Abstract 9613: Short- and Long-Term Vascular Responses of Stent With Biodegradable Graft for Artery Dissection in Rabbit Iliac Model

Abstract

Introduction: Arterial dissection or rupture during percutaneous angioplasty is rare but can be lethal. We invented a balloon-expandable stent with a very thin membrane typed biodegradable graft for the treatment of arterial dissection (BioGard). Hypothesis: The efficacy and safety of BioGard were evaluated in the rabbit iliac artery rupture model. The devices would be helpful to seal the emergent blood extravasation due to arterial perforation and reduce unfavorable vascular events in long-term follow-up. Method: Twenty iliac arterial dissections by balloon over-inflation were induced under the guidance of angiography. Twelve rabbits with huge contrast extravasation to retroperitoneal space (Ellis type 3) were treated using BioGards. Serial histologic examinations and micro-computed tomography (CT) were performed at 1, 2, and 8 weeks and 3, 6, 9, and 12 months. Final angiography at 1 year was performed to evaluate any vascular complication. Results: There are no significant adverse cardiovascular events after one year of BioGard implantation. Micro-CT and follow-up angiography at one year revealed no case of significant in-stent restenosis and thrombotic occlusion in vivo. Early-stage histologic examination demonstrated that disrupted vessels were completely sealed up by BioGard with mural hematoma, inflammatory cell infiltration, and red thrombi. Mid- and long-term histologic examination revealed patent stents and neointimal coverage over the stents with biodegraded graft material and mild peri-strut area inflammatory response. Conclusions: Twelve months post-BioGard implantation in rabbit iliac artery dissections demonstrated good efficacy and safety. BioGard at a severely dissected artery would be an option for preventing lethal vascular events. Further clinical evaluation of this novel technology would be warranted.