3D printed cardiovascular patient specific phantoms used for clinical validation of a CT-derived FFR diagnostic software

Purpose: 3D printed patient specific vascular models provide the ability to perform precise and repeatable benchtop experiments with simulated physiological blood flow conditions. This approach can be applied to CT-derived patient geometries to determine coronary flow related parameters such as Fractional Flow Reserve (FFR). To demonstrate the utility of this approach we compared bench-top results with non-invasive CT-derived FFR software based on a computational fluid dynamics algorithm and catheter based FFR measurements. Materials and Methods: Twelve patients for whom catheter angiography was clinically indicated signed written informed consent to CT Angiography (CTA) before their standard care that included coronary angiography (ICA) and conventional FFR (Angio-FFR). The research CTA was used first to determine CT-derived FFR (Vital Images) and second to generate patient specific 3D printed models of the aortic root and three main coronary arteries that were connected to a programmable pulsatile pump. Benchtop FFR was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. Results: All 12 patients completed the clinical study without any complication, and the three FFR techniques (Angio-FFR, CT-FFR, and Benchtop FFR) are reported for one or two main coronary arteries. The Pearson correlation among Benchtop FFR/Angio-FFR, CT-FFR/Benchtop FFR, and CT-FFR/Angio-FFR are 0.871, 0.877, and 0.927 respectively. Conclusions: 3D printed patient specific cardiovascular models successfully simulated hyperemic blood flow conditions, matching invasive Angio-FFR measurements. This benchtop flow system could be used to validate CTderived FFR diagnostic software, alleviating both cost and risk during invasive procedures.