[Short-term efficacy and safety of cardiac contractility modulation in patients with heart failure]

Zhonghua Xin Xue Guan Bing Za Zhi. 2024 Apr 24;52(4):391-396. doi: 10.3760/cma.j.cn112148-20231009-00274.
[Article in Chinese]

Abstract

Objective: To investigate the short-term efficacy and safety of cardiac contractility modulation (CCM) in patients with heart failure. Methods: This was a cross-sectional study of patients with heart failure who underwent CCM placement at the First Affiliated Hospital of Xinjiang Medical University from February to June 2022. With a follow-up of 3 months, CCM sensation, impedance, percent output, and work time were monitored, and patients were compared with pre-and 3-month postoperative left ventricular ejection fraction (LVEF) values, and 6-minute walk test distance and New York Heart Association (NYHA) cardiac function classification, and the occurrence of complications was recorded. Results: CCM was successfully implanted in all 9 patients. Seven(7/9) of them were male, aged (56±14) years, 3 patients had ischaemic cardiomyopathy and 6 patients had dilated cardiomyopathy. At 3-month postoperative follow-up, threshold was stable, sense was significantly lower at follow-up than before (right ventricle: (16.3±7.0) mV vs. (8.2±1.1) mV, P<0.05; local sense: (15.7±4.9) mV vs. (6.7±2.5) mV, P<0.05), and impedance was significantly lower at follow-up than before (right ventricle (846±179) Ω vs. (470±65) Ω, P<0.05, local sense: (832±246) Ω vs. (464±63) Ω, P<0.05). The CCM output percentage was (86.9±10.7) %, the output amplitude was (6.7±0.4) V, and the daily operating time was (8.6±1.0) h. LVEF was elevated compared to preoperative ((29.4±5.2) % vs. (38.3±4.3) %, P<0.05), the 6-minute walk test was significantly longer than before ((96.8±66.7)m vs. (289.3±121.7)m, P<0.05). No significant increase in the number of NYHA Class Ⅲ-Ⅳ patients was seen (7/9 vs. 2/9, P>0.05). The patient was not re-hospitalised for worsening heart failure symptoms, had no malignant arrhythmic events and experienced significant relief of symptoms such as chest tightness and shortness of breath. No postoperative complications related to pocket hematoma, pocket infection and rupture, electrode detachment, valve function impairment, pericardial effusion, or cardiac perforation were found. Conclusions: CCM has better short-term safety and efficacy in patients with heart failure.

目的: 探讨心肌收缩调节器(CCM)在心力衰竭患者中的短期有效性及安全性。 方法: 该研究为横断面研究,纳入2022年2至6月于新疆医科大学第一附属医院接受CCM置入的心力衰竭患者。随访3个月,监测CCM感知、阻抗、输出百分比、工作时间,比较患者术前及术后3个月左心室射血分数值(LVEF)、6 min步行试验距离和纽约心脏协会(NYHA)心功能分级,记录并发症及不良事件发生情况。 结果: 纳入的9例患者均成功置入CCM。其中男性7例,年龄(56±14)岁,3例患者为缺血性心肌病,6例患者为扩张性心肌病。术后3个月随访结果显示,CCM阈值平稳,感知较术中下降[右心室:(8.2±1.1)mV比(16.3±7.0)mV,P<0.05;局部感知电极:(6.7±2.5)mV比(15.7±4.9)mV,P<0.05],阻抗较术中明显下降[右心室:(470±65)Ω比(846±179)Ω,P<0.05;局部感知电极:(464±63)Ω比(832±246)Ω,P<0.05];CCM输出百分比为(86.9±10.7)%,输出幅度为(6.7±0.4)V,工作时间为(8.6±1.0)h/d。患者LVEF较术前升高[(38.3±4.3)%比(29.4±5.2)%,P<0.05],6 min步行试验距离较术前延长[(289.3±121.7)m比(96.8±66.7)m,P<0.05],NYHA Ⅲ~Ⅳ级患者比例下降,但差异无统计学意义(2/9比7/9,P>0.05)。患者未有因心力衰竭症状加重再次入院,无恶性心律失常事件发生,且胸闷、气短等症状明显缓解。术后未发现囊袋血肿、囊袋感染及破溃、电极脱落、瓣膜功能损害、心包积液、心脏穿孔等相关并发症。 结论: CCM具有较好的短期安全性及有效性。.

Publication types

  • English Abstract

MeSH terms

  • Aged
  • Cross-Sectional Studies
  • Female
  • Heart Failure* / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Myocardial Contraction*
  • Stroke Volume
  • Treatment Outcome
  • Ventricular Function, Left