Enhanced Detection and Prompt Diagnosis of Atrial Fibrillation Using Apple Watch: A Randomized Controlled Trial.

Wearables provide a scalable, noninvasive screening tool.

可穿戴设备提供了一种可扩展的、非侵入性的筛查工具。

This trial evaluated new onset AF detection in patients at elevated stroke risk using remote smartwatch-based screening.

该试验评估了在高卒中风险患者中使用远程智能手表筛查新发房颤的效果。

Methods

This prospective multicenter randomized controlled trialincluded patients ≥65 years with elevated stroke risk (CHA2DS2-VASc ≥2 men, ≥3 women) from 2 secondary care centers in the Netherlands.

这项前瞻性多中心随机对照试验包括来自荷兰两个二级护理中心的≥65岁高卒中风险患者（CHA2DS2-VASc评分男性≥2分，女性≥3分）。

Patients were randomized to 6-month (180-day) monitoring with a smartwatch with photoplethysmography and single-lead electrocardiogram (ECG) functions, or standard care.

患者被随机分配至使用具有光体积描记法和单导联心电图功能的智能手表进行6个月（180天）监测，或接受标准护理。

ECGs were reviewed remotely by an independent eHealth team within 24 hours.

心电图由一个独立的电子健康团队在24小时内远程审查。

The primary outcome was new onset AF, defined as a confirmed episode lasting ≥30 seconds on single-lead ECG or standard ECG methods.

主要结果是新发房颤，定义为在单导联心电图或标准心电图方法上确认的持续时间≥30秒的发作。

Results

Between November 2022 and December 2023, 437 patients were randomized (219 intervention, 218 control); the median age was 75 years, 46.7% were female and the median CHA2DS2-VASc score was 3.0.

从2022年11月到2023年12月，共有437名患者被随机分配（219名干预组，218名对照组）；中位年龄为75岁，46.7%为女性，中位CHA2DS2-VASc评分为3.0。

New onset AF occurred in 21 (9.6%) patients of the intervention group and 5 (2.3%) patients of the control group (risk difference: 7.3 percentage points; 95% CI: 2.9-11.7 percentage points; P = 0.001; HR: 4.40; 95% CI: 1.66-11.66).

干预组中有21名（9.6%）患者新发房颤，而对照组有5名（2.3%）患者新发房颤（风险差异：7.3个百分点；95% 置信区间：2.9-11.7个百分点；P=0.001；风险比：4.40；95% 置信区间：1.66-11.66）。

Several asymptomatic AF episodes were detected only in the intervention group, while paroxysmal AF occurred in both groups.

仅在干预组中检测到几次无症状房颤发作，而阵发性房颤在两组中均发生。

Conclusions

This randomized controlled trialprovides evidence that 6-month smartwatch-based AF screening enhances the detection rate of new onset AF compared with standard care in patients at elevated stroke risk.

这项随机对照试验提供了证据，表明在中风风险增高的患者中，使用智能手表进行6个月的心房颤动筛查，与标准护理相比，可以提高新发心房颤动的检出率。

(Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable [Apple Watch] [EQUAL]; NCT05686330).

（使用智能手表可穿戴设备[Apple Watch]检测和量化高危患者的心房颤动[EQUAL]；NCT05686330）。