Abstract
BackgroundHistorically, the majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The miniaturization of ICMs allows the procedure to be relocated within the hospital without compromising patient safety. We sought to estimate the rate of untoward events associated with procedures performed within the hospital but outside the traditional settings and to characterize resource utilization, procedure time intervals, and physician experience.MethodsThe Reveal LINQ in-Office 2 (RIO 2) International study was a single arm, multicenter, prospective study. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or OR were eligible and followed for 90 days after insertion.ResultsA total of 191 patients (45.5% female aged 63.8 ± 26.9 years) underwent successful Reveal LINQ ICM insertion at 17 centers in Europe, Canada and Australia. The median total visit duration was 106 min (interquartile range [IQR]: 55–61). Patient preparation and patient education accounted for 10 min (IQR: 5–20) and 10 min (IQR: 8–15) of total visit duration, respectively. Preparation and education occurred in the procedure room for 90.6 and 60.2% of patients, respectively. There were no untoward events (0.0, 95% CI: 0.0–2.1%) though four patients presented with procedure-related adverse events that did not require invasive intervention. Physicians rated procedure location as convenient or very convenient.ConclusionsThe Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR.Trial registrationClinicalTrials.gov identifier NCT02412488; registered on April 9, 2015.
Highlights
The majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization lab, electrophysiology (EP) lab, or operating room (OR)
The traditional settings for ICM insertion procedures have been the cardiac catheterization lab, the electrophysiology (EP) lab and the operating room (OR) - the same facilities used for more complex cardiac device implants, such as pacemakers, cardiac resynchronization therapy devices, and implantable cardioverter defibrillators
To further evaluate the safety of Reveal LINQ ICM insertion within the hospital, but outside the traditional settings, we built upon previous literature to conduct the first prospective, international multi-site trial to assess the rate of adverse events through 3 months post device insertion
Summary
The majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The traditional settings for ICM insertion procedures have been the cardiac catheterization (cath) lab, the electrophysiology (EP) lab and the operating room (OR) - the same facilities used for more complex cardiac device implants, such as pacemakers, cardiac resynchronization therapy devices, and implantable cardioverter defibrillators. Miniaturization of ICM devices has resulted in a less invasive insertion procedure, enabling relocation of device insertion within the hospital to clean rooms, procedure rooms and holding areas, and to practice offices outside the hospital walls [1] This approach is appealing because it could reduce costs related to the procedure and increase physician and patient convenience and satisfaction [2, 3]. The study was mainly conducted in Europe and collected patient, physician, and detailed staff procedure time interval data to document the resources necessary for the procedure
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