A Randomized Controlled Study Of Carotid Artery Interventional Angiography And Therapy Via Right Radial Artery Vs Femoral Artery Approach

Background and objective:Stroke has become the first disease threatening the life and health of residents in China.And about 1/4 were directly caused by carotid stenosis.Therefore,it is an important means to prevent and treat ischemic stroke by reasonable screening and diagnosis of carotid artery stenosis.But Restricted by the limitation of hardware and software of basic community medical institutions in China,It is difficult to ensure the reliability of vascular ultrasound screening because of the difference of technical level.At the same time,carotid endarterectomy(CEA)is difficult to carry out in most primary hospitals.Therefore,Carotid angiography and carotid artery stenting(CAS)have become the main methods for the diagnosis and treatment of carotid artery stenosis,which usually via transfemoral approach(TFA).The short and long term effects of stroke prevention of CAS via TFA have been proved by many clinical trials.However,there are still many limitations in clinical practice: 1、with unfavorable anatomic aortic arch such as type III aortic arch and bovine aortic arch;2、severe peripheral vascular disease such as femoral artery stenosis and occlusive disease、iliac artery serious distortion;3、The puncture complications and the discomfort of a long period of bed rest。With the coming of aging society in China,the age related III type arch arch and other unfavorable anatomy will be more and more common.But in reality,some elderly patients with terrible body conditions are difficult to suffer CEA,while the choice of CAS via TFA may increase the neurological complications such as stroke.In contrast,the transradial approach(TRA)shows its unique advantages.However,due to the smaller diameter of the blood vessel,the lack of relevant technical equipment,high technical difficulty,lack of experience and other reasons have not been widely promoted.By searching the domestic and foreign publications we have found that the interventional treatment of carotid artery stenosis via TRA is a frontier technology in the world.A small number of domestic and foreign high-level intervention center in the field has been carried out and preliminary proof of its safety and feasibility.However,there are differences between the Chinese race and the Western race in the vascular conditions and related diseases.The prospects,feasibility,safety and learning curve of the technology in the Chinese is still inadequate.Especially the effectiveness of TRA to address unfavorable anatomic arch such as type III aortic arch and bovine aortic arch,is not yet clear.In summary,we aimed to select the carotid artery stenosis patients with unfavorable anatomic arch(UAA)from our center in this study.Analysis of its incidence rate.On the basis of the above,we design a prospective randomized controlled trail of angiography of superior arch arteries via TRA and TFA to explore the feasibility,safety and learning curve of TRA superior arch arteries angiography,especially the difference between the TRA and TFA with UAA.Furtherly,to explore the feasibility and indications of CAS via TRA in Chinese.We hope our study can provide a evidence for applying TRA in the diagnosis and treatment of carotid artery stenosis.Part 1:A single center investigation on the unfavorable anatomy of aortic arch in patients with carotid artery stenosisObjectives:Preliminary investigation on the occurrence of unfavorable anatomy of aortic arch(type III aortic arch and bovine aortic arch)in Chinese patients with carotid artery stenosis.Methods: Retrospectively analyze the imaging data of 206 cases of carotid artery stenosis in our center from February 2014 to February 2017.Calculate the ratio of arch type(type I、 II、III)and the incidence of and bovine aortic arch.comparing the difference of incidence of unfavorable anatomy of aortic arch between above and below 70 years old.Results: Carotid artery stenosis patients with I,II,III and bovine aortic arch were 39.80%(82/206),33.01%(68/206),27.18%(56/206),9.71%(20/206)respectively.A total of 72 cases of unfavorable arch anatomy,Of which 4 cases with type III aortic arch combine with bovine aortic arch..The incidence of unfavorable anatomic arch(UAA)in patients with carotid artery stenosis was 34.95%.Among them,the incidence of UAA was significantly higher in group above 70 years old than those below(47.37%vs27.69%,P<0.01).Conclusions: UAA is common in patients with carotid stenosis in China,and is more general in the elderly.Part 2:A single center prospective randomized controlled trail of angiography of superior arch arteries via transradial approach vs transfemoral approachObjectives:To explore the difference in procedure parameters and novice learning curves between TRA and TFA superior arch arteries angiography.Methods: Prospective randomized grouping of 101 patients with carotid artery stenosis from February 2016 to April 2017(group TRA and group TFA),TRA and TFA were performed in the superior arch arteries angiography.The success rate of operation,operation time,puncture time,radiation time and radiation dose,contrast agent dose,the number of surgical catheter exchange,postoperative complications,patient comfort,self-care ability difference were compared statistically.The cases with unfavorable anatomic arch(III type arch or horn bow)were selected and analyzed.Multiple linear regression analysis was performed on the operation time in two groups to find the influencing factors.Every 10 cases were defined as a stage.The two groups of patients were both divided into P1(Phase1),P2(Phase2),P3(Phase3),P4(Phase4),P5(Phase5),then comparing the trends and differences in each phase.Results: There was no significant difference between the two groups in the baseline data,success rate of operation,operation time,radiation time,radiation dose,dose of contrast agent,the number of catheter exchange,postoperative complications(P>0.05).The puncture time of group TRA was shorter than that of group TFA(0.6 vs 1,P=0.01).There was no significant difference between patients in the TRA group before and after operation,and the TFA group was significantly lower than that before operation(P<0.01).The TRA group had shorter procedure time(27.73 vs.40 min,P=0.03)、less dosage of contrast agent in the cases with UAA(95.9±8.72 vs.112.43±23.06 ml,P=0.03)and fewer catheter exchanges(1 vs 3,P<0.01).Type of aortic arch(B=5.98,P<0.01)and proximal vascular distortion(B=20.86,P < 0.01)may affect TFA operation time.,while age(B=17.55,P<0.01)may affect the operation time of TRA.TRA learning curve is steeper and longer than TFA.There was no significant difference in parameters of operation between TRA and TFA in P1,P2 and P3 stages.In anaphase(P4-P5),TRA group procedure time(24.71 vs.33.63 min,P<0.01)、fluoroscopy time(24.71 vs.33.63 min,P<0.01)and the number of catheter exchange(P=0.03)was significantly reduced compared with TFA.Only developing to P5,there was significant difference compared with P1 in the TFA group.But,from P3 then on,the operation time,fluorescence time and the number of catheter exchange of TRA group were significantly lower than those of P1 group.Conclusions: TRA is as safe and feasible as TFA in superior arch arteries angiography,especially in the cases with UAA.The postoperative comfort and self-care ability of patients were better than TFA.For novice,TRA learning curve is longer than TFA.The procedure parameters were stable after about 30 cases.In anaphase,it is more advantageous than TFA in the operation time,fluorescence time and the number of catheter exchange.Part 3:The feasibility and indications of carotid artery stenting via transradial approachObjective:To explore the feasibility and safety of carotid artery stenting(CAS)via right transradial approach(TRA),and preliminary summary the indications and surgical skills.Methods: A retrospective analysis of 46 cases who were performed the CAS via right TRA.All cases were divided into the right carotid artery group(RCA)、bovine left carotid artery group(B-LCA)、nonbovine carotid artery group(NB-LCA)according to the lesion location.Low TRA or High TRA were selected,to resolve the difficulties and challenges of the insufficient supporting power of shuttle sheath,sharping the shuttle sheath head vitro、telescope techniqle and Catheter Looping and Retrograde Engagement Technique(CLRET)were selective applied intraoperative.Surgical success rate,operation time,fluoroscopy time of surgery ray and perioperative complications were observed and recorded,and the differences of the operation time and fluoroscopy time among the three group were compared.Results: All CAS were successed(100%),the differences of the operation time and fluoroscopy time among RCA group 、 B-LCA group and NB-LCA group were no significant.In NB-LCA group,CLRET were applied in 10 cases(55.56%,10/18),includeing 8 cases with type III aortic arch(100%,8/8)and 2 cases with type II aortic arch(33.33%,2/6).The CLRET prolonged the operation time and fluoroscopy time(39.45±7.27 vs.30.80±4.66min;11.84±2.05 vs.9.91±1.45 min,P<0.05),and there was significant difference of the operation time and fluoroscopy time between cases which applied CLRET or not in NB-LCA group.no cerebrovascular events and puncture point complications were occurred in perioperative period.Conclution: Right transradial approach for carotid artery stenting is safe and technically feasible,especially in RCA stenosis and LCA stenosis with type I or II aortic arch.