Department of Cardiology, San Filippo Neri Hospital, via Martinotti 20, Rome, Italy.
Europace. 2013 Jul;15(7):970-7. doi: 10.1093/europace/eus440. Epub 2013 Jan 29.
The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management.
The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5-86.0%] and 97.4% (CI, 96.5-98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1-14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53-0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0-107.0) min × health personnel/100 patients.
Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.
HomeGuide 注册中心是一项前瞻性研究（NCT01459874），旨在实施一种在日常临床实践中远程监测心脏植入式电子设备（CIED）的模型，以评估其在主要心血管事件检测和管理方面的效果。
远程监测 [Biotronik Home Monitoring (HM)] 的工作流程基于初级护理：每位患者都分配给一位负责管理的专家护士和一位负责医疗决策的主治医生。每年安排一次面对面就诊。75 个意大利站点共纳入 1650 例患者[27%的起搏器、27%的单腔植入式心律转复除颤器 (ICD)、22%的双腔 ICD、24%的带心脏再同步治疗的 ICD]。该人群与 CIED 患者的预期特征相似。在 20 ± 13 个月的随访期间，在 838 例患者（51%）中收集了 2471 例独立裁定的事件：2033 例（82%）在 HM 期间检测到；438 例（18%）在面对面就诊时检测到。60 例被归类为假阳性，广义估计方程校正后的敏感性和阳性预测值分别为 84.3%（置信区间[CI]，82.5-86.0%）和 97.4%（CI，96.5-98.2%）。总体而言，95%的无症状和 73%的可行动事件在 HM 期间被检测到。中位反应时间为 3 天（四分位距[IQR]，1-14 天）。根据四个主要临床感兴趣的属性计算的广义估计方程校正增量效用支持 HM 会话：+0.56（CI，0.53-0.58%），P < 0.0001。资源消耗：共进行了 3364 次 HM 会话（76%由护士完成），中位数承诺的每月人力为 55.5（IQR，22.0-107.0）分钟×医务人员/100 例患者。
在日常实践中，HM 非常有效地检测和管理 CIED 患者的临床事件，人力和资源消耗极低。
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