In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study
Introduction
Insertable cardiac monitors (ICMs) are subcutaneous electrocardiographic recorders that provide continuous long-term monitoring of cardiac arrhythmias and other physiological parameters such as heart rate variability, average heart rates, and patient activity. These devices facilitate the diagnosis of infrequent arrhythmias that can be difficult to detect with short-term, intermittent monitoring.1, 2, 3 Accordingly, ICMs are used in the diagnostic pathway for unexplained syncope, palpitations, cryptogenic stroke, and for the detection and management of atrial fibrillation.3, 4, 5
Although ICMs are confined to the subcutaneous space, the relatively large size of the initial ICM devices (19 × 61 × 8 mm) promoted adoption of the same hospital insertion environment used for cardiac implantable electronic devices with intravascular leads.5 However, since their advent in the 1990s, ICMs have undergone substantial miniaturization. Today, insertion of the Reveal LINQ device, the smallest commercially available ICM, requires only local anesthesia and an incision <1 cm in length.5, 6, 7 Compared with other cardiac implantable electronic device implantation procedures that involve conscious sedation, fluoroscopy, central vascular access, and contact with the endocardium, insertion of the Reveal LINQ ICM device is minimally invasive. Accordingly, it may now be possible to insert LINQ outside the traditional hospital setting.
Preliminary evidence from a single-arm feasibility trial supports the safety of inserting ICM devices outside an operating room (OR) and electrophysiology (EP) laboratory.8 However, the safety of in-office ICM insertion has not been directly assessed in a randomized controlled study. In addition, no previous investigations have evaluated the safety of in-office insertion of the miniaturized Reveal LINQ device. To address this, we conducted a multicenter randomized study to determine the safety of inserting the Reveal LINQ ICM in an office vs a hospital setting. As an ancillary aim, we also characterized physician responses to a questionnaire addressing satisfaction with the procedure environment.
Section snippets
Study design
The Reveal LINQ In-Office 2 study (ClinicalTrials.gov identifier NCT02395536) was a randomized, unblinded, multicenter, prospective, parallel group clinical study conducted in the United States. Patients indicated for the Reveal LINQ ICM who were willing to undergo device insertion outside a traditional hospital setting were eligible. Indications for ICM insertion were in accordance with current guidelines and physician practices. A complete list of the study’s inclusion and exclusion criteria
Study population
The study enrolled 525 patients at 26 centers in the United States between March 30, 2015 and 19 January 2016, with 521 randomly assigned to the office group (264 patients, 51%) or hospital group (257 patients, 49%). An ICM insertion attempt occurred in 482 of the 521 randomized patients (93%) by 46 physicians. Of the 251 office insertions, 193 (77%) occurred in a primary examination room and 58 (23%) occurred in a procedure room. Enrollment, randomization, and follow-up of study participants
Discussion
This is the first randomized trial to assess the safety of ICM insertion in an office vs hospital environment. In this trial, all 482 attempted ICM insertions were successful, and we observed a similar complication rate between procedure locations (based on a prespecified 5% noninferiority margin). As such, the primary objective was met. In addition, the rate of all adverse events (regardless of severity) was low and similar between procedure locations. These findings provide strong evidence
Conclusion
This is the first randomized study to directly compare the safety of ICM insertion in an office vs hospital environment. We observed a low rate of device- and procedure-related complications and an excellent safety profile that was similar between procedure locations. As such, this study provides support for the safety of inserting ICM devices in an office setting. Furthermore, we found an improved physician experience with office-based device insertion. These data will be influential in
Acknowledgments
We thank Lindsay Werder, B.A., for her outstanding work in managing the study as well as the Reveal LINQ In-Office 2 study investigators, coordinators, and study participants who made this trial possible.
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Cited by (0)
This study was sponsored by Medtronic, Inc. Medtronic was involved in study design, analysis and interpretation of data, and writing of this manuscript.
Dr Rogers, Dr Sanders, Dr Piorkowski, Dr Sohail, Dr Anand, and Dr Kowal are consultants for and receive honoraria and research funding from Medtronic. Dr Sohail reports previous research funding from TYRX and honoraria from Spectranetics and Boston Scientific. Dr Sanders is supported by a Practitioner Fellowship from the National Health and Medical Research Council and the National Heart Foundation of Australia; has received research funding from St. Jude Medical, Boston Scientific, Biotronik, and Sorin; and has served on advisory boards and received lecture/consulting fees for Biosense Webster, St. Jude Medical, Boston Scientific, and CathRx (advisory board only). Dr Piorkowski has received honoraria from St. Jude Medical, Biotronik, Boehringer Ingelheim, and Biosense Webster; is a member of advisory boards for St. Jude Medical, Siemens, and Biosense Webster; and has received research support from St. Jude Medical, Biotronik, Imricor, and Philips. Dr Kaplon and Mr Stromberg are employed by, and stock owners of, Medtronic.