Long-Term Durability of Stylet-Driven Leads for Left Bundle Branch Area Pacing

Area of Science:

• Cardiovascular Engineering
• Biomedical Device Technology
• Electrophysiology

Background:

• Left bundle branch area pacing (LBBAP) is an emerging technique for cardiac pacing.
• Assessing the long-term mechanical durability of pacing leads is crucial for patient safety and device longevity.

Purpose of the Study:

• To quantify the long-term mechanical durability of Abbott stylet-driven leads specifically for LBBAP.
• To compare the mechanical stresses and safety factors of LBBAP leads with those used in traditional pacing locations.

Main Methods:

• Utilized computational modeling to simulate lead curvatures and stresses in a 3D heart model under various implant and cardiac scenarios.
• Determined safety factors based on lead bending curvature and material properties.
• Conducted benchtop fatigue testing at elevated stress levels, simulating extended device usage.

Main Results:

• Computational modeling indicated comparable maximum curvature and safety factors for LBBAP leads versus traditional pacing sites.
• Fatigue testing demonstrated lead durability at curvatures and safety factors significantly exceeding simulated clinical conditions, representing 10 years of service.
• Tested lead conditions represented a twofold increase in maximum curvature and a 2.1-fold reduction in safety factor compared to simulated cases.

Conclusions:

• Abbott stylet-driven leads exhibit sufficient mechanical safety for LBBAP applications.
• The leads are robust even under stress levels far exceeding expected clinical loads, supporting 400 million cardiac cycles.
• No significant differences in long-term mechanical safety were found between LBBAP and traditional pacing lead implantation sites.