castor®分支型主动脉覆膜支架系统上市后临床病例分享2017-云顶国际

微创心脉医疗科技（上海）有限公司“castor®分支型主动脉覆膜支架及输送系统”（以下简称“castor®分支型支架”）于2017年6月获得国家食品药品监督管理总局（cfda）颁发的注册证。近日，景在平教授及其团队成功应用castor®分支型支架治疗主动脉夹层一例。

患者男性，76岁，术前cta显示破口虽不明显但紧贴lsa，临床诊断为主动脉夹层。用endosize软件评估后显示，lcca-lsa长度为5mm，lsa锚定区远端有一明显折角。

手术难点：

1. 破口紧贴lsa根部，需要将锚定区延长至lsa近端。

2. lcca与lsa间长度5mm，需要支架精确定位，否则有覆盖lcca的风险。

手术方案：

景教授在充分评估上述手术难点后，决定选用castor®分支型支架，理由如下：

1. castor®分支型支架可以治疗破口紧贴lsa的主动脉夹层，拓展近端锚定区。

2. castor®分支型支架的分支后移长度有5~30mm多种选择，适应不同的血管解剖情况。本例中选择分支后移5mm的规格，即可重建lsa的同时，不影响lcca血流。

手术过程：

首先经股动脉进行术前造影。造影显示，近端锚定区直径29mm，因此选择近端直径30mm，锥度6mm的castor®分支型支架。按照标准操作流程，建立分支导丝通道后，导入castor®输送系统并释放。

术后造影显示，castor®分支型支架定位精准，无移位；支架近端三重小波段密封性能良好，无内漏；lcca和lsa血流均通畅；夹层破口被完全隔绝，手术取得圆满成功。

微创®心脉“castor®分支型主动脉覆膜支架及输送系统”6个月随访结果于2015年1月30日在vascular news上发表。这是全球首个应用于人体的分支支架多中心临床试验。

castor®覆膜支架6个月随访数据证明了该款产品治疗胸主动脉夹层的临床安全性和有效性。临床试验达到了主要临床终点，临床植入技术成功率为98.6％。六个月随访期间无新增分支动脉闭塞；6个月卒中发生率为2/70，与器械无关；有2例与器械相关的不良事件，1例内漏和1例由于夹层远端发展导致的2次介入。

castor®覆膜支架是一款用于腔内治疗近主动脉弓的胸主动脉夹层的分支型支架。castor®覆膜支架用于完全腔内治疗累及左锁骨下动脉，或破口与左锁骨下动脉距离<15mm的胸主动脉夹层。主体加分支的一体式设计能够安全有效地治疗累及弓部的夹层患者，微创安全、手术效果更好。

景在平教授表示：“castor®分支型支架的设计理念在全球都是领先的，这款产品使临床医生可以运用完全腔内的技术，通过一款覆膜支架来修复累及主动脉弓部区域的夹层，同时维持弓上分支动脉的自然血运。”

以下为在vascular news上发表的原文：

microport® reports six-month follow-up data of castor® branched aortic stent graft system

fri jan 30

data from a clinical trial assessing the safety and efficacy of the castor® branched aortic stent-graft system for the treatment of thoracic dissection has been released by microport®, the device’s manufacturer.

thoracic aortic dissections often involve or lie in close proximity to the left subclavian artery. in order to seek relatively healthy and sufficient landing zone, the left subclavian artery ostium is often covered during tevar with or without concomitant subclavian artery revascularisation. however, subclavian occlusion can cause hand and upper limb ischaemia, subclavian steal syndrome, and spinal cord ischaemia. although it is possible to preserve the left subclavian artery through hybrid technique, chimney technique, or fenestration, all these methods have inherent deficiencies especially endoleak, chiminey graft occlusion, device kink, etc. therefore, an easy-to-use unibody branched stent graft has become key to solve these clinical issues, the company says.

according to microport®, castor® is designed for an entirely endovascular treatment of thoracic dissection encroaching the left subclavian artery or the original tear located within 15mm distal to the left subclavian artery. castor® employs an easy-to-use unibody design, including a main body and a left subclavian branch graft to avoid type iii endoleaks. zhonghua li, vice president of microport® endovascular, said: “the key design of castor is how to safely and accurately place the branch stent in the target artery, which is ensured by a unique two-layer out-sheath design and wire release mechanism. adjustment of the direction of the stent graft can be performed accurately and safely under the protection of two middle soft sheaths for main body and branched stent grafts. a full deployment of the stent graft is conducted through a safe wire release mechanism.

six-month data of the castor® trial from 73 patients demonstrate safety and efficacy of the branched aortic stent graft system for the treatment of thoracic dissections. conducted at 11 centres in china, the trial met its primary efficacy endpoint by achieving 98.6% technical success with two occlusions of the left subclavian artery for operational reasons. no further branch artery occlusions were observed during six-month follow-up. the six-month stroke rate is 2/70, which was not device related. there are two device-related severe adverse events, including one endoleaks and one reintervention due to distal development of the dissection. the dissection-related mortality rate was 2/73, and the all-cause mortality was 4/73.

zaiping jing, chief of vascular surgery department of the 2nd military medical university-changhai hospital, served as the national principal investigator for the castor® trial, and qingsheng lu, from the same hospital, worked as a major operator for castor® trial. they said: “the castor® system is the leading product around the world which allows physicians to safely treat aortic aneurysms or dissections near the aortic arch while maintaining blood flow to all branch vessels using an entirely endovascular approach.”