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植入式心律转复除颤器(ICD)植入后立即进行自动无线远程监测的作用:Lumos-T减少常规门诊设备随访研究(TRUST)试验。

Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial.

作者信息

Varma Niraj, Epstein Andrew E, Schweikert Robert, Michalski Justin, Love Charles J

机构信息

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Department of Cardiology, University of Pennsylvania, Pennsylvania, USA.

出版信息

J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27.

Abstract

INTRODUCTION

The incidence of unscheduled encounters and problem occurrence between ICD implant and first in-person evaluation (IPE) recommended at 12 weeks is unknown. Automatic remote home monitoring (HM) may be useful in this potentially unstable period.

METHODS AND RESULTS

ICD patients were randomized 2:1 to HM enabled post-implant (n = 908) or to conventional monitoring (CM; n = 431). Groups were compared between implant and prior to first scheduled IPE for IPE incidence, causes, and actionability (reprogramming, system revision, medication changes) and event detection time. HM and CM patients were similar (mean age 63 years, 72% male, LVEF 29%, primary prevention 73%, DDD 57%). In the post-implant interval assessed (HM 100 ± 21.3 days vs. CM 101 ± 20.8 days, P = 0.54), 85.4% (776/908) HM patients and 87.7% CM (378/431) patients had no cause for IPE (P = 0.31). When IPE occurred, actionability in HM (64/177 [36.2%]) was greater versus CM (15/62 [24.2%], P = 0.12). Actionable items were discovered sooner with HM (P = 0.025). Device reprogramming or lead revision was triggered following 53/177 (29.9%) IPEs in HM versus 9/62 (14.5%) in CM (P = 0.018). Arrhythmia detection was enhanced by HM: 276 atrial and ventricular episodes were detected in 135 follow-ups in contrast to CM (65 episodes at 17 IPEs). More silent arrhythmic episodes were discovered by HM (7.2% vs. 1.5% [P = 0.15]). Since 27/42 (64.3%) IPEs driven by HM alerts were actionable, event notification was a valuable method for problem detection. Importantly, HM did not increase incidence of non-actionable IPEs (P = 0.72).

CONCLUSION

Activation of automatic remote monitoring should be encouraged soon post-ICD implant.

摘要

引言

植入式心律转复除颤器(ICD)植入与推荐的12周首次面对面评估(IPE)之间计划外就诊和问题发生的发生率尚不清楚。在这个潜在不稳定的时期,自动远程家庭监测(HM)可能会有所帮助。

方法与结果

将ICD患者按2:1随机分为植入后启用HM组(n = 908)和传统监测组(CM;n = 431)。比较两组在植入时和首次计划IPE之前的IPE发生率、原因和可操作性(重新编程、系统修订、药物改变)以及事件检测时间。HM组和CM组患者相似(平均年龄63岁,72%为男性,左心室射血分数29%,一级预防73%,DDD起搏模式57%)。在评估的植入后间隔期(HM组100±21.3天,CM组101±20.8天,P = 0.54),85.4%(776/908)的HM组患者和87.7%的CM组(378/431)患者没有进行IPE的原因(P = 0.31)。当发生IPE时,HM组的可操作性(64/177 [36.2%])高于CM组(15/62 [24.2%],P = 0.12)。HM组能更快发现可操作项目(P = 0.025)。HM组在177次IPE中有53次(29.9%)触发了设备重新编程或导线修订,而CM组在62次中有9次(14.5%)(P = 0.018)。HM增强了心律失常检测:在135次随访中检测到276次房性和室性发作,而CM组在17次IPE中检测到65次发作。HM组发现更多无症状心律失常发作(7.2%对1.5% [P = 0.15])。由于HM警报引发的42次IPE中有27次(64.3%)是可操作的,事件通知是问题检测的一种有价值的方法。重要的是,HM并没有增加不可操作IPE的发生率(P = 0.72)。

结论

应鼓励在ICD植入后尽快激活自动远程监测。

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