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Validating In Silico and In Vitro Patient-Specific Structural and Flow Models with Transcatheter Bicuspid Aortic Valve Replacement Procedure

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Abstract

Introduction

Bicuspid aortic valve (BAV) is the most common congenital cardiac malformation, which had been treated off-label by transcatheter aortic valve replacement (TAVR) procedure for several years, until its recent approval by the Food and Drug Administration (FDA) and Conformité Européenne (CE) to treat BAVs. Post-TAVR complications tend to get exacerbated in BAV patients due to their inherent aortic root pathologies. Globally, due to the paucity of randomized clinical trials, clinicians still favor surgical AVR as the primary treatment option for BAV patients. While this warrants longer term studies of TAVR outcomes in BAV patient cohorts, in vitro experiments and in silico computational modeling can be used to guide the surgical community in assessing the feasibility of TAVR in BAV patients. Our goal is to combine these techniques in order to create a modeling framework for optimizing pre-procedural planning and minimize post-procedural complications.

Materials and Methods

Patient-specific in silico models and 3D printed replicas of 3 BAV patients with different degrees of post-TAVR paravalvular leakage (PVL) were created. Patient-specific TAVR device deployment was modeled in silico and in vitro—following the clinical procedures performed in these patients. Computational fluid dynamics simulations and in vitro flow studies were performed in order to obtain the degrees of PVL in these models.

Results

PVL degree and locations were consistent with the clinical data. Cross-validation comparing the stent deformation and the flow parameters between the in silico and the in vitro models demonstrated good agreement.

Conclusion

The current framework illustrates the potential of using simulations and 3D printed models for pre-TAVR planning and assessing post-TAVR complications in BAV patients.

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Abbreviations

BAV:

Bicuspid aortic valve

CFD:

Computational fluid dynamics

FDA:

Food and Drug Administration

FE:

Finite element

LCL:

Left coronary leaflet

LOA:

Limit of agreement

LVOT:

Left ventricular outflow tract

NCL:

Non-coronary leaflet

PVL:

Paravalvular leak

RCL:

Right coronary leaflet

SAVR:

Surgical aortic valve replacement

TAVR:

Transcatheter aortic valve replacement

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Acknowledgments

We would like to thank the SeaWulf Supercomputer at the Institute for Advanced Computational Science at Stony Brook University for providing computational resources. ANSYS and the Dassault Systèmes Simulia Living Heart Project are in academic partnerships with Professor Danny Bluestein.

Funding

This project was supported by NIH-NIBIB U01EB026414 (DB).

Conflict of interest

Author DB has an equity interest in PolyNova Cardiovascular, Inc. Author BK is a consultant of Polynova Cardiovascular, Inc. All the other authors have no conflict of interest.

Ethical Approval

All procedures involving human participants were in accordance with the ethical standards of the Responsible Committee on Human Experimentation (Institutional and National Research) and with the Helsinki Declaration of 1975, as revised in 2000. IRB approval: 2013-2357-R5, 2/10/2021.

Informed Consent

A waiver of consent was approved by the Stony Brook Committee on Research in Human Subjects (CORIHS-2013-2357-F) and Rabin Medical Center Helsinki Committee (0636-16-RMC) for retrospective collection of de-identified patient images. No animal studies were carried out by the authors for this article.

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Authors and Affiliations

  1. Biofluids Research Group, Department of Biomedical Engineering, Stony Brook University, Stony Brook, NY, USA

    Salwa B. Anam, Brandon J. Kovarovic, Ram P. Ghosh, Matteo Bianchi & Danny Bluestein

  2. Department of Cardiology, Rabin Medical Center, 4941492, Petah Tikva, Israel

    Ashraf Hamdan

  3. School of Mechanical Engineering, Faculty of Engineering, Tel Aviv University, Ramat Aviv, 69978, Tel Aviv, Israel

    Rami Haj-Ali

  4. Department of Biomedical Engineering, Stony Brook University, T8-050 Health Sciences Center, Stony Brook, NY, 11794-8084, USA

    Danny Bluestein

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  1. Salwa B. Anam
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Correspondence to Danny Bluestein.

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Anam, S.B., Kovarovic, B.J., Ghosh, R.P. et al. Validating In Silico and In Vitro Patient-Specific Structural and Flow Models with Transcatheter Bicuspid Aortic Valve Replacement Procedure. Cardiovasc Eng Tech 13, 840–856 (2022). https://doi.org/10.1007/s13239-022-00620-8

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