摘要
目的:观察经导管主动脉瓣置换术(TAVR)患者使用Sentinel抗栓塞脑保护装置的临床结果。方法:回顾性收集2023年10月至2024年9月在首都医科大学附属北京安贞医院心脏瓣膜病介入中心接受TAVR治疗并行Sentinel抗栓塞脑保护装置置入80例患者的临床资料,患者年龄为72(68,76)岁,其中男性52例(65.0%),女性28例(35.0%);三叶式主动脉瓣患者62例(77.5%),二叶式主动脉瓣患者18例(22.5%);Ⅰ型主动脉弓患者34例(42.5%),Ⅱ型主动脉弓患者24例(30.0%),Ⅲ型主动脉弓患者12例(15.0%),牛型主动脉弓10例(12.5%)。主要观察终点为Sentinel抗栓塞脑保护装置置入是否成功以及院内和术后30 d内全因死亡、症状性脑卒中、短暂性脑缺血发作和脑保护装置入路血管并发症。结果:80例患者使用自膨式瓣膜68例(85.0%),球扩式瓣膜12例(15.0%)。成功完成TAVR并置入Sentinel抗栓塞脑保护装置79例(98.8%),74例患者(92.5%)Sentinel抗栓塞脑保护装置的过滤器中捕获肉眼可见的物质。牛型主动脉弓患者Sentinel抗栓塞脑保护装置置入操作时间稍长,但不同类型主动脉弓患者Sentinel抗栓塞脑保护装置置入操作时间差异无统计学意义(P>0.05)。院内和术后30 d内,除发生1例短暂性脑缺血发作外,未发生全因死亡、症状性脑卒中及Sentinel抗栓塞脑保护装置入路血管并发症。结论:TAVR使用Sentinel抗栓塞脑保护装置在不同类型的主动脉弓患者中均具有良好的安全性。本研究为中国中重度瓣膜性心脏病注册研究的一项亚组分析研究,已在中国临床试验注册中心注册(ChiCTR2300075006)。
Objective:To evaluate the feasibility,efficacy and safety of Sentinel cerebral embolic protection device(CEPD)during transcatheter aortic valve replacement(TAVR).Methods:Patients undergoing TAVR with the Sentinel CEPD from October 2023 to September 2024 were retrospectively enrolled.A total of 80 patients were included,with a median age of 72(68,76)years,including 52 males(65.0%)and 28 females(35.0%);62 patients(77.5%)with tricuspid valves,and 18 patients(22.5%)with bicuspid valves;34 patients(42.5%)with typeⅠaortic arch,24 patients(30.0%)with typeⅡaortic arch,12 patients(15.0%)with typeⅢaortic arch,and 10 patients(12.5%)with bovine-type aortic arch.Clinical data of the patients were summarized and analyzed.The primary endpoints were success rate of Sentinel CEPD implantation,as well as all-cause death,symptomatic stroke,transient ischemic attack,and Sentinel CEPD access vessel complications during hospitalization and within 30 days postoperatively.Results:In the 80 patients,self-expanding valves were used in 68 cases(85.0%)and balloon-expandable valves in 12 cases(15.0%).Seventy-nine patients(98.8%)successfully underwent TAVR with Sentinel CEPD deployment.Macroscopically visible debris was captured in 92.5%(74/80)by filters of Sentinel CEPD.Although the procedure time for Sentinel CEPD placement was slightly longer in patients with bovine-type aortic arch,there was no statistically significant difference in deployment time among different aortic arch types(P>0.05).During hospitalization and within 30 days postoperatively,only one case of transient ischemic attack occurred,and there was no all-cause mortality,symptomatic stroke,or access-site vascular complications related to the Sentinel CEPD observed.Conclusion:The Sentinel CEPD demonstrates high feasibility across aortic arch types,potential efficacy in embolic capture,and excellent safety in TAVR.This study is a subgroup analysis of the China Moderate to Severe Valvular Heart Disease Registry,which has been registered at the Chinese Clinical Trial Registry(ChiCTR2300075006).
作者
张岚
刘新民
席子惟
苑飞
姚晶
姜正明
闫云峰
宋光远
ZHANG Lan;LIU Xinmin;XI Ziwei;YUAN Fei;YAO Jing;JIANG Zhengming;YAN Yunfeng;SONG Guangyuan(Center for Valvular Heart Disease Intervention,Beijing Anzhen Hospital,Capital Medical University,National Clinical Research Center for Cardiovascular Diseases,Beijing 100029,China;Department of Cardiovascular Medicine,Zhengzhou Central Hospital Affiliated to Zhengzhou University,Zhengzhou 450007,China)
出处
《浙江大学学报(医学版)》
2025年第4期541-548,共8页
Journal of Zhejiang University(Medical Sciences)
基金
首都卫生发展科研专项(首发2022-2-2065)。
作者简介
第一作者:张岚,副主任医师,主要从事心血管疾病临床诊疗及科研工作,E-mail:zhanglan0621@sina.com,ORCID:0009-0001-6622-1098;第一作者:刘新民,主任医师,主要从事心脏瓣膜病的介入诊疗及相关临床研究,E-mail:anzhenliuxinmin@163.com,ORCID:0009-0006-4877-6870;通信作者:宋光远,主任医师,主要从事结构性心脏病及复杂冠心病的介入治疗及相关基础和临床研究,E-mail:songgy_anzhen@vip.163.com,ORCID:0000-0002-7868-6132。
