心肌收缩力调节器在心力衰竭患者中的有效性和安全性研究  

Efficacy and safety of cardiac contractility modulation in the treatment of heart failure

作　　者：何姗姗 郭金锐 刘可 李庆 郭雨龙 郭涛 He Shanshan;Guo Jinrui;Liu Ke;Li Qing;Guo Yulong;Guo Tao(Department of Arrhythmia,Fuwai Yunnan Cardiovascular Hospital,Chinese Academy of Medical Sciences,Kunming 650102,China)

机构地区：[1]云南省阜外心血管病医院心律失常中心,昆明650102

出　　处：《中国心血管杂志》2025年第2期178-185,共8页Chinese Journal of Cardiovascular Medicine

基　　金：云南省科技厅科技计划项目(202301AY070001-143)。

摘　　要：目的探讨心肌收缩力调节器(CCM)在心力衰竭(HF)患者中的有效性和安全性。方法前瞻性研究。连续纳入2022年1月至2023年11月由云南省阜外心血管病医院行CCM植入的24例患者,平均年龄(56.6±11.2)岁,男性22例(91.7%)。按照左心室射血分数(LVEF)数值,将患者分为LVEF≤25%组(12例)和LVEF>25%组(12例)。CCM植入术后随访1、3、6和12个月。收集患者临床基线资料、影像学资料、术前化验指标、CCM术中资料、住院期间及术后1、3、6和12个月门诊随访结果,包括患者CCM参数设置、纽约心脏病协会(NYHA)心功能分级、6 min步行距离(6MWD)、N末端B型利钠肽原(NT-proBNP)、左心室舒张末期内径(LVEDD)、LVEF、明尼苏达州心力衰竭生活质量问卷(MLHFQ)评分、术后并发症、术前12个月HF住院率、术后12个月HF再住院率和死亡情况等。比较患者总体及组间CCM植入术前和术后上述指标差异。结果24例患者术后1、3、6和12个月LVEF较术前均有改善(均为P<0.001),术后6和12个月LVEDD和6MWD较术前均有改善(均为P<0.05),术后1、3、6和12个月NT-proBNP和较术前均降低(均为P<0.05)。术后1、3和6个月,NYHA心功能Ⅰ~Ⅱ级例数从0例分别增加至13例(54.2%,13/21)、15例(71.4%,18/21)、18例(85.7%,18/21)(均为P<0.001),总体临床应答率为95.2%(20/21)。术后12个月,NYHA心功能Ⅰ~Ⅱ级例数增加至16例(94.1%,16/17)(P<0.001)。MLHFQ评分术后6和12个月较术前均降低(均为P<0.001)。LVEF≤25%组和LVEF>25%组在术后6和12个月LVEF、LVEDD、MLHFQ、6MWD、NYHA心功能分级的改善程度比较,差异均无统计学意义(均为P>0.05),但术后6个月NT-proBNP改善程度组间比较,差异有统计学意义(P=0.021)。总体及不同LVEF组术后12个月的心功能改善程度均比术后1个月的更明显(均为P<0.05)。患者HF年人均住院次数从研究登记前1年的(3.24±1.68)次/人年降至术后1年的(1.41±1.37)次/人年(P=0.002)。LVEF>25%组患者年人均住院Objective To observe the efficacy and safety of cardiac contractility modulation(CCM)in heart failure patients.Methods A prospective study was conducted.A total of 24 heart failure patients(22 males,91.7%)with a mean age of 56.6±11.2 years who underwent CCM implantation at Yunnan Fuwai Cardiovascular Hospital from January 2022 to November 2023 were consecutively included.According to the LVEF level,patients were divided into LVEF≤25%group(12 cases)and LVEF>25%group(12 cases).Clinical data of all patients during hospital and 1,3,6 and 12 months after CCM implantation,including record pacing parameters(threshold,sensing and impedance),New York Heart Association(NYHA)functional classification,6-minute walk distance(6MWD),N-terminal pro-brain natriuretic peptide(NT-proBNP),left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF),Minnesota living with heart failure questionnaire(MLHFQ)scores,and perioperative complications,heart failure readmission and mortality were collected.Results Compared with that before CCM implantation,the average LVEF was improved at 1,3,6 and 12 months after CCM implantation(all P<0.001),LVEDD and 6MWD were improved at 6 and 12 months after CCM implantation(all P<0.05);NT-proBNP was decreased at 1,3,6 and 12 months after CCM implantation(all P<0.05).At 1,3 and 6 months after CCM implantation,the number of NYHA patients with grade I to II cardiac function increased from 0 to 13(54.2%,13/21),15(71.4%,18/21)and 18(85.7%,18/21),respectively(all P<0.001),and the overall clinical response rate was 95.2%(20/21).The number of NYHA patients with grade I to II cardiac function increased to 16 at 12 months after CCM implantation(94.1%,16/17)(P<0.001).MLHFQ scores at 6 and 12 months after CCM implantation were lower than those before CCM implantation(both P<0.001).There was no statistically significant difference in the extent of improvement of LVEF,LVEDD,MLHFQ,6MWD and NYHA cardiac function classification between the LVEF≤25%group and the LVEF>25%group at 6 and 12 mo

关 键 词：心力衰竭 心肌收缩力调节器 有效性 安全性 

分 类 号：R541.6[医药卫生—心血管疾病]