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一项针对直接暴露于 10Gy 以内时心脏植入式电子设备瞬态和永久性故障的随机体外评估。

A randomized in vitro evaluation of transient and permanent cardiac implantable electronic device malfunctions following direct exposure up to 10 Gy.

机构信息

Department of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.

Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.

出版信息

Strahlenther Onkol. 2021 Mar;197(3):198-208. doi: 10.1007/s00066-020-01651-7. Epub 2020 Jun 19.

DOI:10.1007/s00066-020-01651-7
PMID:32561941
Abstract

BACKGROUND AND PURPOSE

High-dose 6‑MV radiotherapy may cause cardiac implantable electronic devices (CIEDs) to malfunction. To assess CIED malfunctions resulting from direct exposure up to 10 Gy, 100 pacemakers (PMs) and 40 implantable cardioverter-defibrillators (ICDs) were evaluated.

MATERIALS AND METHODS

CIEDs underwent baseline interrogation. In ICDs, antitachycardia therapies were disabled via the programmer while the detection windows were left enabled. A computed tomography (CT) scan was performed to build the corresponding treatment plan. CIEDs were "blinded" and randomized to receive single doses of either 2, 5, or, 10 Gy via a 6-MV linear accelerator (linac) in a water phantom. Twenty-two wireless telemetry-enabled CIEDs underwent a real-time session, and their function was recorded by the video camera in the bunker. The CIEDs were interrogated after exposure and once monthly for 6 months.

RESULTS

During exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections. After exposure, a backup reset was observed in 1 PM (0.7% overall, 1% among PMs), while 7 PMs (5% overall, 7% among PMs) reported battery issues (overall immediate malfunction rate was 5.7%). During follow-up, 4 PMs (2.9% overall; 4% among PMs) and 1 ICD (0.7% overall; 2.5% among ICDs) reported abnormal battery depletion, and 1 PM (0.7% overall; 1% among PMs) reported a backup reset (overall late malfunction rate was 4.3%).

CONCLUSION

Apart from transient electromagnetic interference, last-generation CIEDs withstood direct 6‑MV exposure up to 10 Gy. Permanent battery or software errors occurred immediately or later only in less recent CIEDs.

摘要

背景与目的

高剂量 6-MV 放疗可能导致心脏植入式电子设备(CIED)发生故障。为了评估高达 10Gy 直接照射导致的 CIED 故障,对 100 个起搏器(PM)和 40 个植入式心律转复除颤器(ICD)进行了评估。

材料与方法

CIED 进行了基线检查。在 ICD 中,通过编程器禁用抗心动过速治疗,同时保持检测窗口开启。进行计算机断层扫描(CT)以构建相应的治疗计划。CIED 被“蒙蔽”并随机接受单次 2、5 或 10Gy 的剂量,通过 6-MV 线性加速器(linac)在水模体中进行照射。22 个具有无线遥测功能的 CIED 进行了实时测试,其功能由掩体中的摄像机记录。CIED 在照射后以及之后的 6 个月每月进行一次检查。

结果

在照射过程中,无论剂量如何,90.9%的 CIED 记录到电磁干扰,其中 6 个 ICD(27.3%)报告起搏抑制和不适当的心律失常检测。照射后,1 个 PM(总体 0.7%,PM 中 1%)观察到备用重置,而 7 个 PM(总体 5%,PM 中 7%)报告电池问题(总体即时故障发生率为 5.7%)。在随访期间,4 个 PM(总体 2.9%,PM 中 4%)和 1 个 ICD(总体 0.7%,ICD 中 2.5%)报告电池异常耗竭,1 个 PM(总体 0.7%,PM 中 1%)报告备用重置(总体迟发性故障发生率为 4.3%)。

结论

除了短暂的电磁干扰外,最新一代的 CIED 可以承受高达 10Gy 的直接 6-MV 照射。永久性电池或软件错误仅在较新的 CIED 中立即或稍后发生。

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