Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx. Issue 11 (3rd October 2020)

• Record Type: Journal Article
• Authors: Ip, John; Jaffe, Brian; Castellani, Mark; Sheikh, Ali; Castellani, Carson; Ip, Randy
• Is Part Of: Pacing and clinical electrophysiology. Volume 43:Issue 11(2020)
• Page Start: 1344
• Page End: 1350
• Publication Date: 2020-10-03
• Subjects: atrial fibrillation -- cryptogenic stroke -- implantable cardiac monitor -- remote monitoring -- syncope; Cardiac pacing -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1111/pace.14076
• Languages: English
• ISSNs: 0147-8389

Abstract

Abstract: 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.