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 CT-derived FFR diagnostic software, alleviating both cost and risk during invasive procedures.