Left atrial appendage occlusion device: Development and validation of a finite element model

Area of Science:

• Biomedical Engineering
• Computational Fluid Dynamics
• Medical Device Simulation

Background:

• Atrial Fibrillation (AF) increases stroke risk, with oral anticoagulants having significant drawbacks like bleeding.
• Left Atrial Appendage (LAA) closure is an alternative for AF patients unsuitable for anticoagulation.
• Pre-operative planning for LAA closure is complex due to device intricacies and anatomical variations.

Purpose of the Study:

• To develop and validate a numerical model for a commercial Left Atrial Appendage (LAA) occlusion device.
• To establish a credibility assessment process for in-silico models of LAA occlusion devices.
• To address the lack of validated numerical models and detailed credibility assessment in LAA device simulation.

Main Methods:

• Constructed a numerical model of a commercial LAA occlusion device using a single available sample.
• Validated the model through a step-by-step process, assessing individual device behavior and interaction with a deformable conduit.
• Focused on identifying and mitigating uncertainties in the model predictions without manufacturer data.

Main Results:

• Successfully built and validated an in-silico model of a commercial LAA occlusion device.
• Demonstrated a robust validation process to ensure model credibility and reliability.
• Provided a framework for assessing uncertainties in numerical models for LAA occlusion devices.

Conclusions:

• In-silico models can significantly aid pre-operative planning for LAA occlusion procedures.
• The developed validation process ensures the reliability of numerical simulations for medical devices.
• This approach offers a valuable tool for understanding and optimizing LAA device performance and patient outcomes.