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.

可穿戴设备通过跟踪关键生理参数来增强心力衰竭 （HF） 患者的远程监测 （RM），提供了一种很有前途的解决方案。尽管它们具有潜力，但由于缺乏严格的评估，它们的临床集成面临挑战。本综述旨在总结当前证据，并使用医疗器械准备水平 （MDRL） 评估可穿戴设备对临床实践的准备情况。一项系统检索从 3112 篇找到的文章中确定了 99 项研究，其中只有 8 篇是随机对照试验。加速度计是最常用的测量技术。重新用于 HF 监测的消费级可穿戴设备在研究中占主导地位，其中大多数处于可行性测试阶段 （MDRL 6）。所描述的可穿戴设备中只有两种是专门为 HF RM 设计的，并获得了 FDA 的批准。因此，由于证据有限，可穿戴设备对 HF 管理的实际影响仍不确定，这对它们整合到 HF 护理中构成了重大障碍。