Abstract Background Insertable cardiac monitors (ICMs) provide long-term continuous monitoring for arrhythmia diagnosis and management for various clinical indications. However, little data exists on the real-world diagnostic yield of ICMs across indicated patient populations, including both expected and incidental arrhythmic findings. Validated artificial intelligence (AI) algorithms have been developed to identify true arrhythmia episodes while significantly reducing false positives, enabling the adjudication of ICM episodes for larger cohorts of patients. Purpose To characterize comprehensive true arrhythmia detection rates in a large real-world population with long-term ICM monitoring. Methods De-identified patients ≥18 years receiving a Reveal LINQ ICM between Oct 1, 2016 – Sept 30, 2020 with no prior cardiac implantable electronic devices and ≥1 year of follow-up in the CareLink monitoring database were identified (N=12,013). Patients were stratified by reason for ICM placement: N=9,841 who received ICM for diagnosis of suspected arrhythmias (40.8% unexplained syncope, 38.3% cryptogenic stroke, 9.7% palpitations, 9.7% suspected atrial fibrillation (AF), 1.6% ventricular tachycardia), and N=2,172 who received ICM for management of known AF. Device-detected ECGs during long-term follow-up were identified and processed through previously validated arrhythmia-specific AI algorithms designed to reduce false positive arrhythmia detections (each trained using ICM data from ≥25,000 adjudicated ECG episodes and validated on an independent set of ≥5,000 adjudicated ECGs). Results Mean (SD) and median follow-up were 24.6(12.7) and 24.5 months, respectively. In patients receiving ICM for Suspected Arrhythmia, 5,492 patients (55.8%) had ≥1 AI-adjudicated arrhythmia detected during follow-up, with 2,472 (45.0%) of these patients having ≥2 arrhythmia types detected (Table). Mean (SD) time to 1st arrhythmia detection was 7.7(9.1) months; time to 2nd arrhythmia type detected was 12.3(10.4) months. Among the 6,958 patients with longer-term ICM follow-up ≥2 years, 2,931 (42.1%) had no arrhythmias detected (i.e., arrhythmia rule-out occurred). In patients receiving ICM for AF Management, 1,737 patients (80.0%) had ≥1 arrhythmia detected, and notably 1,074 (61.8%) of these patients had ≥1 arrhythmia detected during follow-up that was not AF. Mean (SD) time to 1st arrhythmia detection was 5.3 (7.7) months; time to 2nd arrhythmia type detected was 10.4(9.9) months. Conclusions In a large real-world ICM population, >50% of patients had AI-adjudicated arrhythmia detections during long-term follow-up, with a significant proportion receiving additional arrhythmia diagnoses beyond the initial type diagnosed or suspected. These results suggest that in indicated patients, long-term continuous monitoring with ICMs can enable diagnosis of a variety of cardiac arrhythmias that may have otherwise remained undetected.
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