Scholte Niels T B, van Ravensberg Annemiek E, Shakoor Abdul, Boersma Eric, Ronner Eelko, de Boer Rudolf A, Brugts Jasper J, Bruining Nico, van der Boon Robert M A
Erasmus Medical Center, Thorax Center, Department of Cardiology, Cardiovascular Institute, Rotterdam, the Netherlands.
Department of Cardiology, Reinier de Graaf Hospital, Delft, the Netherlands.
NPJ Digit Med. 2024 Oct 12;7(1):279. doi: 10.1038/s41746-024-01268-5.
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,为加强对心力衰竭(HF)患者的远程监测(RM)提供了一个有前景的解决方案。尽管它们具有潜力,但由于缺乏严格评估,其临床整合面临挑战。本综述旨在总结当前证据,并使用医疗器械准备水平(MDRL)评估可穿戴设备用于临床实践的准备情况。一项系统检索从3112篇检索到的文章中识别出99项研究,其中只有8项是随机对照试验。加速度测量法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款是专门为HF RM设计的,并获得了美国食品药品监督管理局(FDA)的批准。因此,由于有力证据有限,可穿戴设备对HF管理的实际影响仍然不确定,这对将其整合到HF护理中构成了重大障碍。