Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials

Suneet Mittal, Prashanthan Sanders, Evgeny Pokushalo, Lukas Dekker, Dean Kereiakes, Edward J. Schloss, Erika Pouliot, Noreli Franco, Yan Zhong, Marco Di Bacco, Helmut Pürerfellner

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

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 LINQTM Usability study) and a multicenter registry (Reveal LINQTM 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.

Original languageEnglish
Pages (from-to)1464-1469
Number of pages6
JournalPACE - Pacing and Clinical Electrophysiology
Volume38
Issue number12
DOIs
Publication statusPublished - 1 Dec 2015

Keywords

  • adverse events
  • arrhythmia monitoring
  • insertable cardiac monitor
  • safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Mittal, S., Sanders, P., Pokushalo, E., Dekker, L., Kereiakes, D., Schloss, E. J., ... Pürerfellner, H. (2015). Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. PACE - Pacing and Clinical Electrophysiology, 38(12), 1464-1469. https://doi.org/10.1111/pace.12752