LAUSR

Background: Recent enhancements have been introduced to the Abbott Confirm Rx™ insertable cardiac monitor (ICM) arrhythmia detection algorithms (SharpSense™). This study aims to characterize the real-world performance of SharpSense™ algorithms, in the upgraded ICM devices by comparing device detected pause and bradycardia (brady) episodes before and after the SharpSense™ upgrade. Methods: Confirm Rx™ devices with at least 90 days monitoring each before and after SharpSense™ upgrade were included in the study. Brady and pause episodes were extracted from Merlin.net™ patient care network for evaluation and adjudicated by expert adjudicators. Results: A total of 197 devices were included in the analysis. Devices were implanted for syncope (35%), AF management (33%), and other indications, including cryptogenic stroke and palpitations (32%). The SharpSense™ upgrade significantly reduced the total number of detected episodes by 92% (pause: 93%, brady: 87%) and the rate of transmitted episodes by 73.6% from 50.3 to 13.3 (pause: 34.9 to 6.0, brady: 7.8 to 1.5) episodes per patient-week (p < 0.001). SharpSense™ reduced false positive episodes by 82.8% and 91.5% for pause and brady, respectively. The percentage of devices with at least one false positive episode was reduced from 52% to 35% for pause and from 39% for 20% for brady. The number of devices with false positive rate greater than 1 episode per week was reduced from 39% to 20% for pause and from 23% to 8% for brady. Conclusion: SharpSense™ upgrade resulted in substantial reduction of pause and bradycardia episode detections, false positive detections, and frequency of transmitted episodes for clinic review.