A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection
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.
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.
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).
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.
KeywordsAtrial fibrillation detection Permanent pacemaker External cardiac monitoring
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.
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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