Multicenter prospective study on the safety and clinical feasibility of tributary vein ablation using a radial fiber

Abstract

Objectives

While ambulatory phlebectomy and sclerotherapy are established treatments for varicose tributaries, they possess inherent limitations regarding invasiveness and technical consistency. This study aimed to evaluate the safety and clinical feasibility of tributary varicose vein ablation (VVA). The primary endpoint was the safety of VVA based on postoperative complications. Secondary endpoints included the target vessel occlusion rate and the reduction of subcutaneous induration.

Methods

This multicenter prospective study included 311 limbs (240 patients) with saphenous-type varicose veins treated with VVA across four institutions. A 1470 nm diode laser and radial fiber were used with a standardized energy density of 25 J/cm. Early complications were assessed at 1 week (n = 311). For the longitudinal analysis of induration and skin hyperpigmentation, 283 limbs that completed the 6-month follow-up were evaluated. Changes in categorical paired data were analyzed using McNemar’s test. Factors associated with persistent pigmentation were analyzed using the unpaired t-test.

Results

The target vessel occlusion rate was 99.6% at 6 months. At 1 week, no instances of skin burns or infections were recorded. One case (0.3%) of pulmonary embolism occurred but resolved with anticoagulation. Subcutaneous induration was observed in 81.6% of limbs at 1 month (mean diameter: 4.92 ± 2.34 mm) but significantly regressed by 6 months (26.1%, 2.50 ± 1.66 mm; p < .001). Persistent minor nerve injury was rare (0.7% at 6 months). The incidence of subcutaneous induration significantly decreased from 81.6% at 1 month to 26.1% at 6 months (p < .001). Skin hyperpigmentation remained at 16.3% at 6 months (p = .451).

Conclusions

VVA using a radial fiber is a safe and effective alternative that overcomes the limitations of traditional phlebectomy and sclerotherapy. By ensuring thermal delivery exclusively within the target vessels, the procedure provides a reproducible and standardized approach for the comprehensive management of varicose veins.