医疗级柔性可穿戴心电监测与Holter监测在心律失常诊断中的价值对比及其驱动的房颤相关性卒中风险评估和预警模型的探讨

Clinical Value of Flexible Wearable ECG Devices versus Holter Monitors in Arrhythmia Diagnosis: Implications for AF-Related Stroke Risk Prediction and Early Warning Models

摘要: 目的：对比医疗级柔性可穿戴心电监测与Holter监测对心律失常的检出效能和监测价值并探讨前者驱动的房颤相关性卒中风险评估和预警模型的构建。方法：本研究为前瞻性研究设计，在2024年12月至2025年1月期间，对青岛大学附属医院(包括市南、崂山、西海岸三个院区)门诊及住院患者中开具Holter监测的1200名患者，同步进行医疗级柔性可穿戴设备的24小时心电监测，以Holter为金标准，通过计算准确率、敏感度、特异度、Kappa系数、F1得分及受试者工作特征曲线的曲线下面积(area under curve, AUC)来评估医疗级柔性可穿戴设备对心律失常的检出效能，随访其中房颤患者的治疗情况并探讨房颤相关性卒中风险评估和预警模型的构建。结果：医疗级柔性可穿戴心电监测设备检测各种心律失常的平均准确率为0.97，敏感度为0.96，特异度为0.98，F1得分为0.97，AUC为0.97。其中确诊的765例房颤患者均进行了相应治疗。结论：医疗级柔性可穿戴心电监测设备能够较准确地检测出心律失常，在临床应用中展现出显著优势，对提升临床结局具有积极意义，医疗级柔性可穿戴心电监测技术为构建房颤相关性卒中风险分层评估体系及动态预警模型奠定了重要技术基础，其创新性数据支持对优化二级预防策略具有显著的临床应用价值。

Abstract: Objective: To compare the detection efficacy and clinical value of medical-grade flexible wearable ECG monitoring versus Holter monitoring in arrhythmia diagnosis, and to explore the construction of an atrial fibrillation (AF)-associated stroke risk assessment and early warning model driven by wearable technology. Methods: This prospective study enrolled 1200 patients prescribed Holter monitoring at the Affiliated Hospital of Qingdao University (Shinan, Laoshan, and West Coast campuses) from December 2024 to January 2025 (outpatient and inpatient departments). Participants underwent simultaneous 24-hour ECG monitoring using a medical-grade flexible wearable device. With Holter as the gold standard, the detection performance of the wearable device for arrhythmias was evaluated using accuracy, sensitivity, specificity, Kappa coefficient, F1 score, and the area under the receiver operating characteristic curve (AUC). Follow-up on treatment outcomes for AF patients was conducted, and an AF-associated stroke risk assessment and early warning model were developed. Results: The medical-grade flexible wearable ECG monitoring device demonstrated an average accuracy of 0.97, sensitivity of 0.96, specificity of 0.98, F1 score of 0.97, and AUC of 0.97 in detecting arrhythmias. Among the 765 confirmed AF cases, all patients received appropriate treatment. Conclusion: Medical-grade flexible wearable ECG monitoring devices exhibit high diagnostic accuracy for arrhythmias, demonstrating significant clinical advantages and potential to improve clinical outcomes. This technology establishes a critical technical foundation for constructing a risk-stratified assessment system and dynamic early warning model for AF-associated stroke. The innovative data integration supports substantial clinical value in optimizing secondary prevention strategies.