FairEmbo Concept for Postpartum Hemorrhage: Evaluation of the Efficacy of Suture Fragment Compared with Gelatin Sponge Torpedo Embolization in a Post-Gravid Swine Model.

Abstract

Postpartum hemorrhage is the leading cause of maternal mortality in emerging countries. This study aims to evaluate the effectiveness and safety of uterine artery embolization (UAE) using suture fragment (FairEmbo concept) in a swine model. Seven female swine uteri were embolized. The left uterine artery was embolized with 1 cm fragments of absorbable suture (Optime® 0), and with gelatin sponge torpedoes for the contralateral side for comparison. The embolization effectiveness and the time for arterial recanalization with digital subtraction angiography (DSA) controls at D0, D7, and M1, were evaluated. Follow-up protocol also included clinical monitoring and macroscopical analyses at M1. A Mann-Whitney test (significance at P 0.05) was used for statistics. A technical success was obtained for the seven arteries on each side, with no off-target embolization. The procedure time (10 min versus 3.7 min) and number of fragments (13.8 versus 5.7) required for complete occlusion were significantly greater in the FairEmbo group. All arteries were repermeabilized at M1. No necrosis was macroscopically visible at harvest at M1. This experimental study suggests that UAE with SBM FairEmbo method is feasible, safe, and effective in comparison with gelatin sponge procedure.