Empty vein ablation innovative technique for chronic venous disease treatment: proof of concept and ex-vivo analysis

Abstract

Background: Sclerotherapy is among the mainstays of chronic venous disease treatment, yet its occlusion rate remains suboptimal compared to thermal tumescent techniques. An innovative three-balloons catheter has been developed to allow sclerotherapy in empty vein conditions (empty vein ablation technique, EVA). Aim of this investigation was to describe the EVA technical aspects and related ex-vivo effects on vein wall.

Methods: Two samples from jugular veins of an adult sheep were treated by EVA or foam sclerotherapy (FS, Tessari method). Primary outcome was the percentage of circumferential intima treated by EVA or FS; secondary outcomes were intima and media thickness modifications after treatment.

Results: Intact circumferential residual intima were 6.07±2.94% and 16.55±0.70% after EVA and FS, respectively (P=0.020). Despite the average intima and media thickness did not differ between treatments, EVA demonstrated a homogenous damage throughout the vein segment, while FS effect was less destructive distally to the injection site, because moving away from the injection site and floating, it has a less contact with internal surface of the vein.

Conclusions: EVA seems to overcome chemical ablation limits as flushing effect and the increases vein wall/sclerosant agent contact effect compared to FS. Ex-vivo encouraging results need in-vivo validation to evaluate other points like deactivation of sclerosing agent by blood protein and the contact time control between SA and the vein wall. If we have further confirmations in vivo we might think we have a potential higher occlusion rate compared to FS, paving the way for future clinical trials.