Saphenous Vein Mechanochemical Ablation by Flebogrif: One-Year Results of the Prospective Multicentre Trial (POLFLEB Study)

Mechanochemical ablation is an alternative to the thermal tumescent methods. Flebogrif catheter is the OTW mechanochemical nonrotational saphenous vein closure device. In the presentation, 1-year results of the prospective multicenter trial (ClinicalTrials.gov Identifier: NCT0455895) on the safety and efficacy of Flebogrif are presented. Two hundred patients with great saphenous vein (GSV) incompetence and diameter up to 10 mm have been included. The mean length of the treated GSV was 43.3 cm (from 20 to 70 mm) and in all cases 3% polidocanol foam was injected during catheter pull back. According to the study protocol after the 3-month follow-up the supplementary sclerotherapy was allowed (if required). The primary efficacy end point was the GSV occlusion rate at 3 months; the primary safety end point was the rate of SAE within 30 days after the procedure. The secondary outcome measures were: GSV occlusion rates as well as the lack of the reflux presence in the treated vein during the follow-up (up to 24 months). Seven days after procedure, 95.48% of the treated GSVs were completely obliterated and no cases of the vein reopening were reported. In the 3 month follow-up (189 patients), the complete occlusion of the entire length of the treated GSV was found in 87.83%, with the segmental complete lumen occlusion in other 10.58% cases. The lack of the reflux in the GSV was confirmed in 96.3% and in 3 cases (1.59%) the GSV reopening was noticed. The 12-month follow-up was completed by 180 patients. The lack of the reflux in the GSV after 1 year of observation concerned 90% of the patients. The whole vein reopening was noticed in nine cases (5%). The complete occlusion of the treated GSV was confirmed in 82.78% and in the remaining 12.22% patients segmental occlusion and/or vein shrinking without reflux was reported. After 12 months, the significant improvement in rVCSS (4.81 ± 2.31 vs 1.34 ± 1.69) as well as Aberdeen Varicose Vein Questionnaire-based evaluation was observed. Most of the patients reported low periprocedural pain and 94% returned to the normal activity within 2 days after procedure. There were no SAEs related directly to the procedure. The mean foam volume used was 8.69 ± 2.23 mL. High safety and significant rate of the saphenous vein reflux ablation in the mid-term follow-up, together with the simplicity of the procedure and low periprocedural pain, place Flebogrif based mechanochemical ablation among the effective options of the truncal varicose vein treatments. The clinical significance of the segmental GSV recanalization should be evaluated in the long term follow-up.