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

PLoS One. 2023 Feb 24;18(2):e0281818. doi: 10.1371/journal.pone.0281818. eCollection 2023.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Atrial Fibrillation*
  • Catheter Ablation*
  • Clothing
  • Cross-Over Studies
  • Electrocardiography
  • Electrocardiography, Ambulatory
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Treatment Outcome

Grants and funding

This work was supported by Toray Industries, Inc. (CLE30006), which provided the garment-style wearable ECG using hitoe® electrodes. The funding source had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Medical writing support was provided by EDIT, Inc. (Tokyo, Japan) and was funded by Toray Industries, Inc.