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Systematic Analysis of PTFE Monocusp Leaflet Design in a Patient-Based 3D in-Vitro Model of Tetralogy of Fallot

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Abstract

Purpose

Pulmonary valve (PV) monocusp reconstruction in transannular patch (TAP) right ventricular outflow tract (RVOT) repair for Tetralogy of Fallot has variable clinical outcomes across different surgical approaches. The study purpose was to systematically evaluate how monocusp leaflet design parameters affect valve function in-vitro.

Methods

A 3D-printed, disease-specific RVOT model was tested under three infant physiological conditions. Monocusps were sewn into models with the native main pulmonary artery (MPA) forming backwalls that constituted 40% and 50% of the reconstructed circumference for z-score zero PV annulus and MPA diameters (native PV z-score − 3.52 and − 2.99 for BSA 0.32m2). Various leaflet free edge lengths (FEL) (relative to backwall), positions (relative to PV STJ), and scallop depths were investigated across both models. Pressure gradient, regurgitation, and coaptation were analyzed with descriptive statistics and regression models.

Results

Increasing FEL beyond 100% of the MPA backwall decreased gradient but mildly increased regurgitation to a peak of 25%. Positioning the free edge 2 mm past the STJ mildly increased gradient for each FEL without significantly changing regurgitation compared to STJ placement. Scalloping leaflets trivially affected performance. Pre-folding leaflets improved mobility and slightly reduced gradient.

Conclusions

Balancing gradient, regurgitation, and oversizing for growth, a set of leaflet designs have been selected for pre-clinical evaluation. Designs with leaflet widths 140–160% in the 40% backwall model (110–120% in the 50% backwall), positioned at or 2 mm past the STJ, demonstrated the best results. The next stage of ex-vivo testing will additionally consider native RVOT distensibility, native leaflet interactions, and TAP characteristics.

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Abbreviations

BW:

Backwall (native MPA tissue in TAP repair)

CI:

Cardiac Index

ePTFE:

Expanded Polytetrafluoroethylene

FEL:

Free Edge Length

HCO:

High Cardiac Output

HPVR:

High Pulmonary Vascular Resistance

MPA:

Main Pulmonary Artery

MCL:

Mock Circulatory Loop

PI:

Pulmonary Insufficiency

PV:

Pulmonary Valve

RV:

Right Ventricle

RVOT:

Right Ventricular Outflow Tract

RVOTO:

Right Ventricular Outflow Tract Obstruction

STJ:

Sinotubular Junction

TAP:

Transannular Patch

TOF:

Tetralogy of Fallot

TPU:

Thermoplastic Polyurethane

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Acknowledgements

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Funding

This work was supported by internal funds.

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Author notes

  1. Christopher W. Baird

    Present address: Harvard Medical School, Boston, MA, USA

Authors and Affiliations

  1. Department of Cardiac Surgery, Boston Children’s Hospital, 300 Longwood Avenue, Bader, 2nd Floor, Boston, MA, 02215, USA

    Xiaoya Zhang, Shannen B. Kizilski, Dominic P. Recco, Martha D. Chaillo Lizarraga, Nicholas E. Kneier, Noah E. Schulz, Christopher W. Baird, Peter E. Hammer & David M. Hoganson

  2. Harvard Medical School, Boston, MA, USA

    Xiaoya Zhang, Shannen B. Kizilski, Dominic P. Recco, Peter E. Hammer & David M. Hoganson

  3. Department of Cardiac Surgery, First Hospital of Tsinghua University, Beijing, China

    Xiaoya Zhang

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Correspondence to David M. Hoganson.

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Conflict of interest

X. Zhang, S.B. Kizilski, D.P. Recco, M.D. Chaillo Lizarraga, N.E. Kneier, N.E. Schulz, C.W. Baird, P.E. Hammer, and D.M. Hoganson declare that they have no conflicts of interest.

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In-vitro studies performed with exemption by the Boston Children’s Hospital Institutional Review Board.

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Presented as a poster at the AATS 2023 meeting in Los Angeles, Ca on May 8th, 2023.

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Zhang, X., Kizilski, S.B., Recco, D.P. et al. Systematic Analysis of PTFE Monocusp Leaflet Design in a Patient-Based 3D in-Vitro Model of Tetralogy of Fallot. Cardiovasc Eng Tech 14, 827–839 (2023). https://doi.org/10.1007/s13239-023-00690-2

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