Two-year follow-up of a n-butyl-2-cyanoacrylate glue ablation for the treatment of saphenous vein insufficiency with a novel application catheter with guiding light.

OBJECTIVES: This study aims to present the early results of a prospective study of the use of novel n-butyl-2 cyanoacrylate (VenaBlock)-based nontumescent endovenous ablation with a guiding light for the treatment of patients with varicose veins.

METHODS: Five hundred and seventy-three patients with lower-limb venous insufficiency were treated within in the previous four years. The study enrolled adults aged 21-70 years with symptomatic moderate to severe varicosities (C2-C6 patients clinical, etiological, anatomical, and pathophysiological classification) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter ≥ 5.5 mm assessed in the standing position. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, and sixth month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded.

RESULTS: Five hundred and seventy-three patients aged 21-70 years with lower-extremity venous insufficiency treated with n-butyl-2. The mean treatment length was 30.6 ± 5.3 cm and the average n-butyl-2 delivered was 1.2 ± 0.3 ml. The mean procedure time was 10.8 ± 4.7 min. There was no deep venous thrombosis, pulmonary embolism, or paresthesia. We observed ecchymosis in eight patients (1.4%) at the entry site at the third day follow-up. Phlebitis was encountered with 10 (1.8%) patients. No skin pigmentation, hematoma, paresthesia, deep-vein thrombosis, or pulmonary embolism was observed. Procedural success was 100%, and complete occlusion was observed after treatment, at the third day follow-up and at first month. Kaplan-Meier analysis yielded with overall clinical recurrence-free rate after a mean follow-up of 23.96 months was 99.38%. All patients had significant improvement in venous clinical severity score and quality-of-life scores postoperatively ( p < 0.0001). Venous clinical severity score scores at preintervention and 24th month were 5.8 ± 1.0 (range 4-8) and 0.6 ± 0.6 (range 0-4), respectively ( p < 0.0001). Aberdeen varicose vein questionnaire scores at preintervention and 24th month were 19.7 ± 6.4 (range 9-30) and 4.4 ± 1.1 (range 1-9), respectively ( p < 0.0001).

CONCLUSIONS: The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.