国产全磁悬浮左心室辅助装置术后神经系统并发症的单中心临床研究  

Postoperative neurological complications of domestically produced fully magnetically levitated left ventricular assist device:A single-center clinical study

作　　者：张昊天 周星彤 陈海波[1] 陈凯 杜娟[1] 邹亮[1] 陈伊[1] 卿平[1] 金琰 张艳明 尹泽琳 张泽 王现强[1] ZHANG Hao-tian;ZHOU Xing-tong;CHEN Hai-bo;CHEN Kai;DU Juan;ZOU Liang;CHEN Yi;QING Ping;JIN Yan;ZHANG Yan-ming;YIN Ze-lin;ZHANG Ze;WANG Xian-qiang(Department of Cardiac Surgery,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,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心外科,北京市100037

出　　处：《中国心血管病研究》2025年第4期321-325,共5页Chinese Journal of Cardiovascular Research

基　　金：国家重点研发计划(2023YFC2414401);北京高等学校卓越青年科学家计划项目(2024-BZZQ01)。

摘　　要：目的 评估国产全磁悬浮离心泵(CH-VAD)植入术后神经系统并发症的发生率及临床特征。方法 回顾性纳入2017年6月至2025年1月1日于中国医学科学院阜外医院接受CH-VAD植入的93例终末期心力衰竭患者,分析其基线特征、手术参数及随访结局。神经系统并发症定义为缺血/出血性脑卒中或短暂性脑缺血发作(TIA),采用Kaplan-Meier法分析生存率,组间比较应用log-rank检验。结果 中位随访406(194,1262)d,8例(8.60%)发生神经系统并发症,年发生率0.04/人年,1例发生致残性卒中。并发症组术前室性心动过速/心室颤动(62.50%比23.53%,P=0.030)、卒中史(37.50%比7.06%,P=0.028)、CRT-D植入率(37.50%比2.35%,P=0.004)及重度主动脉瓣反流比例(37.50%比5.88%,P=0.028)、N末端B型利钠肽原(NT-proBNP)水平更高(7985.00 pg/ml比2869.50 pg/ml,P=0.032)。生存分析显示,总生存率2年94.2%、3年90.5%,无神经系统相关并发症事件发生率分别为2年95.0%、3年91.2%。结论 CH-VAD术后神经系统并发症发生率低,可能与其全磁悬浮设计、低转速叶轮及优化流道减少血液损伤有关。此外,术前室性心律失常、卒中史、高NT-proBNP水平及瓣膜病变患者可能需要更加谨慎的个体化管理。Objective To evaluate the incidence and clinical characteristics of neurological complications following implantation of the domestically developed fully magnetically levitated centrifugal pump(CH-VAD).Methods 93 patients with end-stage heart failure who underwent CH-VAD implantation at Fuwai Hospital,Chinese Academy of Medical Sciences,from June 2017 to January 1,2025 were included in this retrospective study.Neurological complications(ischemic/hemorrhagic stroke or transient ischemic attack) were defined according to INTERMACS criteria.The survival rates were analyzed using Kaplan-Meier curves,and group comparisons were performed with log-rank tests.Results The median follow-up was 406(194,1262) days,with8 patients(8.60%) experiencing the neurological complications(annualized incidence rate:0.04 events per patientyear),including 1 case of disabling stroke.The complication group exhibited significantly higher preoperative risks:ventricular tachycardia/fibrillation(62.50% vs.23.53%,P=0.030),stroke history(37.50% vs.7.06%,P=0.028),CRT-D implantation rate(37.50% vs.2.35%,P=0.004),severe aortic regurgitation(37.50% vs.5.88%,P=0.028) and elevated N-terminal pro-brain natriuretic peptide(NT-proBNP) levels(7985.00 vs.2869.50 pg/ml,P=0.032).Survival analysis demonstrated overall survival rates of 94.2% at 2 years and 90.5% at 3 years,with neurological complication-free survival rates of 95.0% at 2 years and 91.2% at 3 years.Conclusion CH-VAD demonstrated a low incidence of neurological complications,likely attributable to its fully magnetically levitated design,low rotational speed impeller and optimized flow paths,which reduce blood trauma.Preoperative ventricular arrhythmias,stroke history,elevated NT-proBNP levels and the valvular pathologies warrant vigilant risk stratification and personalized management.

关 键 词：左心室辅助装置 神经系统并发症 全磁悬浮 血液相容性 

分 类 号：R654.2[医药卫生—外科学]