Wouters Femke, Gruwez Henri, Smeets Christophe, Pijalovic Anessa, Wilms Wouter, Vranken Julie, Pieters Zoë, Van Herendael Hugo, Nuyens Dieter, Rivero-Ayerza Maximo, Vandervoort Pieter, Haemers Peter, Pison Laurent
Limburg Clinical Research Center/Mobile Health Unit, Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
Department Future Health, Ziekenhuis Oost-Limburg, Genk, Belgium.
JMIR Form Res. 2025 Jan 9;9:e65139. doi: 10.2196/65139.
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.
This study aimed to evaluate and compare the ability of CWDs to distinguish between sinus rhythm and AF.
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.
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.
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.
以消费者为导向的可穿戴设备(CWD),如智能手机和智能手表,因其能够通过使用基于心电图或光电容积脉搏波描记法(PPG)的数字记录的专有算法来检测心房颤动(AF)而备受关注。尽管有大量的个体验证研究,但缺乏对不同设备性能的直接比较。
本研究旨在评估和比较CWD区分窦性心律和AF的能力。
通过心脏病门诊招募表现为窦性心律或AF的患者。参与者被指示以随机顺序使用手持式6导联心电图(ECG)设备(KardiaMobile 6L)、智能手表衍生的单导联ECG(Apple Watch)以及两个基于PPG的智能手机应用程序(FibriCheck和Preventicus)进行心律测量,同时以同步12导联参考ECG作为金标准。
本研究共纳入122名参与者:中位年龄69(四分位间距61 - 77)岁,男性占63.9%(n = 78),AF患者占25%(n = 30),12人(9.8%)此前无智能手机使用经验,89人(73%)无智能手表使用经验。所有设备检测AF的灵敏度均为100%。KardiaMobile 6L检测窦性心律的特异性为96.4%(95%可信区间89.5% - 98.8%),Apple Watch为97.8%(95%可信区间91.6% - 99.5%),FibriCheck为98.9%(95%可信区间92.5% - 99.8%),Preventicus为97.8%(95%可信区间91.5% - 99.4%)(P = 0.50)。KardiaMobile 6L和Apple Watch在10.7%(95%可信区间6.3% - 17.5%)的病例中观察到测量质量不足,FibriCheck为7.4%(95%可信区间3.9% - 13.6%),Preventicus为14.8%(95%可信区间9.5% - 22.2%)(P = 0.21)。参与者更倾向于使用Apple Watch而非其他设备来监测心律。
在本研究人群中,使用基于ECG或PPG的CWD区分窦性心律和AF的准确性很高,在所检查的设备中性能无显著差异。