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正常 QRS 时限心力衰竭中心脏收缩力调节装置的成本效益。

Cost-effectiveness of a cardiac contractility modulation device in heart failure with normal QRS duration.

机构信息

Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.

Heart Center of Göttingen, University Medical Center Göttingen, Göttingen, Germany.

出版信息

ESC Heart Fail. 2019 Dec;6(6):1178-1187. doi: 10.1002/ehf2.12526.

Abstract

AIMS

The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service.

METHODS AND RESULTS

We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life. We conducted the analysis in line with the National Institute for Health and Care Excellence reference case, modelling costs from an English National Health Service perspective, and considering outcomes in quality-adjusted life years (QALYs) over a patient lifetime perspective. Our base case analysis produced an incremental cost per additional QALY of GBP22 988 (€25 750) when comparing Optimizer + SoC to SoC alone. This result was not sensitive to parameter uncertainty but was sensitive to the time horizon over which costs and QALYs were captured and the duration over which a survival benefit with Optimizer + SoC can be assumed to apply.

CONCLUSIONS

Cardiac contractility modulation is likely to be cost-effective in people with heart failure with reduced ejection fraction, NYHA III, and narrow QRS, provided that the treatment benefit can be maintained beyond the duration of the existing clinical trial follow-up. This analysis supports the current recommendations of the European Society of Cardiology that this therapy may be considered for such patients.

摘要

目的

本文旨在评估心脏收缩力调节(通过优化器系统)加标准治疗(SoC)是否比单独的 SoC 更具成本效益,用于治疗心力衰竭患者[纽约心脏协会(NYHA)III 级、左心室射血分数为 25-45%和窄 QRS],从英国国家医疗服务体系的角度来看。

方法和结果

我们使用来自三个随机对照试验(FIX-HF-5 第 1 阶段和第 2 阶段和 FIX-HF-5C)的个体患者数据,开发了一种基于回归方程的成本效益模型,以填充大多数参数。一系列回归方程预测了 NYHA 分级随时间的变化、死亡率、全因住院率和健康相关生活质量。我们按照英国国家卫生与保健卓越研究所的参考案例进行分析,从英国国家医疗服务体系的角度建模成本,并考虑患者终身的质量调整生命年(QALY)结果。我们的基础案例分析得出,与单独使用 SoC 相比,Optimizer+SoC 每增加一个 QALY 的增量成本为 22,988 英镑(25,750 欧元)。这一结果不受参数不确定性的影响,但对成本和 QALY 的捕获时间范围以及 Optimizer+SoC 的生存获益可以假设适用的时间范围敏感。

结论

在射血分数降低、NYHA III 级和窄 QRS 的心力衰竭患者中,心脏收缩力调节可能具有成本效益,前提是治疗益处可以在现有临床试验随访期之外维持。这项分析支持欧洲心脏病学会目前的建议,即可以考虑为这些患者提供这种治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9aad/6989288/faf66ee941c5/EHF2-6-1178-g001.jpg

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