Lynd Larry D, O'Brien Bernie J
Centre for Evaluation of Medicines, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S99-103. doi: 10.1046/j.1540-8167.14.s9.3.x.
Implantable cardioverter defibrillator (ICD) therapy is indicated for patients at risk for sudden cardiac death (SCD) due to ventricular tachycardia (VT) or ventricular fibrillation (VF). The high relative cost of therapy with the ICD versus antiarrhythmic drugs has raised questions regarding its cost-effectiveness. To address these questions, we review the literature on ICD cost-effectiveness.
MEDLINE and other databases were searched for articles published since 1980 reporting original data on the cost-effectiveness of ICD versus drug therapy for patients at risk for SCD. Data on costs and life-years were abstracted and studies grouped into decision analysis models and trial-based analyses. Cost-effectiveness ratios were inflated to 2002 US dollars. Thirteen economic studies were included in this review: 6 decision-analytic models, 4 economic analysis alongside randomized controlled trials, and 1 observational study. Two additional studies evaluated the cost-effectiveness of ICDs stratified by mortality risk. Studies varied in time horizon, and in all but one study ICD therapy was more costly than drug therapy. Early models assumed larger survival benefits than were observed in subsequent trials; therefore, ICDs appeared to be more cost-effective (i.e., US dollars 28000-US dollars 60000 per life-year gained). Three large clinical trial-based studies estimated that the cost per life-year gained was between US dollars 30181 and US dollars 185000. Stratified analyses show that patients at higher risk for mortality due to structural heart disease (e.g., left ventricular ejection fraction <35%) benefit more from ICD therapy, resulting in lower cost-effectiveness ratios.
ICD therapy continues to evolve with changing methods of implantation and improving technology. Current evidence suggests that ICDs may be a cost-effective option in patients at high risk for VT/VF. The cost-effectiveness of ICD therapy for primary and secondary prevention of SCD depends upon patient characteristics that influence their prior risk of mortality. Further research on patient selection criteria and the measurement of health-related quality of life is required.
植入式心脏复律除颤器（ICD）疗法适用于因室性心动过速（VT）或室颤（VF）而有心脏性猝死（SCD）风险的患者。与抗心律失常药物相比，ICD疗法的相对成本较高，这引发了关于其成本效益的问题。为了解决这些问题，我们回顾了有关ICD成本效益的文献。
检索了MEDLINE及其他数据库，以查找自1980年以来发表的报告ICD与药物疗法对SCD风险患者成本效益的原始数据的文章。提取了成本和生命年的数据，并将研究分为决策分析模型和基于试验的分析。成本效益比折算为2002年美元。本综述纳入了13项经济学研究：6个决策分析模型、4项与随机对照试验并行的经济分析以及1项观察性研究。另外两项研究评估了按死亡风险分层的ICD的成本效益。研究的时间范围各不相同，除一项研究外，所有研究中ICD疗法的成本均高于药物疗法。早期模型假定的生存获益比后续试验中观察到的更大；因此，ICD似乎更具成本效益（即每获得一个生命年28000美元至60000美元）。三项基于大型临床试验的研究估计，每获得一个生命年的成本在30181美元至185000美元之间。分层分析表明，因结构性心脏病导致死亡风险较高的患者（例如左心室射血分数<35%）从ICD疗法中获益更多，从而使成本效益比更低。
随着植入方法的不断变化和技术的不断改进，ICD疗法也在不断发展。目前的证据表明，ICD对于VT/VF高风险患者可能是一种具有成本效益的选择。ICD疗法用于SCD一级和二级预防的成本效益取决于影响患者既往死亡风险的特征。需要对患者选择标准和健康相关生活质量的测量进行进一步研究。
