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經右橈動脈入路與股動脈入路行頸動脈腔內介入診治的隨機對照研究

發(fā)布時間:2018-07-26 09:34
【摘要】:研究背景及目的:腦卒中已經成為威脅我國居民生命健康的首位疾病,在其中,約四分之一直接由頸動脈狹窄引起,因此對頸動脈狹窄的合理篩查診治是預防缺血性腦卒中的重要手段,受限于我國基層社區(qū)醫(yī)療機構軟硬件條件限制,簡便易行的血管超聲篩查因人員技術水平差異而難以保證可信度。同時頸動脈內膜斑塊切除術(Carotid endarterectomy,CEA)對于大多數(shù)基層醫(yī)院難以開展。因此,作為診斷頸動脈狹窄“金標準”的頸動脈造影術及在其基礎上更進一步的頸動脈支架成形術(Carotid artery stenting,CAS)成為我國診治頸動脈狹窄的主要手段,而頸動脈腔內介入診治傳統(tǒng)多選擇經股動脈入路(transfemoral approach,TFA),其預防卒中的近、遠期效果業(yè)已得到諸多大型臨床試驗的證明。但在臨床實踐中依然存在諸多局限性:1、合并III型主動脈弓、牛角型主動脈弓等不利解剖因素;2、外周血管嚴重病變:股動脈狹窄閉塞性病變,髂動脈嚴重扭曲等;3、術后穿刺點并發(fā)癥及下肢制動帶來不適、下肢深靜脈血栓形成風險等。其中,隨著中國老齡化社會的到來,與高齡相關的III型弓等不利弓部解剖勢必越來越普遍,但現(xiàn)實中往往該部分老年患者全身狀況難以耐受CEA,而選擇傳統(tǒng)TFA行CAS又會增加卒中等神經系統(tǒng)并發(fā)癥。此時,橈動脈卻展現(xiàn)其特有的優(yōu)勢,但卻因其血管管徑較細,相關技術器材匱乏,技術難度較高、現(xiàn)有經驗不足等原因未得到廣泛推廣。查閱相關國內外文獻發(fā)現(xiàn),經橈動脈入路(transradial approach,TRA)行頸動脈腔內介入診治在國內外尚屬前沿技術,少部分國內外高水平介入中心在該領域有所開展并初步證明其安全、可行,但中國人種與西方人種在血管條件及相關疾病特點上存在差異。該技術在國人中的應用前景、可行性、安全性及學習曲線等具體情況尚不充分。尤其是TRA是否是解決合并III型弓或牛角弓等弓部不利解剖的有效方法,尚未明確。綜上所述,本研究擬針對“弓部不利解剖”對本中心頸動脈狹窄患者進行篩查,分析其發(fā)生情況。在此基礎上,行TRA與TFA的弓上動脈造影前瞻隨機對照研究,研究TRA的可行性、安全性、學習曲線及其在弓部不利解剖病例中與TFA的差異,進一步探討TRA行CAS在國人中的可行性及適應癥。為該項技術在頸動脈狹窄相關腦卒中的篩查診治方面的應用推廣提供一定依據。第一部分單中心頸動脈狹窄患者主動脈弓不利解剖情況調查目的:初步調查我中心頸動脈狹窄患者不利解剖主動脈弓(III型弓及牛角弓)的發(fā)生情況。方法:回顧性分析我中心2014年2月—2017年2月共206例頸動脈狹窄影像學資料,統(tǒng)計其弓型(I型、II型、III型)構成比及牛角弓發(fā)生率。并比較70歲以上與70歲以下年齡段間合并不利解剖主動脈弓發(fā)生情況的差異。結果:我中心頸動脈狹窄患者I、II、III型弓及牛角弓發(fā)生率分別為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,頸動脈狹窄患者的不利解剖主動脈弓(Unfavorable anatomic arch,UAA)發(fā)生率為34.95%。其中70歲以上較70歲以下年齡段間UAA發(fā)生率顯著升高(47.37%vs27.69%,P0.01)。結論:頸動脈狹窄患者UAA情況較為常見,且在大于70歲以上老年人中更為普遍。第二部分經橈動脈入路與股動脈入路行弓上動脈造影的單中心前瞻性隨機對照研究目的:探討TRA與TFA行弓上動脈造影的手術參數(shù)指標及新手學習曲線差異。方法:對2016年2月至2017年4月期間101例頸動脈狹窄病例行前瞻性隨機分組(TRA組與TFA組),分別經TRA與TFA行弓上動脈造影,統(tǒng)計比較兩者在手術成功率、手術時間、穿刺時間、放射時間、放射劑量、對比劑用量、導管交換次數(shù)等手術參數(shù)指標、術后并發(fā)癥、患者舒適度、生活自理能力方面的差異。對入組病例篩選出合并弓部不利解剖(III型弓或牛角弓)的病例資料,比較二者差異。對兩組的手術時間行多重線性回歸分析,篩選其影響因素。同時以每10例為一階段,將兩組病例分別分為P1(Phase1)、P2(Phase2)、P3(Phase3)、P4(Phase4)、P5(Phase5)階段,比較各階段的趨勢及差異。結果:兩組病例基線資料無明顯差異,二者在手術成功率、手術時間、放射時間、放射劑量、對比劑用量、導管交換次數(shù)、術后并發(fā)癥方面無統(tǒng)計學差異(P0.05)。TFA組穿刺時間較TRA組短(0.6 vs 1,P=0.01)。在患者舒適度及生活自理能力方面,TRA組術前術后無明顯差異,TFA組術后較術前明顯下降(P0.01)。在合并弓部不利解剖的病例中,TRA組的手術時間更短(27.73 vs.40 min,P=0.03)、對比劑用量更少(95.9±8.72 vs.112.43±23.06 ml,P=0.03),導管交換次數(shù)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)可能影響TFA手術時間,而年齡(B=0.86,P0.01)可能影響TRA的手術時間。TRA的學習曲線較TFA更陡峭、更長,在P1、P2、P3階段二者在手術參數(shù)指標方面TRA與TFA無明顯差異,后期(P4-P5)階段,TRA組手術時間(24.71 vs.33.63 min,P0.01)、放射時間(6.3 vs.9.52 min,P=0.03)及導管交換次數(shù)(P=0.03)較TFA明顯減少。TFA組至P5階段的手術時間、穿刺時間才與P1階段出現(xiàn)顯著差異(P0.05)。而TRA組自P3階段開始,其手術時間、放射時間、穿刺時間較P1階段即顯著降低(P0.05)。結論:TRA行弓上動脈造影較TFA同樣安全、可行。尤其適用于合并弓部不利解剖的病例,其術后患者舒適度及生活自理能力較TFA占優(yōu)。對于新手來說,TRA的學習曲線較TFA長,約30例后其手術參數(shù)指標趨于穩(wěn)定,且在手術時間、放射時間、導管交換次數(shù)方面較TFA更具優(yōu)勢。第三部分經右橈動脈入路行頸動脈支架成形術的可行性及適應癥目的:探討經右橈動脈入路(transradial approach,TRA)行頸動脈支架成形術(catotid artery stenting,CAS)的可行性及安全性,初步總結經右側TRA行CAS的適應癥及手術技巧。方法:回顧性分析46例經右側TRA行CAS病例資料,根據病變位置將病例分為右頸動脈組(right carotid artery group,RCA)、合并牛角弓左頸動脈組(bovine left carotid artery group,B-LCA)、非牛角弓左頸動脈組(nonbovine carotid artery group,NB-LCA)。選擇性采用低位橈動脈入路或高位橈動脈入路行CAS術。術中綜合運用長鞘頭端體外成形、同軸技術、主動脈瓣成袢反折技術(Catheter Looping and Retrograde Engagement Technique,CLRET)等技巧解決長鞘支撐不足難點。觀察記錄手術成功率、手術時間、放射時間及圍手術期并發(fā)癥發(fā)生情況。分析比較不同組CAS手術時間、放射時間差異。結果:手術成功率100%,在手術時間及放射時間上,RCA、B-LCA、NB-LCA組間無統(tǒng)計學差異,NB-LCA組中CLRET技術使用率為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技術組手術時間與放射時間較不使用的明顯延長(39.45±7.27 vs.30.80±4.66min;11.84±2.05 vs.9.91±1.45min),兩者具有統(tǒng)計學差異(P0.05)。圍手術期未發(fā)生嚴重心腦血管事件及穿刺點并發(fā)癥。結論:經TRA性CAS安全、可行,尤其適用于右側CAS及合并I或II型弓的左側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.
【學位授予單位】:第二軍醫(yī)大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R743.3

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