Bleomycin Polidocanol Foam (BPF) Stability – In Vitro Evidence for the Effectiveness of a Novel Sclerosant for Venous Malformations

Abstract

This study investigated the invitro stability of a novel sclerosant, bleomycin polidocanol foam (BPF), for venous malformation (VM) sclerotherapy. The study was designed with control groups treated with polidocanol (0.5%, 1%, and 3%) only. Theexperimental groups included 21 BPFs, which was made by dissolving bleomycin at seven differentconcentrations (0.1%-1.5%) in polidocanol (0.5%, 1%, and 3%). The Tessari method was used to prepare sclerosant foam with a liquid:gas ratio of 1:4at room temperature invitro. The foam stability was measured for each group. The decay process, one component of foam stability, was recorded with acamera. Foam decay process experiments were performed 10 times per group. The stability indices included drainage rate, drainage time, half life, and microscopic measurement of the foams (mean bubble diameter, minimum and maximum bubble diameters, wall thickness, and bubble diameter distribution). Compared with the control groups, the half lives of BPFs mainly increased significantly with the addition of bleomycin (p<.001). BPF with 3% polidocanol and 0.1% bleomycin recorded the highest half life (246±1.6sec), and this group also achieved the smallest bubble diameter and wall thickness (69.9μm and 5.80μm) among the experimental groups. For the same polidocanol concentration, the bubble diameter and wall thickness increased when bleomycin was added. Bleomycin concentrations account for different BPF stability. BPF stability mainly increased significantly with the addition of a small amount of bleomycin but this advantage was no longer apparent with increasing bleomycin dose.