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

Overview

Journal Transl Med UniSa

Date 2020 Mar 4

PMID 32123682

Citations 3

Authors

R P Ammollo

A Petrone

A M Giribono

L Ferrante

L Del Guercio

U M Bracale

Affiliations

Soon will be listed here.

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.

Citing Articles

Early Results of Mechanochemical Ablation by Flebogrif and Radiofrequency Ablation in Treating Primary Varicose Veins of Lower Limb.

Razaque A, Shazlee M, Qamar S, Hyder S, Adel H Cureus. 2023; 15(9):e45874.

PMID: 37885503 PMC: 10598325. DOI: 10.7759/cureus.45874.

Study of Flebogrif-A New Tool for Mechanical Sclerotherapy-Effectiveness Assessment Based on Animal Model.

Rybak Z, Janeczek M, Dobrzynski M, Wujczyk M, Czerski A, Kuropka P Nanomaterials (Basel). 2021; 11(2).

PMID: 33669987 PMC: 7924836. DOI: 10.3390/nano11020544.

Editorial: Health Technologies: a challenge to tackle in NETWORK.

Illario M, De Luca V, Bracale U, Bracale G Transl Med UniSa. 2020; 21:1-3.

PMID: 32123671 PMC: 7039263.

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