用心力微电流装置治疗心力衰竭与减少喷射率:C-MIC II开放标签随机对照试验的结果
Jesus E Rame1, Jan D Schmitto2, Dragana N Kosevic3
1Bruce and Robbi Toll Heart and Vascular Institute, Thomas Jefferson University, Philadelphia, PA, USA.
European journal of heart failure
|July 15, 2025
概括
直接微电流疗法 (C-MIC) 在心力衰竭患者中改善了心脏功能. 该C-MIC装置增强了左心室喷射率,减少了症状,改善了生活质量.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 医疗器械 医疗器械
背景情况:
- 心力衰竭中心肌胀与电场变化和左心室功能障碍有关.
- 植入式直微电流治疗 (C-MIC) 对心力衰竭的安全性和有效性尚未得到充分证实.
研究的目的:
- 评估C-MIC治疗在患有非缺血性扩张性心肌病和减少喷射分数的患者的安全性和有效性.
- 评估C-MIC对左心室喷射率 (LVEF),功能能力和生活质量的影响.
主要方法:
- 这是一项随机对照试验,涉及非缺血性扩张性心肌病症的门诊患者 (LVEF 25-35%,NYHA III-IV 类).
- 患者接受了C-MIC装置植入或被分配到对照组,并接受指导方针导向的医学治疗.
- 主要终点是6个月LVEF的变化;次要终点包括6分钟步行距离 (6MWD),堪萨斯城心肌病问卷总结得分 (KCCQ-OSS) 和NYHA功能类.
主要成果:
- 与对照组相比,C-MIC治疗显著改善了LVEF (平均差异:5.1%,p < 0.001).
- 在C-MIC组的患者中,更高比例的患者在NYHA类,KCCQ-OSS和6MWD中表现出改善.
- 没有报告与C-MIC设备相关的重大不良事件.
结论:
- 植入C-MIC器件治疗是安全有效的改善LVEF在患者的非缺血性慢性心力衰竭与减少喷射小部分.
- C-MIC疗法在减少症状,增强功能能力和改善心力衰竭患者的生活质量方面显示出显著的益处.
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