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A 3D-Printed Externally Adjustable Symmetrically Extensible (EASE) Aortic Annuloplasty Ring for Root Repair and Aortic Valve Regurgitation

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Abstract

Purpose

The valve-sparing aortic root replacement (VSARR) procedure was developed to preserve the aortic valve apparatus to replace aneurysmal aortic roots with synthetic grafts and to eliminate associated aortic regurgitation (AR). However, residual post-repair AR is not uncommon and has been found to be associated with recurrent AR and future reoperation.

Methods

We designed and manufactured a 3D-printed, external adjustable symmetrically extensible (EASE) aortic annuloplasty ring that can symmetrically reduce the aortic annulus diameter via a radial constriction, compliant mechanism. An ex vivo porcine VSARR model with annular dilation and AR was developed (n = 4) and used for hemodynamic, echocardiography, and high-speed videography data collection.

Results

After ring annuloplasty repair using the EASE aortic ring, the regurgitant fraction decreased from 23.6 ± 6.9% from the VSARR model to 7.4 ± 5.6% (p = 0.05), which was similar to that measured from baseline with a regurgitant fraction of 10.2 ± 3.9% (p = 0.34). The leaflet coaptation height after annuloplasty repair also significantly increased from that measured in VSARR model (0.4 ± 0.1 cm) to 0.9 ± 0.1 cm (p = 0.0004), a level similar to that measured in baseline (1.1 ± 0.1 cm, p = 0.28).

Conclusion

Using an ex vivo VSARR model, the EASE ring successfully reduced AR by reducing the annular diameter and improving leaflet coaptation. With its broad applicability and ease of use, this device has the potential to have a significant impact on patients suffering worldwide from AR due to root aneurysms.

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Data Availability

Data related to this paper may be provided upon reasonable request.

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Acknowledgements

The authors thank M. Ian Ritchie for making a generous donation that supported this research effort.

Funding

This work was supported by the National Institutes of Health (NIH R01 HL 152155, YJW; F32 HL158151, YZ) and the Thoracic Surgery Foundation Resident Research Fellowship (YZ). The manuscript contents are solely the responsibility of the authors and do not necessarily represent the official views of the funders.

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Author notes

  1. Yuanjia Zhu and Matthew H. Park contributed equally to this work.

Authors and Affiliations

  1. Department of Cardiothoracic Surgery, Falk Cardiovascular Research Center, Stanford University School of Medicine, 300 Pasteur Drive, 94305, Stanford, CA, USA

    Yuanjia Zhu, Matthew H. Park, Robert J. Wilkerson, Hyun-Chel Joo, Pearly K. Pandya & Y. Joseph Woo

  2. Department of Bioengineering, Stanford University, Stanford, CA, USA

    Yuanjia Zhu & Y. Joseph Woo

  3. Department of Mechanical Engineering, Stanford University, Stanford, CA, USA

    Matthew H. Park & Pearly K. Pandya

  4. Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine, Seoul, Korea

    Hyun-Chel Joo

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  1. Yuanjia Zhu
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Corresponding author

Correspondence to Y. Joseph Woo.

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Competing Interests

Authors YZ, MHP, and YJW declare that a planned patent submission of the EASE aortic ring is being prepared. Authors RJW, HJ, and PKP declare that they have no conflict of interest.

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Communicated by Zhenglun Alan Wei.

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Zhu, Y., Park, M.H., Wilkerson, R.J. et al. A 3D-Printed Externally Adjustable Symmetrically Extensible (EASE) Aortic Annuloplasty Ring for Root Repair and Aortic Valve Regurgitation. Cardiovasc Eng Tech (2024). https://doi.org/10.1007/s13239-024-00709-2

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