Total Endovenous Laser Ablation Multicenter Trial (TOTEM): Early Results

Abstract

To evaluate the safety and efficacy of Total Endovenous Laser Ablation (TEVLA) in a multicenter cohort. Prospective multicenter non-randomized study including 153 patients (CEAP C2-C6). TEVLA was performed as a single-session procedure treating truncal veins, tributaries, and perforators. Primary endpoint was occlusion rate. Secondary endpoints included complications, pain (VAS), and rVCSS improvement. Occlusion rate was 99.3% at 7 days and 98.3% at 6 months. No DVT or EHIT events were observed. Minor complications included hyperpigmentation (5.9%) and paresthesia (2.6%). Mean rVCSS significantly improved (-3.24 at 1 month; p<0.001). No association was found between LEED and complications. TEVLA is a safe and effective single-step technique with high occlusion rates and low complication profile. Further randomized studies are warranted.