Aspiration-Assisted Catheter-Directed Foam Sclerotherapy Using the Sclerosafe Device for Anterior Saphenous Vein Insufficiency: A Retrospective Study

Vollständiger Abstract

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Objective: Anterior saphenous vein insufficiency is an underappreciated but clinically significant source of superficial venous reflux. Catheter-directed foam sclerotherapy represents a minimally invasive treatment approach, yet optimisation of sclerosant-to-endothelium contact remains a recognised technical challenge. The Sclerosafe system (VVT Medical, Kefar Sava, Israel)—a dual-lumen aspiration-assisted sclerotherapy device—was developed to address this limitation. The aim of this study was to evaluate the safety and efficacy of the Sclerosafe device in the treatment of anterior saphenous vein insufficiency. Methods: Retrospective analysis of prospectively collected data from 56 patients treated for isolated anterior saphenous vein insufficiency between 2020 and 2023. All procedures were performed in an outpatient setting under local anaesthesia (2 mL of 1% lignocaine at the puncture site) without tumescent infiltration. The Sclerosafe catheter was introduced directly, without an introducer sheath, through a single ultrasound-guided puncture of the ASV at the lowest point of reflux, and its tip was positioned 2 cm distal to the confluence with the common femoral vein. Treated segment length ranged from 8 to 17 cm (mean 10 cm) and vessel diameter from 4 to 12 mm (mean 6 mm). Polidocanol 2% foam (5 mL per session, Tessari technique) was administered and a standardised compression regimen was applied. Duplex ultrasound follow-up was conducted at 1, 2, 6, and 12 months; no venous severity, pain or quality-of-life score was recorded. Results: Technical success was achieved in all 56 cases. Complete occlusion of the treated segment was confirmed by duplex ultrasound at one month in 52 of 56 patients (92.9%). Occlusion rates at 6 months and 12 months were 92.5% (49/53 evaluable) and 90.4% (47/52 evaluable), with 3 and 4 cumulative patients lost to follow-up, respectively. Five occlusion failures were recorded in total: four primary failures at one month and one recanalisation between 6 and 12 months. Kaplan–Meier estimates of primary occlusion probability were 92.9% at 1 month (95% CI 86.1–99.6%), 92.9% at 6 months (no interval events), and 90.9% at 12 months (95% CI 83.3–98.5%). Minor adverse events included superficial skin pigmentation (8 patients, 14.3%), localised tenderness (6 patients, 10.7%), and transient bruising (11 patients, 19.6%); all resolved without specific intervention. No deep vein thrombosis, pulmonary embolism, or neurological complications were observed. Conclusions: Aspiration-assisted catheter-directed foam sclerotherapy using the Sclerosafe device demonstrated promising safety and anatomical efficacy for the treatment of anterior saphenous vein insufficiency, with a 12-month Kaplan–Meier occlusion estimate of 90.9%, without tumescent anaesthesia and in a fully outpatient setting. In the absence of a control group and clinical outcome measures, the technique cannot be presented as an established alternative to thermal or non-thermal ablation, but it may be a technically attractive option in patients with clinical CEAP class C2–C4 disease. Prospective comparative studies are warranted to confirm these findings.