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Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials
Author(s) -
MITTAL SUNEET,
SANDERS PRASHANTHAN,
POKUSHALOV EVGENY,
DEKKER LUKAS,
KEREIAKES DEAN,
SCHLOSS EDWARD J.,
POULIOT ERIKA,
FRANCO NORELI,
ZHONG YAN,
DI BACCO MARCO,
PÜRERFELLNER HELMUT
Publication year - 2015
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.12752
Subject(s) - medicine , incidence (geometry) , usability , clinical trial , adverse effect , emergency medicine , trial registration , physics , human–computer interaction , computer science , optics
Background Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at‐risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion. Methods To evaluate the safety profile of the ICM procedure, we analyzed procedure‐related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ TM Usability study) and a multicenter registry (Reveal LINQ TM Registry) evaluating real‐world experience. For the Registry we reported all procedure‐related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow‐up. Results The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow‐up, an infection was observed in 1.3% patients and a procedure‐related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow‐up, an infection was observed in 1.6% patients and a procedure‐related SAE in 1.6% patients. Conclusions The cumulative experience from a controlled clinical trial and a “real‐world” registry demonstrate that the new ICM can be inserted with very low incidence of AEs.