EVAHEART I全植入式心室辅助装置治疗心力衰竭长期疗效:附15例3年临床随访结果  

Long-term outcome of EVAHEART I implantable ventricular assist device for the treatment of end stage heart failure:clinical 3-year follow-up results of 15 cases

作　　者：陈海波 王现强 杜娟 石佳 吉冰洋 石丽 施怡声 周星彤 杨晓涵 胡盛寿 Chen Haibo;Wang Xianqiang;Du Juan;Shi Jia;Ji Bingyang;Shi Li;Shi Yisheng;Zhou Xingtong;Yang Xiaohan;Hu Shengshou(Department of Cardiac Surgery,Fuwai Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,National Center for Cardiovascular Diseases,State Key Laboratory of Cardiovascular Disease,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、阜外医院心外科心血管疾病国家重点实验室,北京100037

出　　处：《中华心血管病杂志》2023年第4期393-399,共7页Chinese Journal of Cardiology

基　　金：高水平医院临床科研项目(2022-GSP-QZ-7);深圳三名工程项目(SZSM201911018);深圳市医学重点学科建设项目(SZXK080)。

摘　　要：目的评价可植入式心室辅助系统EVAHEART I治疗心力衰竭的长期有效性和安全性。方法连续纳入15例于2018年1月至2021年12月在阜外医院心外科接受左心室辅助装置EVAHEART I治疗的终末期心力衰竭患者,对其临床资料进行回顾性分析。评价植入左心室辅助装置前、术后1、6、12、24和36个月的心功能、肝肾功能、纽约心脏病协会(NYHA)分级、6 min步行距离、生活质量评分等。记录患者在长期携带左心室辅助装置期间有无驱动线缆感染、溶血、脑血管事件、机械故障、异常功耗增高、泵流量异常。随访1、2和3年生存率。结果15例患者均为男性,平均年龄(43.0±7.5)岁,其中扩张型心肌病11例,缺血性心肌病2例,瓣膜性心脏病2例,所有患者血流动力学稳定均依赖1种以上静脉血管活性药物,3例患者行术前主动脉球囊反搏(IABP)支持。同植入装置前比较,患者植入后1周的左心室舒张末内径(LVEDD)显著减小[(80.93±6.69)mm比(63.73±6.31)mm,P<0.05],脑钠肽、总胆红素和肌酐均显著降低[(3544.85±1723.77)ng/L比(770.80±406.39)ng/L;(21.28±10.51)μmol/L比(17.39±7.68)μmol/L;(95.82±34.88)μmol/L比(77.32±43.81)μmol/L;P均<0.05]。本组15例患者术前NYHA分级均为NYHAⅣ级,术后1个月9例患者可恢复到NYHAⅢ级,3例恢复到Ⅱ级,3例恢复到Ⅰ级,术后6个月15例患者均恢复到Ⅰ~Ⅱ级;同术前相比较,患者植入术后1个月的6 min步行距离、生活质量总评分和视觉模拟评分均显著增加或改善(P<0.05)。15例患者植入EVAHEART I的转速在1700~1950转/min之间,流量3.2~4.5 L/min,功耗3~9 W,1、2和3年生存率分别为100%、87%和80%,3例患者分别于术后412、610和872 d死于多器官功能衰竭。在长期携带装置期间,3例患者分别于术后170、220和475 d发生驱动线缆感染,经换药治愈。1例患者因菌血症于术后155 d接受心脏移植。3例发生短暂性脑缺血发作,1例发生出血性脑卒中事件,均Objective To evaluate the long-term efficacy and safety of the implantable ventricular assist system EVAHEART I in clinical use.Methods Fifteen consecutive patients with end-stage heart failure who received left ventricular assist device therapy in Fuwai Hospital from January 2018 to December 2021 were enrolled in this study,their clinical data were retrospectively analyzed.Cardiac function,liver and kidney function,New York Heart Association(NYHA)classification,6-minute walk distance and quality of life were evaluated before implantation and at 1,6,12,24 and 36 months after device implantation.Drive cable infection,hemolysis,cerebrovascular events,mechanical failure,abnormally high-power consumption and abnormal pump flow were recorded during follow up.Results All 15 patients were male,mean average age was(43.0±7.5)years,including 11 cases of dilated cardiomyopathy,2 cases of ischemic cardiomyopathy,and 2 cases of valvular heart disease.All patients were hemodynamically stable on more than one intravenous vasoactive drugs,and 3 patients were supported by preoperative intra aortic balloon pump(IABP).Compared with before device implantation,left ventricular end-diastolic dimension(LVEDD)was significantly decreased((80.93±6.69)mm vs.(63.73±6.31)mm,P<0.05),brain natriuretic peptide(BNP),total bilirubin and creatinine were also significantly decreased((3544.85±1723.77)ng/L vs.(770.80±406.39)ng/L;(21.28±10.51)μmol/L vs.(17.39±7.68)μmol/L;(95.82±34.88)μmol/L vs.(77.32±43.81)μmol/L;P<0.05)at 1 week after device implantation.All patients in this group were in NYHA classⅣbefore implantation,and 9 patients could recover to NYHA classⅢ,3 to classⅡ,and 3 to classⅠat 1 month after operation.All patients recovered to classⅠ-Ⅱat 6 months after operation.The 6-minute walk distance,total quality of life and visual analogue scale were significantly increased and improved at 1 month after implantation compared with those before operation(P<0.05).All patients were implanted with EVAHEART I at speeds between

关 键 词：心力衰竭 左心室辅助装置 并发症 生存 临床疗效 

分 类 号：R541.6[医药卫生—心血管疾病]