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An Interchangeability Test Method for Developing IPG Impedance Equivalency Evidence for Cardiac Implantable

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A new test evaluates radiofrequency (RF) heating for cardiac implantable electronic devices (CIEDs) with mixed-manufacturer parts. This simplified test allows patients with replaced implantable pulse generators (IPGs) to safely undergo MRI scans.

Keywords:
CIEDMR safetyRF‐induced heatingactive implantable devicesmixed‐manufacturer systempulse generator

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Area of Science:

  • Biomedical Engineering
  • Medical Imaging Safety
  • Electromagnetic Compatibility

Background:

  • Patients with cardiac implantable electronic devices (CIEDs) often have components replaced over time, leading to mixed-manufacturer systems.
  • Mixed-manufacturer CIED systems may present unknown risks, particularly concerning radiofrequency (RF)-induced heating during MRI exposure.
  • Current methods for evaluating RF safety in these mixed systems are not efficient.

Purpose of the Study:

  • To develop a least-burdensome method for evaluating RF safety in CIEDs with mixed-manufacturer components.
  • To establish an implantable pulse generator (IPG) equivalency test to support MR Conditional labeling for mixed-manufacturer systems.
  • To determine if replacing an original IPG with a third-party model significantly alters RF-induced heating.

Main Methods:

  • Measured the transfer function of pacing leads in original (LeadA + IPGA) and mixed-manufacturer systems (LeadA + IPGB or IPGC).
  • Compared deposited power near the lead tip under 50 Ω and open-end conditions.
  • Measured lead and IPG impedances at 64 and 128 MHz.

Main Results:

  • Lead tip heating differences between original and third-party IPG configurations were not statistically significant (p < 0.001).
  • RF-induced heating responses remained within measurement uncertainty for most tested conditions, including small IPG impedance changes (< 2.5 Ω) in systems with overall impedance > 80.2 Ω.
  • Significant heating deviations occurred only under specific conditions, such as with a 50 Ω resistor or certain open-end scenarios.

Conclusions:

  • A simplified IPG impedance equivalency test was developed to facilitate MRI access for patients with mixed-manufacturer CIEDs.
  • This test effectively assesses whether IPG replacement significantly increases RF-induced heating compared to the original system.
  • The method supports leveraging existing single-manufacturer MR Conditional labeling for mixed-manufacturer CIED systems.