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A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection

  • Will EysenckEmail author
  • Nick Freemantle
  • Neil Sulke
Article

Abstract

Purpose

Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to ‘gold standard’ monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor ‘R’ Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated.

Methods

Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated.

Results

RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001).

Conclusions

All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications.

Keywords

Atrial fibrillation detection Permanent pacemaker External cardiac monitoring 

Notes

Compliance with ethical standards

Conflict of interest

WE has nothing to disclose. NF has nothing to disclose. NS has financial disclosures as specified below:

Unrestricted research grants received from iRhythm San Francisco, CA, USA, NUUBO Smart Solutions Technologies, SL, Madrid and Bardy Diagnostics Inc., Seattle, WA, USA.

Ethical approval

This study was performed at Eastbourne Hospital, East Sussex Healthcare NHS Trust, and complies with the declaration of Helsinki. The national research ethics committee approved the study. Written informed consent was obtained from all participants.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Eastbourne General HospitalEast Sussex Healthcare NHS TrustEast SussexUK
  2. 2.University College LondonLondonUK

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