FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compared with Microspheres.

Abstract

Microspheres are effective embolic agents, especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with suture-based microparticles (SBM) were assessed in a swine model. In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2®) and the contralateral side with Embozene® 900 for comparison. Swine were followed for 3months (M3) to evaluate the effectiveness and the safety of SBM. Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann-Whitney test (significance at P < 0.05) were used for statistics. The average size of SBM was 1002μm (SD = 258). All targets were effectively embolized by SBM with an angiogram defect estimated at 45.6% (95% CI [35.9-55.2]), compared to 40.5% (95% CI [30.6-55.5]) for Embozene® group (P = 0.342). The average duration of SBM embolization procedure was significantly increased compared to Embozene® embolization (1202s versus 222s, P = 0.029). There were no statistical differences in M3 DSA and CT for SBM and Embozene®, with persistence of partial arterial occlusion and atrophic embolized area. No postoperative complications were observed on clinical and CT controls. This experimental study suggests that embolization with SBM is feasible, safe and effective in short- and medium-term follow-up as compared to microspheres.