This study conducts a comprehensive evaluation focused on assessing the feasibility and validation of patient-specific convergent cavopulmonary connection (CCPC) grafts for individuals with congenital heart defects in comparison with the performance of total cavopulmonary connection (TCPC) grafts. The datasets incorporated in this submission constitute crucial information enabling comprehension of our methodology and replication of our experiments using a mock circulatory flow loop. These datasets encompass 3D models, flow rates, basic demographic information, and 4D Flow DICOMs of 11 TCPC models. Additionally, raw CSV measurements from a 4D Flow software for both CCPC and TCPC grafts have been included. By means of the development and analysis of these datasets, we have effectively demonstrated the non-inferiority of the CCPC configuration compared to the TCPC design. The CCPC modifications to the Fontan design did not incur additional hemodynamic costs and provided improvements in hepatic flow distribution. Therefore, it validates the potential for the CCPC design to improve patient outcomes.

Patients diagnosed with congenital heart defects and requiring TCPC grafts were selected for this study. The TCPC grafts were initially imaged using magnetic resonance imaging (MRI) techniques. Subsequently, the MRI data were processed utilizing segmentation software  Mimics Medical (materialise.com), to meticulously segment and extract the TCPC grafts, generating STL files representing the three-dimensional structure of the grafts. The TCPC grafts were then 3D printed. In vitro testing was then performed via a custom mock circulatory flow loop. A solution of 60% water and 40% glycerin was used to mimic blood viscosity. An MRI-compatible pump (CardioFlow 5000 MR, Shelley) was used to recreate the patients’ cardiac output and was held constant throughout testing. Four ultrasonic flow meters (Onicon, Largo, FL) were used to measure the flow of the inlets at the IVC and SVC and the outlets at the left and right pulmonary arteries (LPA and RPA, respectively). Ball valves were used to achieve the patient specific distribution of flow amongst the vessels as observed in their clinical CMR. The mock circulatory flow loop was then scanned with 4D flow MRI WIP 785A, and then quantified via 4D flow visualization software, ITFlow (www.cfd.life/en/itflow). The same setup was employed for the novel CCPC designs.

In terms of the basic demographic information shown here, such as body surface area and age, they were gathered through direct consultation with the patients involved in the study. Specific properties of the TCPC and CCPC graft models, including wall shear stress, energy loss, vorticity, and helicity, were measured and compiled into .csv files. These properties were assessed using the aforementioned ITFlow software. Finally, the 4D DICOM files from the TCPC mock circulatory flow loops are included here. These DICOM files facilitated the segmentation of the grafts and the subsequent creation of precise 3D models used for analysis.

These data points were imported into Excel (www.microsoft.com/en-us/microsoft-365/excel) and used to conduct a paired t-test to compare the results from TCPC and CCPC grafts.