Abstract

The human heart's remarkable vitality necessitates a deep understanding of its mechanics, particularly concerning cardiac device leads. This paper presents advancements in finite element modeling for cardiac leads and 3D heart models, leveraging computational simulations to assess lead behavior over time. Through detailed modeling and meshing techniques, we accurately captured the complex interactions between leads and heart tissue. Material properties were assigned based on ASTM (American Society for Testing and Materials) standards and in vivo exposure data, ensuring realistic simulations. Our results demonstrate close agreement between experimental and simulated data for silicone insulation in pacemaker leads, with a mean force tolerance of 19.6 N ± 3.6 N, an ultimate tensile strength (UTS) of 6.3 MPa ± 1.15 MPa, and a percentage elongation of 125% ± 18.8%, highlighting the effectiveness of simulation in predicting lead performance. Similarly, for polyurethane insulation in ICD leads, we found a mean force of 65.87 N ± 7.1 N, a UTS of 10.7 MPa ± 1.15 MPa, and a percentage elongation of 259.3% ± 21.4%. Additionally, for polyurethane insulation in CRT leads, we observed a mean force of 53.3 N ± 2.06 N, a UTS of 22.11 MPa ± 0.85 MPa, and a percentage elongation of 251.6% ± 13.2%. Correlation analysis revealed strong relationships between mechanical properties, further validating the simulation models. Classification models constructed using both experimental and simulated data exhibited high discriminative ability, underscoring the reliability of simulation in analyzing lead behavior. These findings contribute to the ongoing efforts to improve cardiac device lead design and optimize patient outcomes.

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