Left atrial appendage occlusion device: Development and validation of a finite element model
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Published on: February 13, 2021
Alissa Zaccaria1, Francesca Danielli1, Emanuele Gasparotti2
1LaBS, Dept. of Chemistry, Materials and Chemical Engineering, Polytechnic of Milan, Milan, Italy.
Insights
This study presents a method for creating and validating in-silico models of Left Atrial Appendage (LAA) occlusion devices. This aids pre-operative planning for stroke prevention in Atrial Fibrillation (AF) patients.
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.
Abstract:
Atrial Fibrillation (AF) is a common disease that significantly increases the risk of strokes. Oral anticoagulants represent the standard preventive treatment, but they involve severe drawbacks, including intracerebral bleedings. Since in patients affected by nonvalvular AF, the Left Atrial Appendage (LAA) is the primary source of thromboembolism, percutaneous closure of the LAA is a viable option for people unsuitable for long-term anticoagulant therapy. However, the complexities related to the implant procedure, occlusion devices and the anatomical variability hinder the pre-operative planning, resulting in unexpected outcomes. In this context, in-silico models may represent a powerful support tool providing clinicians with more detailed information. Nevertheless, few works focusing on numerical modeling of LAA occlusion devices have been presented so far, and a detailed process to assess the model credibility, verifying that different sources of uncertainty did not affect the prediction, is missing. This work aims to illustrate a process that allows to build and validate the numerical model of a commercial occlusion device starting from only one sample available and without data provided by the manufacturer. To better identify potential uncertainties, the validation followed a step-by-step process that led from individual device behavior assessment to interaction with deformable conduit evaluation.
