射血分数降低的心力衰竭（HFrEF）患者 NYHA 心功能 II 级者是否能从 CCM 治疗中获益？MAINTAINED 观察性研究结果。
Should HFrEF patients with NYHA class II expect benefit from CCM therapy? Results from the MAINTAINED observational study.
机构信息
Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Department of Geriatrics, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
出版信息
Clin Res Cardiol. 2022 Nov;111(11):1286-1294. doi: 10.1007/s00392-022-02089-w. Epub 2022 Sep 3.
BACKGROUND
Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II).
PURPOSE
To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study).
METHODS
Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score.
RESULTS
A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: - 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients).
CONCLUSIONS
NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement.
背景
心脏收缩力调节（CCM）是一种经美国食品药品监督管理局批准的设备治疗方法，适用于难治性收缩性心力衰竭且 QRS 波群宽度正常的患者。随机试验主要证明了 CCM 对严重心力衰竭（>NYHA 心功能分级 II 级）患者的益处。
目的
为了更好地了解临床实践中的个体化适应证，我们在大型临床注册研究（MAINTAINED 观察性研究）中比较了基线 NYHA 心功能分级 II 级与 NYHA 心功能分级 III 级或 IV 级患者在 5 年期间接受 CCM 的效果。
方法
将 NYHA 心功能分级、左心室射血分数（LVEF）、三尖瓣环平面收缩期位移（TAPSE）、NT-proBNP 水平和 KDIGO 慢性肾脏病分期作为功能参数进行比较。此外，还比较了 3 年内的死亡率与 Meta-Analysis Global Group in Chronic heart failure 风险评分的预测值。
结果
共纳入 172 例患者进行分析（10%为 NYHA 心功能分级 II 级）。只有 NYHA 心功能分级 III/IV 级的患者在接受 CCM 治疗 5 年后 NYHA 心功能分级显著改善（II 级：0.1±0.6；p=0.96 与 III/IV 级：-0.6±0.6；p<0.0001）。两组患者的 LVEF 均显著改善（II 级：4.7±8.3；p=0.0072 与 III/IV 级：7.0±10.7%；p<0.0001），而 TAPSE 仅在 NYHA 心功能分级 III/IV 级患者中显著改善（II 级：2.2±1.6；p=0.20 与 III/IV 级：1.8±5.2mm；p=0.0397）。两组患者在接受 CCM 治疗 5 年后 LVEF 改善情况相当（p=0.83）。NYHA 心功能分级 II 级患者的 NT-proBNP 基线水平明显较低（858[175/6887]ng/L 与 2632[17/28830]ng/L；p=0.0044），治疗后有所下降（399[323/1497]ng/L 与 901[13/18155]ng/L；p=0.61）。实际 3 年死亡率为 17%和 26%，而预测死亡率分别为 31%和 42%（NYHA 心功能分级 III/IV 级患者 p=0.0038）。
结论
与预测风险相比，NYHA 心功能分级 III/IV 级患者接受 CCM 治疗后，其心功能改善更为直接和广泛，且具有生存获益。然而，我们的数据表明 NYHA 心功能分级 II 级患者可能也能从 LVEF 改善的持续积极影响中获益。
Zotero 插件