A Tool for the Assessment of Electromagnetic Compatibility in Active Implantable Devices: The Pacemaker Physical Twin

TL;DR

A physical twin of a pacemaker was developed to study how low-to-mid-frequency magnetic fields might interfere with cardiac implantable devices.

Contribution

The novel physical twin setup enables detailed experimental analysis of electromagnetic interference mechanisms in cardiac devices.

Findings

The physical twin can reliably measure induced voltages between 5 mV and 1.5 V.

Factors like electrode-tissue interface and body-induced currents influence EMI beyond implant geometry.

The tool provides data to improve numerical models and inform future EMI standards.

Abstract

Background: The increasing use of technologies operating between 10 and 200 kHz, such as RFID, wireless power transfer systems, and induction cooktops, raises concerns about electromagnetic interference (EMI) with cardiac implantable electronic devices (CIEDs). The mechanisms of interaction within this frequency range have been only partially addressed by both the scientific and regulatory communities. Methods: A physical twin of a pacemaker/implantable defibrillator (PM/ICD) was developed to experimentally assess voltages induced at the input stage by low-to-mid-frequency magnetic fields. The setup simulates the two sensing modalities programmable in PMs/ICDs and allows for the analysis of different implant configurations, lead geometries, and positions within a human body phantom. Results: Characterization of the physical twin demonstrated its capability to reliably measure induced voltages in the range of 5 mV to 1.5 V. Its application enabled the identification of factors beyond the implant’s induction area that contribute to the induced voltage, such as the electrode-tissue interface and body-induced currents. Conclusions: This physical twin represents a valuable tool for experimentally validating the mechanisms of EMI in CIEDs, providing insights beyond current standards. The data obtained can serve as a reference for the validation of numerical models and patient-specific digital twins. Moreover, it offers valuable information to guide future updates and revisions of international electromagnetic compatibility standards for CIEDs.

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