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Development of Novel Sutureless Balloon Expandable Fetal Heart Valve Device Using Absorbable Polycaprolactone Leaflets

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Abstract

Congenital heart disease (CHD) accounts for nearly one-third of all congenital defects, and patients often require repeated heart valve replacements throughout their lives, due to failed surgical repairs and lack of durability of bioprosthetic valve implants. This objective of this study is to develop and in vitro test a fetal transcatheter pulmonary valve replacement (FTPVR) using sutureless techniques to attach leaflets, as an option to correct congenital defects such as pulmonary atresia with intact ventricular septum (PA/IVS), in utero. A balloon expandable design was analyzed using computational simulations to identify areas of failure. Five manufactured valves were assembled using the unique sutureless approach and tested in the fetal right heart simulator (FRHS) to evaluate hemodynamic characteristics. Computational simulations showed that the commissural loads on the leaflet material were significantly reduced by changing the attachment techniques. Hemodynamic analysis showed an effective orifice area of 0.08 cm2, a mean transvalvular pressure gradient of 7.52 mmHg, and a regurgitation fraction of 8.42%, calculated over 100 consecutive cardiac cycles. In conclusion, the FTPVR exhibited good hemodynamic characteristics, and studies with biodegradable stent materials are underway.

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Abbreviations

PA/IVS:

Pulmonary atresia with intact ventricular septum

TEHV:

Tissue engineered heart valve

FTPVR:

Fetal transcatheter pulmonary valve replacement

TAVR:

Transcatheter aortic valve replacement

Co–Cr:

Cobalt–chromium

FE:

Finite element

PCL:

Polycaprolactone

FRHS:

Fetal right heart simulator

EOA:

Effective orifice area

RF:

Regurgitation fraction

CV:

Closing volume

LV:

Leakage volume

FV:

Forward volume

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Acknowledgments

This study was supported with funds from Additional Ventures (Grant No. GR00006544). The authors acknowledge the use of ABAQUS software provided through the Cardiovascular Fluid Mechanics Laboratory at Georgia Tech.

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Authors and Affiliations

  1. Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Office 232, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313-2412, USA

    Sanchita S. Bhat, Hieu T. Bui, Anna Farnan, Katherine Vietmeyer & Lakshmi Prasad Dasi

  2. The Heart Center, Nationwide Children’s Hospital, 700 Children’s Dr., Columbus, OH, 43205, USA

    Aimee K. Armstrong

  3. Department of General Pediatric Surgery, Nationwide Children’s Hospital, 700 Children’s Dr., Columbus, OH, 43205, USA

    Christopher K. Breuer

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  1. Sanchita S. Bhat
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Correspondence to Christopher K. Breuer or Lakshmi Prasad Dasi.

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Associate Editor Elizabeth Cosgriff-Hernandez oversaw the review of this article.

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Bhat, S.S., Bui, H.T., Farnan, A. et al. Development of Novel Sutureless Balloon Expandable Fetal Heart Valve Device Using Absorbable Polycaprolactone Leaflets. Ann Biomed Eng 52, 386–395 (2024). https://doi.org/10.1007/s10439-023-03386-9

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