Double-branched stent graft and four-stage deployment in total arch repair: safety and feasibility evaluation in porcine models.

OBJECTIVES: The primary objective of this research was to evaluate the safety and feasibility of an innovative double-branched stent graft system employing four-stage deployment technology for aortic arch repair in porcine models.

METHODS: The double-branched stent graft system consisted of a proximal polyester artificial blood vessel, the main and double-branched stent grafts, and a delivery system. We utilized 12 healthy pigs as experimental animals (6 per group) in this study. Post-implantation, samples were collected at 90 and 180 days of follow-up. Preoperative, postoperative imaging, and intraoperative arterial blood gas analyses were performed. After euthanasia, the implanted product, surrounding tissue, and major organs were collected for pathological analysis.

RESULTS: The technical success rate of stent graft implantation was 100% (12/12). All animals survived to the experimental end-point. Perioperative assessments showed intact stent grafts, and imaging features at the end of the follow-up revealed neither endoleak nor device migration. No major adverse cardiovascular events were observed in the postoperative follow-up. Pathological examination confirmed satisfactory biocompatibility of the stent graft.

CONCLUSIONS: This innovative double-branched stent graft system with four-stage deployment technology was affirmed as a safe and feasible option for aortic arch repair in accordance with our preclinical evaluation with porcine models.