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

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.

An In Vitro Circulatory Loop Model of the Pediatric Right Ventricular Outflow Tract as a Platform for Valve Evaluation.

PURPOSE: Tetralogy of Fallot and other conditions affecting the right ventricular outflow tract (RVOT) are common in pediatric patients, but there is a lack of quantitative comparison among techniques for repairing or replacing the pulmonary valve. The aim of this study was to develop a robust in vitro system for quantifying flow conditions after various RVOT interventions. METHODS: An infant-sized mock circulatory loop that includes a 3D-printed RVOT anatomical model was developed to evaluate flow conditions after different simulated surgical repairs. Physiologically correct flow and pressure were achieved with custom compliant tubing and a tunable flow restrictor. Pressure gradient, flow regurgitation, and coaptation height were measured for two monocusp leaflet designs after tuning the system with a 12 mm Hancock valved conduit. RESULTS: Measurements were repeatable across multiple samples of two different monocusp designs, with the wider leaflet in the 50% backwall model consistently exhibiting lower pressure gradient but higher regurgitation compared to the leaflet in the 40% backwall model. Coaptation height was measured via direct visualization with endoscopic cameras, revealing a shorter area of contact for the wider leaflet (3.3-4.0 mm) compared to the narrower one (4.3 mm). CONCLUSION: The 3D-printed RVOT anatomical model and in vitro pulmonary circulatory loop developed in this work provide a platform for planning and evaluating surgical interventions in the pediatric population. Measurements of regurgitation, pressure gradient, and coaptation provide a quantitative basis for comparison among different valve designs and positions.