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


CONCLUSIONS
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.
Jilek
Clemens
C
Deutsches Herzzentrum und 1. Medizinische Klinik rechts der Isar, Faculty of Medicine, Technische Universität München, Munich, Germany. jilek@dhm.mhn.de
Tzeis
Stylianos
S
Reents
Tilko
T
Estner
Heidi-Luise
HL
Fichtner
Stephanie
S
Ammar
Sonia
S
Wu
Jinjin
J
Hessling
Gabriele
G
Deisenhofer
Isabel
I
Kolb
Christof
C
D017115:Catheter Ablation / Q000295:instrumentation*; D017147:Defibrillators, Implantable; D004567:Electrodes, Implanted; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D008280:Magnetics / Q000295:instrumentation*; D010138:Pacemaker, Artificial; D025321:Surgery, Computer-Assisted / Q000295:instrumentation*; D017216:Telemedicine / Q000295:instrumentation