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

Abstract

The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias. The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission. 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. 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. The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.