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Randomized crossover trial comparing a wearable 2-week ECG versus standard 24-hour ECG to detect a recurrence of atrial fibrillation after the catheter ablation (hitoe-2)

Wearable 2-week ECG to detect atrial fibrillation (hitoe-2)

67

We enrolled 67 patients (63 (11) years old, 53 men) after an initial ablation for paroxysmal AF (n=46), persistent AF (n=18), and long-standing persistent AF (n=3). Their underbust circumference (92 (9) cm) was suited for the wearable monitoring device. They were randomly assigned to group 1 (n=35), in which the 2-week wearable monitoring was presented first, or group 2 (n=32), in which the 24-hour Holter monitoring was presented first.

We enrolled 4 patients/month as expected for the single center. Among 72 patients who gave their consent, 67 completed the whole study. Five patients withdrew their consent and declined their participation because of schedule problems (n=4) and unknown reasons (n=1). This study obtained 67 paired ECGs from the wearable 2-week and standard 24-hour monitoring devices.

There were neither serious adverse events nor unexpected adverse events. Expected effects on the skin were as follows. Wearable 2-week ECG monitoring: Redness (n=2), Erosion (n=0), Scar (n=0) Holter 24-hour ECG monitoring: Redness (n=0), Erosion (n=0), Scar (n=0)

Wearable 2-week ECG detected 12 patients (18%) with AF recurrence; however, Holter 24-hour ECG detected only 4 of them (6%, p=0.008). The acquisition rate of ECG was higher in Holter ECG than in wearable ECG (100% [interquartile range, 100% to 100%] versus 82% [interquartile range, 71% to 91%], p<0.001). Total analysis time, however, was longer in wearable ECG than in Holter ECG (11 days [interquartile range, 9 to 12 days] versus 1 day [interquartile range, 1 to 1 day], p<0.001). Holter 24-hour ECG demonstrated a slightly higher frequency of atrial premature complex than 2-week wearable ECG (0.09% [interquartile range, 0.03% to 0.48%] versus 0.09% [interquartile range, 0.03% to 0.33%], p=0.014) in statics. A questionnaire demonstrated that wearing comfort was better in the wearable 2-week monitoring (79%), Holter 24-hour monitoring (7.5%), or not different (13%).

Wearable 2-week ECG unveiled AF recurrence, which was underdiagnosed with a Holter 24-hour ECG. A 2-week monitoring period overcame the deteriorated acquisition rate of wearable ECG for unveiling the hidden AF recurrence on Holter 24-hour ECG.

April. 01, 2023

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180018

Machino Takeshi

University of Tsukuba Hospital

2-1-1 Amakubo, Tsukuba, Ibaraki

machino@md.tsukuba.ac.jp

Machino Takeshi

University of Tsukuba Hospital

2-1-1 Amakubo, Tsukuba, Ibaraki

+81-29-853-3143

machino@md.tsukuba.ac.jp

Complete

Aug. 01, 2018

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

diagnostic purpose

Patients who underwent an initial catheter ablation for atrial fibrillation

1) Allergies
2) Very sensitive skin to adhesive tape with a history of redness, erosion and scar
3) Cardiac implantable electronic devices

Both

Atrial fibrillation

Wearable ECG monitoring

Detection of recurrent atrial fibrillation

Comfort scale of the materials

+81-29-853-3914

July. 26, 2018

None