Algorithm Improvements in an Insertable Cardiac Monitor Reduce False Positives and Episode Review Burden.

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Insertable cardiac monitors (ICM) are increasingly used for arrhythmia detection.
• Current ICMs face challenges with performance accuracy and data management.
• The LUX-Dx II+ ICM incorporates improvements for atrial fibrillation (AF), pause, and bradycardia detection.

Purpose of the Study:

• To evaluate the impact of enhanced AF and pause detection algorithms in the LUX-Dx II+ ICM.
• To assess the effectiveness of optimized nighttime programming for reducing non-actionable bradycardia and pause detections.

Main Methods:

• Real-world ECG data were used to compare new AF and pause algorithms against predecessor LUX-Dx algorithms.
• Simulated optimized nighttime programming settings (11 p.m. - 7 a.m.) were applied to LUX-Dx data.
• Evaluated reduction in non-actionable nocturnal bradycardia (>30 bpm) and pauses (<5 s).

Main Results:

• The novel AF algorithm reduced false positives by 34-38% (up to 74% in sensitive settings) while maintaining >98% sensitivity.
• The enhanced pause algorithm reduced false positives by 48.6-62.5% with 100% relative sensitivity.
• Adjusted nocturnal thresholds reduced bradycardia and pause episodes by 98% and 90%, respectively (75% and 56% overall).

Conclusions:

• Enhanced ICM algorithms and programming settings significantly decrease false positive AF and pause detections.
• Optimized settings substantially reduce non-actionable nocturnal bradycardia and pause detections.
• These improvements are expected to enhance ICM performance and streamline device clinic workflows.