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Calcium Fracture and Device Over Expansion in Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valves

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Abstract

Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve disease (BAV) has potential risks of under expansion and non-circularity which may compromise long-term durability. This study aims to investigate calcium fracture and balloon over expansion in balloon-expandable TAVs on the stent deformation with the aid of simulation. BAV patients treated with the SAPIEN 3 Ultra with pre- and post-TAVR CTs were analyzed (n = 8). Simulations of the stent deployment were performed (1) with baseline simulation allowing calcium fracture, (2) without allowable calcium fracture and (3) with balloon over expansion (1 mm larger diameter). When compared to post CT, baseline simulations had minimal error in expansion (2.5% waist difference) and circularity (3.0% waist aspect ratio difference). When compared to baseline, calcium fracture had insignificant impact on the expansion (− 0.5% average waist difference) and circularity (− 1.6% average waist aspect ratio difference). Over expansion had significantly larger expansion compared to baseline (15.4% average waist difference) but had insignificant impact on the circularity (− 0.5% waist aspect ratio difference). We conclude that stent deformation can be predicted with minimal error, calcium fracture has small differences on the final stent deformation except in extreme calcified cases, and balloon over expansion expands the waist closer to nominal values.

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Abbreviations

AS:

Aortic stenosis

BAV:

Bicuspid aortic valve

CAVD:

Calcific aortic valve disease

CT:

Computed tomography

HALT:

Hypo-attenuated leaflet thickening

TAVR:

Transcatheter aortic valve replacement

THV:

Transcatheter heart valve

BE:

Balloon-expandable

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Acknowledgments

We acknowledge Dr. Ajit Yoganathan as co-advisor to Breandan Yeats overseeing conflict of interest, serving on the dissertation committee, and providing advice on the scientific direction and interpretation of results.

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Authors and Affiliations

  1. Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Cir NW, Atlanta, GA, 30313, USA

    Breandan B. Yeats, Sri Krishna Sivakumar, Milad Samaee & Lakshmi P. Dasi

  2. Department of Cardiology, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA, USA

    Venkateshwar Polsani & Pradeep K. Yadav

  3. Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA, USA

    Vinod H. Thourani

  4. Cardiovascular Translational Lab, Centre for Heart Lung Innovation & Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, Canada

    Stephanie Sellers & Janarthanan Sathananthan

Authors
  1. Breandan B. Yeats
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  2. Sri Krishna Sivakumar
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Correspondence to Lakshmi P. Dasi.

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Conflict of interest

Breandan B. Yeats has a patent pending as co-inventor of patents related to computational predictive modeling of heart valves and is a stakeholder in DASI Simulations. Sri Krishna Sivakumar has a patent pending as co-inventor of patents related to computational predictive modeling of heart valves. Pradeep K. Yadav is a consultant for Edwards Lifesciences, Medtronic Inc, Abbott Vascular, Shockwave Medical. Vinod H. Thourani is a consultant or research with Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, Medtronic Corp, and Shockwave Medical and stakeholder in Dasi Simulations. Stephanie Sellers is a consultant to Edwards, Anteris and Medtronic and receives research funding from Edwards, Medtronic​, Heartflow, and Michael Smith Health Research BC. Janarthanan Sathananthan is a consultant to Edwards, Boston Scientific, Anteris and Medtronic and receives research funding from Edwards and Medtronic. Lakshmi P. Dasi is a stakeholder in DASI Simulations, and has a patent pending as co-inventor of patents related to computational predictive modeling of heart valves. Other authors report no conflicts of interest.

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Associate Editor Arash Kheradvar oversaw the review of this article.

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Yeats, B.B., Sivakumar, S.K., Samaee, M. et al. Calcium Fracture and Device Over Expansion in Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valves. Ann Biomed Eng 51, 2172–2181 (2023). https://doi.org/10.1007/s10439-023-03246-6

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  • DOI: https://doi.org/10.1007/s10439-023-03246-6

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