Femke Wouters, Henri Gruwez, Christophe Smeets, Anessa Pijalovic, Wouter Wilms, Julie Vranken, Zoë Pieters, Hugo Van Herendael, Dieter Nuyens, Maximo Rivero-Ayerza, Pieter Vandervoort, Peter Haemers, Laurent Pison
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The participants were instructed to perform heart rhythm measurements using a handheld 6-lead electrocardiogram (ECG) device (KardiaMobile 6L), a smartwatch-derived single-lead ECG (Apple Watch), and two PPG-based smartphone apps (FibriCheck and Preventicus) in a random sequence, with simultaneous 12-lead reference ECG as the gold standard.</p><p><strong>Results: </strong>A total of 122 participants were included in the study: median age 69 (IQR 61-77) years, 63.9% (n=78) men, 25% (n=30) with AF, 9.8% (n=12) without prior smartphone experience, and 73% (n=89) without experience in using a smartwatch. The sensitivity to detect AF was 100% for all devices. The specificity to detect sinus rhythm was 96.4% (95% CI 89.5%-98.8%) for KardiaMobile 6L, 97.8% (95% CI 91.6%-99.5%) for Apple Watch, 98.9% (95% CI 92.5%-99.8%) for FibriCheck, and 97.8% (95% CI 91.5%-99.4%) for Preventicus (P=.50). Insufficient quality measurements were observed in 10.7% (95% CI 6.3%-17.5%) of cases for both KardiaMobile 6L and Apple Watch, 7.4% (95% CI 3.9%-13.6%) for FibriCheck, and 14.8% (95% CI 9.5%-22.2%) for Preventicus (P=.21). Participants preferred Apple Watch over the other devices to monitor their heart rhythm.</p><p><strong>Conclusions: </strong>In this study population, the discrimination between sinus rhythm and AF using CWDs based on ECG or PPG was highly accurate, with no significant variations in performance across the examined devices.</p>","PeriodicalId":14841,"journal":{"name":"JMIR Formative Research","volume":"9 ","pages":"e65139"},"PeriodicalIF":2.0000,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11737281/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparative Evaluation of Consumer Wearable Devices for Atrial Fibrillation Detection: Validation Study.\",\"authors\":\"Femke Wouters, Henri Gruwez, Christophe Smeets, Anessa Pijalovic, Wouter Wilms, Julie Vranken, Zoë Pieters, Hugo Van Herendael, Dieter Nuyens, Maximo Rivero-Ayerza, Pieter Vandervoort, Peter Haemers, Laurent Pison\",\"doi\":\"10.2196/65139\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Consumer-oriented wearable devices (CWDs) such as smartphones and smartwatches have gained prominence for their ability to detect atrial fibrillation (AF) through proprietary algorithms using electrocardiography or photoplethysmography (PPG)-based digital recordings. 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引用次数: 0
摘要
背景：面向消费者的可穿戴设备（CWDs），如智能手机和智能手表，通过使用基于心电图或光电体积脉搏波（PPG）的数字记录的专有算法检测心房颤动（AF）的能力已获得突出地位。尽管有许多单独的验证研究，但缺乏对设备间性能的直接比较。目的：本研究旨在评价和比较CWDs区分窦性心律和房颤的能力。方法：通过心脏病科门诊登记有窦性心律或房颤的患者。参与者被指示按随机顺序使用手持6导联心电图（ECG）设备（KardiaMobile 6L）、智能手表衍生的单导联心电图（Apple Watch）和两个基于ppg的智能手机应用程序（FibriCheck和preventticus）进行心律测量，同时使用12导联参考心电图作为金标准。结果：研究共纳入122名参与者：中位年龄为69岁（IQR 61-77）岁，63.9% （n=78）为男性，25% （n=30）为AF患者，9.8% （n=12）没有智能手机使用经验，73% （n=89）没有使用智能手表的经验。所有设备检测自动对焦的灵敏度均为100%。KardiaMobile 6L检测窦性心律的特异性为96.4% (95% CI 89.5%-98.8%)， Apple Watch为97.8% (95% CI 91.6%-99.5%)， FibriCheck为98.9% (95% CI 92.5%-99.8%)， Preventicus为97.8% (95% CI 91.5%-99.4%) （P= 0.50）。在KardiaMobile 6L和Apple Watch中，10.7% （95% CI 6.3%-17.5%）的病例观察到质量测量不足，FibriCheck为7.4% (95% CI 3.9%-13.6%)， preventticus为14.8% (95% CI 9.5%-22.2%) （P= 0.21）。与其他设备相比，参与者更喜欢苹果手表来监测他们的心律。结论：在本研究人群中，基于ECG或PPG使用CWDs对窦性心律和房颤的区分是高度准确的，在检查的设备之间没有明显的性能差异。
Comparative Evaluation of Consumer Wearable Devices for Atrial Fibrillation Detection: Validation Study.
Background: Consumer-oriented wearable devices (CWDs) such as smartphones and smartwatches have gained prominence for their ability to detect atrial fibrillation (AF) through proprietary algorithms using electrocardiography or photoplethysmography (PPG)-based digital recordings. Despite numerous individual validation studies, a direct comparison of interdevice performance is lacking.
Objective: This study aimed to evaluate and compare the ability of CWDs to distinguish between sinus rhythm and AF.
Methods: Patients exhibiting sinus rhythm or AF were enrolled through a cardiology outpatient clinic. The participants were instructed to perform heart rhythm measurements using a handheld 6-lead electrocardiogram (ECG) device (KardiaMobile 6L), a smartwatch-derived single-lead ECG (Apple Watch), and two PPG-based smartphone apps (FibriCheck and Preventicus) in a random sequence, with simultaneous 12-lead reference ECG as the gold standard.
Results: A total of 122 participants were included in the study: median age 69 (IQR 61-77) years, 63.9% (n=78) men, 25% (n=30) with AF, 9.8% (n=12) without prior smartphone experience, and 73% (n=89) without experience in using a smartwatch. The sensitivity to detect AF was 100% for all devices. The specificity to detect sinus rhythm was 96.4% (95% CI 89.5%-98.8%) for KardiaMobile 6L, 97.8% (95% CI 91.6%-99.5%) for Apple Watch, 98.9% (95% CI 92.5%-99.8%) for FibriCheck, and 97.8% (95% CI 91.5%-99.4%) for Preventicus (P=.50). Insufficient quality measurements were observed in 10.7% (95% CI 6.3%-17.5%) of cases for both KardiaMobile 6L and Apple Watch, 7.4% (95% CI 3.9%-13.6%) for FibriCheck, and 14.8% (95% CI 9.5%-22.2%) for Preventicus (P=.21). Participants preferred Apple Watch over the other devices to monitor their heart rhythm.
Conclusions: In this study population, the discrimination between sinus rhythm and AF using CWDs based on ECG or PPG was highly accurate, with no significant variations in performance across the examined devices.
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