The prospective multicenter study assessing safety and efficacy of mechano-chemical ablation with the use of the Flebogrif catheter in patients with Great Saphenous Vein incompetence: one year results

OBJECTIVE: Endovenous thermal ablation is recommended as the primary method of managing symptomatic truncal venous reflux. One of the important alternatives to the thermal energy-based methods is mechanochemical ablation; however, its performance and outcomes can significantly differ in relation to the applied technology and sclerosing agent formula. The aim of the study was to prove the safety and efficacy of the nonrotational mechanochemical ablation with polidocanol foam performed by Flebogrif catheter. The study presents 1-year follow-up results. METHODS: The POLFLEB study was a prospective, multicenter clinical trial assessing the safety, efficacy, and feasibility of the Flebogrif catheter (Balton) in a population of patients with incompetent great saphenous vein (GSV; ClinicalTrials.gov NCT04558957). A total of 200 patients were enrolled and treated (GSV diameter, 4-10 mm). In all cases, during nonrotational mechanochemical ablation, 3% polidocanol foam was used, and the patients underwent the clinical and ultrasound-based 12-month follow-up. The primary efficacy end point was the GSV anatomical occlusion rate 3 months after the procedure. The primary safety study end point was the occurrence of serious adverse events up to 30 days after the procedure. According to the study protocol, the additional foam sclerotherapy treatment was allowed 3 months after the initial truncal ablation. RESULTS: The mean length of the treated GSV segment was 43.30 ± 10.30 cm (minimum, 20 cm; maximum, 70 cm), and the mean foam volume used during the procedure was 8.69 ± 2.23 mL (in 87.5% of the treated cases, the foam volume did not exceed 10 mL in total and in 96% of the patients the foam volume not exceeding 12 mL was used). Successful vein obliteration was achieved in all patients, which was confirmed intraoperatively and within 7 days of postoperative ultrasound control. Three months after the treatment, 95.8% of the treated saphenous veins remained without reflux, including 8.9% with partial vein occlusion and no reflux. No serious adverse events were reported within 30 days after the procedure. In the 12-month follow-up, the whole vein reopening was found in 4.4% and 90.6% of the patients; however, no saphenous vein reflux was noticed. CONCLUSIONS: Mechanochemical ablation by Flebogrif catheter represents the safe and clinically effective option for nonthermal saphenous vein ablation. The efficacy of the method should be confirmed in studies with long-term follow-up.