Early Results of Mechanochemical Ablation with Flebogrif® in great Saphenous Vein Insufficiency: does Polidocanol Concentration Affect Outcome?

Abstract

Background: Flebogrif® (Balton, Poland) is a novel mechanochemical ablation (MOCA) device for saphenous vein insufficiency. It combines endothelial damage performed by radial retractable cutting hooks together with chemical ablation through sclerosant injection of 3% polidocanol foam according to its IFU. The objective of this study is to evaluate Flebogrif's efficacy in terms of recanalization rate and recurrence by varying polidocanol foam concentrations.

Methods: We performed 24 MOCAs on 23 patients with Flebogrif® between January and May 2019. In 12 cases the polidocanol foam was prepared at a 3% concentration, and in another 12 at 1.5%. Great saphenous vein (GSV) recanalization and truncular recurrence were evaluated at 1 and 3 months with a Duplex Ultrasound Anatomy (DUS) examination.

Results: At 1- and 3-month follow-ups, none of the 14 patients treated with the polidocanol 3% foam were observed to have had great saphenous vein GSV recanalization and truncular recurrence. Only 2 of the 14 (14.3%) cases treated with polidocanol 1.5% foam showed evidence of recanalization within the first centimetres from the sapheno-femoral junction (p > .05). All patients experienced clinical benefits without recurrence of symptoms.

Conclusion: MOCA with Flebogrif® is a safe, relatively inexpensive and effective alternative to standard methods in the treatment of saphenous insufficiency with encouraging short-term results. Despite our relatively small patient sample, no statistical significance in evidence of recurrence in the group of patients treated with 3% foam and those treated with 1.5% foam was noted. Longer term analysis of GSV patency and recurrence is necessary to further evaluate Flebogrif's impact and actual indications in the treatment of chronic venous disease.