Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study.

Background: Insertable cardiac monitors (ICMs) are designed to record subcutaneous electrocardiographic data for the diagnosis and management of arrhythmias. Objective: The LUX-Dx PERFORM study evaluated the safety of the LUX-Dx ICM, the utilization of remote reprogramming, and the performance of the LUX-Dx arrhythmia detection algorithms. Methods: The study included 727 patients with multiple indications for an ICM including atrial fibrillation management, syncope, and cryptogenic stroke. The primary safety endpoint was evaluated via 30-day and 12-month ICM system-related complication-free rates. Device programming changes were quantified by type and impact on episode detections. A subset of 601 patients was enrolled in a 14-day Holter study to evaluate the performance of the ICM against a third-party extended Holter monitor patch. Results: ICM implants occurred in hospital (n = 547; 76%) and clinic settings (n = 170; 24%) with an extremely low 12-month complication rate (n = 3; 0.4%). Device reprogramming was performed on 184 patients (26%), with 82% of programming changes occurring remotely. Programming adjustments to reduce or enhance device detections led to an approximately 2-fold decrease or increase in monthly episodes, respectively. In the Holter substudy, the LUX-Dx identified 23 patients with atrial fibrillation episodes that were not detected by the extended Holter monitor and demonstrated 100% sensitivity for detecting pause episodes. Conclusion: Fewer than 1 in 200 patients had a complication within 1 year of ICM implant, and the LUX-Dx ICM demonstrated strong arrhythmia detection performance relative to an industry-standard patch monitor. Remote programming was frequently used, which may enhance detection and streamline data processing and care in the device clinic. Study Identifier: NCT04732728.