Phantom Model Testing of Active Implantable Cardiac Devices at 50/60Hz Electric Field

• Published in: Bioelectromagnetics Vol. 41; no. 2; pp. 136 - 147
• Main Authors: Gerçek, Cihan, Kourtiche, Djilali, Mustapha Nadi, Magne, Isabelle, Schmitt, Pierre, Roth, Patrice, Souques, Martine
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc 01.02.2020
• Subjects: Configurations; Defibrillators; Electric fields; Exposure; Heart; Human body; Level (quantity); Magnetic fields; Mathematical models; Model testing; Numerical methods; Pacemakers; Sensitivity; Surgical implants
• ISSN: 0197-8462; 1521-186X
• DOI: 10.1002/bem.22245

Exposure to external extremely low‐frequency (ELF) electric and magnetic fields induces the development of electric fields inside the human body, with their nature depending on multiple factors including the human body characteristics and frequency, amplitude, and wave shape of the field. The objective of this study was to determine whether active implanted cardiac devices may be perturbed by a 50 or 60 Hz electric field and at which level. A numerical method was used to design the experimental setup. Several configurations including disadvantageous scenarios, 11 implantable cardioverter‐defibrillators, and 43 cardiac pacemakers were tested in vitro by an experimental bench test up to 100 kV/m at 50 Hz and 83 kV/m at 60 Hz. No failure was observed for ICNIRP public exposure levels for most configurations (in more than 99% of the clinical cases), except for six pacemakers tested in unipolar mode with maximum sensitivity and atrial sensing. The implants configured with a nominal sensitivity in the bipolar mode were found to be resistant to electric fields exceeding the low action levels, even for the highest action levels, as defined by the Directive 2013/35/EU. Bioelectromagnetics. 2020;41:136–147. © 2020 Bioelectromagnetics Society.