Premium
Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx
Author(s) -
Ip John,
Jaffe Brian,
Castellani Mark,
Sheikh Ali,
Castellani Carson,
Ip Randy
Publication year - 2020
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.14076
Subject(s) - medicine , bradycardia , atrial fibrillation , cardiology , prospective cohort study , randomized controlled trial , implantable loop recorder , heart rate , blood pressure
Background Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear. Objective The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology. Methods In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy. Results A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P < .0001) was significantly shorter in the Confirm Rx group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient‐month, P < .01), which is likely due to event transmission setting differences between the two groups. Kaplan‐Meier analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6‐month follow‐up ( P = .006). Patient‐averaged true positive detection rates were not statistically significant in the two groups (Reveal LINQ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%). Conclusion Compared to the Reveal LINQ, Confirm Rx has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal.