背景:急性A型主动脉夹层(ATAAD)是一种具有高发病率和死亡率的灾难性疾病。虽然开放手术仍是治疗ATAAD的金标准,一些病人,高龄和多种合并症,只能单独接受医疗管理。如今,胸主动脉腔内修复术(TEVAR)为ATAAD患者提供了潜在的治疗选择,但是传统的支架移植物(SGs),不是为ATAAD设计的,不适用于主动脉弓的独特解剖结构。因此,我们创新地创建了桥梁系统(创新医疗,深圳,中国),设计用于治疗ATAAD的完整血管内重建系统。本研究旨在评估新型StanfordA型主动脉夹层完整血管内重建系统在猪模型中的可行性和安全性。
方法:BRIDGE系统由A型支架系统和C型支架系统组成。在2020年11月至2021年3月之间,研究中使用了三只白猪。BRIDGE系统在血管造影引导下通过经导管入路展开。用我们的系统治疗的猪(n=3)在植入后1个月处死前使用血管造影术进行评估,随后进行大体标本评估和收获组织的组织学检查。
结果:急性手术成功率为100%(3/3)。术后即刻血管造影显示A型SGs和C型SGs均部署在满意位置,主动脉上主干通畅,无内漏。30天的累积死亡率为0%,无任何不良事件。血管造影未观察到装置迁移或渗漏,在牺牲之前。粗略的观察证实了A型SG涵盖了anonyma条目的一部分。有利的内皮化,没有血栓形成,在所有猪中通过显微镜检查证实装置周围组织的轻微炎性浸润。
结论:在猪模型中使用StanfordA主动脉夹层完整血管内重建系统实施经导管血管内修复是可行且安全的。有了这个新颖的系统,治疗急性A型主动脉夹层可能更有效和安全。
Acute type A aortic dissection (ATAAD) is a catastrophic disease with high morbidity and mortality. Although open surgery is still the gold standard for the treatment of ATAAD, some patients, with advanced age and multiple comorbidities, can only receive medical management alone. Nowadays, thoracic aortic endovascular repair (TEVAR) provides a potential treatment option for the patient with ATAAD, but traditional stent grafts (SGs), which are not designed for the ATAAD, are inapplicable to the unique anatomy of the aortic arch. Therefore, we innovatively created the BRIDGE system (Chuangxin Medical, Shenzhen,
China), a complete endovascular reconstruction system designed to treat ATAAD. This study aimed to evaluate the feasibility and safety of the novel Stanford A aortic dissection complete endovascular reconstruction system in a porcine model.
The BRIDGE system consists of the type A stent system and the type C stent system. Between November 2020 and March 2021, three white swine were utilized in the study. The BRIDGE system was deployed via the transcatheter approach under angiographic guidance. The swine(n = 3) treated with our system were evaluated using angiography before sacrifice 1-month after implantation, which was followed by gross specimen evaluation and histological examination of harvested tissues.
The acute procedure success rate was 100% (3/3). The immediate post-procedural angiography showed that both type A SGs and type C SGs were deployed in satisfactory locations, with patency of the supra-aortic trunk and no endoleak. The cumulative mortality of 30-day was 0% without any adverse events. No device migration or leakage was observed angiographically, before sacrifice. The gross observation confirmed a type A SG covered part of the entry of anonyma. Favorable endothelialization, no thrombogenesis, and slight inflammatory infiltration of the tissues around the device were confirmed by microscopic examinations in all pigs.
It was feasible and secure to use Stanford A aortic dissection complete endovascular reconstruction system to implement a transcatheter endovascular repair in a porcine model. With this novel system, treating acute type A aortic dissection may be more efficient and secure in human.