边支导丝“逃逸”技术在分叉病变必要时支架术中的应用研究

发布时间：2018-07-17 02:58

【摘要】：1.背景与目的:冠状动脉分叉病变(coronary bifurcation lesion,CBL)是指冠状动脉狭窄邻近和(或)累及重要边支血管开口的一种病变类型。CBL的经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)约占所有PCI总量的20%,已成为PCI领域中最常见和最具技术挑战的病变之一。多个随机、对照、临床试验(randomized controlled trial,RCT)报道,在主要不良心脏事件(major adverse cardiovascular events,MACE)等方面,双支架术并不比单支架术占优。因此欧洲分叉病变俱乐部(European bifurcation club,EBC)推荐简单、安全、有效的必要时支架术为介入治疗分叉病变时的优选技术。但在使用该技术时,术中因斑块移位或嵴移位导致的重要边支血管闭塞丢失仍是人们关注的重点。必要时支架术中在主支支架释放后若出现1)影像学提示边支残余狭窄仍重75%,或2)TIMI血流3级,需行对吻球囊扩张(kissing balloon inflation,KBI)。而主支支架释放后,送入导丝再穿网眼进入边支血管时,所穿过的网眼越靠近远端血管嵴,覆盖边支开口病变越完全,支架贴壁效果越佳,而越靠近近端血管嵴,覆盖病变不完全,支架可能部分悬挂于主支血管管腔内。然而,精确定位并穿过最远端网眼在仅仅依靠造影的指导下很难完成,在技术上具有相当大的难度和挑战性。本研究评估导丝“逃逸”技术能否有效保证边支导丝精确定位于分叉处血管嵴远端,从而改善边支保护效果。2.方法2.1体外实验2.1.1仿真模型利用人工硅胶血管分叉模型实施导丝“逃逸”技术,首先要求将边支导丝装置于主支支架的金属钢梁和未扩张的球囊之间,主支与分支导丝分别进入主支血管与边支血管管腔,将主支支架沿着边支导丝向着远端血管嵴的方向推送,主支支架到达分叉处开口最远端血管嵴,整个操作过程中边支导丝不需要被囚禁在血管壁和主支支架之间,释放主支支架后进行最终对吻球囊扩张。2.2动物实验观察边支导丝和主支支架钢梁的位置分布,评估导丝“逃逸”技术是否能达到精确定位和覆盖边支开口的效果。2.3安全性测试利用拉伸试验机对使用JET技术处理过的支架进行脱载力测试,观察JET技术是否引起支架扭曲变形和支架脱载力改变。利用扫描电镜观察JET技术处理过的支架是否发生药物涂层等材料剥离受损。2.4人体试验在32例患者实施JET技术,观察术后6个月的MACE发生率情况。3.结果3.1体外实验体外模拟实验结果显示边支导丝可精确定位于分叉处血管嵴远端,球囊扩张后无支架贴壁不良。3.2动物实验结果显示边支导丝可精确定位于远端网眼,支架钢梁贴壁良好。3.3安全性测试JET技术对支架形态、脱载力无明显影响,聚合物材料无明显损伤。3.3.1观察使用JET技术处理过的支架,导丝通过微突的皇冠进入的支架钢梁未见明显扭曲变形.3.3.2 JET技术处理的支架脱载力比制造商提供的最小值更大(6.105±0.73 N vs 5.74N)。3.3.3扫描电镜观察支架整体未见明显的涂层材料损伤。3.4在32个病人中,JET技术成功30例。6个月随访时间内均无主要心脏不良事件发生。4.结论4.1 JET具有一定可行性;4.2 JET技术可在造影条件下达到精确定位边支导丝于远端血管嵴的目的;4.3 JET技术在需要最终对吻球囊扩张时可减少血管嵴处的支架贴壁不良;
[Abstract]:1. background and objective: coronary bifurcation lesion (CBL) is a type of coronary artery interventional therapy (percutaneous coronary intervention, PCI), which refers to a type of coronary artery stenosis (percutaneous coronary intervention, PCI), which is the most common in PCI field. It is a type of coronary artery stenosis (percutaneous coronary intervention, PCI). One of the most technical challenges. Multiple random, controlled, clinical trials (randomized controlled trial, RCT) reported that double stenting is no better than single stenting in the major adverse cardiac events (major adverse cardiovascular events, MACE). Therefore, the European bifurcated disease Club (European bifurcation Club) is recommended. Simple, safe, and effective stent placement is the preferred technique for interventional treatment of bifurcated lesions. However, in the use of this technique, the loss of important peripheral vascular occlusion caused by plaque displacement or ridge displacement is still the focus of attention. The narrow still weighs 75%, or 2) TIMI blood flow 3, and needs to dilate the balloon (kissing balloon inflation, KBI). And when the main support is released, the mesh is closer to the distal vascular crest when it is sent into the guide wire and reticulated eyes. The more complete the edge branch opening is, the better the stent adherence effect, and the closer to the proximal vascular crest, covering the disease. The stent may be partially suspended in the main vascular cavity. However, it is difficult and challenging technically to locate and pass through the most distal reticulated eyes only under the guidance of the radiography. At the end of the crista, the protective effect of the side branch is improved by the.2. method 2.1 in vitro 2.1.1 simulation model, using the artificial silica gel branching model to implement the "escape" technique of the guide wire. First, the edge guide wire is placed between the metal steel beam of the main support and the non dilated balloon, and the main branch and the branch guide wire enter the main vessel and the side vessel respectively. In the lumen, the main support was pushed along the edge guide wire to the distal vascular ridge, and the main support reached the most distal vascular crest at the fork. In the whole operation, the edge wire did not need to be imprisoned between the vessel wall and the main support, and the main support was released to the end of the.2.2 animal experiment of the balloon dilation. The position distribution of the steel beam of the main support bracket is used to evaluate the effect of the "escape" technology of the guide wire to the accuracy of positioning and covering the edge of the opening..2.3 safety test by using the tensile test machine to test the deloading force of the support treated with JET technology, and observe whether the JET technology causes the distortion of the bracket and the change of the support load of the support. Scanning electron microscopy (SEM) was used to observe whether the scaffold treated by JET technology had been stripped of drug coating and other materials in.2.4 human test. JET technique was performed in 32 patients. The incidence of MACE was observed at 6 months after operation. Results 3.1 in vitro experiment in vitro showed that the side branch wire could be located at the distal end of the vascular ridge in the fork and balloon dilatation. The results of.3.2 animal experiment without stent placement showed that the edge guide wire could be accurately located in the distal mesh, and the.3.3 safety test of the supporting steel beam adhered to the wall, JET technology had no obvious effect on the shape of the support, and the polymer material had no obvious damage to the.3.3.1 observation with the support of the JET technology, and the guide wire entered the crown through the crown of the micro process. The scaffolding of the stents was not obviously distorted by.3.3.2 JET technology. The stenting force was higher than the manufacturer's minimum value (6.105 + 0.73 N vs 5.74N).3.3.3 scanning electron microscopy (.3.3.3) scanning electron microscopy. There was no obvious coating material damage.3.4 in 32 patients. There was no major heart failure during the successful 30 months of.6 follow-up. The occurrence of.4. conclusion 4.1 JET is feasible. 4.2 JET technique can accurately locate the edge of the distal vascular crest under the condition of contrast, and 4.3 JET technology can reduce the stent placement at the crest at the vascular crest when the balloon dilation is needed.
【学位授予单位】：第三军医大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R54

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