Abstract

BackgroundPatient-specific simulations can provide insight into the mechanics of cardiovascular procedures. Amongst cardiovascular devices, non-compliant balloons are used in several minimally invasive procedures, such as balloon aortic valvuloplasty. Although these balloons are often included in the computer simulations of these procedures, validation of the balloon behaviour is often lacking. We therefore aim to create and validate a computational model of a valvuloplasty balloon.MethodsA finite element (FE) model of a valvuloplasty balloon (Edwards 9350BC23) was designed, including balloon geometry and material properties from tensile testing. Young’s Modulus and distensibility of different rapid prototyping (RP) rubber-like materials were evaluated to identify the most suitable compound to reproduce the mechanical properties of calcified arteries in which such balloons are likely to be employed clinically. A cylindrical, simplified implantation site was 3D printed using the selected material and the balloon was inflated inside it. The FE model of balloon inflation alone and its interaction with the cylinder were validated by comparison with experimental Pressure–Volume (P–V) and diameter–Volume (d–V) curves.ResultsRoot mean square errors (RMSE) of pressure and diameter were RMSEP = 161.98 mmHg (3.8 % of the maximum pressure) and RMSEd = 0.12 mm (<0.5 mm, within the acquisition system resolution) for the balloon alone, and RMSEP = 94.87 mmHg (1.9 % of the maximum pressure) and RMSEd = 0.49 mm for the balloon inflated inside the simplified implantation site, respectively.ConclusionsThis validated computational model could be used to virtually simulate more realistic valvuloplasty interventions.

Highlights

  • Patient-specific simulations can provide insight into the mechanics of cardiovascular procedures

  • The aim of this work is to present a novel methodology to validate a finite element (FE) model of a non-compliant valvuloplasty balloon interacting with a realistic implantation site

  • Validation of balloon FE model The shape of the valvuloplasty balloon is displayed in Fig. 1, showing a central cylindrical region closed by two pseudo-conical heads

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Summary

Introduction

Patient-specific simulations can provide insight into the mechanics of cardiovascular procedures. The latter work at high pressure (≫1 atm) and are made of non-compliant materials, such as PET and Nylon, which exhibit high tensile strength with relatively low elongation, maintaining their designed size and shape even at high pressures Due to these properties, they are adopted in procedures meant to impose large deformations (e.g., to anatomical structures or to a device). Despite short-term positive outcomes, the survival rates of long-term follow-up patients are low, and comparable to the natural course of untreated patients [10] Their limited success as a therapeutic option, the number of performed BAV has increased significantly with the advent of transcatheter aortic valve replacement (TAVR), where the balloon is used to pre-dilate the stenosed valve and facilitate TAVR delivery, or as a bridging therapy [9, 10]

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