Preclinical Evaluation of a Non-Customized Modular Inner Branched Stent Graft for Total Endovascular Aortic Arch Repair in a Porcine Model.

OBJECTIVES

The aim of this study was to evaluate the feasibility and safety of a non-customized modular inner branched stent graft for total endovascular aortic arch repair in a porcine model.

METHODS

The modular inner branched stent graft system with a split main body design included 1 proximal main component, 1 distal main component, and 1 branched covered stent. The gutter in the proximal main component was sealed with sutured membrane. Fatigue testing was performed to evaluate the durability of the stent graft. Fifteen pigs were used in this study. In each pig, a stent graft was delivered and deployed to the aortic arch through the femoral arterial access and right carotid arterial access. Angiography and computed tomography angiography were used to evaluate the morphological features before euthanasia. After euthanasia, the implanted device, surrounding tissue, and major organs were harvested for gross and histological examination.

RESULTS

There were no collapses and no stent graft fractures detected after fatigue testing. The technical success rate was 14/15, and the incidence of major adverse cardiovascular events was 2/15. Angiography performed at the end of follow-up revealed no endoleaks and no device migration. Histological examination demonstrated excellent biocompatibility of the stent graft.

CONCLUSIONS

The non-customized modular inner branched stent graft system is safe and feasible for the endovascular reconstruction of the aortic arch in a porcine model.