评估MagiCath导管消融系统行经导管肾去交感神经术的安全性及有效性的实验研究  

Experiment research on evaluating safety and efficiency of Magi Cath ablation system for renal sympathetic denervation

作　　者：杨鹏[1] 孟庆怡 秦廷莉[1] 姜红[1] 叶小钧[1] 付东亮[1] 李佳慧[1] 周颖[1] 张丽芳[1] 陈莉[1] 王勇[1] 李宪伦[1] YANG Peng MENG Qing-yi QIN Ting-li JIANG Hong YE Xiao-jun FU Dong-liang LI Jia-hui ZHOU Ying ZHANG Li- fang CHEN Li WANG Yong LI Xian-lun(Department of Cardiology, China-Japan Friendship Hospital Beo＇ing 100029, China Beijing Transeasy Medical Tech. Co.Ltd., Beijing 101102, China)

机构地区：[1]中日友好医院心内科,北京100029 [2]北京天助畅运医疗器械有限公司,北京101102

出　　处：《中国医刊》2016年第12期25-30,共6页Chinese Journal of Medicine

基　　金：国际科技合作专项<难治性高血压病规范化诊治体系的合作研究>(No.2014DFA30790)

摘　　要：目的通过实验猪探讨自主研制Magi Cath导管消融系统行经导管肾去交感神经术(renal sympathetic denervation,RDN)的安全性及有效性。方法将12只约克猪随机分为4组:双侧消融组-1(随访7天)、双侧消融组-2(随访14天)、双侧消融组-3(随访30天)和假手术组(随访30天)。于RDN术前、术后分别抽血、验尿及双侧肾动脉造影,监测动脉血压、心率及评估肾动脉形态,随访结束后分别取出实验猪的肾动脉,经苏木精-伊红染色法染色后观察肾动脉内膜及肾动脉周围交感神经的形态学变化,并检测肾组织中去甲肾上腺素的含量。结果经病理学及造影检查,Magi Cath消融系统行RDN术对实验猪的肾动脉内膜未造成严重并发症。随访30天后动脉收缩压为(110±2.0)mm Hg,较术前基础收缩压[(142.5±2.3)mm Hg]明显下降,舒张压未见明显下降。该系统可导致肾动脉周围神经明显变性坏死、纤维化及空泡化,并且较假手术组能够明显降低肾组织内去甲肾上腺素的含量,差异具有显著性(P<0.01)。结论应用Magi Cath消融系统行RDN术是安全的。在30天随访中,该系统行RDN术的疗效是肯定的。Objective This study aims at the safety and efficiency of RDN with MagiCath ablation system in swine model.MethodTwelve York swines were randomly separated into four groups： bilateral ablation group-1 （7 days）, bilateral ablation group-2 （14 days）, bilateral ablation group-3 （30 days）, Shamp group （30 days）. Before and after RDN, the blood and urine samples of all the swines were collected, blood pressure and heart rate were monitored during the operation and renal artery angiogram was performed to assess bilateral renal arteries. After follow-up the renal arteries and their media have pathologically analyzed by HE staining and the change of norepinephrine in the kidney tissue has been detected.ResultMagiCath ablation system has no any serious adverse effects on the intima of renal artery in swine by pathological examination and angiogram. After follow-up of thirty days, the systolic blood pressure has significantly decreased from （142.5±2.3）mmHg at baseline to （110±2.0）mmHg while diastolic blood pressure slightly decreased without any statistical significance. This system could result in necrosis, fibrillation and atrophy of nerve around renal artery and decrease the secretion of norepinephrine in renal tissue.Conclusion MagiCath ablation system is safe for renal sympathetic denervation. After follow-up of thirty days, the effect of RDN by the means of it is comfirmed.

关 键 词：MagiCath消融系统 肾去交感神经术 去甲肾上腺素 

分 类 号：R544.1[医药卫生—心血管疾病]