Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience

H. Pürerfellner, P. Sanders, E. Pokushalov, M. Di Bacco, T. Bergemann, L.R.C. Dekker, Reveal LINQ Usability Study Investigators

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Abstract

BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.

OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.

METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.

RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.

CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.

Original languageEnglish
Pages (from-to)1113-1119
JournalHeart Rhythm
Volume12
Issue number6
DOIs
Publication statusPublished - Jun 2015

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