Faculty of Medicine, University of Southampton, Tremona Road, Southampton SO16 6YD, UK.
Wessex Cardiology Centre, University Hospital Southampton NHS Foundation Trust, Southampton SO16 6YD, UK.
Eur Heart J. 2017 Aug 7;38(30):2352-2360. doi: 10.1093/eurheartj/ehx227.
Remote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs).
Between 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23-98); 86% were male. Patients were followed for a median of 2.8 years (range 0-4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87-1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components.
Among patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.
使用植入式电子设备（REM-HF）进行心力衰竭远程管理，旨在评估心力衰竭患者心脏植入电子设备（CIED）的远程监测（RM）的临床和成本效益。
在 2011 年 9 月 29 日至 2014 年 3 月 31 日期间，我们将 1650 名心力衰竭合并 CIED 的患者随机分配至主动 RM 组或常规护理（UC）组。主动 RM 组采用了规范化的远程随访方案，UC 组则采用了英国 9 个招募中心的标准做法。事件时间分析的主要终点是首次因任何原因导致的死亡或因心血管原因导致的非计划性住院。次要终点包括任何原因导致的死亡、心血管原因导致的死亡、心血管原因和非计划性心血管住院导致的死亡、非计划性心血管住院、非计划性住院。REM-HF 已在 ISRCTN（ISRCTN81006133）注册。人群的平均年龄为 70 岁（范围 23-98 岁），86%为男性。中位随访时间为 2.8 年（范围 0-4.3 年），截止到 2016 年 1 月 31 日完成随访。研究过程中，患者的依从性较高，脱落率为 4.3%。主动 RM 组和 UC 组的主要终点发生率无显著差异，分别为 42.4%和 40.8%[风险比 1.01；95%置信区间（CI）0.87-1.18；P=0.87]。两组在次要终点或主要终点组成部分的时间方面均无显著差异。
在心力衰竭合并 CIED 的患者中，每周下载并采用规范化随访方式的 RM 并不能改善结局。
