Abstract Background Left bundle branch area pacing (LBBAP) has emerged as a promising approach to cardiac physiologic pacing. However, the mechanical stress and fracture risk has not been studied for stylet-driven leads implanted in the left bundle branch area (LBBA). Purpose The main purpose of this study was to evaluate the change in curvature during a cardiac cycle when a stylet-driven lead with a rigid distal end was implanted in LBBA and to identify any increased risk of conductor fracture for the LBBAP lead compared to those implanted at the His bundle (HB), traditional right atrium (RA) and right ventricle (RV) locations. Methods A high-resolution, four-dimensional human beating heart model was utilized for simulating the stress on the lead. The bending stiffness of lead body segments was measured with 3-pts bending test and the values were assigned to the finite element model. The curvature change of lead body during one cardiac cycle was measured. The safety factor of lead conductors was calculated using the curvature measurements, the conductor’s endurance limit, and the ultimate stress of the material (MP35N). A higher safety factor indicates better lead durability and lower risk of fracture. A parametric study was also performed to investigate how additional implant factors impact the safety factor of LBBAP leads: lead insertion angle, implant depth, degree of slack, and implant location (Figure 1). Results A total of 8 implant scenarios for LBBAP were defined and tested using the combination of the implant factors described above. Two RV implanted locations were tested: RV apex and RV apical septum. One HBP and one RA implant location were tested. The region with maximum change in curvature for LBBAP lead was at 0-10 mm proximal to the ring electrode (Figure 2A). The maximum change in curvature on the lead body for LBBAP, HBP, RV, and RA implants were: 0.022±0.005 (n=8), 0.033 (n=1), 0.036±0.002 (n=2), and 0.024 mm-1 (n=1), respectively (Figure 2B). The safety factor for the lead conductors for LBBAP, HBP, RV, and RA implants were 5.57±1.35 (n=8), 3.48 (n=1), 4.62±0.04 (n=2), and 4.65 (n=1), respectively (Figure 2C). The highest safety factor among all implant locations was 7.63, corresponding to a LBBAP implant scenario with mid-septum location, a 45 degree lead insertion angle towards apex, 7.5 mm lead depth in the septum, and low lead slack. HBP had the lowest safety factor among all implant locations. Conclusion The stylet-driven lead with a rigid distal end implanted at the left bundle branch area does not introduce any further risk of fracture compared to the HBP or traditional RA/RV implant locations in this computational modeling study.Fig 1: LBBAP implants testedFig 2: Lead curvature and safety factor
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