Abstract
目的
为保留主动脉弓上分支动脉，对主动脉弓部病变进行开窗的胸主动脉腔内修复术(thoracic endovascular aortic repair，TEVAR)即开窗TEVAR(fenestrated-TEVAR，f-TEVAR)，其中最常用的是体外开窗和原位开窗技术。然而这两种技术均改变了支架的物理结构，可能影响支架的远期稳定性。笔者所在的团队设计了一款可调节预开窗主动脉覆膜支架并获得了专利。本研究旨在通过动物实验证明这款支架的可行性和安全性，为其临床应用提供前期数据。
方法
对8只健康的拉布拉多犬行可调节预开窗主动脉覆膜支架的腔内植入术和主动脉弓部的开窗操作，植入支架前后分别行数字减影血管造影，评价手术是否成功。术后将8只实验犬分为4周组(饲养4周组)和12周组(饲养12周组)。处死前1天行主动脉计算机体层摄影血管造影(computed tomography angiography，CTA)检查。
结果
手术成功率为100%。术中无大出血发生，无开窗无法释放事件发生。开窗位置移动平滑，支架退出均顺利。4周和12周的主动脉CTA复查结果提示支架无移位。所有弓上动脉均保持通畅。
结论
使用可调节预开窗主动脉覆膜支架在犬类主动脉植入模型中具有良好的可行性和安全性。本研究为该款支架的进一步优化和涉及主动脉弓部病变的人类f-TEVAR植入提供了参考。
Keywords: 开窗胸主动脉腔内修复术, 可调节预开窗主动脉覆膜支架, 犬, 主动脉弓
Abstract
Objective
To isolate aortic arch pathologies and keep the branches superior in arch patent, it always need physicians to do in-vivo fenestration or in-situ fenestration when performing the thoracic endovascular aortic repair (TEVAR). However, both of those fenestration techniques need structure modification of the stent-graft，which may affect their long-term stability. We designed an adjustable pre-fenestration aortic stent-graft to treat pathologies in this area and obtained a patent branch arteries. This study used this new designed stent-graft to perform fenestrated-TEVAR (f-TEVAR) in canine aorta. This study aims to identify its feasibility and safety through animal experiments, which might provide preliminary data for potential human implantation.
Methods
A total of 8 Labrador Retrievers were underwent f-TEVAR by using the new devices. Digital subtraction angiography was performed before and after f-TEVAR to evaluate the success of the procedures. All the canines were divided into a 4-week group (feeding for 4 weeks after operation) and a 12-week group (feeding for 12 weeks after operation). Computed tomography angiography (CTA) were performed before euthanasia.
Results
The success rate of operation was 100%. During the operation, there was no accident of major bleeding or failure to be released by fenestration. Adjustable fenestration worked well. No stent-graft migration was found in CTA at 4 weeks and 12 weeks after the operation. All branch arteries kept by the adjustable fenestration were patent.
Conclusion
The result of feasibility and safety of the new designed adjustable pre-fenestration aortic stent-graft in f-TEVAR of canine is acceptable. This study provides a reference for further optimization of this stent and human f-TEVAR implantation involving aortic arch lesions.
Keywords: fenestrated-thoracic endovascular aortic repair, adjustable pre-fenestration aortic stent-graft, canine, aortic arch
胸主动脉腔内修复术(thoracic endovascular aortic repair，TEVAR)是近30年来发展的微创主动脉手术。目前，相对于体外循环下开放手术，TEVAR和TEVAR加开放旁路手术(杂交手术)已成为治疗复杂和有并发症的Stanford B型主动脉夹层、降主动脉瘤和降主动脉穿透性溃疡等疾病的优选治疗方式[1-2]。累及主动脉弓部的主动脉病变是TEVAR的难点之一，其难度在于既要有效地隔绝病变(没有内漏的产生)，又要保持弓上重要分支动脉的通畅，从而降低严重的神经系统并发症的发生率。为满足以上要求，目前常用的方法为“开窗技术”，即改造现有支架的结构，为弓上分支动脉的开口在覆膜支架上开一扇“窗”。进行开窗的TEVAR称为开窗TEVAR(fenestrated-TEVAR，f-TEVAR)。开窗技术分为体外开窗技术(physician-modified fenestration，PMF)[3-4]和原位开窗技术[5]。原位开窗技术难度要求大，所需腔内器械、介入材料及各种辅助器械较多，手术时间较长；PMF存在一定程度的开窗与分支血管对位不准的风险；且以上两种开窗方式均改变了支架的物理结构，对支架结构的远期稳定性是否存在影响尚无定论。因此，临床上迫切需要一种已预先开好窗且窗口的大小和位置可以根据患者弓上动脉的实际大小和位置灵活调节的支架。
本研究作者团队申请的国家发明专利——一种预开窗主动脉覆膜支架及其输送系统和使用方法[6](专利号：ZL201710941546.0；授权公告号：CN107550601B)。本研究旨在通过犬为对象的动物实验来检验这款支架的可行性和安全性。
1. 材料与方法
1.1. 材料
支架原型已由湖南埃普特科技有限公司(湖南湘乡)制作(图1)。本动物实验经中南大学湘雅二医院医学伦理委员会批准(审批号：2018伦审第S034号)。8只拉布拉多犬，体重20~35(26.5±2.8) kg，雌雄不限，购自深圳市领先医疗服务有限公司(合格证号：370825210100047374)。
图1.
可调节预开窗支架装置
Figure 1 Adjustable pre-fenestration stent-graft device
A: Pre-fenestration sealed by membrane patch. B: Already-opened fenestration by membrane patch moving distally. C: View from the inner angle of the adjustable pre-fenestration stent-graft. The black arrow shows the initial situation of the fenestration. D: Radiopaque maeker (black arrow) in the tip of the stent-graft. E, F: Stay line at the end of the delivery system loaded in an independent tube. The line is located in a separate pipe in the bracket delivery system to prevent entanglement with other devices.
1.2. 方法
在手术室进行可调节预开窗主动脉覆膜支架的植入手术。手术步骤(图2)：1)仰卧位，妥善固定犬的四肢和头部，全身麻醉气管插管，备皮和消毒一侧腹股沟部皮肤；2)切开犬腹股沟处皮肤，分离暴露一侧股动脉，过带控制，置入5F穿刺鞘；3)使犬全身部分肝素化(2 000 U/kg)后，将5F标记猪尾造影导管(丹麦库克欧洲公司)送至升主动脉行数字减影血管造影(digital subtraction angiography，DSA)；4)更换Lunderquist超硬导丝(丹麦库克欧洲公司)建立导丝轨道；5)退出穿刺鞘，将可调节预开窗主动脉覆膜支架(直径22~26 mm，长度12 cm，锥度4 mm)导入主动脉弓部，在X线透视下观察Tip头端内不透X线标志以确定预开窗位置方向朝向大弯侧；6)后退主动脉支架外鞘，将支架尾端与覆膜片相连的拉线沿支架纵轴向远端方向拉出，根据要保留的弓上分支动脉选择开窗释出的长度；7)确定开窗位置满意后，完全释放支架，退出导送系统；8)行DSA确定支架位置和所保留的弓上分支动脉通畅情况；9)使用6-0 Prolene线缝合动脉，关闭切口。术后将8只实验犬分为4周组(饲养4周组)和12周组(饲养12周组)。处死前1天行主动脉计算机体层摄影血管造影(computed tomography angiography，CTA)检查。所有犬只的信息及手术情况见表1。
图2.
可调节预开窗主动脉覆膜支架用于犬开窗胸主动脉腔内修复术的手术步骤
Figure 2 Surgical procedures of adjustable pre-fenestration aortic stent-graft for fenestrated-thoracic endovascular aortic repair (f-TEVAR) in dogs
A: Digital subtraction angiography (DSA) was performed before f-TEVAR. B: When the stent-graft approaches the aortic arch, DSA was performed again to check the location of the branches. C: Outer sheath was already pulled distally, and the main body of the stent-graft was deployed. Pulling distally of the membrane patch made it move distally. The black arrow shows the radiopaque marker on the membrane patch at its initial site. D: Radiopaque marker (black arrow) on the membrane patch at its final site. E: Fenestration location (black arrow) was satisfactory and that the rear-release lock was unlocked; F: DSA after the surgery was completed. Both branches on the aortic arch remained patent (black arrow). The red curve shows the rough location of the fenestration.
表1.
实验动物基本数据及手术信息
Table 1 Basic data and surgical information of experimental animals
| 组别 | 动物编号 | 性别 | 体重/kg | 支架尺寸（近端直径×远端直径×长度)/mm | 输送鞘直径 | 开窗保留分支 |
|---|---|---|---|---|---|---|
| 4周组 | C642 | 雌 | 24.0 | 24×20×140 | 16F | 头臂干动脉+左锁骨下动脉 |
| C646 | 雌 | 27.0 | 26×22×140 | 18F | 左锁骨下动脉 | |
| C649 | 雄 | 23.0 | 22×18×140 | 16F | 头臂干动脉+左锁骨下动脉 | |
| C650 | 雄 | 28.0 | 24×20×140 | 17F | 头臂干动脉+左锁骨下动脉 | |
| 12周组 | C651 | 雌 | 26.0 | 22×18×140 | 16F | 头臂干动脉+左锁骨下动脉 |
| C652 | 雌 | 24.8 | 22×18×140 | 16F | 头臂干动脉+左锁骨下动脉 | |
| C655* | 雌 | 27.4 | 22×18×140 | 16F | 左锁骨下动脉 | |
| C656 | 雄 | 32.0 | 24×20×140 | 17F | 头臂干动脉+左锁骨下动脉 |
*C655犬于术后第5天死于感染。
2. 结 果
手术成功率100%，手术时间45~90(54±32) min；X线暴露时间12~25(16±8) min。术中无大出血、心脑血管事件、逆撕夹层发生。术中支架释放正常，无开窗无法释放事件发生，开窗位置移动平滑，支架导送系统退出均顺利。4周组和12周组均有1只犬为开窗保留1支弓上分支动脉，其余均为开窗保留2支弓上分支动脉。
12周组术后有1只犬死于全身感染，解剖证实为非主动脉相关死亡，总体存活率87.5%。主动脉CTA(图3，4)结果示：存活的7只犬主动脉支架无移位，无近端逆撕夹层和远端支架相关的夹层形成，支架近端和远端未见动脉瘤或假性动脉瘤形成；保留的弓上分支动脉未见夹层形成；未见支架开窗部位或分支动脉处血栓形成；不管是支架跨过整个主动脉弓利用可调节窗孔同时保留2支弓上分支动脉，还是利用可调节窗孔只保留锁骨下动脉，保留的弓上分支动脉均保持通畅。
图3.
术后CTA显示支架开窗位置和通畅的弓上分支动脉
Figure 3 Postoperative CTA shows fenestration position of stent and patency of the suprarcuate branch arteries
A: CTA at 4 weeks after surgery showing the position of the stent at the top of the aortic arch (blue arrow); B: CTA at 4 weeks after surgery showing the patency of the 2 superior arch branches (red and green arrows); C: CTA at 12 weeks after surgery showing the position of the stent at the top of the aortic arch (blue arrow); D: CTA at 12 weeks after surgery showing the patency of the 2 superior arch branches (red and green arrows).
图4.
术后主动脉计算机体层摄影血管造影三维血管重建结果
Figure 4 Three-dimensional vascular reconstruction results of aorta computed tomography angiography after surgery
A: At 4 weeks after surgery, the windows were opened and the 2 branches of the superior arch were preserved at the same time. B: At 4 weeks after surgery, the stent covered part was located behind the brachiocephalic artery opening, and only the subclavian artery was retained by fenestration. C: At 12 weeks after surgery, the 2 branches of the superior arch were preserved by fenestration. D: At 12 weeks after surgery, the stent covered part was located behind the brachiocephalic artery opening, and only the subclavian artery was retained by fenestration.
3. 讨 论
可调节预开窗主动脉覆膜支架是笔者所在研究团队自行设计并拥有专利的用于主动脉弓部病变的新型主动脉支架。该支架的预先开窗设计免除了体外开窗技术将支架部分释放、改造覆膜结构的步骤，也避免了原位开窗技术需要较多腔内器械和操作步骤的弊端，由外层覆膜拉帘沿滑轨向远端移动即可实现开窗大小和位置的调节。如将覆膜起始部分置于头臂干动脉开口远端，将开窗向后拉至左锁骨下动脉远端则可同时保留左颈总动脉和左锁骨下动脉，实现双开窗；如将覆膜支架起始部分置于头臂干动脉开口近端，则可利用同一入路通过窗孔可超选进入弓上动脉建立轨道并置入分支支架[7]。该支架的优点在于无需在术中对支架进行改造，避免了改造支架结构带来的潜在风险；窗孔大小和位置可调节，可在保留弓上分支动脉的基础上尽量减小开窗面积，以防止内漏的发生。
覆膜支架上预设有长窗口，窗的轴向两侧有支撑架，确保窗口边缘贴壁，避免窗口边缘内漏。窗口的4个顶点有不透X线的铂金标记，用于显示窗口位置。支撑架外侧有导轨，导轨位于金属支架与覆膜之间。窗口设有可沿导轨轴向移动的覆膜片，可移动覆膜片宽度大于预设窗口宽度，利用金属支架支撑和血管壁压缩使移动覆膜片与支架覆膜形成相对闭合状态，阻止窗口内漏。移动覆膜片两边各有一排小孔，用于穿在导轨上。可移动覆膜片近端有不透X线的铂金标记，用于移动覆膜片近端位置。可移动覆膜片远端有V型架，用于联合输送系统调节窗口大小，避免调节时发生覆膜破损及严重褶皱。可移动覆膜片的V型架底与调节线通过芯丝拴住固定。在后拉调节线时会带动可移动覆膜往后移动。调整到位后，后撤芯丝实现V型架底与调节线的解脱。虽然这种预先开窗可能无法杜绝内漏的发生，但其与带有预防内漏装置的分支支架配合使用可进一步降低内漏的风险。
本研究显示手术存活率为87.5%。1例于术后第4天死亡。经解剖后证实与植入的主动脉支架无关，且为非主动脉相关的死亡。死亡原因考虑为术后感染。其余7只犬的主动脉弓部植入支架后所保留的弓上分支动脉通畅率为100%。这证明了该款支架在运用于主动脉弓部时，保留了弓上分支动脉的灵活性。与已有的用于主动脉弓部的三开窗支架相比可能具有更好的选择性[8-10]。术后第4和12周的CTA检查结果均显示保留的弓上分支动脉保持通畅。存活的犬亦没有发生开窗处慢性血栓引起的脑血管事件，与其他犬类弓部支架的动物实验[11-13]一致。支架在经过犬类比较陡峭的主动脉弓时表现良好，未发生支架引起的主动脉破裂事件，亦没有在释放和回撤过程损伤入路血管。总体而言，支架具有良好的安全性能。
本研究显示支架具有良好的可操控性，具体表现在以下5个方面：1)支架顺应性好，犬类的主动脉弓的角度比人类陡峭，接近人类的3型主动脉弓[14]。在人类TEVAR中，这类主动脉弓的治疗往往伴随较大的手术难度和较高的并发症发生率[15]。本研究的8只实验犬的支架近端都锚定在Zone 0。支架整体在过弓的过程中表现出良好的顺应性，仅有1只犬因升主-主动脉弓角度太大，尝试多次后考虑风险极大，因此将外鞘部分释放，使外鞘过度弯曲导致的巨大摩擦力减小，最后成功通过主动脉弓。这表明即使在极限角度的主动脉弓中，这款支架仍能被成功释放。2)不透X线标记指向准确。TEVAR开窗手术的成功离不开支架上的不透X线标志的指引。其指引方向必须与窗孔位置的方向一致，才能保证支架释放后窗孔对准弓上动脉。这款支架的不透X线标记是安装在Tip头上，从支架的镍钛合金丝上“抽离”出来。这样可以减少标记与镍钛合金丝的干扰。标记呈纵向长条形时，其向头侧的方向即为窗孔的方向。本研究依据标记释放支架后，支架的窗孔位置均位于大弯侧。这也证实了该标记指引方式的可靠性。3)开窗调节过程中的显影准确。该支架的核心部件是可调节覆膜中部不透X线标记，在支架向后退的过程中可根据该标识清晰地看到可调节覆膜移动到了什么位置，留出了多大的纵向窗孔空间。4)拉线稳定。可调节覆膜尾端有移动拉线，在手术过程中通过手柄处的拉线将可调节覆膜拉向远端释放预开窗孔。8例手术中拉线均可稳定地向后拉动大弯侧的可调节覆膜。即使是在犬类陡峭的主动脉弓内，支架弯曲度很大的情况下，拉线也能保持稳定工作，且不会与手柄中的其他部件发生缠绕现象。5)所保留的弓上分支动脉在4周和12周随访中均保持通畅，分支动脉内无血栓和夹层的形成。该支架在大弯侧设计了比较大的预开窗孔，而实际开窗面积则可以通过调节活动的覆膜片灵活决定。因此在人类主动脉弓部使用中完全可以考虑应用到升主动脉的病变中[16-18]。而在应对弓部分支动脉位置变异的情况下，灵活的开窗位置选择则可能更有优势[19-20]。
该款支架的设计初衷是为了方便开窗，并使开窗支架实现立即投入使用[21]，普遍适用于各种主动脉弓部病变。通过此次犬类动物的植入手术研究，笔者发现该支架还存在需要完善的方面：1)开窗周围的防内漏设计应更加完善。内漏是所有TEVAR都要防止的并发症，尤其在应用开窗技术的TEVAR中更容易产生。该款支架没有在开窗孔周围进一步设计防止内漏的装置，主要是因为考虑到现在已存在有专用于开窗分支支架的防止内漏装置(裙边支架)[22-23]。本款开窗支架对准分支动脉开口后再结合裙边支架可起到一定的防止内漏的作用。当然如果能够在开窗周边的主动脉支架外层再进一步行防内漏装置的设计则可能进一步降低内漏发生率，这也是后期可以改进的地方。2)本研究未涉及动物累计主动脉弓部病变的主动脉夹层或动脉瘤疾病模型[24-25]。本研究只检验了支架的开窗可行性和手术安全性，对其隔绝病变如主动脉夹层或动脉瘤的有效性的验证作用不足。
新型可调节预开窗主动脉覆膜支架在犬类保留弓上分支动脉的f-TEVAR中的可行性和安全性令人满意。该支架术中进行开窗位置调节操作平顺，术后支架结构稳定。预开窗所保留的弓上分支动脉的近期通畅率较为理想。本动物实验所获得的数据为该款支架的进一步优化和涉及主动脉弓部病变的人类f-TEVAR植入提供了参考。
基金资助
湖南省杰出青年基金(2020JJ2054)。
This work was supported by the Fund for Distinguished Young Scholars of Hunan Province, China (2020JJ2054).
利益冲突声明
作者声称无任何利益冲突。
作者贡献
李鑫 论文设计与撰写，动物实验；张雷 动物实验，论文修改；郭鹏程 论文修改；舒畅 实验指导，论文修改。全体作者阅读并同意最终的文本。
原文网址
http://xbyxb.csu.edu.cn/xbwk/fileup/PDF/2022091227.pdf
参考文献
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