Abstract
A critical feature of an Insertable Cardiac Monitor (ICM) is to identify clinically significant pauses/bradycardic events in patients (pts) with unexplained syncope. Reducing the number of false positive pause episodes will reduce the clinic review workload. To evaluate an enhanced pause detection algorithm and reduce the clinical burden of evaluating pause episodes while maintaining high relative sensitivity and increasing specificity. The development set consisted of 1033 real world stored LUX-Dx (Boston Scientific) ICM pause events (347 pts) which were selected to include more episodes with low signal to noise ratio (SNR). Another independent test set of 728 real world stored Pause events (93 pts) was randomly selected from a large pool of sequestered patient episode data and adjudicated by two experts until agreement as to specificity. The LUX-Dx pause algorithm uses a proprietary two-step detect/confirm process: step 1 detects when an R-R interval is longer than a programmed threshold, and step 2 confirms (or rejects) a suspected pause after analyzing for broadband myopotential noise and signal-to-noise ratios (SNR) (undersensing). Using the development set (1033 episodes), we have enhanced this algorithm to reject false positive pauses caused by noise and low amplitude signals. The false positive (FP) reduction was 62.5% in the Development set and 48.6% in the Test set. Further, the pt-level reduction in FP episodes ranged from 31.3 - 74.1%. No previously detected true positives were eliminated by the enhanced algorithm in either the development or test sets. This enhanced pause detection algorithm maintained high relative sensitivity, and exhibited a substantial reduction in false pauses, which would decrease the review burden in ICM device clinics while preserving sensitivity to detect clinically important events.Tabled 1DatasetNumber of PatientsNumber of episodesRelative Sensitivity (%)Reduction in FP episodes (%)Reduction in patients with FP events (%)Development347103310062.574.1Test9372810048.631.3 Open table in a new tab
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