Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein.

BACKGROUND: This was an 8-year follow-up of an RCT comparing ultrasound-guided foam sclerotherapy (UGFS) with high ligation and surgical stripping (HL/S) of the great saphenous vein (GSV). METHODS: Patients were randomized to UGFS or HL/S of the GSV. The primary outcome was the recurrence of symptomatic GSV reflux. Secondary outcomes were patterns of reflux according to recurrent varices after surgery, Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification, Venous Clinical Severity Score (VCSS) and EuroQol Five Dimensions (EQ-5D™) quality-of-life scores. RESULTS: Of 430 patients originally randomized (230 UGFS, 200 HL/S), 227 (52·8 per cent; 123 UGFS, 103 HL/S) were available for analysis after 8 years. The proportion of patients free from symptomatic GSV reflux at 8 years was lower after UGFS than HL/S (55·1 versus 72·1 per cent; P = 0·024). The rate of absence of GSV reflux, irrespective of venous symptoms, at 8 years was 33·1 and 49·7 per cent respectively (P = 0·009). More saphenofemoral junction (SFJ) failure (65·8 versus 41·7 per cent; P = 0·001) and recurrent reflux in the above-knee GSV (72·5 versus 20·4 per cent; P = 0·001) was evident in the UGFS group. The VCSS was worse than preoperative scores in both groups after 8 years; CEAP classification and EQ-5D® scores were similar in the two groups. CONCLUSION: Surgical stripping had a technically better outcome in terms of recurrence of GSV and SFJ reflux than UGFS in the long term. Long-term follow-up suggests significant clinical progression of venous disease measured by VCSS in both groups, but less after surgery. Registration number: NCT02304146 (http://www.clinicaltrials.gov).

How specific are venous symptoms for diagnosis of chronic venous disease?

OBJECTIVE: The objective of this study is to evaluate whether and which 'venous' symptoms are characteristic for patients affected with chronic venous disease compared to patients with other diseases of the lower limbs (e.g. arthrosis, peripheral arterial disease, spinal disc herniation). METHODS: A cross-sectional study was performed to compare the frequency of venous symptoms among 76 patients with chronic venous disease and reflux and 74 patients with other diseases of the legs without reflux. The VEINES-Sym of the VEINES-QOL/Sym questionnaire was used to evaluate the frequency of symptoms. Demographic, clinical classification and ultrasound findings were also noted. RESULTS: A total of 122 patients were included for analysis (response rate of 87%). Presence of venous symptoms was slightly more often reported in the chronic venous disease group than in the non-chronic venous disease group, but differences were small and statistically non-significant. Severity of chronic venous disease as classified by the CEAP classification was not associated with higher proportions of patients reporting symptoms than in non-chronic venous disease patients, except for swelling (p = .016) and itching (p = .007) in C3-C6 patients. The largest difference between the chronic venous disease and non-chronic venous disease group was observed for the time of the day at which symptoms were most intense; patients with chronic venous disease were more likely to experience symptoms at the end of the day (p < .001). CONCLUSIONS: The small differences in prevalence of reported 'venous' symptoms between chronic venous disease patients and patients with other diseases of the legs suggest that these symptoms may be less specific for patients with chronic venous disease and refluxing veins than is usually assumed.

In vivo effects of foam sclerotherapy on coagulation.

OBJECTIVE: The aim of this study was to evaluate whether foam sclerotherapy (FS) induces changes in CAT (calibrated automated thrombinography) and other coagulation parameters which could indicate an increased risk of thrombotic events. METHODS: Blood samples from eight patients treated with FS were taken before treatment and 30 minutes, one and four hours and one week after treatment. CAT parameters (ETP1n, Peak1n, Lag time 1), thrombin antithrombin complexes (TAT), d-dimers, fibrinogen, Von Willebrand (vWf Ag) factor and platelet-derived microparticles (MIPAs) were measured. RESULTS: Significant changes over time for Peak1n, fibrinogen, d-dimers, vWfAg and TAT complexes were observed. CAT parameters decreased over time, except for Lag time 1. D-dimers and TAT complexes increased and fibrinogen, vWf Ag, MIPA's decreased during the first hours. CONCLUSION: The findings in this study support the hypothesis that FS initiate coagulation pathways, but there is no evidence that this activation results in an increased thrombosis risk.