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

## TL;DR

This study tested a new stent graft system for aortic arch repair in pigs and found it to be safe and effective.

## Contribution

The study introduces a novel double-branched stent graft with four-stage deployment for aortic arch repair.

## Key findings

- The stent graft had a 100% technical success rate in 12 pigs.
- No endoleaks or device migration were observed during follow-up.
- Pathological analysis confirmed good biocompatibility of the graft.

## Abstract

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.

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). Postimplantation, samples were collected at 90 and 180 days after the operations. Preoperative and postoperative imaging and intraoperative arterial blood gas analyses were performed. After the pigs were euthanized, the implanted product, surrounding tissue and major organs were collected for pathological analysis.

The technical success rate of the stent graft implants 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 period revealed neither endoleak nor device migration. No major adverse cardiovascular events were observed during the postoperative follow-up period. Pathological examinations confirmed the satisfactory biocompatibility of the stent graft.

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.

Aortic diseases, particularly type A acute aortic dissection, are recognized as life-threatening cardiovascular emergencies.