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

Abstract Background Insertable cardiac monitors (ICM) are designed to record subcutaneous ECG 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 AF 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 performance of the ICM against a third-party extended Holter monitor (EHM) patch. Results ICM implants occurred in hospital (n=547, 76%) and clinic (n=170, 24%) settings with an extremely low 12-month complication rate (n=3, 0.4%). Device reprogramming was performed on 184 (26%) patients, with 80% of programming changes occurring remotely. Programming adjustments to reduce or enhance device detections led to an approximately two-fold decrease or increase in monthly episodes, respectively. In the Holter sub-study, the LUX-Dx identified 23 patients with AF that were not detected by the EHM 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 utilized, which may enhance detection and streamline data processing and care in the device clinic.