监测再同步化设备与心脏患者（MORE-CARE）随机对照试验：早期干预远程监测动态的1期结果

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring.

作者信息

Boriani Giuseppe, Da Costa Antoine, Ricci Renato Pietro, Quesada Aurelio, Favale Stefano, Iacopino Saverio, Romeo Francesco, Risi Arnaldo, Mangoni di S Stefano Lorenza, Navarro Xavier, Biffi Mauro, Santini Massimo, Burri Haran

机构信息

Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S Orsola-Malpighi University Hospital, Bologna, Italy.

出版信息

J Med Internet Res. 2013 Aug 21;15(8):e167. doi: 10.2196/jmir.2608.

BACKGROUND

Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting.

OBJECTIVE

The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions.

METHODS

In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year.

RESULTS

The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65).

CONCLUSIONS

RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits.

TRIAL REGISTRATION

Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).

背景

对于晚期心力衰竭患者以及植入心脏再同步治疗除颤器（CRT-D）的患者，远程监测（RM）可通过传输自动警报减少临床决策的延迟。然而，这一策略从未在该患者群体中专门针对肺液超负荷警报进行过测试，也未在欧洲环境中进行过测试。

目的

第一阶段（本文所述）的主要目的是评估远程监测策略是否能够缩短从设备检测到事件到做出临床决策的时间。

方法

在这项多中心随机对照试验中，植入CRT-D设备的中重度心力衰竭患者被随机分为远程组（进行远程随访并接收无线自动警报）或对照组（进行标准随访且无警报）。第一阶段的主要终点是在前154名入组患者中，警报事件与针对该事件的临床决策之间的延迟，这些患者随访1年。

结果

与对照组相比，远程组从设备检测到事件到做出临床决策的中位延迟显著更短：分别为2天（第25-75百分位数，1-4天）和29天（第25-75百分位数，3-51天），P = 0.004。远程组的住院次数减少（2.0次/患者/年，而对照组为3.2次/患者/年，相对减少37.5%，P < 0.001）。远程组93%发生在院外的事件中自动警报成功传输。两组患者的全因住院年发生率无差异（P = 0.65）。