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

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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 Rx… Click to show full 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 Rx TM (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 Rx TM 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 SharpSense TM 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 m 2 : 0.76 mV, < 1.5 m 2 : 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). SharpSense TM 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 Rx TM 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 Rx TM ICM missed.

Keywords: accuracy safety; diagnostic accuracy; insertable cardiac; accuracy; confirm; pediatric patients

Journal Title: Pediatric Cardiology
Year Published: 2020

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