Translation of Animal Study to Human: In Silico Based Development of Implantable Pulmonary Artery Pressure Sensor

Abstract

Implantable pulmonary artery pressure sensors (PAPS) might impose a flow-induced risk of thrombus formation in the pulmonary artery (PA). To assess this risk, an in silico study-enhanced animal study with 20 sensors implanted in 10 pigs had previously been conducted. In the in silico study, PAPS were virtually implanted mimicking real implantations, based upon data acquired by CT. This animal in silico study investigated changes in hemodynamics caused by PAPS using image-based computational fluid dynamics (CFD). However, porcine and human PA differ significantly in geometry and hemodynamics. To investigate the transferability of animal in silico study findings toward human conditions, we propose a parallel in silico human study. Based on a similarity analysis (L1 norm for 8 geometric features) human PA geometries with the least difference to 10 porcine PA were selected. PAPS were virtually implanted in human PA as close as possible, mimicking the implantation configuration of the animal study. Finally, a numerical flow analysis of the hemodynamic changes due to PAPS implantation was done. Comparing human and porcine PA, we found significantly larger left and right PA diameters in humans, whereas no differences were found for main PA diameters and bifurcation angle. Comparing hemodynamic boundary conditions, we found a significantly smaller heart rate and a significantly higher peak systolic main PA flow rate in humans, whereas no significant differences for cardiac output were found. The human in silico PAPS study found no relevant changes in hemodynamics increasing the risk of thrombus formation after sensor implantation. This is also valid for PAPS that were non-optimally implanted. Thus, despite differences between species, findings of the in silico animal study were confirmed by the human in silico study.

Keywords: animal trial; computational fluid dynamics; pressure sensor; pulmonary artery; thrombus formation.