This publication was supported by the German Heart Foundation/German Foundation of Heart Research.

Ethical approval was considered by the ethical committee of the Ludwig-Maximilians-Universit&#228;t M&#252;nchen&#160;and was waived given that the radiological datasets used in this study were retrospectively collected and fully anonymized.
Please refer to the institute&#39;s MRI safety guidelines, especially regarding the used LVAD ventricle and metal components of the flow loop.
1. Data acquisition
<ol>
	<li>Prior to creating the anatomical phantoms, select a s...

<ol>
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C., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Operative+Planning+in+thoracic+surgery:+A+pilot+study+comparing+imaging+techniques+and+three-dimensional+printing.">Operative Planning in thoracic surgery: A pilot study comparing imaging techniques and three-dimensional printing.</a> The Annals of Thoracic Surgery. 107 (2), 401-406 (2019).</li><li>Masaeli, R., Zandsalimi, K., Rasoulianboroujeni, M., Tayebi, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Challenges+in+three-dimensional+printing+of+bone+substitutes.">Challenges in three-dimensional printing of bone substitutes.</a> Tissue Engineering Part B: Reviews. 25 (5), 387-397 (2019).</li><li>Rafiee, M., Farahani, R. D., Therriault, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Multi-material+3D+and+4D+printing:+A+survey.">Multi-material 3D and 4D printing: A survey.</a> Advanced Science. 7 (12), 1902307 (2020).</li><li>Wang, S., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+and+testing+of+an+ultrasound-compatible+cardiac+phantom+for+interventional+procedure+simulation+using+direct+three-dimensional+printing.">Development and testing of an ultrasound-compatible cardiac phantom for interventional procedure simulation using direct three-dimensional printing.</a> 3D Printing and Additive Manufacturing. 7 (6), 269-278 (2020).</li><li>D'Souza, W. D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Tissue+mimicking+materials+for+a+multi-imaging+modality+prostate+phantom.">Tissue mimicking materials for a multi-imaging modality prostate phantom.</a> Medical Physics. 28 (4), 688-700 (2001).</li><li>Tejo-Otero, A., Buj-Corral, I., Fenollosa-Art&#233;s, F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=3D+printing+in+medicine+for+preoperative+surgical+planning:+A+review.">3D printing in medicine for preoperative surgical planning: A review.</a> Annals of Biomedical Engineering. 48 (2), 536-555 (2020).</li><li>Rotman, O. M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Realistic+vascular+replicator+for+TAVR+procedures.">Realistic vascular replicator for TAVR procedures.</a> Cardiovascular Engineering and Technology. 9 (3), 339-350 (2018).</li><li>Hussein, N., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Hands-on+surgical+simulation+in+congenital+heart+surgery:+Literature+review+and+future+perspective.">Hands-on surgical simulation in congenital heart surgery: Literature review and future perspective.</a> Seminars in Thoracic and Cardiovascular Surgery. 32 (1), 98-105 (2020).</li><li>Fedorov, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=3D+slicer+as+an+image+computing+platform+for+the+quantitative+imaging+network.">3D slicer as an image computing platform for the quantitative imaging network.</a> Magnetic resonance imaging. 30 (9), 1323-1341 (2012).</li><li>Katsura, M., Sato, J., Akahane, M., Kunimatsu, A., Abe, O. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Current+and+novel+techniques+for+metal+artifact+reduction+at+ct:+practical+guide+for+radiologists.">Current and novel techniques for metal artifact reduction at ct: practical guide for radiologists.</a> Radiographics. 38 (2), 450-461 (2018).</li><li>P&#233;pin, A., Daouk, J., Bailly, P., Hapdey, S., Meyer, M. E. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Management+of+respiratory+motion+in+PET/computed+tomography:+the+state+of+the+art.">Management of respiratory motion in PET/computed tomography: the state of the art.</a> Nuclear Medicine Communications. 35 (2), 113-122 (2014).</li><li>Scott, A. D., Keegan, J., Firmin, D. N. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Motion+in+cardiovascular+MR+imaging.">Motion in cardiovascular MR imaging.</a> Radiology. 250 (2), 331-351 (2009).</li></ol>

The authors declare no conflict of interest.

The presented workflow allows to establish individualized models and thereby perform pre-interventional therapy planning, as well as physician training on individualized anatomies. To achieve this, patient-specific tomographic data can be used for segmentation and 3D-printing of flexible cardiovascular phantoms. By implementation of these 3D-printed models in a mock circulation, different clinical situations can be realistically simulated.
Nowadays, many therapy planning procedures focus upon ...

Individualized therapies are gaining increasing importance in modern clinical practice. Essentially, they can be classified in two groups: genetic and morphologic approaches. For individualized therapies based on unique personal DNA, either genome sequencing or the quantification of gene expression levels is necessary1. One can find these methods in oncology, for example, or in metabolic disorder treatment2. The unique morphology (i.e., anatomy) of each individual plays an important role in interventional, surgical, and prosthetic medicine. The development of individualized prostheses and pre-interventional/-operative therapy planning represent central focusses of research groups today3,4,5.
Coming from industrial prototype production, 3D-printing is ideal for this field of personalized medicine6. 3D-printing is classified as an additive manufacturing method and normally based on a layer-by-layer deposition of material. Nowadays, a broad variety of 3D-printers with different printing techniques is available, enabling processing of polymeric, biologic, or metallic materials. Due to increasing printing speeds as well as the continuous widespread availability of 3D-printers, manufacturing costs are becoming progressively less expensive. Therefore, the use of 3D-printing for pre-interventional planning in daily routines has become economically feasible7.
The aim of this study was to establish a method for generating patient-specific or disease-specific phantoms, usable in individualized therapy planning in cardiovascular medicine. These phantoms should be compatible with common imaging methods, as well as for different therapeutic approaches. A further goal was the use of the individualized anatomies as training models for physicians.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>3-matic</td>
			<td>Materialise AB</td>
			<td></td>
			<td>Software Version 15.0 - Commercial 3D-Modeling Software</td>
		</tr>
		<tr>
			<td>Affiniti 50</td>
			<td>Philips Medical Systems GmbH</td>
			<td></td>
			<td>Ultrasonic Imaging System</td>
		</tr>
		<tr>
			<td>Agilista W3200</td>
			<td>Keyence Co.</td>
			<td></td>
			<td>Polyjet 3D-Printer with a spatial resolution of 30&#181;m</td>
		</tr>
		<tr>
			<td>AR-G1L</td>
			<td>Keyence Co.</td>
			<td></td>
			<td>flexible 3D-Printing material</td>
		</tr>
		<tr>
			<td>Artis Zee</td>
			<td>Siemens Healthcare GmbH</td>
			<td></td>
			<td>Angiographic X-ray Scanner</td>
		</tr>
		<tr>
			<td>cvi42</td>
			<td>CCI Inc.</td>
			<td></td>
			<td>Software Version 5.12 - 4D Flow Analysis Software</td>
		</tr>
		<tr>
			<td>Diagnostic Catheter, Multipurpose MPA 2</td>
			<td>Cordis, A Cardinal Health company</td>
			<td></td>
			<td>Catheter for pediatric training models, Sizes 4F for infants and 5F for children, young adults</td>
		</tr>
		<tr>
			<td>Excor Ventricular Assist Device</td>
			<td>Berlin Heart GmbH</td>
			<td></td>
			<td>80 -100ml stroke volume</td>
		</tr>
		<tr>
			<td>Imeron 400 Contrast Agent</td>
			<td>Bracco Imaging</td>
			<td></td>
			<td>CT - Contrast Agent</td>
		</tr>
		<tr>
			<td>IntroGuide F</td>
			<td>Angiokard Medizintechnik GmbH</td>
			<td></td>
			<td>Guidewire with J-tip; diameter: 0.035&#34; length: 220cm</td>
		</tr>
		<tr>
			<td>Lunderquist Guidewire</td>
			<td>Cook Medical Inc.</td>
			<td></td>
			<td>(T)EVAR interventional guidewire</td>
		</tr>
		<tr>
			<td>MAGNETOM Aera</td>
			<td>Siemens Healthcare GmbH</td>
			<td></td>
			<td>MRI Scanner</td>
		</tr>
		<tr>
			<td>Magnevist Contrast Agent</td>
			<td>Bayer Vital GmbH</td>
			<td></td>
			<td>MRI - Contrast Agent</td>
		</tr>
		<tr>
			<td>Mimics</td>
			<td>Materialise AB</td>
			<td></td>
			<td>Software Version 23.0 - Commercial Segmentation Software</td>
		</tr>
		<tr>
			<td>Modeling Studio</td>
			<td>Keyence Co.</td>
			<td></td>
			<td>3D-Printer Slicing Software</td>
		</tr>
		<tr>
			<td>PVC tubing</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Radifocus Guide Wire M</td>
			<td>Terumo Europe NV</td>
			<td></td>
			<td>Straight guidewire; diameter: 0.035&#34; length: 260cm</td>
		</tr>
		<tr>
			<td>Really useful box 9L</td>
			<td>Really useful products Ltd.</td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Rotigarose - Standard Agar</td>
			<td>Carl Roth GmbH</td>
			<td>3810.4</td>
			<td></td>
		</tr>
		<tr>
			<td>Solidworks</td>
			<td>Dassault Systemes SE</td>
			<td></td>
			<td>Software Version 2019-2020; CAD Design Software</td>
		</tr>
		<tr>
			<td>SOMATOM Force</td>
			<td>Siemens Healthcare GmbH</td>
			<td></td>
			<td>Computed Tomography Scanner</td>
		</tr>
		<tr>
			<td>syngo via</td>
			<td>Siemens Healthcare GmbH</td>
			<td></td>
			<td>Radiological Imaging Software</td>
		</tr>
	</tbody>
</table>

development and evaluation of 3d-printed cardiovascular phantoms for interventional planning and training

Catheter-based interventions are standard treatment options for cardiovascular pathologies. Therefore, patient-specific models could help training physicians&#39; wire-skills as well as improving planning of interventional procedures. The aim of this study was to develop a manufacturing process of patient-specific 3D-printed models for cardiovascular interventions.
To create a 3D-printed elastic phantom, different 3D-printing materials were compared to porcine biological tissues (i.e., aortic tissue) in terms of mechanical characteristics. A fitting material was selected based on comparative tensile tests and specific material thicknesses were defined. Anonymized contrast-enhanced CT-datasets were collected retrospectively. Patient-specific volumetric models were extracted from these datasets and subsequently 3D-printed. A pulsatile flow loop was constructed to simulate the intraluminal blood flow during interventions. Models&#39; suitability for clinical imaging was assessed by x-ray imaging, CT, 4D-MRI and (Doppler) ultrasonography. Contrast medium was used to enhance visibility in x-ray-based imaging. Different catheterization techniques were applied to evaluate the 3D-printed phantoms in physicians&#39; training as well as for pre-interventional therapy planning.
Printed models showed a high printing resolution (~30 &#181;m) and mechanical properties of the chosen material were comparable to physiological biomechanics. Physical and digital models showed high anatomical accuracy when compared to the underlying radiological dataset. Printed models were suitable for ultrasonic imaging as well as standard x-rays. Doppler ultrasonography and 4D-MRI displayed flow patterns and landmark characteristics (i.e., turbulence, wall shear stress) matching native data. In a catheter-based laboratory setting, patient-specific phantoms were easy to catheterize. Therapy planning and training of interventional procedures on challenging anatomies (e.g., congenital heart disease (CHD)) was possible.
Flexible patient-specific cardiovascular phantoms were 3D-printed, and the application of common clinical imaging techniques was possible. This new process is ideal as a training tool for catheter-based (electrophysiological) interventions and can be used in patient-specific therapy planning.

The described representative results focus on a few cardiovascular structures commonly used in planning, training, or testing settings. These were created using isotropic CT-datasets with a ST of 1.0 mm and a voxel size of 1.0 mm&#179;. The aortic aneurysm models&#39; wall thickness was set at 2.5 mm complying with comparative tensile testing results of the printing material (tensile strength: 0.62 &#177; 0.01 N/mm2; Fmax: 1. 55 &#177; 0.02 N; elongation: 9.01 &#177;...

Watch this Scientific Journal Video about Development and Evaluation of 3D-Printed Cardiovascular Phantoms for Interventional Planning and Training at JoVE.com

Development and Evaluation of 3D-Printed Cardiovascular Phantoms for Interventional Planning and Training

Here we present development of a mock circulation setup for multimodal therapy evaluation, pre-interventional planning, and physician-training on cardiovascular anatomies. With the application of patient-specific tomographic scans, this setup is ideal for therapeutic approaches, training, and education in individualized medicine.

Catheter-based interventions are standard treatment options for cardiovascular pathologies. Therefore, patient-specific models could help training ...

The presented method allows for the creation of patient-specific anatomical cardiovascular models for in vitro testing, teaching, and planning of procedures. This method offers a standardized approach to creating 3D printable individualized anatomical models based on radiological data sets that can be easily included in flow loops or training setups. While this modeling approach is focused on the cardiovascular system, it can be transferred to other anatomical structures.The quality of the radiological data set has a big influence on the difficulties encountered during modeling. For the first models, use a dataset with minimal movement artifacts and a high spatial resolution. To begin, define a range of Hounsfield unit values by opening the thresholding tool resulting in a combined mask of the contrast enhanced blood volume and bone structures.Remove all bone parts that are undesirable in the final 3D model by using the Split Mask tool, which enables the marking and separation of multiple areas in overall slices based on Hounsfield values and location. Following this separation, ensure that a mask containing the contrast enhanced blood volume remains. This can be done by scrolling through the coronal and axial planes and matching the created mask with the underlying dataset.From this mask, calculate a rendered 3D polygon surface model. Click the Local Smoothing tool to adjust the surface of the segmented model manually and locally. Focus on removing rough polygon shapes, single peaks, and rough edges created by previous trimming operations.To allow the later connection of the model to a flow loop, include tubular parts with defined diameters adjusted to the available hose connectors and tube diameters. To place a datum plane parallel to the opening cross-section of the vessels, select the tool, Create Datum Plane, and use the preset 3 Point Plane. Next, click on three equally spaced points on the vessel's cross-section to create the plane.Input an offset of 10 millimeters in the command window and confirm the operation. Select the draw sketch tool from the menu and choose the previously created datum plane as the location of the sketch. In the sketch, place a circle roughly on the center line of the vessel and set the radius constraint to match the outer diameter of the hose connector.From the created sketch, use the Extrude tool to create a cylinder with a length of 10 millimeters. Orient the extrusion to move away from the vessel opening to create a distance between the cylinder and the vessel cross section of 10 millimeters. Then use the Loft tool to create a connection between the vessel ending and the geometrically defined cylinder.Ensure a smooth transition between the two cross sections, thereby avoiding turbulence and low flow areas in the final 3D flow model. Finally, use the Hollow tool to make a hollow blood space in the command window, and put the required wall thickness and set the direction of the hollowing process to move outward. Confirm the selection to execute the hollowing process.After uploading the printing file from the slicing software to the 3D printer, ensure that the amount of printing material and support material in the printer's cartridges is sufficient for the 3D model and start the print. Following the printing process, remove the support material from the finished model. First, remove the support material manually by gently squeezing the model.Place the model on the sink, and then immerse it in water or a respective solvent after removing the cover. Dry the model in an incubator set to 40 degrees Celsius overnight. On the next day, embed the model in 1%agar.Use a plastic box with at least two centimeter side margins around the model and drill holes into the walls to allow the tubes to be connected from the vessels to the pump and the reservoir. Add agar to water and bring it to a boil. After stirring the mixture, let it cool for five minutes and pour it into the box to create a bed of at least two centimeter height.While the agar bed sets, connect the model to a non-compliant PVC tube using commercial hose connectors at every opening. Use zip ties to fix the connection between the hose connectors and the 3D model and ensure that there is no fluid leakage. Guide the PVC tubes through the drilled holes into the box, then place the model on top of the set agar bed.To prevent agar leaking from these holes, use heatproof modeling clay to seal it. Next, fill the box with agar and cover the model by adding a two centimeter layer on top. Allow the agar to fully cool and set for an hour at room temperature.Agitate the ventricle using a piston pump with a stroke volume of 120 to 150 milliliters. For CT imaging, place the entire flow loop within the CT scanner with the drive unit standing close by. Connect the contrast agent pump directly to the reservoir of the flow loop so the flooding of the model with contrast agent can be simulated during scanning.This is especially useful for visualizing vascular pathologies. Perform CT as a dynamic scan over the whole model to visualize contrast agent inflow. Inject 100 milliliters of one to 10 diluted iodinated contrast agent into the model's reservoir at a speed of four milliliters per second.Start the scan using bolus triggering in the leading tube with a 100 Hounsfield unit threshold in a four second delay. To perform sonography, put a small amount of ultrasonic gel on top of the agar block to reduce artifacts. Start the pump and use the ultrasonic head to locate the anatomical structure of interest.Use 2D echo mode to evaluate leaflet movement as well as the opening and closing behavior of the valve. Use color Doppler to evaluate blood flow across the valve and spectral Doppler to quantify the flow velocity following the heart valve. Insert an access port into the PVC tube directly below the 3D model to allow for an easier access of the anatomy with a cardiac catheter or guide wire.After starting the flow loop, check for leakage at the port entrance point. If necessary, use a two component adhesive to seal the opening. Place the 3D model on the patient table underneath the C arms of the x-ray machine.Use x-ray imaging to guide the catheter and guide wires through the anatomic structure. For 4D MRI, use a 1.5 Tesla scanner and ensure that the acquisition protocol consists of a non-contrast enhanced MRA in the 4D flow sequence. Acquire an isotropic dataset with 25 phases in a slice thickness of 1.2 millimeters.Set the velocity encoding at 100 centimeters per second. Perform the 4D flow image analysis with a commercially available software. First, import the 4D MRI dataset by selecting it from the flash drive, then perform semi-automated offset correction and correction of aliasing to improve image quality.The center line of the vessel will be automatically traced, and the software extracts the 3D volume. Finally, perform quantitative analysis of flow parameters by clicking on the individual tabs in the analysis window. Flow visualization, path line visualization, and flow vector can be visualized without further input.For quantification of pressure and wall shear stress in the representative tab, place two planes by clicking on the Add Plane button. Move the planes to the ROI by dragging them along the center line so that one plane is placed at the beginning of the ROI and one at the end. The pressure drop across the ROI and wall shear stress will be visualized and quantified in the diagram next to the 3D model.The presented 3D printed models offer a wide range of possibilities in CT imaging. The printed material can be easily distinguished from the surrounding agar and possible metallic implants. Therefore, the use of a contrast agent is normally not required, except for generating dynamic imaging sequences.When using ultrasonic imaging, it is possible to distinguish between the model's wall, the surrounding agar, and thin dynamic objects like heart valve leaflets. The agar layer on top of the model provides realistic haptic feedback during the scanning process. Flow analysis within the flow loop offers a wide range of possible applications and pre-interventional imaging.4D MRI sequence enables visualization of fluid flow, turbulences, and wall shear stress within the 3D printed model, making it possible to analyze flow patterns following artificial heart valves. This workflow can be transferred to different interventional medical procedures for training or planning purposes. The technique allows for a closer in vitro examination of the flow behavior in large cardiovascular vessels and offers great potential for individualized therapy planning.

development-evaluation-3d-printed-cardiovascular-phantoms-for

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JoVE Journal

Medicine

3.7K Görüntüleme.  Ludwig Maximilian University Munich. Sunulan yöntem, in vitro test, öğretim ve prosedürlerin planlanması için hastaya özgü anatomik kardiyovasküler modellerin oluşturulmasına izin verir. Bu yöntem, akış döngülerine veya eğitim kurulumlarına kolayca dahil edilebilen radyolojik veri kümelerine dayalı 3D yazdırılabilir bireyselleştirilmiş anatomik modeller oluşturmak için standartlaştırılmış bir yaklaşım sunar. Bu modelleme yaklaşımı kardiyovasküler sisteme odaklanırken, diğer anatomik yapıla...