A remote monitoring system was feasible and well-tolerated in pediatric end-stage heart failure, identifying worsening heart failure in 39% of patients and prompting unplanned management.
Is a remote monitoring system feasible, well-tolerated, and clinically useful for identifying major cardiovascular events in pediatric end-stage heart failure patients?
Remote monitoring using a skin patch is feasible, well-tolerated, and helps identify major cardiovascular events in pediatric patients with end-stage heart failure.
Abstract Background/Introduction Remote monitoring in heart failure (HF) pediatric population is significantly reduced if compared with adults and several barriers account for these differences as the availability of pediatric devices, the lack of pediatric clinical trials, the relative low volumes of pediatric HF patients and the absence of standardization. Purpose Aim of the HOPE-HF study was to the evaluate the feasibility, tolerability, satisfaction and the clinical usefulness of a remote monitoring system to identify potential major cardiovascular events (MACEs) in HF pediatric patients. Methods In this prospective, non-profit, single-center, open-label, single-arm, pilot study chronic end-stage HF patients aged ≥ 1 month 18 years with NYHA/Ross ≥III class and history of previous hospitalization for acute HF or worsening HF were enrolled and a commercially available adult remote monitoring device was supplied to patients. The device consists of a skin patch to be applied on the chest to monitor vital parameters including 1-lead ECG, O2 saturation (SO2) and the Pediatric Early Warning Score (PEWS), a transmission component and a dedicated software for collection and storage of the patients’ parameters. A dedicated virtual clinic was developed to support the enrolled patients and their caregivers during the monitoring and to manage MACEs during the 3-month monitoring study. Results Eighteen chronic HF patients (50% male, median age 8.8 6.5; 14.6 years, range 6 months-18 years, median NT-proBNP 1191 282; 1947 pg/ml) were enrolled and 10 (56%) patients had a congenital heart disease (CHD) with univentricular circulation physiology after surgical interventions including Fontan (2 pts), Glenn (7 pts) and Norwood (1 pt). The remaining 8 patients had a biventricular circulation with diagnosis of dilated or restrictive cardiomyopathy (2 and 1 patients respectively), 1 unoperated CHD, 2 patients in left ventricular assist device and 2 heart transplant patients. The median duration of telemonitoring was 78.5 46.2; 90 days and the median daily hours 8.1 4.9; 10, with a significant difference between the first and last week of monitoring (13.1 8; 14.7 vs 7.6 4.4; 10.7 hours respectively, p=0.002). Early stop of monitoring occurred in 5 patients (28%) 2 (11%) for severe skin reaction, 2 (11%) for consent withdrawal and 1 for heart transplant. In 7 patients (39%) worsening/acute HF was identified by monitoring parameters and prompted hospitalization in 3 (17%) patients and an unplanned surgical intervention in 1 patient. The monitoring was uneventful in 5 patients. The median satisfaction score was high: 40 out of 50 37.5; 42.5 both after the 1st week and at the end of monitoring. Conclusion Remote monitoring is feasible and appreciated by pediatric HF patients and their caregivers. The remote monitoring helped to identify a high rate of MACEs and to prompt unplanned management of end-stage HF patients.Study flowchart remote monitoring outcomes
Adorisio et al. (Sat,) conducted a other in Pediatric end-stage heart failure (n=18). Remote monitoring system (wearable skin patch) was evaluated on Feasibility, tolerability, satisfaction and clinical usefulness to identify potential major cardiovascular events (MACEs). A remote monitoring system was feasible and well-tolerated in pediatric end-stage heart failure, identifying worsening heart failure in 39% of patients and prompting unplanned management.