IQVIA , Vilvoorde , Belgium.
Performation Healthcare , Bilthoven , the Netherlands.
J Med Econ. 2019 Nov;22(11):1221-1234. doi: 10.1080/13696998.2019.1663355.
Atrial fibrillation (AF) is the most common arrhythmia and a major marker of ischemic stroke risk. Early detection is crucial and, once diagnosed, anticoagulation therapy can be initiated to reduce stroke risk. The aim of this study was to assess the cost-effectiveness of employing an insertable cardiac monitor (ICM), BIOMONITOR, for the detection of AF compared to standard of care (SoC) ECG and Holter monitoring in patients with cryptogenic stroke, that is, stroke of unknown origin and where paroxysmal, silent AF is suspected. A Markov model was developed which consisted of five main health states reflecting the potential lifetime evolution of the AF disease: post cryptogenic stroke (index event), subsequent mild, moderate and severe stroke, and death. Sub-states were included to track a patient's AF diagnostic status and the use of antiplatelet or anticoagulant therapy. AF detection was assumed to result in a treatment switch from aspirin to anticoagulants, except among those with a history of major bleeding. Detection yield and accuracy, clinical actions and treatment effects were derived from the literature and validated by an expert clinician. All relevant costs from a US Medicare perspective were included. An ICM-based strategy was associated with a reduction of 37 secondary ischemic strokes per 1000 patients monitored compared with SoC. Total per-patient costs with an ICM were higher (US$90,052 vs. US$85,157) although stroke-related costs were reduced. The use of an ICM was associated with a base-case incremental cost-effectiveness ratio of US$18,487 per life year gained compared with SoC and US$25,098 per quality-adjusted life year gained, below established willingness-to-pay thresholds. The conclusions were found to be robust over a range of input values. From a US Medicare perspective the use of a BIOMONITOR ICM represents a cost-effective diagnostic strategy for patients with cryptogenic stroke and suspected AF.
心房颤动（AF）是最常见的心律失常，也是缺血性中风风险的主要标志物。早期发现至关重要，一旦确诊，可启动抗凝治疗以降低中风风险。本研究旨在评估与标准护理（SoC）心电图和动态心电图监测相比，使用植入式心脏监测仪（ICM）BIOMONITOR 检测隐源性中风（即病因不明且怀疑阵发性、无症状 AF）患者 AF 的成本效益。开发了一个马尔可夫模型，该模型由五个主要健康状态组成，反映了 AF 疾病潜在的终生演变：隐源性中风后（指数事件）、随后的轻度、中度和重度中风以及死亡。包括亚状态以跟踪患者的 AF 诊断状态和抗血小板或抗凝治疗的使用情况。假设 AF 检测会导致从阿司匹林转为抗凝剂的治疗转换，除非有大出血史的患者。检测结果和准确性、临床操作和治疗效果均来自文献，并由临床专家进行验证。所有相关成本均来自美国医疗保险的角度。与 SoC 相比，基于 ICM 的策略与每 1000 名监测患者中减少 37 例继发性缺血性中风相关。尽管中风相关成本降低，但使用 ICM 的每位患者的总成本较高（90052 美元对 85157 美元）。与 SoC 相比，ICM 的使用具有较低的增量成本效益比（每获得 1 个生命年增加 18487 美元，每获得 1 个质量调整生命年增加 25098 美元），低于既定的支付意愿阈值。在一系列输入值下，结论都是稳健的。从美国医疗保险的角度来看，使用 BIOMONITOR ICM 代表了一种针对隐源性中风和疑似 AF 患者的具有成本效益的诊断策略。
