经右桡动脉入路与股动脉入路行颈动脉腔内介入诊治的随机对照研究

发布时间：2018-07-26 09:34

【摘要】：研究背景及目的:脑卒中已经成为威胁我国居民生命健康的首位疾病,在其中,约四分之一直接由颈动脉狭窄引起,因此对颈动脉狭窄的合理筛查诊治是预防缺血性脑卒中的重要手段,受限于我国基层社区医疗机构软硬件条件限制,简便易行的血管超声筛查因人员技术水平差异而难以保证可信度。同时颈动脉内膜斑块切除术(Carotid endarterectomy,CEA)对于大多数基层医院难以开展。因此,作为诊断颈动脉狭窄“金标准”的颈动脉造影术及在其基础上更进一步的颈动脉支架成形术(Carotid artery stenting,CAS)成为我国诊治颈动脉狭窄的主要手段,而颈动脉腔内介入诊治传统多选择经股动脉入路(transfemoral approach,TFA),其预防卒中的近、远期效果业已得到诸多大型临床试验的证明。但在临床实践中依然存在诸多局限性:1、合并III型主动脉弓、牛角型主动脉弓等不利解剖因素;2、外周血管严重病变:股动脉狭窄闭塞性病变,髂动脉严重扭曲等;3、术后穿刺点并发症及下肢制动带来不适、下肢深静脉血栓形成风险等。其中,随着中国老龄化社会的到来,与高龄相关的III型弓等不利弓部解剖势必越来越普遍,但现实中往往该部分老年患者全身状况难以耐受CEA,而选择传统TFA行CAS又会增加卒中等神经系统并发症。此时,桡动脉却展现其特有的优势,但却因其血管管径较细,相关技术器材匮乏,技术难度较高、现有经验不足等原因未得到广泛推广。查阅相关国内外文献发现,经桡动脉入路(transradial approach,TRA)行颈动脉腔内介入诊治在国内外尚属前沿技术,少部分国内外高水平介入中心在该领域有所开展并初步证明其安全、可行,但中国人种与西方人种在血管条件及相关疾病特点上存在差异。该技术在国人中的应用前景、可行性、安全性及学习曲线等具体情况尚不充分。尤其是TRA是否是解决合并III型弓或牛角弓等弓部不利解剖的有效方法,尚未明确。综上所述,本研究拟针对“弓部不利解剖”对本中心颈动脉狭窄患者进行筛查,分析其发生情况。在此基础上,行TRA与TFA的弓上动脉造影前瞻随机对照研究,研究TRA的可行性、安全性、学习曲线及其在弓部不利解剖病例中与TFA的差异,进一步探讨TRA行CAS在国人中的可行性及适应症。为该项技术在颈动脉狭窄相关脑卒中的筛查诊治方面的应用推广提供一定依据。第一部分单中心颈动脉狭窄患者主动脉弓不利解剖情况调查目的:初步调查我中心颈动脉狭窄患者不利解剖主动脉弓(III型弓及牛角弓)的发生情况。方法:回顾性分析我中心2014年2月—2017年2月共206例颈动脉狭窄影像学资料,统计其弓型(I型、II型、III型)构成比及牛角弓发生率。并比较70岁以上与70岁以下年龄段间合并不利解剖主动脉弓发生情况的差异。结果:我中心颈动脉狭窄患者I、II、III型弓及牛角弓发生率分别为39.80%(82/206)、33.01%(68/206)、27.18%(56/206)、9.71%(20/206),其中牛角弓合并III型弓4例,不利弓部解剖共72例,颈动脉狭窄患者的不利解剖主动脉弓(Unfavorable anatomic arch,UAA)发生率为34.95%。其中70岁以上较70岁以下年龄段间UAA发生率显著升高(47.37%vs27.69%,P0.01)。结论:颈动脉狭窄患者UAA情况较为常见,且在大于70岁以上老年人中更为普遍。第二部分经桡动脉入路与股动脉入路行弓上动脉造影的单中心前瞻性随机对照研究目的:探讨TRA与TFA行弓上动脉造影的手术参数指标及新手学习曲线差异。方法:对2016年2月至2017年4月期间101例颈动脉狭窄病例行前瞻性随机分组(TRA组与TFA组),分别经TRA与TFA行弓上动脉造影,统计比较两者在手术成功率、手术时间、穿刺时间、放射时间、放射剂量、对比剂用量、导管交换次数等手术参数指标、术后并发症、患者舒适度、生活自理能力方面的差异。对入组病例筛选出合并弓部不利解剖(III型弓或牛角弓)的病例资料,比较二者差异。对两组的手术时间行多重线性回归分析,筛选其影响因素。同时以每10例为一阶段,将两组病例分别分为P1(Phase1)、P2(Phase2)、P3(Phase3)、P4(Phase4)、P5(Phase5)阶段,比较各阶段的趋势及差异。结果:两组病例基线资料无明显差异,二者在手术成功率、手术时间、放射时间、放射剂量、对比剂用量、导管交换次数、术后并发症方面无统计学差异(P0.05)。TFA组穿刺时间较TRA组短(0.6 vs 1,P=0.01)。在患者舒适度及生活自理能力方面,TRA组术前术后无明显差异,TFA组术后较术前明显下降(P0.01)。在合并弓部不利解剖的病例中,TRA组的手术时间更短(27.73 vs.40 min,P=0.03)、对比剂用量更少(95.9±8.72 vs.112.43±23.06 ml,P=0.03),导管交换次数更少(1 vs 3,P0.01)。弓型(B=5.98,P0.01)及近端血管扭曲(B=17.55,P0.01)可能影响TFA手术时间,而年龄(B=0.86,P0.01)可能影响TRA的手术时间。TRA的学习曲线较TFA更陡峭、更长,在P1、P2、P3阶段二者在手术参数指标方面TRA与TFA无明显差异,后期(P4-P5)阶段,TRA组手术时间(24.71 vs.33.63 min,P0.01)、放射时间(6.3 vs.9.52 min,P=0.03)及导管交换次数(P=0.03)较TFA明显减少。TFA组至P5阶段的手术时间、穿刺时间才与P1阶段出现显著差异(P0.05)。而TRA组自P3阶段开始,其手术时间、放射时间、穿刺时间较P1阶段即显著降低(P0.05)。结论:TRA行弓上动脉造影较TFA同样安全、可行。尤其适用于合并弓部不利解剖的病例,其术后患者舒适度及生活自理能力较TFA占优。对于新手来说,TRA的学习曲线较TFA长,约30例后其手术参数指标趋于稳定,且在手术时间、放射时间、导管交换次数方面较TFA更具优势。第三部分经右桡动脉入路行颈动脉支架成形术的可行性及适应症目的:探讨经右桡动脉入路(transradial approach,TRA)行颈动脉支架成形术(catotid artery stenting,CAS)的可行性及安全性,初步总结经右侧TRA行CAS的适应症及手术技巧。方法:回顾性分析46例经右侧TRA行CAS病例资料,根据病变位置将病例分为右颈动脉组(right carotid artery group,RCA)、合并牛角弓左颈动脉组(bovine left carotid artery group,B-LCA)、非牛角弓左颈动脉组(nonbovine carotid artery group,NB-LCA)。选择性采用低位桡动脉入路或高位桡动脉入路行CAS术。术中综合运用长鞘头端体外成形、同轴技术、主动脉瓣成袢反折技术(Catheter Looping and Retrograde Engagement Technique,CLRET)等技巧解决长鞘支撑不足难点。观察记录手术成功率、手术时间、放射时间及围手术期并发症发生情况。分析比较不同组CAS手术时间、放射时间差异。结果:手术成功率100%,在手术时间及放射时间上,RCA、B-LCA、NB-LCA组间无统计学差异,NB-LCA组中CLRET技术使用率为55.56%(10/18),其中合并III型弓的8例(8/8),合并II型弓的2例(2/6),使用CLRET技术组手术时间与放射时间较不使用的明显延长(39.45±7.27 vs.30.80±4.66min;11.84±2.05 vs.9.91±1.45min),两者具有统计学差异(P0.05)。围手术期未发生严重心脑血管事件及穿刺点并发症。结论:经TRA性CAS安全、可行,尤其适用于右侧CAS及合并I或II型弓的左侧CAS。
[Abstract]:Background and purpose: stroke has become the first disease that threatens the life and health of the residents in our country. About 1/4 of them are directly caused by carotid stenosis. Therefore, the rational screening and treatment of carotid stenosis is an important means to prevent ischemic stroke, limited to the soft and hardware conditions of the grass-roots community medical institutions in China. Carotid endarterectomy (CEA) is difficult for most grass-roots hospitals. Therefore, carotid angiography as a "gold standard" for the diagnosis of carotid stenosis and a further carotid artery on its basis. Carotid artery stenting (CAS) is the main method for the diagnosis and treatment of carotid artery stenosis in China. The traditional carotid artery endovascular interventional therapy and the traditional multiple selective femoral artery approach (transfemoral approach, TFA) can prevent the stroke. The long-term effect has been proved by many large clinical trials, but it still exists in clinical practice. Many limitations: 1, unfavourable anatomical factors such as III type aortic arch and horns type aortic arch; 2, severe peripheral vascular lesions: femoral artery stenosis occlusion, severe iliac artery distortion, 3, postoperative complications of puncture points and lower extremity braking, risk of deep vein thrombosis in the lower extremities, and so on. The dissection of the III arches, such as the older age, is becoming more and more common, but in reality, the general condition of the elderly patients is often difficult to tolerate CEA, and the choice of the traditional TFA line CAS will increase the neurological complications such as stroke. At this time, the radial artery shows its unique advantage, but the relative technique is due to the smaller vascular diameter. The reasons for lack of equipment, high technical difficulty and lack of existing experience have not been widely popularized. It is found that the diagnosis and treatment of carotid artery endovascular intervention by transradial approach (TRA) is still a frontier technology at home and abroad, and a few high level interventional centers at home and abroad have been carried out in this field and have been preliminarily proved in this field and have been preliminarily proved. It is safe and feasible, but there is a difference in the vascular conditions and related disease characteristics between Chinese and western people. The application prospect, feasibility, safety and learning curve of this technology are not sufficient. Especially, it is not clear whether TRA is an effective method to solve the disadvantageous anatomy of the arch or bows of the III bow or ox horn. To sum up, to sum up, this study aims to screen and analyze the incidence of carotid artery stenosis in this center according to the "disadvantageous anatomy of the arch". On this basis, a randomized controlled study of the TRA and TFA supra arch arteriography is conducted to study the feasibility, safety, learning curve and the difference from the TFA in the disadvantageous anatomy of the arch of the TRA. To further explore the feasibility and indications of TRA line CAS in Chinese people. To provide some basis for the application of this technique in the diagnosis and treatment of cerebral apoplexy related to carotid stenosis. The occurrence of aortic arch (III type arch and horns arch) was dissected. Methods: a retrospective analysis of 206 cases of carotid artery stenosis in our center from February 2014 to February 2017 was reviewed. The ratio of arch type (type I, II type, III type) and the incidence of horns arch were statistically analyzed, and the disadvantageous aortic arch was compared between the age of 70 years and under 70 years of age. Results: the incidence of I, II, III arch and horns arch in patients with central carotid artery stenosis was 39.80% (82/206), 33.01% (68/206), 27.18% (56/206), 9.71% (20/206), of which 4 cases with horns arch combined with III bow, 72 dissection of the arch dissection, and disadvantageous aortic arch (Unfavorable anatomic arch, UAA) in patients with carotid stenosis The incidence of the incidence of UAA increased significantly in 34.95%. over 70 years old (47.37%vs27.69%, P0.01). Conclusion: UAA in patients with carotid stenosis is more common and is more common among older people over 70 years of age. Second part of the radial artery approach and the femoral artery approach a single center prospective approach to the supra arteriography The purpose of a randomized controlled study was to investigate the parameters of the surgical parameters of the supra arch arteriography of TRA and TFA and the difference in the learning curve of the novice. Methods: 101 cases of carotid artery stenosis from February 2016 to April 2017 were prospectively randomized (group TRA and TFA), with TRA and TFA respectively on the superior arch arteriography, and the success rates of the two were compared. Operation time, time of puncture, time of radiation, dose of radiation, dosage of contrast agent, frequency of exchange of catheter and other surgical parameters, postoperative complications, comfort and self-care ability of the patients. The cases of adversely dissection of the arch (III bow or horns arch) were selected and compared with the two groups. Time line multiple linear regression analysis was used to screen the influence factors. At the same time, the two cases were divided into P1 (Phase1), P2 (Phase2), P3 (Phase3), P4 (Phase4) and P5 (Phase5), respectively. Results: there was no significant difference in baseline data between the two groups, and the two were in the operation success rate, operation time, and radiation. Time, dose, dosage of contrast agent, exchange times of catheterization, and postoperative complications were not statistically different (P0.05) group.TFA puncture time was shorter than group TRA (0.6 vs 1, P=0.01). There was no significant difference between group TRA before and after operation in the comfort and self-care ability of the patients, and in group TFA (P0.01) after operation (P0.01). In the cases, the operation time of group TRA was shorter (27.73 vs.40 min, P=0.03), and the dosage of contrast agent was less (95.9 + 8.72 vs.112.43 + 23.06 ml, P=0.03), and the exchange of catheter was less (1 vs 3, P0.01). The arch type (B=5.98, P0.01) and proximal vascular distortion (B=17.55,) may affect the operation time. The learning curve of.TRA was more steep and longer than that of TFA. In P1, P2, P3 stage, there was no significant difference between TRA and TFA in the parameters of operation parameters. At the later stage (P4-P5), the operation time of the TRA group (24.71 vs.33.63 min, P0.01), and the time of radiation (6.3) and the number of catheter exchange were significantly reduced. The puncturing time was significantly different from the P1 stage (P0.05). While the TRA group started from the P3 stage, the operation time, the time of radiation, and the puncture time were significantly lower than that in the P1 stage (P0.05). Conclusion: TRA line supra arch arteriography is as safe and feasible as TFA. It is especially suitable for the cases of adverse anatomy of the combined arch and the postoperative comfort and life of the patients. The ability of self-care is superior to TFA. For the novice, the learning curve of TRA is longer than that of TFA. After about 30 cases, the parameters of the operation parameters tend to be stable, and the operation time, the time of radiation, the exchange of catheter are more advantageous than the TFA. The third part of the right radial artery approach for carotid artery stenting is feasible and adaptable: To explore the right radius The feasibility and safety of carotid artery stenting (catotid artery stenting, CAS) were performed by transradial approach (TRA). The indications and surgical techniques of CAS on the right side of TRA were preliminarily summarized. Methods: a retrospective analysis of 46 cases of CAS cases on the right side of TRA was carried out, and the cases were divided into the right carotid artery group (right) according to the location of the lesions. Rtery group, RCA), combined with bovine left carotid artery group (B-LCA), non horns arch left carotid artery group (nonbovine carotid artery). Selective use of low radial artery approach or high radial artery approach. Intraoperative combined use of long sheath head end external forming, coaxial technique, aortic valve loop Catheter Looping and Retrograde Engagement Technique, CLRET) and other techniques to solve the difficulty of long sheath support. Observe and record the success rate of surgery, operation time, radiation time and perioperative complications. Analysis and comparison of different groups of CAS operation time, release time difference. Results: the success rate of operation was 100%, during the operation. There was no statistical difference between group RCA, B-LCA and NB-LCA. The use of CLRET technology in group NB-LCA was 55.56% (10/18), including 8 cases with III type (8/8) and 2 cases of II type arch (2/6). The operation time and radiation time of CLRET technique group were not significantly prolonged (39.45 + 7.27 vs.30.80 + 2.05; 11.84 + 2.05). 1.45min) there were statistical differences (P0.05). There was no serious cardio cerebral vascular events and puncture point complications during the perioperative period. Conclusion: TRA CAS is safe and feasible, especially for right CAS and left CAS. with I or II type arch.
【学位授予单位】：第二军医大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R743.3

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