冠状动脉粥样硬化性心脏病患者经皮冠状动脉介入治疗的个性化研究

发布时间：2018-04-24 20:33

本文选题：个性化锥形支架 + 冠状动脉　；参考：《首都医科大学》2017年博士论文

【摘要】：目的:目前广泛应用于经皮冠状动脉介入治疗(Percutaneous Coronary Intervention,PCI)中的支架是传统柱形支架,其管腔直径由近端到远端保持一致,不符合冠状动脉管腔由近到远逐渐变细的生理情况,因此置入传统柱形支架后会存在近端血管贴壁不良或远端血管过度膨胀等情况,容易发生支架血栓和支架内再狭窄,导致心血管不良事件发生。个性化锥形支架作为一种新型专利,其管腔自近端至远端逐渐变细,与生理冠状动脉的管腔变化一致,更符合生理情况。因此,从形态学上个性化锥形支架更加贴近于冠状动脉正常血管,但是其置入冠状动脉后对血管血流动力学的影响并不清楚,本研究拟通过电脑模拟建立冠状动脉狭窄模型,并模拟置入传统柱形支架和锥形支架,通过计算血流动力学的相关参数,包括血流储备分数(Fractional Flow Reserve,FFR)、血液流速及分布(Blood flow Velocity Distribution,BVD)和血管壁剪切力(Wall Shear Stress,WSS),对比两者在置入后对冠状动脉血流动力学的影响,以验证个性化锥形支架置入冠状动脉的效果。方法:利用3D冠状动脉实体建模软件(Solidworks software)建立冠状动脉模型,并在模型的基础上制造出80%的偏心、局限性狭窄,狭窄成分为脂质和钙化的混合斑块,同时建立与管腔尺寸相对应的传统柱形支架和个性化锥形支架模型,并置入狭窄管腔。将建立好的所有模型导入专业计算机血流动力学模拟软件(ansysicem-cfd),在进行网格划分,设定边界条件及相关参数后,进行血流动力学计算,计算完成后,将结果保存并进行后处理分析。血流动力学评价指标包括血管壁剪切力、血液流速及分布和血流储备分数,通过上述指标对比冠状动脉置入传统柱形支架和个性化锥形支架后对血管血流动力学的影响。结果:1.无论是置入传统柱形支架还是置入个性化锥形支架,血流动力学的相关参数包括ffr、bvd及wss都得到了改善,证明两种支架对于改善冠状动脉血流动力学状态均是有效的;2.冠状动脉置入锥形支架后,ffr明显改善,并且从支架近端到支架远端,ffr的改变更加平缓均匀,更顺应生理结构;3.冠状动脉置入个性化锥形支架后,bvd更顺应生理结构,血液流速较快且均匀,未见明显的血流停滞区,也未见明显的血流方向改变;4.冠状动脉置入个性化锥形支架后,wss平缓升高,过度均匀,更顺应生理结构,可有效避免斑块的沉积及破裂。结论:相比于传统柱形支架,个性化锥形支架应用于冠状动脉后可以改善冠状动脉支架置入后的血流动力学状态,使其更贴近冠状动脉的生理状态,这种血流动力学的改善可能会降低支架置入后支架血栓和支架内再狭窄的发生率,因此可能更适合应用于pci治疗。目的:在行经皮冠状动脉介入治疗(Percutaneous Coronary Intervention,PCI)进行血运重建的冠心病患者中,约25%的患者合并糖尿病。糖尿病是冠心病的等危症,糖尿病患者的冠心病患病率是普通人群的2-4倍,并且早发。冠心病合并糖尿病的患者冠脉造影结果多支病变、弥漫病变多、复杂病变发生率高,狭窄程度重。因此,此类患者在行介入治疗时,是否进行完全血运重建,血运重建到何种程度仍是困扰临床医生的一大难题。本研究通过一种新的计算方式:计算SYNTAX血运重建指数(SYNTAX Revascularization Index,SRI)来评估血运重建程度对冠心病合并糖尿病患者临床预后的影响。通过分析高龄冠心病合并糖尿病患者血运重建程度情况,明确血运重建程度对高龄冠心病合并糖尿病患者临床预后的影响,找到临床最佳血运重建程度的截点,为临床合理的不完全性血运重建提供依据。对于不同的病人,采取不同程度的血运重建,对于减少心血管的发生有重要意义。方法:本研究是一项单中心、大样本的回顾性研究,严格按照研究设计的入选与排除标准,最终纳入2012年1月至2013年12月期间于首都医科大学附属北京安贞医院接受PCI手术的70岁以上冠心病合并糖尿病患者共计1055名,根据患者血运重建程度的不同分为完全性血运重建组和不完全性血运重建组,不完全性血运重建组根据血运重建程度的不同再细分为血运重建程度在50-99%组以及血运重建程度在50%以下组,血运重建程度根据SRI计算而来,完全性血运重建组计为SRI 100%组,不完全性血运重建组依据血运重建程度分为SRI 50-99%组及SRI50%组。观察三组患者随访2年时患者心血管事件的发生情况,包括主要不良心血管事件(Major Adverse Cardiovascular Events,MACE)、心绞痛、死亡、心血管死亡、心肌梗死、非计划血运重建以及血栓等。通过统计学分析血运重建程度对高龄冠心病合并糖尿病患者临床预后的影响,并根据ROC曲线(受试者工作特征Receiver Operating Characterisitics)计算约登指数(Youden index),进而找到临床最佳血运重建程度的截点。所有数据以均值±标准差(Mean±SD)表示,组间比较采用t检验或非参数检验。计数资料采用χ2检验。P0.05为差异有显著统计学意义。全部数据采用SPSS 20.0统计软件进行统计学分析。结果:三组患者的基线资料分析结果显示:与完全性血运重建组相比,不完全性血运重建组患者的年龄更大,且差异有明显统计学意义,左室射血分数偏低,但差异无明显统计统计学意义,其余基线资料无明显统计学差异。常规药物治疗情况、手术情况等均无明显统计学差异。三组患者随访2年的心血管事件发生情况中:MACE事件的发生率分别为12.6%、19.5%和28.5%,组间比较有明显统计学差异(P0.001),并且两两比较也有明显的统计学差异;心绞痛的发生率分别为26.4%、36.7%和54.7%,组间比较有明显统计学差异(P0.001),并且两两比较也有明显的统计学差异;死亡、心血管死亡以及心肌梗死的发生率上,组间比较有统计学差异(P值分别为0.040、0.038和0.025),两两比较后发现这种差异主要源于SRI 100%组和SRI50%组,两组间差异有明显统计学(P值分别为0.014、0.016和0.009);非计划血运重建的发生率上,组间比较有统计学差异(P0.001),两两比较后发现这种差异主要源于SRI 100%组和SRI50%组以及SRI50%组和SRI 50%-99%组,两组间差异有明显统计学(P值分别为0.001和0.031);在支架内血栓的发生率上,三组患者间没有明显的统计学差异(P=0.809)。Logistic回归分析结果提示SRI是高龄冠心病合并糖尿病患者介入治疗术后发生2年MACE事件的保护因素,其中合理的SRI可以使2年MACE事件的发生风险降低64%(p0.010)。ROC曲线显示SRI的ROC曲线下面积为0.65,95%的可信区间为(0.57-0.72),其中其最大约登指数为0.291,对应的SRI值为65%,即血运重建程度的最佳截点值为65%。结论:对于高龄冠心病合并糖尿病的患者而言,进行完全性血运重建患者随访2年的心血管事件(包括MACE、心绞痛、死亡、心源性死亡、心肌梗死、非计划血运重建)更低,血运重建程度(SRI)是高龄冠心病合并糖尿病患者介入治疗术后发生2年MACE事件的保护因素,其中合理的SRI可以使2年MACE事件的发生风险降低64%。SRI的最佳截点值为65%,提示对于不能进行完全性血运重建的高龄冠心病合并糖尿病患者,进行不完全性血运重建时应尽可能使血运重建程度达到65%以上,以降低长期随访的死亡率。
[Abstract]:Objective: the scaffolding, widely used in Percutaneous Coronary Intervention (PCI), is a traditional columnar stent. The diameter of the lumen is consistent from the proximal to the distal, and does not conform to the physiological condition of the coronary artery from the near to the far. Stent thrombosis and stent restenosis may lead to cardiovascular adverse events. As a new patent, the individualized conical stent is gradually finer from the proximal to the distal, which is consistent with the physiological coronary artery cavity and is more in line with the physiological condition. Therefore, from the morphology, the morphology is more consistent with the physiologic condition. The individualized conical stent is more close to the normal blood vessels of the coronary artery, but the influence of the coronary artery on the hemodynamics is not clear. This study is to establish the coronary artery stenosis model by computer simulation and simulate the implantation of the traditional cylindrical stent and conical stent. The parameters of hemodynamics are calculated, including the parameters of hemodynamics. Blood flow reserve score (Fractional Flow Reserve, FFR), blood flow velocity and distribution (Blood flow Velocity Distribution, BVD) and vascular wall shear force (Wall Shear Stress), to compare the effects of both on coronary artery hemodynamics after implantation in order to verify the effect of the individualized conical stent implantation in the coronary artery. The Solidworks software (pulse entity modeling software) establishes the coronary artery model, and based on the model, it produces 80% eccentricity, limited narrow, narrow composition of the mixed plaques of lipid and calcification. At the same time, the traditional columnar scaffold and the individualized conical stent model corresponding to the size of the lumen are set up, which will be set up into the narrow cavity. All models were introduced into professional computer hemodynamic simulation software (ansysicem-cfd). After dividing the grid, setting boundary conditions and related parameters, the hemodynamic calculation was carried out. After the calculation was completed, the results were saved and analyzed. The hemodynamic evaluation index included the shear force of blood vessel wall, blood flow velocity and distribution. Blood flow reserve scores were used to compare the effects of coronary artery stents and individualized conical stents on vascular hemodynamics. Results: 1. the parameters of hemodynamics including FFR, BVD and WSS were improved, and two branches were proved. The frame was effective for improving the hemodynamic state of the coronary artery. 2. after the coronary artery was inserted into the conical stent, the FFR was obviously improved, and the change of FFR was more smooth and uniform from the proximal end of the stent to the distal end of the stent. 3. after the coronary artery was put into the individualized conical stent, the BVD was more responsive to the physiological structure and the blood flow velocity was faster. There was no obvious stagnation area and no obvious change of blood flow direction. 4. after the coronary artery was put into the individualized conical stent, the WSS was gently elevated, over uniform, more conforming to the physiological structure and effectively avoiding the plaque deposition and rupture. Conclusion: compared to the traditional cylindrical scaffold, the individualized conical scaffold can be applied to the coronary artery. Amelioration of the hemodynamic state of coronary artery stents close to the physiological state of the coronary arteries may reduce the incidence of stent thrombosis and stent restenosis after stent implantation, so it may be more suitable for PCI treatment. Objective: percutaneous coronary intervention (Percutan About 25% of patients with coronary heart disease with eous Coronary Intervention, PCI) are associated with diabetes. Diabetes is a critical disease of coronary heart disease. The prevalence of coronary heart disease in patients with diabetes is 2-4 times that of the general population, and early onset. Coronary heart disease complicated with diabetes mellitus patients with coronary angiography results in multiple lesions, diffuse lesions, complex diseases. The degree of variation is high and the degree of stenosis is heavy. Therefore, the extent of complete revascularization and the degree of revascularization in such patients is still a difficult problem for clinicians. This study uses a new method of calculation: the SYNTAX SYNTAX Revascularization Index (SRI) is used to evaluate the revascularization. The effect of the degree on the clinical prognosis of patients with coronary heart disease combined with diabetes. Through the analysis of the degree of blood transport in patients with elderly coronary heart disease and diabetes, the effect of the degree of blood transport on the clinical prognosis of the elderly patients with coronary heart disease combined with diabetes is determined, and the intercepting point of the best clinical blood revascularization is found, which is a reasonable and incomplete clinical blood. Methods: This study is a single center, a large sample of retrospective study, strictly according to the selection and exclusion criteria of research design, and finally included in the capital of the capital from January 2012 to December 2013. A total of 1055 patients with coronary heart disease and diabetes mellitus above 70 years old received PCI surgery in An Zhen Hospital affiliated to Beijing were divided into complete blood reconstructive group and incomplete revascularization group according to the different degree of blood transport reconstruction. The incomplete revascularization group was subdivided into the degree of blood transport reconstruction according to the degree of blood transport reconstruction to the degree of blood transport reconstruction in 50-99% The degree of blood transport reconstruction was below 50%, and the degree of blood transport reconstruction was calculated according to SRI. The complete revascularization group was group SRI 100%. The incomplete revascularization group was divided into SRI 50-99% group and SRI50% group according to the degree of blood transport reconstruction. The occurrence of cardiovascular events in the three groups of patients was observed during the 2 year follow-up, including the major inconsciences. Vascular events (Major Adverse Cardiovascular Events, MACE), angina, death, cardiovascular death, myocardial infarction, unplanned blood revascularization, and thrombus. The effect of blood revascularization on the clinical prognosis of patients with coronary heart disease and diabetes mellitus was statistically analyzed by the ROC curve (Receiver Operating Ch in the subjects' working characteristics). Aracterisitics) calculated the Youden index, and then found the intercepting point of the best clinical blood revascularization. All data were expressed with mean mean standard deviation (Mean + SD). T test or non parametric test were used among groups. The count data using the chi 2 test of.P0.05 was statistically significant. All data were used in SPSS 20 statistics software Results of statistical analysis. Results: the results of baseline data analysis in the three groups showed that compared with the complete revascularization group, the patients in the incomplete revascularization group were older, and the difference was statistically significant, the left ventricular ejection fraction was low, but the difference was not statistically significant, and there was no significant difference in the rest of the baseline data. Three groups of patients were followed up for 2 years of cardiovascular events: the incidence of MACE events was 12.6%, 19.5% and 28.5%, respectively, and there were significant differences between the groups (P0.001), and 22 were also statistically significant differences; the incidence of angina pectoris was respectively For 26.4%, 36.7% and 54.7%, there was a significant difference between groups (P0.001), and there was a significant difference between 22, and the incidence of death, cardiovascular death and myocardial infarction were statistically different (P value was 0.040,0.038 and 0.025, respectively). 22, after comparison, found that this difference was mainly derived from the SRI 100% and SR In group I50%, there were significant differences between the two groups (P value was 0.014,0.016 and 0.009), and the incidence of non planned blood transport was statistically different (P0.001). 22, the difference was found mainly in SRI 100% and SRI50%, SRI50% group and SRI 50%-99% group, and there was significant difference between the two groups (P value, respectively). For 0.001 and 0.031); in the incidence of stent thrombosis, there was no significant statistical difference between the three groups (P=0.809).Logistic regression analysis suggested that SRI was a protective factor for 2 years of MACE event in patients with elderly coronary heart disease and diabetes after interventional therapy, of which a reasonable SRI could reduce the risk of the occurrence of MACE events of 2 years by 64 The% (p0.010).ROC curve showed that the confidence interval of the ROC curve under the ROC curve of SRI was (0.57-0.72), of which the maximum reduction index was 0.291 and the corresponding SRI value was 65%, that is, the best point of blood revascularization was 65%. conclusion: for patients with elderly coronary heart disease with diabetes, complete blood revascularization was followed up for 2 years. Cardiovascular events (including MACE, angina, death, cardiac death, myocardial infarction, unplanned revascularization), and the degree of blood revascularization (SRI) are the protective factors for the 2 year MACE event in elderly patients with coronary heart disease and diabetes after interventional therapy, of which a reasonable SRI can reduce the risk of the occurrence of the 2 year MACE event to the best part of the 64%.SRI. The point value is 65%. It is suggested that for patients with coronary heart disease and diabetes who can not complete revascularization, incomplete revascularization should be made as far as possible to achieve more than 65% of the revascularization, in order to reduce the mortality of long-term follow-up.

【学位授予单位】：首都医科大学
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R541.4

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