ABSTRACT
Tomasz Urbanek, MD, PhD
Professor
Medical University of Silesia, Katowice, Poland
Katowice, Poland
Mechano-chemical ablation is an alternative to the thermal tumescent methods. Flebogrif® catheter is the OTW mechano-chemical non – rotational saphenous vein closure device. In the presentation, one year results of the prospective multicentre trial (ClinicalTrials.gov Identifier: NCT0455895) on the safety and efficacy of Flebogrif® are presented.
Methods:
200 patients with GSV incompetence and diameter up to 10mm 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 3 month follow up the supplementary sclerotherapy was allowed (if required). The p</span>rimary efficacy endpoint was the GSV occlusion rate at 3 months; primary safety endpoint 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). 7 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. 12 month follow up was completed by 180 patients . The lack of the reflux in the GSV after 1 year observation concerned 90% of the patients. The whole vein reopening was noticed in 9 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 AVVQ 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 mechano-chemical 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.
Results:
Conclusions: