Abstract
OBJECTIVE: The study attempts to test whether ultrasound-guided foam sclerotherapy (UGFS) is a durable treatment for incompetent great saphenous vein (GSV) and incompetent small saphenous vein (SSV) in primary chronic venous disease (CVD), Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical grade 2 to 4 disease. Secondary end points are to evaluate its safety in terms of complications, to compare patients' quality of life before and after the treatment, and to identify risk factors that may predict recurrence of CVD after UGFS. METHODS: Multicenter retrospective cohort study on 346 patients. The sclerosing agent was sodium tetradecyl sulfate (STS) in foam. The foam was prepared with the double-syringe technique (liquid-to-gas CO(2)O(2 30:70) ratio of 1:4). The sclerosing agent concentrations were 1% for saphenous trunk diameter 4 to 7 mm, 3% for saphenous trunk of >7 mm. Sodium tetradecyl sulfate was injected directly into the GSV/SSV, achieving a total maximum volume of 10 mL per session. A median of two sessions was performed (range, 1-5). RESULTS: In this cohort, 205 patients were categorized as CEAP C2 (59.2%), and 141 (40.8%) had worse CVD (CEAP ≥3). The median follow-up was 60 months (range, 6-60 months). At the end of follow-up, 296 patients (85.5%) had no truncal reflux, with a 5-year disease-free time (between last procedure and evidence of recurrent disease) of 77.7 ± 2.16%. GSV and SSV showed similar 5-year recurrence-free time rates (69.9% vs 76.8%; P = ns), whereas patients with a diameter of the saphenous trunk of ≤8 mm had lower recurrence than those with >8 mm (91.3% vs 46%; P < .0001). Ninety patients (26%) showed CVD recurrence, occurring at a median of 48 months. A further UGFS treatment was needed in 50 symptomatic patients (14.4%), resulting in an 80% success rate. At univariate analysis, large diameter of the saphenous trunk (P < .0001), male sex (P = .030) and greater number of treatment sessions (P = .009) were identified as significant prognostic factors for recurrence. Immediate complications occurred in 3.7% of patients: seven headache and six visual disturbances. Endovenous foam-induced thrombosis was detected in six patients (2.8%) 1 week after treatment. Cutaneous hyperpigmentation appeared in 37 patients (10.7%). Post-treatment revised Venous Clinical Severity Score and Chronic Venous Disease Quality of Life Questionnaire 14 scores were significantly lower than before treatment (P < .001). CONCLUSIONS: UGFS of the GSV/SSV is effective, safe in the long term and well-accepted by patients. UGFS is a viable option to surgery and endovenous thermal or nonthermal ablation in the treatment of saphenous trunk incompetence (CEAP clinical grade 2-4).