Abstract
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.
Highlights
Downloads of Home Monitoring parameters for retrospective mathematical analysis were available for 60 implantable cardioverter-defibrillator (ICD) patients, of which 47 had episodes of ventricular tachycardia (VT), ventricular fibrillation (VF) and/or atrial tachyarrhythmia (AT)
Based on daily transmission of physiologically meaningful Home Monitoring parameters, the study results demonstrate the feasibility of developing a prediction algorithm for adverse events
Comparative analysis of the arrhythmias rate based on the diseases etiology showed statistically significant correlations between the VT number and supraventricular tachycardia (SVT), congestive heart failure (CHF) and valvular heart disease (VHD) comorbidity
Summary
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. ”yellow“ (attention) status, and to register all resultant changes of the HM options. If necessary, based on the physician’s decision and/or patient’s need and in view of received HM alert, FU was scheduled, to prevent an anticipated a serious adverse event (SAE). An EchoCG was recommended in case of the following patient‘s status changes: dramatic increase of atrial arrhythmia burden, dramatic increase of the ventricular paced events ratio Vp, rapid worsening of the Heart Failure Monitor (HFM, Biotronik) parameters
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