Effectiveness and accuracy of arrhythmia detection algorithm with the Reveal LINQ insertable cardiac monitor

Objective: To investigate the accuracy of arrhythmia detection algorithm and the effectiveness of Reveal LINQ insertable cardiac monitor (ICM). Methods: This single-center, descriptive, non-controlled clinical study was designed to enroll consecutive patients who were implanted with Reveal LINQ ICM in Minneapolis Veterans Affairs Medical Center from June 19, 2014 to April 18, 2017. The safety of implant procedure, the accuracy of automatic arrhythmia detection algorithm and the clinical effectiveness were evaluated and validated independently by two physicians. Results: Sixty patients with average age of (65±13) years (30-89 years) were enrolled and the follow-up duration was 466 days (30-1 072 days). Of these, 57 patients are male. The indications of ICM implantation were unexplained syncope in 35 cases, cryptogenic stroke in 13 cases, atrial fibrillation (AF) management in 5 cases, and palpitations in 7 cases. The implantation procedure was safe and successful in all patients without complications. The detection accuracy of arrhythmia algorithm was 86% (620/723), 82% (2 369/2 876), and 30% (411/1 380) for tachycardia, bradycardia, and pause events, respectively. The detection accuracy of arrhythmia algorithm for AF was 17% (5/30), 60% (1 569/2 632) and 69% (172/251) for cryptogenic stroke, unexplained syncope, and AF management, respectively. Important clinical findings were observed in 15% (9/60) patients. Only 5% (3/60) patients had important findings based on the intended clinical indications. Conclusion: The Reveal LINQ ICM is a safe, simple, and effective procedure for the detection of tachycardia and bradycardia events. However, the automatic AF and pause events detection algorithm had high false positive rate which requires further improvement.