Novel Biomatrix Sclerofoam: Equal to or Better Than Thermo-Occlusion?

Abstract

Common sclerofoams (Cabrera type, including Varithena [BTG International, West Conshohocken, Pa) are inferior to thermo-occlusion in regard to primary and long-term results. Such foams are of low viscosity and stability; they will collapse within 60 to 240 seconds and rapidly loose effect. With increasing vein diameters, common foams will displace blood less but float on it with zones of uncertain effects. A novel viscous microfoam using a biomatrix based on denatured autologous blood proteins with an in vitro half-life of >60 minutes and fast disintegration within flowing blood was evaluated in the great saphenous vein (GSV) using a safety setting to prevent foam migration through the junction. There were 120 patients (78 women, 42 men; 32-81 years) with GSV insufficiency (diameter, 6-24 mm; mean, 10.3 mm) who were randomized to two modalities of treatment: A, junction closure by endovenous laser (EVL) in coaxial perivenous anesthesia (EVL 810 nm, ball tip, or 1470 nm, slim/radial; segment length, 3-20 cm), combined with catheter sclerofoam (biomatrix sclerofoam [BSF], 1% Aethoxysklerol; segment length, 28-35 cm; n = 60), for the segment below; and B, EVL alone for comparison (treated segment length, 38-55 cm; n = 60). Both modalities used the same polytetrafluoroethylene vein catheter (PhleboCath 2.3 mm, over the wire). BSF was deployed during catheter withdrawal. Postinterventional examinations with ultrasound were performed after 2 weeks and at 2, 6, and 12 months by independent investigators. Initial vein occlusion was obtained in all cases (120/120). There were no adverse events, in particular no thoracic or cerebral symptoms in the group receiving BSF. The patterns of echogenicity were similar in both groups at all presentations. Vein diameter regression and mild postinterventional symptoms were similar for EVL and BSF. Concerning group A, the investigators were not able to discriminate any borderline of the methods (Fig). During 1-year follow-up, junction segments showed reperfusion in 2 of 60 cases (A, 3.33%) and 1 of 60 cases (B, 1.6%). The thigh-to-knee segments, representing the closure quality of each method, showed reperfusion in 5 of 60 cases (8.33%) after BSF and in 6 of 60 cases (10%) after EVL alone. BSF seems to provide a quality of vein occlusion similar to that of EVL, apart from the GSV junction segment. BSF is more convenient for patient and physician as no tumescence is required. Studies using BSF also in the junction with temporary or permanent blocking devices (eg, V-block) or hyaluronan vein compression (IntraShape project) will follow.