Jakob Johannes Reichl, Khaled Abdel Hamid, Thilo Burkard, Annina Salome Vischer, Caroline Guzman, Dariusz Dudek, Artur Pawlik, Bela Merkely, Janos Marcell László, Athanasios J Manolis, Manolis S Kallistratos, Dominik Linz, Markus Dörr, Christine Bahr, Branko Belesin, Thomas Hübner, Nicole König, Diana Piper, Jens Eckstein
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Screening tools are becoming increasingly popular to detect AF for stroke prevention, yet data from randomized trials are lacking.</p><p><strong>Objective: </strong>The purpose of this study was to analyze AF detection rates using a smartphone application with early intervention (intervention group) compared with no intervention (sham group).</p><p><strong>Methods: </strong>This is an international, multicenter, prospective, randomized, sham-controlled, double-blinded trial conducted between October 2019 and May 2024. Patients with no prior AF were randomized 1:1 to an intervention group or a sham group. The study application used the smartphone camera to generate photoplethysmography signals. If an arrhythmia was detected, patients in the intervention group received a notification and a 7-day patch electrocardiogram to confirm AF.</p><p><strong>Results: </strong>A total of 1021 patients from 8 centers were randomized. The mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score was 3.4 ± 0.92 in the intervention group and 3.5 ± 1.02 in the sham group. Arrhythmia was detected in 32 (3.1%) cases: 20 (3.9%) in the intervention group and 12 (2.4%) in the sham group. AF was diagnosed in 13 (1.3%) patients. AF detection rates were numerically higher in the intervention group (10 [1.9%] vs 3 [0.5%]; P = .094), especially in cases of asymptomatic AF (4 [0.8%] vs 0 [0%]; P = .13). There was no difference in the rate of stroke, transient ischemic attack, or systemic embolism after 6 months.</p><p><strong>Conclusion: </strong>In this multicenter trial, application usage in combination with early intervention did not significantly increase overall AF detection rates. 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The mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score was 3.4 ± 0.92 in the intervention group and 3.5 ± 1.02 in the sham group. Arrhythmia was detected in 32 (3.1%) cases: 20 (3.9%) in the intervention group and 12 (2.4%) in the sham group. AF was diagnosed in 13 (1.3%) patients. AF detection rates were numerically higher in the intervention group (10 [1.9%] vs 3 [0.5%]; P = .094), especially in cases of asymptomatic AF (4 [0.8%] vs 0 [0%]; P = .13). There was no difference in the rate of stroke, transient ischemic attack, or systemic embolism after 6 months.</p><p><strong>Conclusion: </strong>In this multicenter trial, application usage in combination with early intervention did not significantly increase overall AF detection rates. 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引用次数: 0
摘要
背景：房颤（AF）是世界范围内最常见的心律失常，也是缺血性卒中的主要原因。检测房颤以预防中风的筛查工具越来越受欢迎，但缺乏随机试验的数据。目的：分析智能手机应用程序早期干预与不干预（假手术组）的房颤检出率。方法：这是一项国际、多中心、前瞻性、随机、假对照、双盲试验，时间为2019年10月至2024年5月。无房颤病史的患者按1:1随机分为干预组和假组。该研究应用程序利用智能手机摄像头产生光容积脉搏波信号。如果检测到心律失常，干预组患者将收到通知并接受7天贴片心电图以确认af。结果：随机选取8个中心的1021例患者。干预组平均CHA2DS2VASc为3.4（±0.92），假手术组平均CHA2DS2VASc为3.5（±1.02）。心律失常32例，干预组20例，假手术组12例。13例患者被诊断为房颤。干预组的房颤检出率更高（1.9% vs. 0.5%, p=0.094），特别是无症状房颤（0.8% vs. 0, p=0.13）。6个月后卒中、短暂性脑缺血发作（TIA）或全身性栓塞的发生率无差异。结论：在这项多中心试验中，app使用结合早期干预并没有显著提高总体检出率。然而，干预组的无症状房颤检出率在数值上更高，这与目前推荐基于ppg的房颤筛查设备的指南一致。
PPG-based smartphone application vs usual care for atrial fibrillation screening: A European multicenter randomized trial.
Background: Atrial fibrillation (AF) is the most frequent arrhythmia worldwide and a major cause of ischemic stroke. Screening tools are becoming increasingly popular to detect AF for stroke prevention, yet data from randomized trials are lacking.
Objective: The purpose of this study was to analyze AF detection rates using a smartphone application with early intervention (intervention group) compared with no intervention (sham group).
Methods: This is an international, multicenter, prospective, randomized, sham-controlled, double-blinded trial conducted between October 2019 and May 2024. Patients with no prior AF were randomized 1:1 to an intervention group or a sham group. The study application used the smartphone camera to generate photoplethysmography signals. If an arrhythmia was detected, patients in the intervention group received a notification and a 7-day patch electrocardiogram to confirm AF.
Results: A total of 1021 patients from 8 centers were randomized. The mean CHA2DS2-VASc score was 3.4 ± 0.92 in the intervention group and 3.5 ± 1.02 in the sham group. Arrhythmia was detected in 32 (3.1%) cases: 20 (3.9%) in the intervention group and 12 (2.4%) in the sham group. AF was diagnosed in 13 (1.3%) patients. AF detection rates were numerically higher in the intervention group (10 [1.9%] vs 3 [0.5%]; P = .094), especially in cases of asymptomatic AF (4 [0.8%] vs 0 [0%]; P = .13). There was no difference in the rate of stroke, transient ischemic attack, or systemic embolism after 6 months.
Conclusion: In this multicenter trial, application usage in combination with early intervention did not significantly increase overall AF detection rates. However, asymptomatic AF detection was numerically higher in the intervention group, aligning with current guidelines that recommend photoplethysmography-based devices for AF screening.
期刊介绍：
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.
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