Department of Neurology, Vagelos College of Physicians and Surgeons, and Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
BMC Cardiovasc Disord. 2023 Jan 25;23(1):45. doi: 10.1186/s12872-023-03073-6.
Insertable cardiac monitors (ICMs) are a clinically effective means of detecting atrial fibrillation (AF) in high-risk patients, and guiding the initiation of non-vitamin K oral anticoagulants (NOACs). Their cost-effectiveness from a US clinical payer perspective is not yet known. The objective of this study was to evaluate the cost-effectiveness of ICMs compared to standard of care (SoC) for detecting AF in patients at high risk of stroke (CHADS ≥ 2), in the US.
Using patient data from the REVEAL AF trial (n = 393, average CHADS score = 2.9), a Markov model estimated the lifetime costs and benefits of detecting AF with an ICM or with SoC (specifically intermittent use of electrocardiograms and 24-h Holter monitors). Ischemic and hemorrhagic strokes, intra- and extra-cranial hemorrhages, and minor bleeds were modelled. Diagnostic and device costs, costs of treating stroke and bleeding events and medical therapy-specifically costs of NOACs were included. Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3% per annum, in line with standard practice in the US setting. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken.
Lifetime per-patient cost for ICM was $31,116 versus $25,330 for SoC. ICMs generated a total of 7.75 QALYs versus 7.59 for SoC, with 34 fewer strokes projected per 1000 patients. The model estimates a number needed to treat of 29 per stroke avoided. The incremental cost-effectiveness ratio was $35,528 per QALY gained. ICMs were cost-effective in 75% of PSA simulations, using a $50,000 per QALY threshold, and a 100% probability of being cost-effective at a WTP threshold of $150,000 per QALY.
The use of ICMs to identify AF in a high-risk population is likely to be cost-effective in the US healthcare setting.
可植入式心脏监测器（ICM）是一种临床上有效的检测高危患者心房颤动（AF）的方法，并能指导非维生素 K 口服抗凝剂（NOAC）的起始使用。然而，从美国临床支付方的角度来看，其成本效益尚不清楚。本研究旨在评估与标准护理（SoC）相比，在美使用 ICM 检测 CHADS≥2 高危卒中患者 AF 的成本效益。
使用 REVEAL AF 试验（n=393，平均 CHADS 评分=2.9）的患者数据，采用 Markov 模型估算使用 ICM 或 SoC（具体为间歇性使用心电图和 24 小时动态心电图监测）检测 AF 的终生成本和获益。缺血性和出血性卒中和颅内和颅外出血以及轻微出血均纳入模型。包括诊断和设备成本、卒中及出血事件治疗成本以及具体的抗凝药物成本。成本和健康结果（以质量调整生命年（QALY）衡量）按每年 3%贴现，符合美国标准实践。进行了单因素确定性和概率敏感性分析（PSA）。
与 SoC 相比，ICM 每位患者终生费用为 31116 美元，而 SoC 为 25330 美元。ICM 共产生 7.75 个 QALYs，而 SoC 为 7.59 个，预计每 1000 名患者可减少 34 例卒中。模型估计每治疗 29 例卒中可避免一次治疗。增量成本效益比为每获得 1 个 QALY 增加 35528 美元。在使用 50000 美元/QALY 阈值的 PSA 模拟中，ICM 在 75%的模拟中具有成本效益，在使用 150000 美元/QALY 的意愿支付阈值时，有 100%的概率具有成本效益。
在美国医疗保健环境中，使用 ICM 来识别高危人群中的 AF 可能具有成本效益。
