Division of Cardiovascular Medicine, The Ohio State University, 244 Davis Heart &Lung Research Institute, 473 West 12th Avenue, Columbus, OH 43210, USA.
Campbell University College of Pharmacy and Health Sciences, 143 Main Street, Buies Creek, NC 27506, USA.
Nat Rev Cardiol. 2014 Oct;11(10):576-85. doi: 10.1038/nrcardio.2014.114. Epub 2014 Aug 12.
Implantable monitoring devices have been developed to detect early evidence of heart failure (HF) decompensation, with the hypothesis that early detection might enable clinicians to commence therapy sooner than would otherwise be possible, and potentially to reduce the rate of hospitalization. In addition to the usual challenges inherent to device trials (such as the difficulty of double-blinding and potential for bias), studies of implantable monitoring devices present unique difficulties because they involve assessment of therapeutic end points for diagnostic devices. Problems include the lack of uniform approaches to treatment in study protocols for device alerts or out-of-range values, and the requirement of levels of evidence traditionally associated with therapeutic devices to establish effectiveness and safety. In this Review, the approaches used to deal with these issues are discussed, including the use of objective primary end points with blinded adjudication, identical duration of follow-up and number of encounters for patients in active monitoring and control groups, and treatment recommendations between groups that are consistent with international guidelines. Remote monitoring devices hold promise for reducing the rate of hospitalization among patients with HF. However, optimization of regulatory approaches and clinical trial design is needed to facilitate further evaluation of the effectiveness of combining health information technology and medical devices.
植入式监测设备已经被开发出来，以检测心力衰竭（HF）失代偿的早期迹象，其假设是早期检测可能使临床医生能够比以往更早地开始治疗，并有可能降低住院率。除了设备试验固有的常见挑战（例如双盲的难度和潜在的偏见）之外，植入式监测设备的研究还存在独特的困难，因为它们涉及到诊断设备治疗终点的评估。问题包括研究方案中缺乏针对设备警报或超出范围值的统一治疗方法，以及需要传统上与治疗设备相关的证据水平来确定有效性和安全性。在这篇综述中，讨论了用于解决这些问题的方法，包括使用客观的主要终点和盲法裁决，对主动监测和对照组患者进行相同的随访时间和接触次数，以及组间的治疗建议与国际指南一致。远程监测设备有望降低 HF 患者的住院率。然而，需要优化监管方法和临床试验设计，以促进进一步评估将健康信息技术和医疗设备相结合的有效性。
