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).

Predictors of recurrence of great saphenous vein reflux following treatment with ultrasound-guided foamsclerotherapy.

OBJECTIVE: To investigate which clinical characteristics at baseline are predictive for great saphenous vein recurrence following ultrasound-guided foamsclerotherapy. MATERIAL AND METHODS: Data of patients treated for great saphenous vein incompetence with ultrasound-guided foamsclerotherapy were derived from a multicentre prospective randomized controlled trial comparing surgery versus ultrasound-guided foamsclerotherapy with a follow-up of two years. Recurrence of reflux was determined on colour duplex scans at three months, one year and two years. Univariate and multivariate Cox regression analysis was used to evaluate the effect of gender, age, C of CEAP classification, diameter of great saphenous vein, injected foam volume, presence of distal great saphenous vein reflux, presence of reflux in the anterior accessory saphenous vein and Venous Clinical Severity Score on risk of recurrent reflux. RESULTS: Two hundred twenty-five patients were available for analysis. Treatment after one single session was successful in 120 patients and recurrence of saphenous reflux was observed in 105 patients within two years during follow-up. Significant associations with risk of recurrence were observed for mid thigh great saphenous vein diameter (HR = 1.012 with 95% CI: 1.002-1.022, p = 0.022) and presence of distal great saphenous vein reflux (HR = 1.882 with 95% CI: 1.029-3.443, p = 0.040). CONCLUSION: In conclusion, this prospective study suggests that ultrasound-guided foamsclerotherapy treatment for the proximal great saphenous vein is less effective for patients with a large vein and a refluxing distal great saphenous vein at baseline.

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.

Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.

BACKGROUND: New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. METHODS: Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs. RESULTS: Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping. CONCLUSION: At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).