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The 3D model was connected to a pulsatile flow loop for simulating interventions using clinical devices such as catheters and stents. To validate the x-ray attenuation and establish clinical accuracy, the automatic exposure selection by a clinical c-arm system for the phantom was compared with that for a commercial anthropomorphic head phantom (SK-150, Phantom Labs). The percentage difference between automatic exposure selection for the neuro-intervention phantom and the SK-150 phantom was under 10%.
By changing 3D printed models, various patient diseased anatomies can be simulated accurately with the necessary x-ray attenuation. Using this platform various interventional procedures were performed using new imaging technologies such as a high-resolution x-ray fluoroscope and a dose-reduced region-of-interest attenuator and differential temporally filtered display for enhanced interventional imaging. Simulated clinical views from such phantom-based procedures were used to evaluate the potential clinical performance of such new technologies.
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.
3DP idealized and patient specific vascular phantoms were manufactured using Stratasys Objet 500 Connex 3. The idealized phantoms were created using a sine wave shape, patient specific phantoms were based on CT- angiography volumes. The phantoms were coated with a hydrophilic material to mimic vascular surface properties. We tested various endovascular procedures using an Interventional Device Testing Equipment (IDTE) 2000 and measured push/pull force used to actuate endovascular devices during EIGIs.
The force needed to advance devices in neurovascular phantoms varied based on tortuosity, material and coating, ranging from -3 to 21 grams-force. Hydrophilic coating reduced maximum force from 21 to 4.8 grams-force in the same model. IDTE 2000 results of neurovascular models were compared to hand manipulation of guidewire access using a six-axis force sensor with forces ranging from -50 to 440 grams. The clot retriever tested in carotid models experienced most friction around tortuous bends ranging from -65 to -90 grams-force, with increasing rigidity of materials creating increased friction. Sine wave model forces varied from -2 to 105 grams.
3DP allows manufacturing of vascular phantoms with precise mechanical and surface properties which can be used for EIGI simulations for imaging protocol optimization and device behavior assessment.
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