动态植入式原发性心脏植入式电子设备后的家庭监测：家庭救护车试点研究。
Home monitoring after ambulatory implanted primary cardiac implantable electronic devices: The home ambulance pilot study.
作者信息
Parahuleva Mariana S, Soydan Nedim, Divchev Dimitar, Lüsebrink Ulrich, Schieffer Bernhard, Erdogan Ali
机构信息
Internal Medicine/Cardiology and Angiology Department, University Hospital of Giessen and Marburg, Marburg, Germany.
Internist Practice Center, Balserische Stiftung Hospital, Giessen, Germany.
出版信息
Clin Cardiol. 2017 Nov;40(11):1068-1075. doi: 10.1002/clc.22772. Epub 2017 Aug 21.
BACKGROUND
The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization.
HYPOTHESIS
We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs.
METHODS
This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices.
RESULTS
The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients.
CONCLUSIONS
Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs.
背景
心脏植入式电子设备（CIED）的家庭监测（HM）系统可早期检测心律失常或设备系统故障。本试点研究的目的是探讨动态植入原发性CIED患者中HM系统的安全性和有效性与接受标准程序和住院治疗的患者相比如何。
假设
我们假设HM及其改进将是目前动态植入CIED概念的有益扩展。
方法
这项回顾性分析评估了6年间在一个动态单中心从364例患者获得的遥测数据。患者被分为活动组（n = 217），包括那些在原发性CIED植入当天较早出院的患者，或对照组（n = 147），包括那些按照常规医疗实践出院并使用HM系统进行随访的患者。
结果
活动组的平均住院时间比对照组短73.2%，相当于住院时间减少20.5±13小时（95%置信区间[CI]：6.3 - 29.5；P < 0.01）（7.5±1.5小时对28±4.5小时）。平均住院时间缩短归因于活动组术后时间缩短78.8%。活动组治疗相关不良事件患者比例为11%（n = 23），对照组为17%（n = 25）（95% CI：5.5 - 8.3；P = 0.061）。这6%的绝对风险降低（95% CI：3.3 - 9.1；P = 0.789）证实了动态植入CIED与这些患者的标准管理相比的非劣效性。
结论
动态CIED植入后使用HM系统早期出院是安全的，且不劣于传统医疗程序。因此，连同较低的成本，HM及其改进将是目前动态植入CIED概念的有益扩展。
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