. Side effects were few with no statistical difference between the two groups. Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results, and good or very good for compression in 50% of the CG cases. CONCLUSION: We found no difference between compression and control groups when comparing efficacy, side effects, satisfaction scores, symptoms and QOL. Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies.

Sclerotherapy of varicose veins in patients with documented thrombophilia: a prospective controlled randomized study of 105 cases.

OBJECTIVES: The aim of this study was to assess thrombotic complications following sclerotherapy in thrombophilic patients in combination with thromboprophylaxis, in two randomized arms using low molecular weight heparin (LMWH) or warfarin. Patients and methods This study received approval from the Ethics Committee. A total of 105 patients (81 females, 24 males) ranging in age from 20 to 82 years (mean 50) were selected: 75 with Factor V Leiden mutation, 18 with prothrombin 20210A mutation, 7 with high level of Factor VIII, 5 combinations of these. After randomization, 51 and 54 patients received warfarin and LMWH, respectively. A total of 199 sclerotherapy sessions were performed. Foam was used in 160 treatments. RESULTS: No episodes of symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred; no instances of DVT were revealed by ultrasound-monitoring. CONCLUSIONS: This study suggests that in the three most common forms of thrombophilia, sclerotherapy, in combination with thromboprophylaxis, can be performed safely. Prophylaxis with LMWH is easier to use than warfarin.