Diagnostic Accuracy and Safety of Confirm Rx™ Insertable Cardiac Monitor in Pediatric Patients.

ABSTRACT

Insertable cardiac monitors (ICM) are subcutaneously implanted devices that monitor a patient's heart rate and rhythm (Rossano in Pediatrics 112(3)e228, 2003). The diagnostic accuracy and safety of the Confirm RxTM (Abbott, Minneapolis, MN) ICM in pediatric patients is unknown. This is a single center, retrospective, IRB-approved review of patients ≤ 21 years implanted with Confirm RxTM ICMs from 2017 to 2020. Data collected included demographics, indications, presence of P-wave and R-wave amplitude at implantation and follow-up, number/appropriateness of transmissions pre and post implementation of SharpSenseTM technology, reprogramming to improve accuracy, time from implantation to arrhythmia detection, and complications. There were 29 patients (median age 8 years, 59% females). P-waves were identified in all patients and average R-wave amplitude was 0.85 mV (0.26-1.03 mV). There was no significant difference in R-wave amplitude based on size (BSA ≥ 1.5 m2 0.76 mV, < 1.5 m2 0.91 mV) or congenital heart disease (+CHD 0.86 mV, -CHD 0.85 mV). Arrhythmias identified were the following wide complex tachycardia (1), supraventricular tachycardia (4), bradycardia/sinus pause (3), and premature ventricular contraction (1). SharpSenseTM implementation decreased the false-positive rate in device-initiated transmissions (55.4% to 0%, p < 0.00001). Average time from implantation to arrhythmia detection was 2.63 months (range 0-8.8). A single complication of cellulitis occurred. Confirm RxTM is appropriate for implant in pediatric patients regardless of age, BSA, or CHD. Implementation of SharpSense™ technology dramatically decreased the false-positive rate. Follow-up studies could utilize additional monitoring devices to provide analysis on potential events that the Confirm RxTM ICM missed.