不适合心脏移植的终末期心力衰竭患者使用左心室辅助装置的成本效用：经济评估的系统评价和批判性评估。

The cost-utility of left ventricular assist devices for end-stage heart failure patients ineligible for cardiac transplantation: a systematic review and critical appraisal of economic evaluations.

机构信息

1 ME-TA, Medical Evaluation and Technology Assessment, Belgium ; 2 Independent researcher, the Netherlands ; 3 Department of Cardiology, University Medical Centre Utrecht, Utrecht, the Netherlands.

出版信息

Ann Cardiothorac Surg. 2014 Sep;3(5):439-49. doi: 10.3978/j.issn.2225-319X.2014.09.02.

DOI:10.3978/j.issn.2225-319X.2014.09.02

PMID:25452904

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4229461/

Abstract

BACKGROUND

A health technology assessment (HTA) of left ventricular assist devices (LVADs) as destination therapy in patients with end-stage heart failure was commissioned by the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)]. In this context, a systematic review of the economic literature was performed to assess the procedure's value for money.

METHODS

A systematic search (updated in December 2013) for economic evaluations was performed by consulting various databases: the HTA database produced by the Centre for Reviews and Dissemination (CRD HTA), websites of HTA institutes, CRD's National Health Service Economic Evaluation Database (NHS EED), Medline (OVID) and EMBASE. No time or language restrictions were imposed and pre-defined selection criteria were used. The two-step selection procedure was performed by two people. References of the selected studies were checked for additional relevant citations.

RESULTS

Six relevant studies were selected. Four economic evaluations relied on the results of the REMATCH trial to compare a pulsatile-flow LVAD with optimal medical therapy (OMT). These evaluations were performed before the publication of the HeartMate II (HM-II) Destination Therapy Trial which compared a pulsatile-flow with a continuous-flow LVAD. Two more recent economic evaluations combined the results of both trials to make an indirect comparison of a continuous-flow LVAD with OMT. In all studies, the largest part of the incremental cost was due to the reimplantation cost of an LVAD, with a device cost of €58,000-€75,000 and about €55,000 for the surgical procedure. The survival gain was highest with a continuous-flow LVAD, up to about three life-years gained (LYG) versus OMT in the most optimistic study. Quality of life (QoL) was improved but measures with a generic utility instrument were lacking, making estimates on quality-adjusted life-years (QALYs) gained more uncertain. Incremental cost-effectiveness ratios of the two most recent studies were on average €107,600 and $198,184 (ca.€145,800) per QALY gained.

CONCLUSIONS

Although LVAD destination therapy improves survival and QoL, it remains questionable as to whether it offers value for money. This conclusion may alter if the price of the device/procedure decreases sufficiently, in combination with further improved outcomes for mortality, adverse events and QoL.

摘要

背景

荷兰医疗保健保险公司[荷兰医疗保健保险委员会（CVZ）]委托对左心室辅助装置（LVAD）作为终末期心力衰竭患者的目标治疗进行卫生技术评估（HTA）。在此背景下，对经济文献进行了系统回顾，以评估该程序的性价比。

方法

通过查阅各种数据库，对经济评估进行了系统搜索（2013 年 12 月更新）：中心审查和传播（CRD HTA）制作的 HTA 数据库、HTA 机构的网站、CRD 的国家卫生服务经济评估数据库（NHS EED）、Medline（OVID）和 EMBASE。未施加时间或语言限制，并使用了预定义的选择标准。由两个人进行两步选择程序。对所选研究的参考文献进行了检查，以查找其他相关引文。

结果

选择了 6 项相关研究。四项经济评估依赖于 REMATCH 试验的结果，比较了脉动流 LVAD 与最佳药物治疗（OMT）。这些评估是在 HeartMate II（HM-II）目标治疗试验公布之前进行的，该试验比较了脉动流与连续流 LVAD。另外两项更近期的经济评估结合了两项试验的结果，对连续流 LVAD 与 OMT 进行了间接比较。在所有研究中，增量成本的最大部分归因于 LVAD 的再植入成本，设备成本为 58,000-75,000 欧元，手术费用约为 55,000 欧元。在最乐观的研究中，连续流 LVAD 的生存获益最高，可达约 3 个生命年（LYG）相对于 OMT。生活质量（QoL）得到改善，但缺乏通用效用工具的措施，使得对质量调整生命年（QALY）获益的估计更加不确定。两项最新研究的增量成本效益比平均为每获得 1 个 QALY 的 107,600 欧元和 198,184 美元（约 145,800 欧元）。