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

Area of Science:

• Pediatric Cardiology
• Cardiac Electrophysiology
• Medical Device Technology

Background:

• Insertable cardiac monitors (ICMs) are subcutaneous devices for heart rate and rhythm monitoring.
• The diagnostic accuracy and safety of the Confirm Rx™ ICM in pediatric populations were previously unknown.

Purpose of the Study:

• To evaluate the diagnostic accuracy and safety of the Confirm Rx™ ICM in pediatric patients (≤21 years).
• To assess the impact of SharpSense™ technology on the performance of the Confirm Rx™ ICM.

Main Methods:

• Retrospective, single-center review of 29 pediatric patients implanted with Confirm Rx™ ICMs (2017-2020).
• Data included demographics, implantation parameters (P-wave, R-wave amplitude), arrhythmia detection, SharpSense™ impact, and complications.
• Analysis compared device performance pre- and post-SharpSense™ implementation.

Main Results:

• P-waves were identified in all patients; average R-wave amplitude was 0.85 mV, with no significant difference based on body size or congenital heart disease.
• SharpSense™ technology implementation reduced the false-positive rate in device-initiated transmissions from 55.4% to 0% (p < 0.00001).
• Identified arrhythmias included supraventricular tachycardia, bradycardia/sinus pause, and premature ventricular contractions. A single complication (cellulitis) occurred.

Conclusions:

• Confirm Rx™ ICM is appropriate for pediatric patients, irrespective of age, body surface area, or congenital heart disease.
• SharpSense™ technology significantly enhances the accuracy of the Confirm Rx™ ICM by minimizing false positives.
• Further studies with additional monitoring devices are recommended to identify potential missed events.