中国慢性心力衰竭患者中左心室多位点起搏有效性和安全性的观察和评价

Efficacy and safety of multipoint pacing in Chinese patients with chronic heart failure

目的评估在中国慢性心力衰竭(CHF)治疗中多位点起搏(MPP)的性能,并获得在中国植入心脏再同步治疗(CRT)的心力衰竭(心衰)人群中MPP程控和使用的经验。方法本研究是一项单组、前瞻性、多中心、非随机观察性研究。在植入带有MPP功能的心脏再同步治疗起搏器(CRT-P)或心脏再同步治疗除颤器(CRT-D)的患者中,收集植入信息、超声心动图指标、临床指标以及不良事件等信息。患者对CRT有反应定义为患者在随访时相比基线的左心室收缩末期容积下降≥15%。结果2016年11月至2019年10月,共有11家医学中心的101例患者入选本研究,实际植入患者99例。患者年龄(61.7±11.3)岁,男73例(74%,73/99),植入成功率为100%,术中不良事件发生率为1.0%。出院前MPP功能开启比例为81%,至12个月随访时MPP功能开启比例为76%。6个月随访时患者的CRT反应率为67.8%,12个月时CRT反应率为73.5%。12个月随访期间,患者的左心室射血分数(43%±13%对27%±9%)、6 min步行距离[(541.6±472.4)m对(320.4±113.5)m]、明尼苏达心衰生活质量评分[(22.5±23.5)分对(45.3±23.6)分]与基线相比均有显著提高,差异有统计学意义(P<0.05)。12个月随访期间,全因死亡率为3.0%,全因住院率为11.1%。结论在中国CHF患者的多中心中长期随访研究中,带有多位点起搏功能的CRT能安全且有效提升患者的超声心动图及临床反应指标。

Objective To evaluate the performance of multipoint pacing(MPP)in a large Chinese heart failure(HF)patient cohort and collect the real-world experience and clinical evidence.Methods A prospective,multi-center,nonrandomized study evaluated patients who received cardiac resynchronization therapy pacemaker(CRT-P)or cardiac resynchronization therapy defibrillator(CRT-D)system with the MPP feature that have been approved in China.Data collected included implant experience,echocardiography parameters,and clinical parameters.Response to cardiac resynchronization therapy(CRT)was defined as an absolute increase of≥15%in left ventricular end systolic volume(LVESV)at follow-up compared to baseline.Results Between November 2016 and October 2019,a total of 101 patients were enrolled from 11 hospitals in China.The CRT system was successfully implanted in 99 cases[average age was(61.7±11.3)years;73(74%,73/99)were male]with acute complication rate of 1.0%.The MPP feature was turned on in 81%of cases before discharge and in 76%of cases after 12 month.Among patients who completed 6-and 12-month follow-up visit,the CRT response rates were 67.8%and 73.5%,respectively.During the 12-month follow-up,the left ventricular ejection fraction(LVEF,43%±13%vs.27%±9%),6-min walk test[(541.6±472.4)m vs.(320.4±113.5)m],and Minnesota Living with Heart Failure Score(22.5±23.5 vs.45.3±23.6)all improved significantly compared to baseline(P<0.05).The all cause mortality rate and all cause hospitalization rate at 12 month were 3.0%and 11.1%,respectively.Conclusion From a large Chinese HF population receiving MPP CRT,we found that MPP is safe and effective for treating HF with significant improvements in clinical outcome and quality of life over one-year follow-up.