Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe

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.

Keywords: Arrhythmias; Atrial fibrillation; Cryptogenic stroke; Implantation; Insertable cardiac monitor; Loop recorder; Syncope.

Fig. 1

The LUX-Dx™ implantable cardiac monitor (ICM). The system comprises an incision tool and a single-piece insertion tool pre-loaded with the ICM. The LUX-Dx™ Clinic Assistant App allows the operator to connect to the ICM. The myLUX™ Patient App activates the implanted device and transmits data between the ICM and the LATITUDE server

Fig. 2

Procedural time, R-wave amplitude, and P-wave visibility at implantation across patient characteristics, indications, and procedural variables (*p < 0.01 versus others)

Fig. 3

Programmed frequency of scheduled device transmissions and number of days of no connection set for notification