冠狀動脈粥樣硬化性心臟病患者經(jīng)皮冠狀動脈介入治療的個性化研究
本文選題:個性化錐形支架 + 冠狀動脈; 參考:《首都醫(yī)科大學(xué)》2017年博士論文
【摘要】:目的:目前廣泛應(yīng)用于經(jīng)皮冠狀動脈介入治療(Percutaneous Coronary Intervention,PCI)中的支架是傳統(tǒng)柱形支架,其管腔直徑由近端到遠(yuǎn)端保持一致,不符合冠狀動脈管腔由近到遠(yuǎn)逐漸變細(xì)的生理情況,因此置入傳統(tǒng)柱形支架后會存在近端血管貼壁不良或遠(yuǎn)端血管過度膨脹等情況,容易發(fā)生支架血栓和支架內(nèi)再狹窄,導(dǎo)致心血管不良事件發(fā)生。個性化錐形支架作為一種新型專利,其管腔自近端至遠(yuǎn)端逐漸變細(xì),與生理冠狀動脈的管腔變化一致,更符合生理情況。因此,從形態(tài)學(xué)上個性化錐形支架更加貼近于冠狀動脈正常血管,但是其置入冠狀動脈后對血管血流動力學(xué)的影響并不清楚,本研究擬通過電腦模擬建立冠狀動脈狹窄模型,并模擬置入傳統(tǒng)柱形支架和錐形支架,通過計算血流動力學(xué)的相關(guān)參數(shù),包括血流儲備分?jǐn)?shù)(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),對比兩者在置入后對冠狀動脈血流動力學(xué)的影響,以驗(yàn)證個性化錐形支架置入冠狀動脈的效果。方法:利用3D冠狀動脈實(shí)體建模軟件(Solidworks software)建立冠狀動脈模型,并在模型的基礎(chǔ)上制造出80%的偏心、局限性狹窄,狹窄成分為脂質(zhì)和鈣化的混合斑塊,同時建立與管腔尺寸相對應(yīng)的傳統(tǒng)柱形支架和個性化錐形支架模型,并置入狹窄管腔。將建立好的所有模型導(dǎo)入專業(yè)計算機(jī)血流動力學(xué)模擬軟件(ansysicem-cfd),在進(jìn)行網(wǎng)格劃分,設(shè)定邊界條件及相關(guān)參數(shù)后,進(jìn)行血流動力學(xué)計算,計算完成后,將結(jié)果保存并進(jìn)行后處理分析。血流動力學(xué)評價指標(biāo)包括血管壁剪切力、血液流速及分布和血流儲備分?jǐn)?shù),通過上述指標(biāo)對比冠狀動脈置入傳統(tǒng)柱形支架和個性化錐形支架后對血管血流動力學(xué)的影響。結(jié)果:1.無論是置入傳統(tǒng)柱形支架還是置入個性化錐形支架,血流動力學(xué)的相關(guān)參數(shù)包括ffr、bvd及wss都得到了改善,證明兩種支架對于改善冠狀動脈血流動力學(xué)狀態(tài)均是有效的;2.冠狀動脈置入錐形支架后,ffr明顯改善,并且從支架近端到支架遠(yuǎn)端,ffr的改變更加平緩均勻,更順應(yīng)生理結(jié)構(gòu);3.冠狀動脈置入個性化錐形支架后,bvd更順應(yīng)生理結(jié)構(gòu),血液流速較快且均勻,未見明顯的血流停滯區(qū),也未見明顯的血流方向改變;4.冠狀動脈置入個性化錐形支架后,wss平緩升高,過度均勻,更順應(yīng)生理結(jié)構(gòu),可有效避免斑塊的沉積及破裂。結(jié)論:相比于傳統(tǒng)柱形支架,個性化錐形支架應(yīng)用于冠狀動脈后可以改善冠狀動脈支架置入后的血流動力學(xué)狀態(tài),使其更貼近冠狀動脈的生理狀態(tài),這種血流動力學(xué)的改善可能會降低支架置入后支架血栓和支架內(nèi)再狹窄的發(fā)生率,因此可能更適合應(yīng)用于pci治療。目的:在行經(jīng)皮冠狀動脈介入治療(Percutaneous Coronary Intervention,PCI)進(jìn)行血運(yùn)重建的冠心病患者中,約25%的患者合并糖尿病。糖尿病是冠心病的等危癥,糖尿病患者的冠心病患病率是普通人群的2-4倍,并且早發(fā)。冠心病合并糖尿病的患者冠脈造影結(jié)果多支病變、彌漫病變多、復(fù)雜病變發(fā)生率高,狹窄程度重。因此,此類患者在行介入治療時,是否進(jìn)行完全血運(yùn)重建,血運(yùn)重建到何種程度仍是困擾臨床醫(yī)生的一大難題。本研究通過一種新的計算方式:計算SYNTAX血運(yùn)重建指數(shù)(SYNTAX Revascularization Index,SRI)來評估血運(yùn)重建程度對冠心病合并糖尿病患者臨床預(yù)后的影響。通過分析高齡冠心病合并糖尿病患者血運(yùn)重建程度情況,明確血運(yùn)重建程度對高齡冠心病合并糖尿病患者臨床預(yù)后的影響,找到臨床最佳血運(yùn)重建程度的截點(diǎn),為臨床合理的不完全性血運(yùn)重建提供依據(jù)。對于不同的病人,采取不同程度的血運(yùn)重建,對于減少心血管的發(fā)生有重要意義。方法:本研究是一項(xiàng)單中心、大樣本的回顧性研究,嚴(yán)格按照研究設(shè)計的入選與排除標(biāo)準(zhǔn),最終納入2012年1月至2013年12月期間于首都醫(yī)科大學(xué)附屬北京安貞醫(yī)院接受PCI手術(shù)的70歲以上冠心病合并糖尿病患者共計1055名,根據(jù)患者血運(yùn)重建程度的不同分為完全性血運(yùn)重建組和不完全性血運(yùn)重建組,不完全性血運(yùn)重建組根據(jù)血運(yùn)重建程度的不同再細(xì)分為血運(yùn)重建程度在50-99%組以及血運(yùn)重建程度在50%以下組,血運(yùn)重建程度根據(jù)SRI計算而來,完全性血運(yùn)重建組計為SRI 100%組,不完全性血運(yùn)重建組依據(jù)血運(yùn)重建程度分為SRI 50-99%組及SRI50%組。觀察三組患者隨訪2年時患者心血管事件的發(fā)生情況,包括主要不良心血管事件(Major Adverse Cardiovascular Events,MACE)、心絞痛、死亡、心血管死亡、心肌梗死、非計劃血運(yùn)重建以及血栓等。通過統(tǒng)計學(xué)分析血運(yùn)重建程度對高齡冠心病合并糖尿病患者臨床預(yù)后的影響,并根據(jù)ROC曲線(受試者工作特征Receiver Operating Characterisitics)計算約登指數(shù)(Youden index),進(jìn)而找到臨床最佳血運(yùn)重建程度的截點(diǎn)。所有數(shù)據(jù)以均值±標(biāo)準(zhǔn)差(Mean±SD)表示,組間比較采用t檢驗(yàn)或非參數(shù)檢驗(yàn)。計數(shù)資料采用χ2檢驗(yàn)。P0.05為差異有顯著統(tǒng)計學(xué)意義。全部數(shù)據(jù)采用SPSS 20.0統(tǒng)計軟件進(jìn)行統(tǒng)計學(xué)分析。結(jié)果:三組患者的基線資料分析結(jié)果顯示:與完全性血運(yùn)重建組相比,不完全性血運(yùn)重建組患者的年齡更大,且差異有明顯統(tǒng)計學(xué)意義,左室射血分?jǐn)?shù)偏低,但差異無明顯統(tǒng)計統(tǒng)計學(xué)意義,其余基線資料無明顯統(tǒng)計學(xué)差異。常規(guī)藥物治療情況、手術(shù)情況等均無明顯統(tǒng)計學(xué)差異。三組患者隨訪2年的心血管事件發(fā)生情況中:MACE事件的發(fā)生率分別為12.6%、19.5%和28.5%,組間比較有明顯統(tǒng)計學(xué)差異(P0.001),并且兩兩比較也有明顯的統(tǒng)計學(xué)差異;心絞痛的發(fā)生率分別為26.4%、36.7%和54.7%,組間比較有明顯統(tǒng)計學(xué)差異(P0.001),并且兩兩比較也有明顯的統(tǒng)計學(xué)差異;死亡、心血管死亡以及心肌梗死的發(fā)生率上,組間比較有統(tǒng)計學(xué)差異(P值分別為0.040、0.038和0.025),兩兩比較后發(fā)現(xiàn)這種差異主要源于SRI 100%組和SRI50%組,兩組間差異有明顯統(tǒng)計學(xué)(P值分別為0.014、0.016和0.009);非計劃血運(yùn)重建的發(fā)生率上,組間比較有統(tǒng)計學(xué)差異(P0.001),兩兩比較后發(fā)現(xiàn)這種差異主要源于SRI 100%組和SRI50%組以及SRI50%組和SRI 50%-99%組,兩組間差異有明顯統(tǒng)計學(xué)(P值分別為0.001和0.031);在支架內(nèi)血栓的發(fā)生率上,三組患者間沒有明顯的統(tǒng)計學(xué)差異(P=0.809)。Logistic回歸分析結(jié)果提示SRI是高齡冠心病合并糖尿病患者介入治療術(shù)后發(fā)生2年MACE事件的保護(hù)因素,其中合理的SRI可以使2年MACE事件的發(fā)生風(fēng)險降低64%(p0.010)。ROC曲線顯示SRI的ROC曲線下面積為0.65,95%的可信區(qū)間為(0.57-0.72),其中其最大約登指數(shù)為0.291,對應(yīng)的SRI值為65%,即血運(yùn)重建程度的最佳截點(diǎn)值為65%。結(jié)論:對于高齡冠心病合并糖尿病的患者而言,進(jìn)行完全性血運(yùn)重建患者隨訪2年的心血管事件(包括MACE、心絞痛、死亡、心源性死亡、心肌梗死、非計劃血運(yùn)重建)更低,血運(yùn)重建程度(SRI)是高齡冠心病合并糖尿病患者介入治療術(shù)后發(fā)生2年MACE事件的保護(hù)因素,其中合理的SRI可以使2年MACE事件的發(fā)生風(fēng)險降低64%。SRI的最佳截點(diǎn)值為65%,提示對于不能進(jìn)行完全性血運(yùn)重建的高齡冠心病合并糖尿病患者,進(jìn)行不完全性血運(yùn)重建時應(yīng)盡可能使血運(yùn)重建程度達(dá)到65%以上,以降低長期隨訪的死亡率。
[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.
【學(xué)位授予單位】:首都醫(yī)科大學(xué)
【學(xué)位級別】:博士
【學(xué)位授予年份】:2017
【分類號】:R541.4
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