Assessing the effectiveness and safety of high-intensity focused ultrasound in treating venous insufficiency using a hemodynamic approach

Abstract

Objective

To evaluate the effectiveness and safety of High-Intensity Focused Ultrasound (HIFU) treatment in Chronic Venous Insufficiency (CVI) using a hemodynamic approach.

Methods

This real-world, observational, and retrospective study analyzed 80 patients with CVI from stage C2 to C5 (Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) classification). A single vascular surgeon included and treated all patients consecutively between September 2022 and July 2023. Outcomes were assessed by Doppler ultrasound at 1-month and 1-year. The primary outcome was technical success (complete/partial occlusion by reducing reflux involving reduction in vein diameter >50%); the secondary outcomes included clinical improvement, measured by the Aberdeen varicose vein questionnaire (AVVQ) with visual analogue scale (VAS) and adverse effects. Descriptive statistics include 95% confidence intervals (CI). Subgroups were compared using Chi-squared/Fisher’s or Student’s t-test/Wilcoxon tests.

Results

Treated veins included great saphenous veins (GSV), small saphenous veins (SSV), anterior accessory saphenous veins (AASV), leg perforating veins (LPV), thigh perforating veins (TPV), perineal veins and GSV neocrosses. At 1-month follow-up, technical success reached 80.6% (95% CI 74.8–85.5%) of cases, with optimal outcomes for LPV (94.4%) and GSV (87.5%). Clinical improvement occurred in 78.8% of patients (68.81–86.54%). At baseline, patients were stratified into subgroups according to their CEAP stage. No significant difference in improvement rates was found across these subgroups (C2S: 78.7%, C3: 83.3%, C4: 75%, C5: 85.7%, p = 0.83). However, adverse events occurred in 21.8% of cases, the most frequent being neuropathic pain (5%) and skin burns (5%), all quickly resolved.

One-year per-protocol analysis showed maintained technical success at 79% (73.8–83.9%) and clinical improvement at 95.2% (84.2–99.4%) despite the attrition of 36% of participants.

Conclusion

HIFU treatment demonstrates lasting effectiveness for CVI, particularly on LPV and GSV, with an acceptable safety profile. Limitations include a steep learning curve and anatomical constraints. Further studies are necessary for confirmation.