Background: Traditionally, insertable cardiac monitor (ICM) procedures have been performed in the cardiac catheterization (CATH) or electrophysiology (EP) laboratory. The introduction of the miniaturized Reveal LINQ ICM has led to simplified and less invasive procedures, affording hospitals flexibility in planning where these procedures occur without compromising patient safety or outcomes.
Methods: The present analysis of the ongoing, prospective, observational, multicenter Reveal LINQ Registry sought to provide real-world feasibility and safety data regarding the ICM procedure performed in the CATH/EP lab or operating room and to compare it with insertions performed outside of these traditional hospital settings. Patients included had at least a 30-day period after the procedure to account for any adverse events.
Results: We analyzed 1222 patients (58.1% male, age 61.0 ± 17.1 years) enrolled at 18 centers in the US, 17 centers in Middle East/Asia, and 15 centers in Europe. Patients were categorized into 2 cohorts according to the location of the procedure: in-lab (CATH lab, EP lab, or operating room) (n = 820, 67.1%) and out-of-lab (n = 402, 32.9%). Several differences were observed regarding baseline and procedure characteristics. However, no significant differences in the occurrence of procedure-related adverse events (AEs) were found; of 19 ICM/procedure-related AEs reported in 17 patients (1.4%), 11 occurred in the in-lab group (1.3%) and 6 in the out-of-lab group (1.5%) (P = .80).
Conclusions: This real-world analysis demonstrates the feasibility of performing Reveal LINQ ICM insertion procedures outside of the traditional hospital settings without increasing the risk of infection or other adverse events.
Trial registration: ClinicalTrials.gov NCT02746471.
Copyright © 2018 Elsevier Inc. All rights reserved.