Tschöpe Carsten, Butler Javed, Farmakis Dimitrios, Morley Deborah, Rao Ishu, Filippatos Gerasimos
Department of Cardiology, Charité-Berlin University of Medicine, Campus Rudolf Virchow, Berlin, Germany.
Berlin Brandenburg Center for Regenerative Therapies (BCRT), Berlin, Germany.
ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3.
Increasing attention is being given to patients with heart failure and 'mid-range' left ventricular ejection fraction (LVEF, ≥40% and <50%) for whom there are no approved therapies that improve prognosis. We aim to assess for the first time the effects of cardiac contractility modulation (CCM) therapy in this patient population.
We assessed the effects of 6- month CCM therapy on functional status, exercise tolerance and quality of life in a subgroup of 53 patients with a LVEF of 40-45% recruited in previous CCM studies, including 37 patients in the CCM group and 16 in the control group. New York Heart Association classification improved by ≥1 class from baseline to 24 weeks in 80.6% (95% confidence interval [62.5%, 92.5%]) of patients in the CCM group compared with 57.1% in the control group (95% confidence interval [28.9%, 82.3%], P = 0.15). Six-minute walk distance increased significantly in the CCM group with a net between-group treatment effect of 53.9 ± 74.2 m (P = 0.05). Peak VO improved in the CCM group with a net between-group treatment effect of 2.0 ± 2.8 mL/kg/min (P = 0.02). Minnesota Living with Heart Failure Questionnaire score decreased from baseline to 24 weeks with a net between-group treatment effect of -13.1 ± 21.0 (P = 0.10). There were no significant differences in the adverse event rate between the CCM and control groups.
These preliminary results suggest that CCM exerts favourable effects on exercise tolerance and quality of life in patients with LVEF in the range of 40-45% with an acceptable safety profile. Further randomized controlled studies are planned to prove these effects.
心力衰竭且左心室射血分数处于“中等范围”（LVEF，≥40%且<50%）的患者日益受到关注，目前尚无经批准可改善其预后的治疗方法。我们旨在首次评估心脏收缩力调制（CCM）疗法对该患者群体的疗效。
我们评估了6个月CCM疗法对先前CCM研究中招募的53例LVEF为40 - 45%患者亚组的功能状态、运动耐量和生活质量的影响，其中CCM组37例，对照组16例。与对照组57.1%（95%置信区间[28.9%，82.3%]，P = 0.15）的患者相比，CCM组80.6%（95%置信区间[62.5%，92.5%]）的患者从基线到24周纽约心脏协会分级改善≥1级。CCM组6分钟步行距离显著增加，组间净治疗效应为53.9±74.2米（P = 0.05）。CCM组峰值摄氧量改善，组间净治疗效应为2.0±2.8毫升/千克/分钟（P = 0.02）。从基线到24周，明尼苏达心力衰竭生活问卷评分降低，组间净治疗效应为 -13.1±21.0（P = 0.10）。CCM组和对照组之间不良事件发生率无显著差异。
这些初步结果表明，CCM对LVEF在40 - 45%范围内的患者的运动耐量和生活质量具有有益影响，且安全性可接受。计划进行进一步的随机对照研究以证实这些效果。
