Desteghe Lien, Raymaekers Zina, Lutin Mark, Vijgen Johan, Dilling-Boer Dagmara, Koopman Pieter, Schurmans Joris, Vanduynhoven Philippe, Dendale Paul, Heidbuchel Hein
Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium
Heart Center Hasselt, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium.
Europace. 2017 Jan;19(1):29-39. doi: 10.1093/europace/euw025. Epub 2016 Feb 17.
To determine the usability, accuracy, and cost-effectiveness of two handheld single-lead electrocardiogram (ECG) devices for atrial fibrillation (AF) screening in a hospital population with an increased risk for AF.
Hospitalized patients (n = 445) at cardiological or geriatric wards were screened for AF by two handheld ECG devices (MyDiagnostick and AliveCor). The performance of the automated algorithm of each device was evaluated against a full 12-lead or 6-lead ECG recording. All ECGs and monitor tracings were also independently reviewed in a blinded fashion by two electrophysiologists. Time investments by nurses and physicians were tracked and used to estimate cost-effectiveness of different screening strategies. Handheld recordings were not possible in 7 and 21.4% of cardiology and geriatric patients, respectively, because they were not able to hold the devices properly. Even after the exclusion of patients with an implanted device, sensitivity and specificity of the automated algorithms were suboptimal (Cardiology: 81.8 and 94.2%, respectively, for MyDiagnostick; 54.5 and 97.5%, respectively, for AliveCor; Geriatrics: 89.5 and 95.7%, respectively, for MyDiagnostick; 78.9 and 97.9%, respectively, for AliveCor). A scenario based on automated AliveCor evaluation in patients without AF history and without an implanted device proved to be the most cost-effective method, with a provider cost to identify one new AF patient of €193 and €82 at cardiology and geriatrics, respectively. The cost to detect one preventable stroke per year would be €7535 and €1916, respectively (based on average CHADS-VASc of 3.9 ± 2.0 and 5.0 ± 1.5, respectively). Manual interpretation increases sensitivity, but decreases specificity, doubling the cost per detected patient, but remains cheaper than sole 12-lead ECG screening.
Using AliveCor or MyDiagnostick handheld recorders requires a structured screening strategy to be effective and cost-effective in a hospital setting. It must exclude patients with implanted devices and known AF, and requires targeted additional 12-lead ECGs to optimize specificity. Under these circumstances, the expenses per diagnosed new AF patient and preventable stroke are reasonable.
确定两种手持式单导联心电图（ECG）设备在房颤（AF）风险增加的医院人群中进行房颤筛查的可用性、准确性和成本效益。
使用两种手持式心电图设备（MyDiagnostick和AliveCor）对心脏病科或老年病房的住院患者（n = 445）进行房颤筛查。将每种设备的自动算法性能与完整的12导联或6导联心电图记录进行比较评估。所有心电图和监测记录还由两名电生理学家以盲法独立审查。跟踪护士和医生的时间投入，并用于估计不同筛查策略的成本效益。在心脏病科和老年患者中，分别有7%和21.4%的患者无法进行手持式记录，原因是他们无法正确握持设备。即使排除植入设备的患者后，自动算法的敏感性和特异性仍不理想（心脏病科：MyDiagnostick的敏感性和特异性分别为81.8%和94.2%；AliveCor的敏感性和特异性分别为54.5%和97.5%；老年科：MyDiagnostick的敏感性和特异性分别为89.5%和95.7%；AliveCor的敏感性和特异性分别为78.9%和97.9%）。在无房颤病史且无植入设备的患者中，基于AliveCor自动评估的方案被证明是最具成本效益的方法，在心脏病科和老年科，识别一名新房颤患者的医疗服务提供者成本分别为193欧元和82欧元。每年检测到一例可预防中风的成本分别为7535欧元和1916欧元（分别基于平均CHADS-VASc为3.9±2.0和5.0±1.5）。人工解读可提高敏感性，但会降低特异性，使每例检测到的患者成本翻倍，但仍比单独进行12导联心电图筛查便宜。
在医院环境中，使用AliveCor或MyDiagnostick手持式记录仪需要采用结构化筛查策略才能有效且具有成本效益。必须排除植入设备的患者和已知房颤患者，并且需要针对性地额外进行12导联心电图检查以优化特异性。在这些情况下，每例诊断出的新房颤患者和可预防中风的费用是合理的。
