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3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software.

ABSTRACT: 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.

SUBMITTER: Sommer KN

PROVIDER: S-EPMC5994607 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software.

Sommer Kelsey N KN Shepard Lauren L Karkhanis Nitant Vivek NV Iyer Vijay V Angel Erin E Wilson Michael F MF Rybicki Frank J FJ Mitsouras Dimitrios D Rudin Stephen S Ionita Ciprian N CN

Proceedings of SPIE--the International Society for Optical Engineering 20180201

<h4>Purpose</h4>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 ...[more]

PMID: 29899591

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Project description:IntroductionAdditive manufacturing or 3-dimensional printing has become a widespread technology with many applications in medicine. We have conducted a systematic review of its application in radiation oncology with a particular emphasis on the creation of phantoms for image quality assessment and radiation dosimetry. Traditionally used phantoms for quality assurance in radiotherapy are often constraint by simplified geometry and homogenous nature to perform imaging analysis or pretreatment dosimetric verification. Such phantoms are limited due to their ability in only representing the average human body, not only in proportion and radiation properties but also do not accommodate pathological features. These limiting factors restrict the patient-specific quality assurance process to verify image-guided positioning accuracy and/or dose accuracy in "water-like" condition.Methods and resultsEnglish speaking manuscripts published since 2008 were searched in 5 databases (Google Scholar, Scopus, PubMed, IEEE Xplore, and Web of Science). A significant increase in publications over the 10 years was observed with imaging and dosimetry phantoms about the same total number (52 vs 50). Key features of additive manufacturing are the customization with creation of realistic pathology as well as the ability to vary density and as such contrast. Commonly used printing materials, such as polylactic acid, acrylonitrile butadiene styrene, high-impact polystyrene and many more, are utilized to achieve a wide range of achievable X-ray attenuation values from -1000 HU to 500 HU and higher. Not surprisingly, multimaterial printing using the polymer jetting technology is emerging as an important printing process with its ability to create heterogeneous phantoms for dosimetry in radiotherapy.ConclusionGiven the flexibility and increasing availability and low cost of additive manufacturing, it can be expected that its applications for radiation medicine will continue to increase.

Project description:PurposeInterventional fluorescence imaging is increasingly being utilized to quantify cancer biomarkers in both clinical and preclinical models, yet absolute quantification is complicated by many factors. The use of optical phantoms has been suggested by multiple professional organizations for quantitative performance assessment of fluorescence guidance imaging systems. This concept can be further extended to provide standardized tools to compare and assess image analysis metrics.Procedures3D-printed fluorescence phantoms based on solid tumor models were developed with representative bio-mimicking optical properties. Phantoms were produced with discrete tumors embedded with an NIR fluorophore of fixed concentration and either zero or 3% non-specific fluorophore in the surrounding material. These phantoms were first imaged by two fluorescence imaging systems using two methods of image segmentation, and four assessment metrics were calculated to demonstrate variability in the quantitative assessment of system performance. The same analysis techniques were then applied to one tumor model with decreasing tumor fluorophore concentrations.ResultsThese anatomical phantom models demonstrate the ability to use 3D printing to manufacture anthropomorphic shapes with a wide range of reduced scattering (μs': 0.24-1.06 mm-1) and absorption (μa: 0.005-0.14 mm-1) properties. The phantom imaging and analysis highlight variability in the measured sensitivity metrics associated with tumor visualization.Conclusions3D printing techniques provide a platform for demonstrating complex biological models that introduce real-world complexities for quantifying fluorescence image data. Controlled iterative development of these phantom designs can be used as a tool to advance the field and provide context for consensus-building beyond performance assessment of fluorescence imaging platforms, and extend support for standardizing how quantitative metrics are extracted from imaging data and reported in literature.

Project description:ObjectivesThe addition of CT-derived fractional flow reserve (FFR-CT) increases the diagnostic accuracy of coronary CT angiography (CCTA). We assessed the impact of FFR-CT in routine clinical practice on clinical decision-making and patient prognosis in patients suspected of stable coronary artery disease (CAD).MethodsThis retrospective, single-center study compared a cohort that received CCTA with FFR-CT to a historical cohort that received CCTA before FFR-CT was available. We assessed the clinical management decisions after FFR-CT and CCTA and the rate of major adverse cardiac events (MACEs) during the 1-year follow-up using chi-square tests for independence. Kaplan-Meier curves were used to visualize the occurrence of safety outcomes over time.ResultsA total of 360 patients at low to intermediate risk of CAD were included, 224 in the CCTA only group, and 136 in the FFR-CT group. During follow-up, 13 MACE occurred in 12 patients, 9 (4.0%) in the CCTA group, and three (2.2%) in the FFR-CT group. Clinical management decisions differed significantly between both groups. After CCTA, 60 patients (26.5%) received optimal medical therapy (OMT) only, 115 (51.3%) invasive coronary angiography (ICA), and 49 (21.9%) single positron emission CT (SPECT). After FFR-CT, 106 patients (77.9%) received OMT only, 27 (19.9%) ICA, and three (2.2%) SPECT (p < 0.001 for all three options). The revascularization rate after ICA was similar between groups (p = 0.15). However, patients in the CCTA group more often underwent revascularization (p = 0.007).ConclusionAddition of FFR-CT to CCTA led to a reduction in (invasive) diagnostic testing and less revascularizations without observed difference in outcomes after 1 year.Key points• Previous studies have shown that computed tomography-derived fractional flow reserve improves the accuracy of coronary computed tomography angiography without changes in acquisition protocols. • This study shows that use of computed tomography-derived fractional flow reserve as gatekeeper to invasive coronary angiography in patients suspected of stable coronary artery disease leads to less invasive testing and revascularization without observed difference in outcomes after 1 year. • This could lead to a significant reduction in costs, complications and (retrospectively unnecessary) usage of diagnostic testing capacity, and a significant increase in patient satisfaction.

Dataset Information

3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software.

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3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software.

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