Key result
Confirm Rx ICM yields ~75% positive predictive value for AF episodes, improving with longer duration.
Why the study?
The novel Confirm Rx ICM with SharpSense technology incorporates a new P-wave discriminator designed to improve AF detection, but its diagnostic performance across AF episodes of varying durations required evaluation.
Does the Confirm Rx implantable cardiac monitor with SharpSense technology accurately detect atrial fibrillation episodes in patients with documented AF?
Observational
Yes
Does the Confirm Rx implantable cardiac monitor with SharpSense technology accurately detect atrial fibrillation episodes in patients with documented AF?
The Confirm Rx ICM provides modest overall positive predictive value for AF detection, but its diagnostic accuracy improves significantly for longer AF episodes.
Short AF detections warrant clinical verification; leaves open optimal duration thresholds for Confirm Rx use.
Introduction: The novel Confirm Rx™ implantable cardiac monitor (ICM) with SharpSense™ technology incorporates a new P-wave discriminator designed to improve AF detection. This study aimed to evaluate the diagnostic performance of the Confirm Rx™ ICM in detecting AF episodes of varying durations. Methods: We conducted a multicenter retrospective analysis of consecutive patients implanted with a Confirm Rx™ ICM (v1.2) across nine UK hospitals, all with documented AF lasting at least 6 min. Electrocardiograms (ECGs) were manually adjudicated by cardiologists. To account for intra- and inter-reviewer variability, a random sample of 10% of ECGs underwent additional review. Disagreements were resolved by a third reviewer. Diagnostic performance was determined by calculating the gross and patient-averaged positive predictive value (PPV) for AF episodes of different duration. The source of false positive (FP) detection was also categorized. The gross and patient-averaged PPV were 75.0% and 67.0%, respectively. Diagnostic performance (gross) increased with progressively longer AF episodes: 88.0% for ≥1 h, 97.3% for 6 h, and 100% for 24 h. The main source of FP during tachycardia was T-wave oversensing (54.2%), while in non-tachycardic episodes it was predominantly ectopy (71.2%). The AF burden precision was excellent (93.3%). Conclusion: The Confirm Rx™ ICM diagnostic performance was modest for all AF episodes (75%), with accuracy increasing for longer AF episodes.
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Gala et al. (2024) conducted an observational in Atrial fibrillation. Confirm Rx implantable cardiac monitor (ICM) with SharpSense technology was evaluated on Diagnostic performance (gross and patient-averaged positive predictive value) for AF episodes. The Confirm Rx ICM demonstrated a gross positive predictive value of 75.0% for all AF episodes, which increased to 88.0% for episodes ≥1 hour, 97.3% for 6 hours, and 100% for 24 hours.
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