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Designing a Novel Asymmetric Transcatheter Aortic Valve for Stenotic Bicuspid Aortic Valves Using Patient-Specific Computational Modeling

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Abstract

Bicuspid aortic valve (BAV), the most common congenital heart malformation, is characterized by the presence of only two valve leaflets with asymmetrical geometry, resulting in elliptical systolic opening. BAV often leads to early onset of calcific aortic stenosis (AS). Following the rapid expansion of transcatheter aortic valve replacement (TAVR), designed specifically for treating conventional tricuspid AS, BAV patients with AS were initially treated “off-label” with TAVR, which recently gained FDA and CE regulatory approval. Despite its increasing use in BAV, pathological BAV anatomy often leads to complications stemming from mismatched anatomical features. To mitigate these complications, a novel eccentric polymeric TAVR valve incorporating asymmetrical leaflets was designed specifically for BAV anatomies. Computational modeling was used to optimize its asymmetric leaflets for lower functional stresses and improved hemodynamic performance. Deployment and flow were simulated in patient-specific BAV models (n = 6) and compared to a current commercial TAVR valve (Evolut R 29 mm), to assess deployment and flow parameters. The novel eccentric BAV-dedicated valve demonstrated significant improvements in peak systolic orifice area, along with lower jet velocity and wall shear stress (WSS). This feasibility study demonstrates the clinical potential of the first known BAV-dedicated TAVR design, which will foster advancement of patient-dedicated valvular devices.

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Abbreviations

AP-BAV:

Asymmetric polymeric bicuspid aortic valve

BAV:

Bicuspid aortic valve

CAVD:

Calcific aortic valve disease

CFD:

Computational fluid dynamics

EOA:

Effective orifice area

FEA:

Finite element analysis

TAV:

Trileaflet aortic valve

TAVR:

Transcatheter aortic valve replacement

SAVR:

Surgical aortic valve replacement

WSS:

Wall shear stress

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Acknowledgments

The authors would like to thank the continued research collaboration with the Simulia Living Heart Project (Dassault Systemes), ANSYS software, and SeaWulf Cluster at Stony Brook University for providing computational resources. This project was supported by NIH-NIBIB-BRPU01EB026414 (DB), and STTR-R42HL134418-03A1.

Conflict of interest 

Authors DB and MJS have 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.

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Authors and Affiliations

  1. Biofluids Research Group, Department of Biomedical Engineering, T8-050 Health Sciences Center, Stony Brook University, Stony Brook, NY11794-8084, USA

    Ryan T. Helbock, Salwa B. Anam, Brandon J. Kovarovic & Danny Bluestein

  2. Department of Medicine and Biomedical Engineering Sarver Heart Center, University of Arizona, Tucson, AZ, 85721, USA

    Marvin J. Slepian

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

    Ashraf Hamdan

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

    Rami Haj-Ali

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  1. Ryan T. Helbock
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Correspondence to Danny Bluestein.

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Helbock, R.T., Anam, S.B., Kovarovic, B.J. et al. Designing a Novel Asymmetric Transcatheter Aortic Valve for Stenotic Bicuspid Aortic Valves Using Patient-Specific Computational Modeling. Ann Biomed Eng 51, 58–70 (2023). https://doi.org/10.1007/s10439-022-03039-3

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