Real-world performance of the atrial fibrillation monitor in patients with a subcutaneous ICD

Abstract

Introduction: The third-generation subcutaneous implantable cardioverter-defibrillator (S-ICD) (EMBLEM™ A219, Boston Scientific) contains a new diagnostic tool to detect atrial fibrillation (AF) in S-ICD patients, without the use of an intracardiac lead. This is the first study to evaluate the performance of the S-ICD AF monitor (AFM).

Methods: The AFM algorithm analyzes a subcutaneous signal for the presence of AF, similar to the signals collected by implantable and wearable diagnostic devices. The AFM algorithm combines heart rate (HR) scatter analysis with an HR histogram. The algorithm was tested against publicly available electrocardiogram databases (simulated performance). Real-world performance of the algorithm was evaluated by using the S-ICD LATITUDE remote monitoring (RM) database.

Results: The simulated performance of the AFM algorithm resulted in a sensitivity of 95.0%, specificity of 100.0%, and positive predictive value (PPV) of 100.0%. To evaluate the real-world performance of the AFM, 7744 S-ICD devices were followed for up to 30 months by RM, whereof 99.5% had the AFM enabled. A total of 387 AF episodes were randomly chosen for adjudication, resulting in a PPV of 67.7%. The main cause of misclassification was atrial and ventricular ectopy.

Conclusion: The AFM exhibited a very high sensitivity and specificity in a simulated setting, designed to maximize PPV in order to minimize the clinical burden of reviewing falsely detected AF events. The real-world performance of the AFM, enabled in 99.5% of S-ICD patients, is a PPV of 67.7%.

Keywords: S-ICD; algorithm; atrial fibrillation; remote monitoring; subclinical atrial fibrillation; subcutaneous implantable cardioverter-defibrillator.