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新型远程磁导航系统磁场中植入式起搏器和除颤器的安全性。

Safety of implantable pacemakers and cardioverter defibrillators in the magnetic field of a novel remote magnetic navigation system.

机构信息

Deutsches Herzzentrum und 1. Medizinische Klinik rechts der Isar, Faculty of Medicine, Technische Universität München, Munich, Germany.

出版信息

J Cardiovasc Electrophysiol. 2010 Oct;21(10):1136-41. doi: 10.1111/j.1540-8167.2010.01806.x.

Abstract

INTRODUCTION

Electromagnetic interference with pacemaker and implantable cardioverter defibrillator (ICD) systems may cause temporary or permanent system malfunction of implanted devices. The aim of this study was to evaluate potential interference of a novel magnetic navigation system with implantable rhythm devices.

METHODS

A total of 121 devices (77 pacemakers, 44 ICDs) were exposed to an activated NIOBE II® Magnetic Navigation System (Stereotaxis, St. Louis, MO, USA) at the maximal magnetic field strength of 0.1 Tesla and evaluated in vitro with respect to changes in parameter settings of the device, changes of the battery status/detection of elective replacement indication, or alterations of data stored in the device.

RESULTS

A total of 115 out of 121 (95%) devices were free of changes in parameter settings, battery status, and internally stored data after repeated exposition to the electromagnetic field of the remote magnetic navigation system. Interference with the magnetic navigation field was observed in 6 pacemakers, resulting in reprogramming to a power-on-reset mode with or without detection of the elective replacement indication in 5 devices and abnormal variance of battery status in one device. All pacemakers could be reprogrammed to the initial modes and the battery status proved to be normal some minutes after the pacemakers had been removed from the magnetic field.

CONCLUSION

Interference of a remote magnetic navigation system (at maximal field strength) with pacemakers and ICDs not connected to leads with antitachycardic detection and therapies turned off is rare. Occurring functional abnormalities could be reprogrammed in our sample. An in vitro study will give information about interference of devices connected to leads.

摘要

简介

起搏器和植入式心脏复律除颤器(ICD)系统受到电磁干扰可能导致植入设备的暂时或永久性系统故障。本研究的目的是评估新型磁导航系统对植入式心律设备的潜在干扰。

方法

将 121 个设备(77 个起搏器,44 个 ICD)暴露于激活的 NIOBE II®磁导航系统(Stereotaxis,密苏里州圣路易斯)最大磁场强度为 0.1 特斯拉,并在体外评估设备参数设置的变化、电池状态的变化/检测是否需要更换、或设备中存储的数据是否发生变化。

结果

在重复暴露于远程磁导航系统的电磁场后,121 个设备中有 115 个(95%)设备的参数设置、电池状态和内部存储的数据没有变化。在 6 个起搏器中观察到与磁场的干扰,导致在 5 个设备中重新编程到电源复位模式,其中 5 个设备检测到需要更换,1 个设备电池状态异常。所有起搏器都可以重新编程到初始模式,并且在起搏器从磁场中取出几分钟后,电池状态被证明正常。

结论

远程磁导航系统(最大场强)与未连接抗心动过速检测和治疗功能的起搏器和 ICD 之间的干扰很少见。在我们的样本中,发生的功能异常可以重新编程。体外研究将提供有关连接到导线上的设备干扰的信息。

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