Initial simulated FFR investigation using flow measurements in patient-specific 3D printed coronary phantoms

Purpose: Accurate patient-specific phantoms for device testing or endovascular treatment planning can be 3D printed. We expand the applicability of this approach for cardiovascular disease, in particular, for CT-geometry derived benchtop measurements of Fractional Flow Reserve, the reference standard for determination of significant individual coronary artery atherosclerotic lesions. Materials and Methods: Coronary CT Angiography (CTA) images during a single heartbeat were acquired with a 320x0.5mm detector row scanner (Toshiba Aquilion ONE). These coronary CTA images were used to create 4 patientspecific cardiovascular models with various grades of stenosis: severe, <75% (n=1); moderate, 50-70% (n=1); and mild, <50% (n=2). DICOM volumetric images were segmented using a 3D workstation (Vitrea, Vital Images); the output was used to generate STL files (using AutoDesk Meshmixer), and further processed to create 3D printable geometries for flow experiments. Multi-material printed models (Stratasys Connex3) were connected to a programmable pulsatile pump, and the pressure was measured proximal and distal to the stenosis using pressure transducers. Compliance chambers were used before and after the model to modulate the pressure wave. A flow sensor was used to ensure flow rates within physiological reported values. Results: 3D model based FFR measurements correlated well with stenosis severity. FFR measurements for each stenosis grade were: 0.8 severe, 0.7 moderate and 0.88 mild. Conclusions: 3D printed models of patient-specific coronary arteries allows for accurate benchtop diagnosis of FFR. This approach can be used as a future diagnostic tool or for testing CT image-based FFR methods.

[1]  Stephen Rudin,et al.  Challenges and limitations of patient-specific vascular phantom fabrication using 3D Polyjet printing , 2014, Medical Imaging.

[2]  G. Biglino,et al.  Rapid prototyping compliant arterial phantoms for in-vitro studies and device testing , 2013, Journal of Cardiovascular Magnetic Resonance.

[3]  Bernard J. Gersh,et al.  Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention , 2010 .

[4]  M. Budoff,et al.  Diagnostic performance of transluminal attenuation gradient and fractional flow reserve by coronary computed tomographic angiography (FFRCT) compared to invasive FFR: a sub-group analysis from the DISCOVER-FLOW and DeFACTO studies , 2015, The International Journal of Cardiovascular Imaging.

[5]  J. Mocco,et al.  Stent retriever thrombectomy with the Cover accessory device versus proximal protection with a balloon guide catheter: in vitro stroke model comparison , 2015, Journal of NeuroInterventional Surgery.

[6]  Stephen Rudin,et al.  3D printed cardiac phantom for procedural planning of a transcatheter native mitral valve replacement , 2016, SPIE Medical Imaging.

[7]  B. Nallamothu,et al.  FFR(CT): a new technology in search of a clinical application. , 2015, European heart journal.

[8]  F. Rybicki,et al.  Medical 3D Printing for the Radiologist. , 2015, Radiographics : a review publication of the Radiological Society of North America, Inc.

[9]  Andreu Badal,et al.  A novel physical anthropomorphic breast phantom for 2D and 3D x‐ray imaging , 2017, Medical physics.

[10]  N. Silverman,et al.  Cardiac ventricular diastolic and systolic duration in children with heart failure secondary to idiopathic dilated cardiomyopathy. , 2006, The American journal of cardiology.

[11]  Stephen Rudin,et al.  Advanced 3D mesh manipulation in stereolithographic files and post-print processing for the manufacturing of patient-specific vascular flow phantoms , 2016, SPIE Medical Imaging.

[12]  J. Ortiz,et al.  Duration of Systole and Diastole for Hydrodynamic Testing of Prosthetic Heart Valves: Comparison Between ISO 5840 Standards and in vivo Studies , 2016, Brazilian journal of cardiovascular surgery.

[13]  Christof Karmonik,et al.  Validation of computational fluid dynamics methods with anatomically exact, 3D printed MRI phantoms and 4D pcMRI , 2014, 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[14]  S Rudin,et al.  TU-H-CAMPUS-IeP2-03: Development of 3D Printed Coronary Phantoms for In-Vitro CT-FFR Validation Using Data from 320- Detector Row Coronary CT Angiography. , 2016, Medical physics.

[15]  Daniel R. Bednarek,et al.  Treatment planning for image-guided neuro-vascular interventions using patient-specific 3D printed phantoms , 2015, Medical Imaging.

[16]  Stephan E Maier,et al.  Three‐dimensional printing of MRI‐visible phantoms and MR image‐guided therapy simulation , 2017, Magnetic resonance in medicine.

[17]  Paul Schoenhagen,et al.  Computed tomography-based fractional flow reserve (FFR-CT) – an attractive concept, but still lacking proof of clinical utility. , 2015, Circulation journal : official journal of the Japanese Circulation Society.

[18]  Stephen Rudin,et al.  Primary stentriever versus combined stentriever plus aspiration thrombectomy approaches: in vitro stroke model comparison , 2014, Journal of NeuroInterventional Surgery.

[19]  W. Leber Is FFR-CT a “game changer” in the diagnostic management of stable coronary artery disease? , 2016, Herz.

[20]  Matthias Gutberlet,et al.  Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFRCT: outcome and resource impacts study , 2015, European heart journal.

[21]  A. Dunning,et al.  Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. , 2011, Journal of the American College of Cardiology.

[22]  S. V. Setlur Nagesh,et al.  Comparison ofModern Stroke Thrombectomy Approaches Using an In Vitro Cerebrovascular , 2014 .