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

AbstractInsertable 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)...

Source: Pediatric Cardiology - October 9, 2020 Category: Cardiology Source Type: research