Relationship between activity and sleep, as measured through a wearable accelerometer, and appropriate cardioverter-defibrillator interventions: a prospective SafeHeart substudy.

INTRODUCTION: Physical activity has shown association with ventricular arrhythmia, however, the role of specific behavioral patterns over a 24-hour cycle remains unknown. Therefore, we aimed to explore associations between physical behavior and appropriate implantable cardioverter-defibrillator (ICD) therapy. METHODS: We included patients with an ICD at two European sites, who wore wrist-based accelerometers capturing 24-hour movement and sleep behaviors for 28 days. Behavioral measures included activity volume, duration and intensity, sleep duration and efficiency. Patients were followed for 12 months for the outcome of appropriate ICD therapy. Cox proportional hazard models with restricted cubic splines were used for the analysis. Lastly, the predictive capacity was tested. RESULTS: : A total of 253 ICD patients were included (mean age 63.8 (±10.2), 50 (19.8%) female). During follow-up, 40 patients (15.8%) received appropriate ICD therapy; 32 ATP only (12.6%), 5 shock only (2.0%) and 3 combined ATP and shock (1.2%). In the adjusted model, high inactive duration (HR 1.40 (95% 1.10-1.78), peak walking cadence (HR 1.07 (95% 1.03-1.12) and total sleep duration (HR 1.50 (1.02-2.22) were associated with the outcome. The dose-response relationship was U-shaped for inactive duration with a cutoff at 16 hours, and linear for peak cadence and sleep. The prediction model reached an AUROC of 0.70 ±0.03, with highest accuracy in the first months. CONCLUSION: Wearable-derived 24-hour movement and sleep behaviors collected over 28 days were associated with later appropriate ICD therapy risk. Testing of the predictive value of digital biomarkers for enhanced risk stratification of ventricular arrhythmia warrants larger prospective studies. TRIAL REGISTRATION: National Trial Registration (NL9218, http://onderzoekmetmensen.nl/).

Accelerometer-assessed physical behavior and the association with clinical outcomes in implantable cardioverter-defibrillator recipients: A systematic review.

Background: Current implantable cardioverter-defibrillator (ICD) devices are equipped with a device-embedded accelerometer capable of capturing physical activity (PA). In contrast, wearable accelerometer-based methods enable the measurement of physical behavior (PB) that encompasses not only PA but also sleep behavior, sedentary time, and rest-activity patterns. Objective: This systematic review evaluates accelerometer-based methods used in patients carrying an ICD or at high risk of sudden cardiac death. Methods: Papers were identified via the OVID MEDLINE and OVID EMBASE databases. PB could be assessed using a wearable accelerometer or an embedded accelerometer in the ICD. Results: A total of 52 papers were deemed appropriate for this review. Out of these studies, 30 examined device-embedded accelerometry (189,811 patients), 19 examined wearable accelerometry (1601 patients), and 3 validated wearable accelerometry against device-embedded accelerometry (106 patients). The main findings were that a low level of PA after implantation of the ICD and a decline in PA were both associated with an increased risk of mortality, heart failure hospitalization, and appropriate ICD shock. Second, PA was affected by cardiac factors (eg, onset of atrial fibrillation, ICD shocks) and noncardiac factors (eg, seasonal differences, societal factors). Conclusion: This review demonstrated the potential of accelerometer-measured PA as a marker of clinical deterioration and ventricular arrhythmias. Notwithstanding that the evidence of PB assessed using wearable accelerometry was limited, there seems to be potential for accelerometers to improve early warning systems and facilitate preventative and proactive strategies.

Rationale and design of the SafeHeart study: Development and testing of a mHealth tool for the prediction of arrhythmic events and implantable cardioverter-defibrillator therapy.

Background: Patients with an implantable cardioverter-defibrillator (ICD) are at a high risk of malignant ventricular arrhythmias. The use of remote ICD monitoring, wearable devices, and patient-reported outcomes generate large volumes of potential valuable data. Artificial intelligence-based methods can be used to develop personalized prediction models and improve early-warning systems. Objective: The purpose of this study was to develop an integrated web-based personalized prediction engine for ICD therapy. Methods: This international, multicenter, prospective, observational study consists of 2 phases: (1) a development study and (2) a feasibility study. We plan to enroll 400 participants with an ICD (with or without cardiac resynchronization therapy) on remote monitoring: 300 participants in the development study and 100 in the feasibility study. During 12-month follow-up, electronic health record data, remote monitoring data, accelerometry-assessed physical behavior data, and patient-reported data are collected. By using machine- and deep-learning approaches, a prediction engine is developed to assess the risk probability of ICD therapy (shock and antitachycardia pacing). The feasibility of the prediction engine as a clinical tool, the SafeHeart Platform, is assessed during the feasibility study. Results: Development study recruitment commenced in 2021. The feasibility study starts in 2022. Conclusion: SafeHeart is the first study to prospectively collect a multimodal data set to construct a personalized prediction engine for ICD therapy. Moreover, SafeHeart explores the integration and added value of detailed objective accelerometer data in the prediction of clinical events. The translation of the SafeHeart Platform to clinical practice is examined during the feasibility study.