Department of Translational Medical Sciences, "Federico II" University of Naples, Via S. Pansini 5, Naples, 80131, Italy.
Advent Health Transplant Institute, Orlando, FL, USA.
ESC Heart Fail. 2020 Oct;7(5):2922-2932. doi: 10.1002/ehf2.12902. Epub 2020 Jul 23.
Cardiac contractility modulation, also referred to as CCM™, has emerged as a promising device treatment for heart failure (HF) in patients not indicated for cardiac resynchronization therapy. We performed a comprehensive individual patient data meta-analysis of all non-confounded prospective randomized controlled trials of CCM vs. control that have measured functional capacity and/or quality of life questionnaires in patients with HF.
The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in January 2020 to identify eligible randomized controlled trials. We also asked the sole manufacturer of the device for their list of known trials. Primary outcomes of interest were peak oxygen consumption (peak VO ), 6 min walk test distance, and quality of life measured by Minnesota Living with Heart Failure Questionnaire (MLWHFQ), and all data were received as individual patient and individual time point data-points. Mean differences and 95% confidence intervals (CIs) were calculated for continuous data using a fixed-effects model. Five trials were identified, four randomized studies enrolling 801 participants for all endpoints of interest, and for peak VO alone (n = 60), there was an additional single arm non-randomized trial (FIX-HF-5C2) with a prospective comparison of its 24 week peak VO data compared with the control group of the FIX-HF-5C control patients. Pooled analysis showed that, compared with control, CCM significantly improved peak VO (mean difference +0.93, 95% CI 0.56 to 1.30 mL/kg/min, P < 0.00001), 6 min walk test distance (mean difference +17.97, 95% CI 5.48 to 30.46 m, P = 0.005), and quality of life measured by MLWHFQ (mean difference -7.85, 95% CI -10.76 to -4.94, P < 0.00001). As a sensitivity analysis, we excluded the FIX-HF-5C2 trial (only relevant for peak VO ), and the result was similar, mean difference +0.65, 95% CI 0.21 to 1.08 mL/kg/min, P = 0.004.
This comprehensive meta-analysis of individual patient data from all known randomized trials has shown that CCM provides statistically significant and clinically meaningful benefits in measures of functional capacity and HF-related quality of life.
心脏收缩力调节，也称为 CCM，已成为一种有前途的设备治疗方法，适用于不适合心脏再同步治疗的心力衰竭（HF）患者。我们对所有非混杂的前瞻性随机对照试验进行了综合的个体患者数据荟萃分析，这些试验测量了心力衰竭患者的功能能力和/或生活质量问卷。
2020 年 1 月，我们在 Cochrane 对照试验中心注册数据库、MEDLINE 和 EMBASE 中进行了检索，以确定合格的随机对照试验。我们还向设备的唯一制造商询问了他们已知试验的列表。主要研究终点为峰值摄氧量（peak VO ）、6 分钟步行试验距离和明尼苏达州心力衰竭生活质量问卷（MLWHFQ）测量的生活质量，所有数据均作为个体患者和个体时间点数据点收到。使用固定效应模型计算连续数据的均数差值和 95%置信区间（CI）。确定了五项试验，其中四项随机研究共纳入 801 名参与者，对所有感兴趣的终点进行了研究，单独对峰值 VO 进行分析（n = 60），还进行了一项额外的单臂非随机试验（FIX-HF-5C2），对其 24 周峰值 VO 数据与 FIX-HF-5C 对照组进行了前瞻性比较。汇总分析显示，与对照组相比，CCM 显著改善了峰值 VO（平均差值+0.93，95%CI 0.56 至 1.30 mL/kg/min，P < 0.00001）、6 分钟步行试验距离（平均差值+17.97，95%CI 5.48 至 30.46 m，P = 0.005）和明尼苏达州心力衰竭生活质量问卷（MLWHFQ）测量的生活质量（平均差值-7.85，95%CI -10.76 至-4.94，P < 0.00001）。作为敏感性分析，我们排除了 FIX-HF-5C2 试验（仅与峰值 VO 相关），结果相似，平均差值+0.65，95%CI 0.21 至 1.08 mL/kg/min，P = 0.004。
本研究对所有已知随机试验的个体患者数据进行了综合荟萃分析，结果表明 CCM 在功能能力和心力衰竭相关生活质量的测量中提供了具有统计学意义和临床意义的益处。
