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2.
J Interv Card Electrophysiol ; 65(1): 133-139, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35538270

ABSTRACT

BACKGROUND: Electronic products, including the iPhone 12, Apple Watch Series 6, and 2nd Generation AirPods, contain magnets to facilitate wireless charging. Permanent magnets may affect CIED magnet mode features by causing pacemakers to pace asynchronously and defibrillators to suspend arrhythmia detection. This study determined if CIEDs are affected by static magnetic fields from commonly used portable electronics (PE) at any distance and intends to reinforce FDA recommendations concerning consumer PE which contain permanent magnets. METHODS: The maximum magnet field measurement was evaluated by a Gauss meter. The interaction between PE and CIEDs from Boston Scientific and Medtronic were tested ex vivo using a body torso model. The CIED was placed in physiologic saline, and the PE was placed at the surface and at increasing distances of 0.5, 1.0, and 1.5 cm. Interactions were recorded by assessment of magnet mode status. RESULTS: The iPhone 12 had almost three times the static magnetic field measured at the surface as the iPhone XR, but magnetic field strength decreased dramatically with increasing distance. At the surface of the model, PE triggered magnet mode in all CIEDs. The maximum interaction distance for all combinations of CIEDs and Apple products was 1.5 cm. CONCLUSIONS: The iPhone 12 produces a stronger static magnetic field than previous iPhone models. Magnets in PE tested will not interact with CIEDs when they are 15 cm from the implanted device. Since no interaction was observed beyond 1.5 cm, it is unlikely that magnet mode activation will occur during most daily activities.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Electromagnetic Fields , Electronics , Humans , Magnetic Fields
3.
Heart Rhythm ; 10(12): 1815-21, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24096164

ABSTRACT

BACKGROUND: Although there are several hazards for patients with implanted pacemakers and defibrillators in the magnetic resonance imaging (MRI) environment, evaluation of lead electrode heating is the most complex because of the many influencing variables: patient size, anatomy, body composition, patient position in the bore, scan sequence (radiofrequency power level), lead routing, and lead design. Although clinical studies are an important step in demonstrating efficacy, demonstrating safety through clinical trials alone is not practical because of this complexity. OBJECTIVE: The purpose of this study was to develop a comprehensive modeling framework to predict the probability of pacing capture threshold (PCT) change due to lead electrode heating in the MRI environment and thus provide a robust safety evaluation. METHODS: The lead heating risk was assessed via PCT change because this parameter is the most clinically relevant measure of lead heating. The probability for PCT change was obtained by combining the prediction for power at the electrode-tissue interface obtained via simulations with a prediction for PCT change as a function of radiofrequency power obtained via an in vivo canine study. RESULTS: The human modeling framework predicted that the probability of a 0.5-V PCT change due to an MRI scan for the Medtronic CapSureFix MRI SureScan model 5086 MRI leads is <1/70,000 for chest scans and <1/10,000,000 for either head scans or lower torso scans. CONCLUSION: The framework efficiently models millions of combinations, delivering a robust evaluation of the lead electrode heating hazard. This modeling approach provides a comprehensive safety evaluation that is impossible to achieve using phantom testing, animal studies, or clinical trials alone.


Subject(s)
Arrhythmias, Cardiac/therapy , Computer Simulation , Magnetic Resonance Imaging, Cine/methods , Pacemaker, Artificial , Animals , Arrhythmias, Cardiac/diagnosis , Disease Models, Animal , Dogs , Equipment Design , Equipment Safety , Humans , Imaging, Three-Dimensional , Phantoms, Imaging , Reproducibility of Results
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