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Patient Directed Recording of a Bipolar Three-Lead Electrocardiogram using a Smartwatch with ECG Function
Published on: December 11, 2019
An efficient approach for detecting atrial fibrillation in ischemic stroke patients using a wearable device: a
Tomonari Saito1, Yasuhiro Nishiyama1,2, Toshiaki Otsuka3
1Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Insights
A wearable ECG patch detected atrial fibrillation (AF) in 8.7% of stroke patients without a prior AF diagnosis. This early detection of AF in stroke patients enables timely anticoagulant therapy to prevent recurrent strokes.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Atrial fibrillation (AF) is a significant cause of stroke, leading to high mortality and morbidity.
- Early detection of AF in stroke patients is crucial for initiating anticoagulant therapy and preventing recurrent strokes.
Purpose of the Study:
- To evaluate the efficacy of a wearable wireless patch ECG system (Duranta) for detecting atrial fibrillation (AF) in patients who have experienced an ischemic stroke but have no prior AF diagnosis.
- To assess the AF detection rate using the Duranta system in this patient population.
Main Methods:
- A prospective, multicenter study involving 241 ischemic stroke patients without a diagnosed AF.
- Continuous monitoring using the Duranta wearable non-invasive wireless patch ECG system for 7 days.
- Analysis of the primary outcome: the detection rate of AF during the monitoring period.
Main Results:
- Atrial fibrillation (AF) was detected in 8.7% (21/241) of patients during the follow-up period.
- The Duranta wearable ECG system demonstrated a high detection rate for new-onset AF.
- Dyslipidemia and increased left atrial dimension were identified as determinants for AF detection in patients with no prior AF history.
Conclusions:
- Wearable wireless patch ECG systems like Duranta are effective and simple tools for detecting AF in stroke patients.
- Early detection of AF using such devices can facilitate prompt anticoagulant therapy, thereby preventing recurrent strokes.
Objective:
Stroke caused by atrial fibrillation (AF) is associated with high mortality and severe morbidity. Screening patients for AF may facilitate early initiation of anticoagulant therapy and prevent recurrent stroke; therefore, strategies to effectively detect AF in stroke patients are important.
Methods:
This prospective multicenter study was conducted between April 27, 2020 and March 31, 2021 at seven sites in Japan, as a substudy of the STABLED trial, a multicenter prospective randomized study to evaluate the efficacy and safety of catheter ablation with anticoagulant therapy using edoxaban in patients with ischemic stroke and AF. This substudy included 241 patients who suffered ischemic stroke but had no diagnosis of AF. Patients were monitored with Duranta, a wearable non-invasive wireless patch ECG system. The primary outcome was the detection rate for AF while wearing Duranta.
Results:
Of the 241 patients, 66.8% were men, and the mean age was 71.0 years. AF was detected in 21 of the 241 patients (8.7, 95% CI: 5.4-12.4) during follow-up using the Duranta wearable ECG system. ECG data were recorded for 7 days in all patients. The median number of days from stroke onset to Duranta placement was 2.0, but this duration varied considerably (median; IQR, 0-22.0). An adverse event of dermal pruritus was observed in 1 of the 241 patients (0.4%). Determinants for the detection of AF in patients with no previous history of AF were dyslipidemia and left atrial dimension.
Conclusion:
Wearable wireless patch ECG systems such as Duranta are simple and efficient devices for detecting AF. In patients with ischemic stroke and no diagnosis of AF, their use for detecting new AF may provide benefit through early initiation of anticoagulants and prevention of recurrent stroke.
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