What is the clinical evidence from this study?

Study design: RCT. Population: Atrial fibrillation (n=67). Intervention: 2-week Garment ECG vs. 24-hour Holter ECG. Primary outcome: Detection rate of patients with AF recurrence (p=0.008).

February 24, 2023Open Access

Randomized crossover trial of 2-week Garment electrocardiogram with dry textile electrode to reveal instances of post-ablation recurrence of atrial fibrillation underdiagnosed during 24-hour Holter monitoring

TMTakeshi MachinoUniversity of Tsukuba KAKazutaka AonumaElectrophysiology KMKazushi MaruoUniversity of Tsukuba

Key Result

A 2-week Garment ECG significantly increased the detection of atrial fibrillation recurrence compared to a standard 24-hour Holter ECG (18% vs 6%, p=0.008) in patients 3 months after catheter ablation.

Study Design

Type

RCT (n=67)

Blinding

Open-label

Randomization

Block randomization

Multicenter

Structured PICO

Does a 2-week Garment ECG improve the detection of atrial fibrillation recurrence compared to 24-hour Holter monitoring in patients 3 months post-ablation?

Population

67 adults (mean age 63.1 years, 21% female) who had undergone initial catheter ablation for atrial fibrillation, monitored 3 months post-ablation in a crossover design.

Intervention

2-week Garment electrocardiogram (ECG) with dry textile electrode made of PEDOT:PSS and nanofiber

Comparator

Standard 24-hour Holter ECG

Outcome

Detection of atrial fibrillation recurrencesurrogate

Main Result

Absolute Event Rate: 18% vs 6%

p-value: p=0.008

Limitations

The Garment ECG monitoring system is not waterproof, requiring interruption of monitoring during bathing.
Small sample size with only 12 out of 67 patients experiencing recurrent AF after ablation.

Abstract

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia and often recurs despite catheter ablation. The recurrence of AF is often underdiagnosed by standard 24-hour electrocardiogram (ECG) because of its transient and silent nature. A garment-style ECG with a highly conductive textile electrode made of poly(3,4-ethylenedioxythiophene) poly(styrenesulfonate)(PEDOTPSS) and nanofiber (Garment ECG) has been developed that can provide longer-term continuous monitoring. This study investigated whether 2-week Garment ECG can reveal instances of AF recurrence in patients who are diagnosed as remaining in sinus rhythm by 24-hour Holter ECG. METHODS: The open-label randomized crossover study enrolled 67 patients (63.1±10.6 years old, 53 men) who had undergone initial AF ablation. Three months after ablation, patients were randomly assigned to group 1 (n = 35), 2-week Garment ECG followed by 24-hour Holter ECG, or group 2 (n = 32), 24-hour Holter ECG followed by 2-week Garment ECG. The detection of AF recurrence was compared between the two devices. RESULTS: The Garment ECG showed AF recurrence in 12 patients (18%) compared to 4 patients for the Holter ECG (6%, p = 0.008). The ECG acquisition rate was higher for Holter ECG than for Garment ECG (100.0% interquartile range 100.0-100.0% versus 82.4% 71.1-91.0%, p<0.001), but the Garment ECG provided longer total analysis time (11.0 days 9.0-12.2 days for Garment; 1.0 day 1.0-1.0 day for Holter, p<0.001). CONCLUSIONS: Despite the lower ECG acquisition rate, the 2-week Garment ECG revealed instances of AF recurrence after ablation in patients who were underdiagnosed by 24-hour Holter ECG. TRIAL REGISTRATION: Clinical Trial Registration: URL: https://jrct.niph.go.jp/en-latest-detail/jRCTs032180018 Unique Identifier: jRCTs032180018.

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