ABSTRACT
BACKGROUND: The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022. PURPOSE: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use. METHODS: The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge. RESULTS: A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation. CONCLUSIONS: LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.
ABSTRACT
Background: Coronavirus Disease-2019 (COVID-19) has been associated with myocardial injury and higher risk of arrhythmic complications. However, no reports are available about the effect of the ongoing pandemic on arrhythmias in patients at risk. Objective: To describe the effect of COVID-19 pandemic on arrhythmic burden among high-risk patients. Methods: This is a cross-sectional study on the incidence of ventricular arrhythmia (VA) during the pandemic outbreak (study period), compared to the same timeframe in 2019 (reference period). Inclusion criteria were age (>18 years) and having an implantable cardiac defibrillator (ICD). Results: Among 455 patients enrolled (mean age 64.9 ± 15.7 years; 25.1% females and 39.6% with CRTD), in the study period, 45 (9.9%) patients experienced a total of 86 VA; 8 patients (1.7%) required antitachycardia-pacing (ATP) and 6 (1.3%) at least one shock. In the reference period, a total of 69 events occurred in 36 patients (7.9%). Six patients (1.3%) required ATP and three (0.7%) at least one shock. The number of patients that suffered from any arrhythmic events in the study period (9.9% vs 7.9%) did not significantly differ from the reference period (χ2 = 1.09, P = .29). The main predictor of VA during the COVID-19 pandemic was the previous history of any ICD therapy (OR = 3.84, P < .001). Conclusions: No evidence of an increase of arrhythmic burden was found during the COVID-19 pandemic among patients with an ICD.
