Ultrasound-guided foam sclerotherapy of the saphenous trunks is associated with a low 5-years recurrence rate and improved quality of life in patients with chronic venous disease: a multicenter study.

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), CEAP clinical grade 2-4 disease. Secondary endpoints 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 CO₂O_{2 30:70} ratio 1:4). The sclerosing agent concentrations were 1% for saphenous trunk diameter 4-7 mm, 3% for saphenous trunk >7 mm. STS was injected directly into the GSV/SSV, achieving a total maximum volume of 10 ml per session. A median of 2 sessions were performed (range 1-5).

Results: 205 patients were categorized as CEAP C2 (59.2%), while 141 (40.8%) had worse CVD (CEAP≥3). Median follow-up was 60 (range 6-60) months. At the end of follow-up, 296 (85.5%) patients had no truncal reflux, with a five-year disease-free time (between last procedure and evidence of recurrent disease) of 77.7 ± 2.16%. GSV and SSV showed similar five-year recurrence-free time rates (69.9% vs. 76.8%, p ns), whereas patients with a diameter of the saphenous trunk ≤ 8 mm had lower recurrence than those with > 8 mm (91.3% vs. 46%, p <0.0001). 90 (26%) patients showed CVD recurrence, occurring in a median time of 48 months. A further UGFS treatment was needed in 50 symptomatic patients (14.4%), resulting in 80% success rate. At univariate analysis, large diameter of the saphenous trunk (p < 0.0001), male sex (p 0.030) and higher number of treatment sessions (p 0.009) were identified as significant prognostic factors for recurrence. Immediate complications occurred in 3.7% of patients: 7 headache, 6 visual disturbances. Endovenous foam-induced thrombosis was detected in 6 patients (2.8%) a week after treatment. Cutaneous hyperpigmentation appeared in 37 patients (10.7%). Post-treatment r-VCSS and CIVIQ-14 scores were significantly lower than before treatment (p<0.001).

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 non-thermal ablation in the treatment of saphenous trunk incompetence (CEAP clinical grade 2 to 4).