Key result
Home Monitoring of patients with cardiac implantable electronic devices recorded 26 serious adverse events over 28.3 months, showing a significantly higher serious adverse event prevalence in ICD patients with concomitant coronary artery disease (p=0.0249).
Why the study?
The study aimed to analyze the adverse events rate and trends of physiologically meaningful parameters in CIED patients with mobile remote monitoring.
Does continuous remote monitoring detect adverse events and enable predictive modeling of clinical status changes in patients with cardiac implantable electronic devices?
Observational (n=126)
Open-label
Yes
Does continuous remote monitoring detect adverse events and enable predictive modeling of clinical status changes in patients with cardiac implantable electronic devices?
Continuous remote monitoring of CIEDs provides ongoing detection of physiological changes, supporting the feasibility of machine learning models to predict clinically significant arrhythmias.
May warrant closer surveillance in ICD patients with CAD; leaves open whether remote monitoring improves outcomes or enables reliable prediction.
Aims: To perform the analysis of adverse events (AE) rate and trends of physiologically meaningful parameters in patients with cardiac implantable electronic devices (CIEDs) with the mobile remote monitoring option. Methods: In 9 clinical centers of the Russian Federation and 2 clinical centers of the Republic of Kazakhstan, 126 patients with an implantable cardioverter-defibrillator (ICD) or a pacemaker (PM) equipped with the Home Monitoring (HM) technology (BIOTRONIK, Berlin, Germany) were enrolled. Based on the daily data transmission, all alarm alerts, all HM options changes and all AE were recorded with dated alert content and undertaken measures. Results: The study patients, followed up at least for one year, experienced 42 adverse events (AE), of which 26 were serious AE (SAE) and 3 SAE were defined as device-related (SAED). ICD patients (N=90) with concomitant coronary artery disease (CAD) had a statistically significantly higher SAE prevalence (p=0.0249). Patients with CRT-D had a lower SAE rate than patients with dual- or single-chamber ICD (р=0.046). Downloads of Home Monitoring parameters for retrospective mathematical analysis were available for 60 ICD patients, of which 47 had episodes of ventricular tachycardia (VT), ventricular fibrillation (VF) and/or atrial tachyarrhythmia (AT). Machine learning analysis of the trends of the physiologically meaningful parameters revealed correlations between changes and arrhythmia episodes, with the random forest and gradient boosting methods demonstrating the random effect of the results. Conclusion: Home Monitoring of CIED patients enables the evaluation of different devices applications and their clinical advantages. This might implement the prevention of adverse events and iatrogenic effects of pacing. Based on daily transmission of physiologically meaningful Home Monitoring parameters, the study results demonstrate the feasibility of developing a prediction algorithm for adverse events.
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Ревишвили et al. (2020) conducted an observational in Cardiac implantable electronic devices (CIEDs) (n=126). Home Monitoring (HM) technology was evaluated on Occurrence of a serious adverse event (SAE). Home Monitoring of patients with cardiac implantable electronic devices recorded 26 serious adverse events over 28.3 months, showing a significantly higher serious adverse event prevalence in ICD patients with concomitant coronary artery disease (p=0.0249).
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