Total Endovenous Laser Ablation Multicenter (TOTEM) trial: Early results
Luca Palombi1, Jan Szczepański2, Fabio Martinelli1
1Angiology and Advanced Surgical Phlebology Service, Villa Salus Foundation, Villa Salus Hospital, Venice Mestre, Italy.
Objective:
To evaluate the safety and efficacy of total endovenous laser ablation (TEVLA) in a multicenter cohort.
Methods:
This prospective multicenter nonrandomized study included 153 patients (Clinical, Etiologic, Anatomic, Pathophysiologic Classification [CEAP] C2-C6). TEVLA was performed as a single-session procedure for the treatment of truncal veins, tributaries, and perforators. The primary end point was the occlusion rate. The secondary end points included complications, pain (visual analog scale [VAS]), and revised Venous Clinical Severity Score (rVCSS) improvement.
Results:
The occlusion rate was 99.3% at 7 days and 98.3% at 6 months. No deep vein thrombosis or endothermal heat-induced thrombosis events were observed. Minor complications included hyperpigmentation (5.9%) and paresthesia (2.6%). The mean rVCSS significantly improved (-3.24 at 1 month; P < .001). No association was found between linear endovenous energy density and complications.
Conclusions:
TEVLA is a safe and effective single-step technique with high occlusion rates and low complication rates. Further randomized studies are warranted.