The prospective multicenter study assessing safety and efficacy of mechanochemical ablation with the use of the Flebogrif catheter in patients with great saphenous vein incompetence: One year results.
Tomasz Zubilewicz, Tomasz Urbanek, Dariusz Janczak et al.
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In 30 seconds
The POLFLEB study was a prospective, multicenter clinical trial of Flebogrif mechanochemical ablation using 3% polidocanol foam in 200 patients with incompetent great saphenous veins measuring 4–10 mm. At 12 months, whole-vein reopening was reported in 4.4%; 90.6% of patients had no saphenous vein reflux. No serious adverse events occurred within 30 days. The findings support short-term safety and clinical efficacy, while the authors note that longer-term studies are needed to confirm durability.
Key findings
- At 3 months, 95.8% of treated veins remained without reflux, including 8.9% with partial occlusion and no reflux.
- At 12 months, whole-vein reopening was found in 4.4%; 90.6% of patients had no saphenous vein reflux.
- No serious adverse events were reported within 30 days after the procedure.
Why it matters
Mechanochemical ablation offers a nonthermal approach to treating great saphenous vein incompetence. These multicenter results provide evidence of maintained reflux control for one year and a low reported rate of serious early adverse events, outcomes relevant when considering nonthermal options. The findings also underscore that anatomical reopening and reflux are distinct outcomes.
What to keep in mind
Follow-up was limited to 12 months, and the authors state that longer-term studies are needed to confirm efficacy.