经导管主动脉瓣置换术过程中使用Sentinel脑保护装置的效果和安全性分析  

Effectiveness and safety of the use of Sentinel cerebral embolic protection device during transcatheter aortic valve replacement

作　　者：谭冠昶[1] 李炜杰 李捷[2] 谭健锹[1] 罗淞元[2] 赵巧仪 罗建方 TAN Guan-chang;LI Wei-jie;LI Jie;TAN Jian-qiao;LUO Song-yuan;Zhao Qiao-yi;LUO Jian-fang(Department of Cardiology,Kiang Wu Hospital,Macao Special Administrative Region 999708,China)

机构地区：[1]澳门镜湖医院心内科,中国澳门999708 [2]广东省心血管病研究所、广东省医学科学院、南方医科大学附属广东省人民医院心内科 [3]佛山市第一人民医院心血管内科

出　　处：《中国介入心脏病学杂志》2023年第10期741-746,共6页Chinese Journal of Interventional Cardiology

摘　　要：目的探讨Sentinel脑保护装置(CEPD)在接受经导管主动脉瓣置换术(TAVR)患者中的应用效果和安全性。方法回顾性分析从2017年3月至2022年10月在中国澳门镜湖医院进行的TAVR过程中置入CEPD的患者。随访时间截点为7 d和30 d,主要观察终点包括全因死亡、症状性脑卒中、短暂性脑缺血发作(TIA)、CEPD置入成功率、置入CEPD路径的血管并发症、CEPD成功捕获物质事件。绘制CEPD置入的操作时间折线图评价CEPD置入的学习曲线。结果共29例患者纳入分析,所有患者均成功置入CEPD。女性13例(44.8%),平均年龄为(78.3±7.3)岁。三叶瓣患者16例(55.2%),二叶瓣患者13例(44.8%)。所有患者TAVR所使用的的瓣膜均为自膨胀瓣膜,其中55.2%为Evolut R/PRO,44.8%为Venus-A/A Plus。随访7 d和30 d时,29例患者均未出现全因死亡、症状性脑卒中、TIA及桡动脉或肱动脉的血管并发症。根据主动脉瓣的类型将患者分为三叶瓣组和二叶瓣组,两组患者的钙化积分、人工瓣膜类型、置入CEPD操作时间比较,差异均无统计学意义(均P>0.05)。在肉眼观察下,两组均各有7例患者在CEPD中发现捕获血栓、钙化物质或瓣膜组织碎片等,组间比较差异无统计学意义(P>0.05)。随着手术例数的增加,CEPD的操作时间逐渐缩短,从第6例手术开始,操作时间均在11 min以内。结论在TAVR术中置入CEPD的可操控性强,手术学习周期短且安全性高。Sentinel CEPD能明确捕获术中产生的部分血栓、钙化物质或瓣膜组织碎片,但在国内人群中使用Sentinel CEPD预防脑栓塞事件的有效性尚需要更多大规模随机对照研究的证实。Objective To investigate the effectiveness and safety of Sentinel cerebral embolic protection device(CEPD)in patients undergoing transcatheter aortic valve replacement(TAVR)in China.Methods Patients who had a CEPD placement during TAVR performed at our center from March 2017 to October 2022 were retrospectively analyzed.The follow-up time were 7 and 30 days,and the primary endpoints included all-cause mortality,symptomatic stroke,transient ischemic attack(TIA),success rate of CEPD placement,vascular complications,and events of successful capture of material by CEPD.The learning curve of CEPD placement was evaluated by plotting the operating time line graph.Results A total of 29 patients were included in the analysis,and all patients had successful CEPD placement(Sentinel,Boston Scientific).Females comprised 44.8%of the included patients,and the mean age was(78.3±7.3)years.The percentage of patients with tricuspid aortic valves(TAV)and bicuspid aortic valves(BAV)was 55.2%and 44.8%,respectively.All patients were replaced by self-expanding valves,of which 55.2%were Evolut R/PRO and 44.8%were Venus-A/A Plus.Follow-up to 7 and 30 days,all patients were free of all-cause mortality,symptomatic stroke,TIA,and vascular complications in the radial or brachial arteries.There was no statistically significant difference between patients with BAV and TAV in terms of calcification score,prosthetic valve type,or CEPD operation time(all P>0.05).Under visual observation,thrombus,calcified material,or valve tissue debris were found in CEPD in 7 patients in each of the two groups,with no statistical difference between the groups(P>0.05).The operation time for Sentinel implantation was gradually shortened with the increase of the number of surgical cases,and the operation time was less than11 minutes from the 6th case.Conclusions The placement of Sentinel device is highly maneuverable,has a short learning curve,and is safe during TAVR.The Sentinel can definitively capture some of the thrombus,calcified material,or valvular tissue de

关 键 词：经导管主动脉瓣置换术 脑保护装置 脑栓塞 

分 类 号：R541[医药卫生—心血管疾病]