Most noninvasive wearables for heart failure monitoring are consumer-grade devices in the feasibility stage (MDRL 6), with limited robust evidence to support their clinical integration.
Systematic Review (n=13,879)
Does noninvasive wearable technology improve remote monitoring in heart failure patients?
Most noninvasive wearables for heart failure monitoring are currently in the feasibility phase (MDRL 6) and lack robust evidence from large randomized controlled trials to support their clinical integration.
Wearables offer a promising solution for enhancing remote monitoring (RM) of heart failure (HF) patients by tracking key physiological parameters. Despite their potential, their clinical integration faces challenges due to the lack of rigorous evaluations. This review aims to summarize the current evidence and assess the readiness of wearables for clinical practice using the Medical Device Readiness Level (MDRL). A systematic search identified 99 studies from 3112 found articles, with only eight being randomized controlled trials. Accelerometery was the most used measurement technique. Consumer-grade wearables, repurposed for HF monitoring, dominated the studies with most of them in the feasibility testing stage (MDRL 6). Only two of the described wearables were specifically designed for HF RM, and received FDA approval. Consequently, the actual impact of wearables on HF management remains uncertain due to limited robust evidence, posing a significant barrier to their integration into HF care.
Scholte et al. (Sat,) conducted a systematic review in Heart failure (n=13,879). Noninvasive wearable technology was evaluated on Medical Device Readiness Level (MDRL) and clinical integration readiness. Most noninvasive wearables for heart failure monitoring are consumer-grade devices in the feasibility stage (MDRL 6), with limited robust evidence to support their clinical integration.