微创血管介入手术辅助系统的临床前评价研究  

Pre-clinical Evaluation of Self-developed Auxiliary System for Minimally Invasive Vascular Intervention

作　　者：朱瑾彦 张敏[1] 杨伯清 彭鹏 罗佳菲 孙洋 秦冠博 李彬 岳广新 ZHU Jinyan;ZHANG Min;YANG Boqing;PENG Peng;LUO Jiafei;SUN Yang;QIN Guanbo;LI Bin;YUE Guangxin(Beijing Key Laboratory of Preclinical Research and Evaluation for Cardiovascular Implant Materials,Animal Experimental Center,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China;Department of Clinical Pathology,Experimental Diagnosis Center,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China;Wire Science Technology(Suzhou)Co.Ltd,Suzhou 215031,China)

机构地区：[1]中国医学科学院、北京协和医学院国家心血管病中心、阜外医院动物实验中心、心血管植入材料临床前研究评价北京市重点实验室,北京100037 [2]中国医学科学院、北京协和医学院国家心血管病中心、阜外医院实验诊断中心临床病理科,北京100037 [3]微亚医疗科技(苏州)有限公司,苏州215031

出　　处：《中国循环杂志》2023年第7期761-766,共6页Chinese Circulation Journal

摘　　要：目的:对中国自主研发的微创血管介入手术辅助系统(微亚医疗)进行在体临床前安全性和可行性评价。方法:选用6只健康雌性巴马小型猪作为实验动物。实验组(n=3)由微创血管介入手术辅助系统完成小型猪的冠状动脉(冠脉)造影术,对照组(n=3)由具有冠脉介入治疗10年以上工作经验的主任医师完成并评价小型猪的冠脉造影术。所有动物均采用股动脉入路,并对每只动物分别进行左、右冠脉造影。介入手术辅助系统的功能评价由术者术后即刻完成。冠脉造影评价报告手术总时间、X线曝光时间、造影结果评价。术前和术后3 h均进行血液学检查,术后3 h为实验终点,然后对实验动物安乐死进行组织病理取材。结果:6只实验动物的冠脉造影操作均顺利完成,并存活至实验终点。血液学检查结果显示,对照组与实验组均未发生感染、失血、肝肾功能障碍等并发症;冠脉造影结果显示,对照组与实验组的手术总时间[(30.00±11.53)min vs(.19.33±7.57)min]、造影时间[(19.67±12.22)min vs(.6.00±1.00)min]、血管痉挛评分[左冠脉造影(:0.50±0.84)分vs.(0.00±0.00)分;右冠脉造影:(0.50±0.55)分vs.(0.33±0.52)分]差异均无统计学意义(P均>0.05),两组均未发生动脉夹层,造影结果良好。病理结果显示,实验组主动脉窦部,左、右冠脉开口均未见损伤,左前降支、左回旋支、右冠脉及后降支心表全程血管内皮完整,内外弹力板未见撕裂或损伤,未见血栓形成,未见夹层或穿孔,心包无出血和积血,未见炎症。结论:采用该微创血管介入手术辅助系统进行冠脉造影,安全性及可行性均良好。Objectives:To evaluate the safety and feasibility of the independently developed China minimally invasive vascular intervention assistance system in vivo before the clinical application.Methods:In this study,six healthy female pigs were used.The minimally invasive vascular intervention surgery assistance system developed by Wire Science Technology(Suzhou)Co.Ltd(experimental group)and the chief physician with more than 10 years of experience in coronary intervention therapy(control group)completed the coronary angiography in the pigs(n=3 each).Hematological examinations were performed preoperatively and at 3 hours postoperatively.The experimental endpoint was 3 hours after coronary angiography.The experimental animals were euthanized under deep anesthesia and subjected to gross necropsy and histopathological examination.Results:All six experimental animals completed coronary angiography and survived to the experimental endpoint.The procedure was uneventful in the experimental group and control group,and the procedure of guide wire,catheter,and contrast was uneventful.Blood examination results before and 3 hours after coronary angiography showed that no infection,blood loss or liver and kidney dysfunction occurred in the control group and the experimental group.Coronary angiography results showed that the total surgical time([30.00±11.53]minutes vs.[19.33±7.57]minutes),imaging time([19.67±12.22]min vs.[6.00±1.00]min),vasospasm score(left coronary angiography:[0.50±0.84]points vs.[0.00±0.00]points;right coronary angiography:[0.50±0.55]points vs.[0.33±0.52]points)were similar between the two groups(all P>0.05).No arterial dissection occurred in both groups,and the imaging results were satisfactory.The pathological results showed that there was no damage to the aortic sinus,left and right coronary openings,left anterior descending branch,left circumflex branch,right coronary artery,and posterior descending branch have intact vascular endothelium throughout the heart surface,no tearing or damage found on the in

关 键 词：介入手术辅助系统 经皮冠状动脉介入治疗 冠状动脉造影 临床前评价 

分 类 号：R54[医药卫生—心血管疾病]