Extra-Corporeal thermal ablation with High Intensity Focused Ultrasound for superficial venous insufficiency: Preliminary results at twelve months follow-up.

Abstract

ObjectiveThe aim of this study is to present our results with an innovative extracorporeal thermal therapy using High Intensity Focused Ultrasound (HIFU) to treat Superficial Venous Insufficiency (SVI).DesignObservational retrospective study with prospective data collection.MethodsA total of 102 consecutive patients were included. All types of incompetent veins that met the HIFU-device criteria were treated. The primary endpoint of our analysis was vein occlusion rate. As secondary endpoints, shrinkage, absence of reflux, clinical improvement and complications related to the treatment were analyzed. Clinical and Ultrasound (US) follow-up was planned at 15 days, 3 months, 6 months, and 12 months. For clinical assessment, simplify CEAP classification and Venous Clinical Severity Score (VCSS) were registered.ResultsA total of 164 veins were treated: 92 saphenous trunks [65 Great Saphenous Veins (GSV), 15 Short Saphenous Veins (SSV), 12 Anterior Accessory Saphenous Veins (AASV)], 48 perforator veins and 24 other veins (15 tributaries, 4 Giacomini veins, 5 neovascularizations). For all types of veins, occlusion rates were 85% to 96% at early follow-up and from 85% to 90% twelve months after the treatment. Regarding reflux-free rate, it ranged from 85% to 96% 2 weeks after treatment, and from 85% to 93% at twelve months. Finally, shrinkage rates ranged from 96% to 97% 2 weeks after the treatment, and from 94% to 97% at twelve months. All patients showed statistically significant clinical improvement in VCSS and CEAP classification trough the different follow-ups. No major adverse events were observed.ConclusionTreatment of varicose veins with the HIFU therapy seems to be competitive with the state-of-the-art techniques and has shown to be effective and safe in our initial 102 patients' data analysis. Nevertheless, further studies are needed for stronger evidence.