Long-term results of a randomized controlled trial on ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins

Abstract

The long-term results of a prospective, randomized controlled trial in patients with primary varicose veins are reported. Saphenofemoral ligation (SFL) was done in 73 patients (82 legs). In addition, 43 (23 women; age, 47) underwent stripping and multiple phlebectomies under general anesthesia (group S), and 39 (32 women; age, 49) had concurrent sclerotherapy under local anesthesia (group F). Assessments included CEAP C status, Venous Clinical Severity Score (VCSS), Venous Segmental Disease Score (VSDS), Aberdeen Varicose Vein Questionnaire (AVVQ), and 36-Item Short-Form (SF-36) scores. CEAP C was similar between groups (C(2-6)). In group S, 40% of legs required 25 additional foam sessions (mean volume, 11 mL). In group F, 47.5% of legs required 33 sessions (mean volume, 9 mL) The groups had equivalent preoperative VCSS scores and similar changes at 3 (P = .504) and 5 years (P = .484), as were the absolute VCSS scores at 3 (P = .313) and 5 years (P = .104; Mann-Whitney U). The VSDS score improved (median [interquartile range]) preoperatively vs 3 years (group S, 16.32 [14.7] vs 8.94 [11.51], P = .003; group F, 12.28 [10.37] vs 4.97 [6.19]; P < .0005, Wilcoxon). Above knee obliteration occurred in 17 of 26 (65.4%) for group S and in 16 of 33 (48.5%) for group F at 3 years, and in 14 (53.8%) and 19 (57.6%) at 5 years. AVVQ scores were similar before and at 3 years (P = .703) but significantly favored group S at 5 years (P = .015; Mann-Whitney U). The AVVQ also improved within both groups. The SF-36 mental summary score over 3 years deteriorated in group S (P = .04). However, the physical summary scores did not change between groups (S, P = .361; F, P = .889) or the mental score in group F (P = .285). Changes in the physical (P = .724) and mental (P = .354, Mann-Whitney U) scores did not differ between the groups due to treatment. At 3 and 5 years of follow-up, the treatment was equally effective in the surgical and foam groups, as demonstrated with VCSS, VSDS, and the SF-36 physical component score. At 5 years, the AVVQ was significantly better in the surgical group. The additional foam sessions were also similar. Because traditional surgery for varicose veins does not provide a definitive treatment, foam sclerotherapy could be offered as in a dental care treatment model: "treat as and when the problem appears."