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TH-A-207B-01: Basics and Current Implementations of Ultrasound Imaging of Shear Wave Speed and Elasticity

Imaging of tissue elastic properties is a relatively new and powerful approach to one of the oldest and most important diagnostic tools. Imaging of shear wave speed with ultrasound is has been added to most high-end ultrasound systems. Understanding this exciting imaging mode aiding its most effective use in medicine can be a rewarding effort for medical physicists and other medical imaging and treatment professionals. Assuring consistent, quantitative measurements across the many ultrasound systems in a typical imaging department will constitute a major step toward realizing the great potential of this technique and other quantitative imaging. This session will target these two goals with two presentations. A. Basics and Current Implementations of Ultrasound Imaging of Shear Wave Speed and Elasticity - Shigao Chen, Ph.D. Learning objectives-To understand: Introduction: Importance of tissue elasticity measurement Strain vs. shear wave elastography (SWE), beneficial features of SWE The link between shear wave speed and material properties, influence of viscosity Generation of shear waves External vibration (Fibroscan) ultrasound radiation force Point push Supersonic push (Aixplorer) Comb push (GE Logiq E9) Detection of shear waves Motion detection from pulse-echo ultrasound Importance of frame rate for shear wave imaging Plane wave imaging detection How to achieve high effective frame rate using line-by-line scanners Shear wave speed calculation Time to peak Random sample consensus (RANSAC) Cross correlation Sources of bias and variation in SWE Tissue viscosity Transducer compression or internal pressure of organ Reflection of shear waves at boundaries B. Elasticity Imaging System Biomarker Qualification and User Testing of Systems – Brian Garra, M.D. Learning objectives-To understand: Goals Review the need for quantitative medical imaging Provide examples of quantitative imaging biomarkers Acquaint the participant with the purpose of the RSNA Quantitative Imaging Biomarker Alliance and the need for such an organization Review the QIBA process for creating a quantitative biomarker Summarize steps needed to verify adherence of site, operators, and imaging systems to a QIBA profile Underlying Premise and Assumptions Objective, quantifiable results are needed to enhance the value of diagnostic imaging in clinical practice Reasons for quantification Evidence based medicine requires objective, not subjective observer data Computerized decision support tools (eg CAD) generally require quantitative input. Quantitative, reproducible measures are more easily used to develop personalized molecular medical diagnostic and treatment systems What is quantitative imaging? Definition from Imaging Metrology Workshop The Quantitative Imaging Biomarker Alliance Formation 2008 Mission Structure Example Imaging Biomarkers Being Explored Biomarker Selection Groundwork Draft Protocol for imaging and data evaluation QIBA Profile Drafting Equipment and Site Validation Technical Clinical Site and Equipment QA and Compliance Checking Ultrasound Elasticity Estimation Biomarker US Elasticity Estimation Background Current Status and Problems Biomarker Selection-process and outcome US SWS for Liver Fibrosis Biomarker Work Groundwork Literature search and analysis results Phase I phantom testing-Elastic phantoms Phase II phantom testing-Viscoelastic phantoms Digital Simulated Data Protocol and Profile Drafting Protocol: based on UPICT and existing literature and standards bodies protocols Profile-Current claims, Manufacturer specific appendices What comes after the profile Profile Validation Technical validation Clinical validation QA and Compliance Possible approaches Site Operator testing Site protocol re-evaluation Imaging system Manufacturer testing and attestation User acceptance testing and periodic QA Phantom Tests Digital Phantom Based Testing Standard QA Testing Remediation Schemes Profile Evolution Towards additional applications Towards higher accuracy and precision Supported in part by NIH contract HHSN268201300071C from NIBIB. Collaboration with GE Global Research, no personal support.; S. Chen, Some technologies described in this presentation have been licensed. Mayo Clinic and Dr. Chen have financial interests these technologies.

60 APPLIED LIFE SCIENCES↗

TH-A-207B-02: QIBA Ultrasound Elasticity Imaging System Biomarker Qualification and User Testing of Systems

Imaging of tissue elastic properties is a relatively new and powerful approach to one of the oldest and most important diagnostic tools. Imaging of shear wave speed with ultrasound is has been added to most high-end ultrasound systems. Understanding this exciting imaging mode aiding its most effective use in medicine can be a rewarding effort for medical physicists and other medical imaging and treatment professionals. Assuring consistent, quantitative measurements across the many ultrasound systems in a typical imaging department will constitute a major step toward realizing the great potential of this technique and other quantitative imaging. This session will target these two goals with two presentations. A. Basics and Current Implementations of Ultrasound Imaging of Shear Wave Speed and Elasticity - Shigao Chen, Ph.D. Learning objectives-To understand: Introduction: Importance of tissue elasticity measurement Strain vs. shear wave elastography (SWE), beneficial features of SWE The link between shear wave speed and material properties, influence of viscosity Generation of shear waves External vibration (Fibroscan) ultrasound radiation force Point push Supersonic push (Aixplorer) Comb push (GE Logiq E9) Detection of shear waves Motion detection from pulse-echo ultrasound Importance of frame rate for shear wave imaging Plane wave imaging detection How to achieve high effective frame rate using line-by-line scanners Shear wave speed calculation Time to peak Random sample consensus (RANSAC) Cross correlation Sources of bias and variation in SWE Tissue viscosity Transducer compression or internal pressure of organ Reflection of shear waves at boundaries B. Elasticity Imaging System Biomarker Qualification and User Testing of Systems – Brian Garra, M.D. Learning objectives-To understand: Goals Review the need for quantitative medical imaging Provide examples of quantitative imaging biomarkers Acquaint the participant with the purpose of the RSNA Quantitative Imaging Biomarker Alliance and the need for such an organization Review the QIBA process for creating a quantitative biomarker Summarize steps needed to verify adherence of site, operators, and imaging systems to a QIBA profile Underlying Premise and Assumptions Objective, quantifiable results are needed to enhance the value of diagnostic imaging in clinical practice Reasons for quantification Evidence based medicine requires objective, not subjective observer data Computerized decision support tools (eg CAD) generally require quantitative input. Quantitative, reproducible measures are more easily used to develop personalized molecular medical diagnostic and treatment systems What is quantitative imaging? Definition from Imaging Metrology Workshop The Quantitative Imaging Biomarker Alliance Formation 2008 Mission Structure Example Imaging Biomarkers Being Explored Biomarker Selection Groundwork Draft Protocol for imaging and data evaluation QIBA Profile Drafting Equipment and Site Validation Technical Clinical Site and Equipment QA and Compliance Checking Ultrasound Elasticity Estimation Biomarker US Elasticity Estimation Background Current Status and Problems Biomarker Selection-process and outcome US SWS for Liver Fibrosis Biomarker Work Groundwork Literature search and analysis results Phase I phantom testing-Elastic phantoms Phase II phantom testing-Viscoelastic phantoms Digital Simulated Data Protocol and Profile Drafting Protocol: based on UPICT and existing literature and standards bodies protocols Profile-Current claims, Manufacturer specific appendices What comes after the profile Profile Validation Technical validation Clinical validation QA and Compliance Possible approaches Site Operator testing Site protocol re-evaluation Imaging system Manufacturer testing and attestation User acceptance testing and periodic QA Phantom Tests Digital Phantom Based Testing Standard QA Testing Remediation Schemes Profile Evolution Towards additional applications Towards higher accuracy and precision Supported in part by NIH contract HHSN268201300071C from NIBIB. Collaboration with GE Global Research, no personal support.; S. Chen, Some technologies described in this presentation have been licensed. Mayo Clinic and Dr. Chen have financial interests these technologies.

60 APPLIED LIFE SCIENCES↗

WE-DE-207A-00: Advances in Image-Guided Neurointerventions-Clinical Pull and Technology Push

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introduction of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are being pursued. For the highest spatial and temporal resolution, x-ray guidance with fluoroscopy and angiography although dominant are still being vastly improved. New detectors such as the Micro-Angiographic Fluoroscope (MAF) and x-ray source designs that enable higher outputs while maintaining small focal spots will be highlighted along with new methods for minimizing the radiation dose to patients. Additionally, new platforms for training and device testing that include patient-specific 3D printed vascular phantoms and new metrics such as generalized relative object detectability for objectively inter-comparing systems will be discussed. This will improve the opportunity for better evaluation of these technological advances which should contribute to the safety and efficacy of image guided minimally invasive neuro-endovascular procedures. Learning Objectives: To understand the operation of new x-ray imaging chain components such as detectors and sources To be informed about the latest testing methods, with 3D printed vascular phantoms, and new evaluation metrics for advanced imaging in x-ray image guided neurovascular interventions Advances in cone beam CT anatomical and functional imaging in angio-suite to enable one-stop-shop stroke imaging workflow Guang-Hong Chen - The introduction of flat-panel detector based cone-beam CT in clinical angiographic imaging systems enabled treating physicians to obtain three-dimensional anatomic roadmaps for bony structure, soft brain tissue, and vasculatures for treatment planning and efficacy checking after the procedures. However, much improvement is needed to reduce image artifacts, reduce radiation dose, and add potential functional imaging capability to provide four-dimensional dynamic information of vasculature and brain perfusion. In this presentation, some of the new techniques developed to address radiation dose issues, image artifact reduction and brain perfusion using C-arm cone-beam CT imaging system will be introduced for the audience. Learning Objectives: To understand the clinical need of one-stop-shop stroke imaging workflow To understand to technical challenges in cone beam CT perfusion To understand the potential technical solutions to enable one-stop-shop imaging workflow Recent advances in devices used in neuro--interventions Mattew Gounis - Over the past two decades, there has been explosive development of medical devices that have revolutionized the endovascular treatment of cerebrovascular diseases. There is now Level 1, Class A evidence that intra-arterial, mechanical thrombectomy in acute ischemic stroke is superior to medical management; and similarly that minimally invasive, endovascular repair of ruptured brain aneurysms is superior to surgical treatment. Stent-retrievers are now standard of care for emergent large vessel occlusions causing a stroke, with a number of patients need to treat for good clinical outcomes as low as 4. Recent technologies such as flow diverters and disrupters, intracranial self-expanding stents, flexible large bore catheters that can reach vessels beyond the circle of Willis, stent-retrievers, and super-compliant balloons are the result of successful miniaturization of design features and novel manufacturing technologies capable of building these devices. This is a rapidly evolving field, and the device technology enabling such advancements will be reviewed. Importantly, image-guidance technology has not kept pace in neurointervention and the ability to adequately characterize these devices in vivo remains a significant opportunity. Learning Objectives: A survey of devices used in neurointerventions, their materials and essential design characteristics Funding support received from NIH and DOD; Funding support received from GE Healthcare; Funding support received from Siemens AX; Patent royalties received from GE Healthcare; G. Chen, Funding received from NIH; funding received from DOD; funding received from GE Healthcare; funding received from Siemens AX.; M. Gounis, consultant for Codman Neurovascular and Stryker Neurovascular; Holds stock in InNeuroCo Inc, research grants: NIH, Medtronic Neurovascular, Microvention/Terumo, Cerevasc LLC, Gentuity, Codman Neurovascular, Philips Healthcare, Stryker Neurovascular, Tay Sachs Foundation, and InNeuroCo Inc.; S. Rudin, Supported in part by NIH Grant R01EB002873 and the Toshiba Medical System Corp.

60 APPLIED LIFE SCIENCES↗

WE-DE-207A-01: Parallels in the Evolution of X-Ray Angiographic Systems and Devices Used for Minimally Invasive Endovascular Therapy

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introduction of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are being pursued. For the highest spatial and temporal resolution, x-ray guidance with fluoroscopy and angiography although dominant are still being vastly improved. New detectors such as the Micro-Angiographic Fluoroscope (MAF) and x-ray source designs that enable higher outputs while maintaining small focal spots will be highlighted along with new methods for minimizing the radiation dose to patients. Additionally, new platforms for training and device testing that include patient-specific 3D printed vascular phantoms and new metrics such as generalized relative object detectability for objectively inter-comparing systems will be discussed. This will improve the opportunity for better evaluation of these technological advances which should contribute to the safety and efficacy of image guided minimally invasive neuro-endovascular procedures. Learning Objectives: To understand the operation of new x-ray imaging chain components such as detectors and sources To be informed about the latest testing methods, with 3D printed vascular phantoms, and new evaluation metrics for advanced imaging in x-ray image guided neurovascular interventions Advances in cone beam CT anatomical and functional imaging in angio-suite to enable one-stop-shop stroke imaging workflow Guang-Hong Chen - The introduction of flat-panel detector based cone-beam CT in clinical angiographic imaging systems enabled treating physicians to obtain three-dimensional anatomic roadmaps for bony structure, soft brain tissue, and vasculatures for treatment planning and efficacy checking after the procedures. However, much improvement is needed to reduce image artifacts, reduce radiation dose, and add potential functional imaging capability to provide four-dimensional dynamic information of vasculature and brain perfusion. In this presentation, some of the new techniques developed to address radiation dose issues, image artifact reduction and brain perfusion using C-arm cone-beam CT imaging system will be introduced for the audience. Learning Objectives: To understand the clinical need of one-stop-shop stroke imaging workflow To understand to technical challenges in cone beam CT perfusion To understand the potential technical solutions to enable one-stop-shop imaging workflow Recent advances in devices used in neuro--interventions Mattew Gounis - Over the past two decades, there has been explosive development of medical devices that have revolutionized the endovascular treatment of cerebrovascular diseases. There is now Level 1, Class A evidence that intra-arterial, mechanical thrombectomy in acute ischemic stroke is superior to medical management; and similarly that minimally invasive, endovascular repair of ruptured brain aneurysms is superior to surgical treatment. Stent-retrievers are now standard of care for emergent large vessel occlusions causing a stroke, with a number of patients need to treat for good clinical outcomes as low as 4. Recent technologies such as flow diverters and disrupters, intracranial self-expanding stents, flexible large bore catheters that can reach vessels beyond the circle of Willis, stent-retrievers, and super-compliant balloons are the result of successful miniaturization of design features and novel manufacturing technologies capable of building these devices. This is a rapidly evolving field, and the device technology enabling such advancements will be reviewed. Importantly, image-guidance technology has not kept pace in neurointervention and the ability to adequately characterize these devices in vivo remains a significant opportunity. Learning Objectives: A survey of devices used in neurointerventions, their materials and essential design characteristics Funding support received from NIH and DOD; Funding support received from GE Healthcare; Funding support received from Siemens AX; Patent royalties received from GE Healthcare; G. Chen, Funding received from NIH; funding received from DOD; funding received from GE Healthcare; funding received from Siemens AX.; M. Gounis, consultant for Codman Neurovascular and Stryker Neurovascular; Holds stock in InNeuroCo Inc, research grants: NIH, Medtronic Neurovascular, Microvention/Terumo, Cerevasc LLC, Gentuity, Codman Neurovascular, Philips Healthcare, Stryker Neurovascular, Tay Sachs Foundation, and InNeuroCo Inc.; S. Rudin, Supported in part by NIH Grant R01EB002873 and the Toshiba Medical System Corp.

60 APPLIED LIFE SCIENCES↗

WE-DE-207A-02: Advances in Cone Beam CT Anatomical and Functional Imaging in Angio-Suite to Enable One-Stop-Shop Stroke Imaging Workflow

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introduction of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are being pursued. For the highest spatial and temporal resolution, x-ray guidance with fluoroscopy and angiography although dominant are still being vastly improved. New detectors such as the Micro-Angiographic Fluoroscope (MAF) and x-ray source designs that enable higher outputs while maintaining small focal spots will be highlighted along with new methods for minimizing the radiation dose to patients. Additionally, new platforms for training and device testing that include patient-specific 3D printed vascular phantoms and new metrics such as generalized relative object detectability for objectively inter-comparing systems will be discussed. This will improve the opportunity for better evaluation of these technological advances which should contribute to the safety and efficacy of image guided minimally invasive neuro-endovascular procedures. Learning Objectives: To understand the operation of new x-ray imaging chain components such as detectors and sources To be informed about the latest testing methods, with 3D printed vascular phantoms, and new evaluation metrics for advanced imaging in x-ray image guided neurovascular interventions Advances in cone beam CT anatomical and functional imaging in angio-suite to enable one-stop-shop stroke imaging workflow Guang-Hong Chen - The introduction of flat-panel detector based cone-beam CT in clinical angiographic imaging systems enabled treating physicians to obtain three-dimensional anatomic roadmaps for bony structure, soft brain tissue, and vasculatures for treatment planning and efficacy checking after the procedures. However, much improvement is needed to reduce image artifacts, reduce radiation dose, and add potential functional imaging capability to provide four-dimensional dynamic information of vasculature and brain perfusion. In this presentation, some of the new techniques developed to address radiation dose issues, image artifact reduction and brain perfusion using C-arm cone-beam CT imaging system will be introduced for the audience. Learning Objectives: To understand the clinical need of one-stop-shop stroke imaging workflow To understand to technical challenges in cone beam CT perfusion To understand the potential technical solutions to enable one-stop-shop imaging workflow Recent advances in devices used in neuro--interventions Mattew Gounis - Over the past two decades, there has been explosive development of medical devices that have revolutionized the endovascular treatment of cerebrovascular diseases. There is now Level 1, Class A evidence that intra-arterial, mechanical thrombectomy in acute ischemic stroke is superior to medical management; and similarly that minimally invasive, endovascular repair of ruptured brain aneurysms is superior to surgical treatment. Stent-retrievers are now standard of care for emergent large vessel occlusions causing a stroke, with a number of patients need to treat for good clinical outcomes as low as 4. Recent technologies such as flow diverters and disrupters, intracranial self-expanding stents, flexible large bore catheters that can reach vessels beyond the circle of Willis, stent-retrievers, and super-compliant balloons are the result of successful miniaturization of design features and novel manufacturing technologies capable of building these devices. This is a rapidly evolving field, and the device technology enabling such advancements will be reviewed. Importantly, image-guidance technology has not kept pace in neurointervention and the ability to adequately characterize these devices in vivo remains a significant opportunity. Learning Objectives: A survey of devices used in neurointerventions, their materials and essential design characteristics Funding support received from NIH and DOD; Funding support received from GE Healthcare; Funding support received from Siemens AX; Patent royalties received from GE Healthcare; G. Chen, Funding received from NIH; funding received from DOD; funding received from GE Healthcare; funding received from Siemens AX.; M. Gounis, consultant for Codman Neurovascular and Stryker Neurovascular; Holds stock in InNeuroCo Inc, research grants: NIH, Medtronic Neurovascular, Microvention/Terumo, Cerevasc LLC, Gentuity, Codman Neurovascular, Philips Healthcare, Stryker Neurovascular, Tay Sachs Foundation, and InNeuroCo Inc.; S. Rudin, Supported in part by NIH Grant R01EB002873 and the Toshiba Medical System Corp.

60 APPLIED LIFE SCIENCES↗

WE-DE-207A-03: Recent Advances in Devices Used in Neuro--Interventions

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introduction of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are being pursued. For the highest spatial and temporal resolution, x-ray guidance with fluoroscopy and angiography although dominant are still being vastly improved. New detectors such as the Micro-Angiographic Fluoroscope (MAF) and x-ray source designs that enable higher outputs while maintaining small focal spots will be highlighted along with new methods for minimizing the radiation dose to patients. Additionally, new platforms for training and device testing that include patient-specific 3D printed vascular phantoms and new metrics such as generalized relative object detectability for objectively inter-comparing systems will be discussed. This will improve the opportunity for better evaluation of these technological advances which should contribute to the safety and efficacy of image guided minimally invasive neuro-endovascular procedures. Learning Objectives: To understand the operation of new x-ray imaging chain components such as detectors and sources To be informed about the latest testing methods, with 3D printed vascular phantoms, and new evaluation metrics for advanced imaging in x-ray image guided neurovascular interventions Advances in cone beam CT anatomical and functional imaging in angio-suite to enable one-stop-shop stroke imaging workflow Guang-Hong Chen - The introduction of flat-panel detector based cone-beam CT in clinical angiographic imaging systems enabled treating physicians to obtain three-dimensional anatomic roadmaps for bony structure, soft brain tissue, and vasculatures for treatment planning and efficacy checking after the procedures. However, much improvement is needed to reduce image artifacts, reduce radiation dose, and add potential functional imaging capability to provide four-dimensional dynamic information of vasculature and brain perfusion. In this presentation, some of the new techniques developed to address radiation dose issues, image artifact reduction and brain perfusion using C-arm cone-beam CT imaging system will be introduced for the audience. Learning Objectives: To understand the clinical need of one-stop-shop stroke imaging workflow To understand to technical challenges in cone beam CT perfusion To understand the potential technical solutions to enable one-stop-shop imaging workflow Recent advances in devices used in neuro--interventions Mattew Gounis - Over the past two decades, there has been explosive development of medical devices that have revolutionized the endovascular treatment of cerebrovascular diseases. There is now Level 1, Class A evidence that intra-arterial, mechanical thrombectomy in acute ischemic stroke is superior to medical management; and similarly that minimally invasive, endovascular repair of ruptured brain aneurysms is superior to surgical treatment. Stent-retrievers are now standard of care for emergent large vessel occlusions causing a stroke, with a number of patients need to treat for good clinical outcomes as low as 4. Recent technologies such as flow diverters and disrupters, intracranial self-expanding stents, flexible large bore catheters that can reach vessels beyond the circle of Willis, stent-retrievers, and super-compliant balloons are the result of successful miniaturization of design features and novel manufacturing technologies capable of building these devices. This is a rapidly evolving field, and the device technology enabling such advancements will be reviewed. Importantly, image-guidance technology has not kept pace in neurointervention and the ability to adequately characterize these devices in vivo remains a significant opportunity. Learning Objectives: A survey of devices used in neurointerventions, their materials and essential design characteristics Funding support received from NIH and DOD; Funding support received from GE Healthcare; Funding support received from Siemens AX; Patent royalties received from GE Healthcare; G. Chen, Funding received from NIH; funding received from DOD; funding received from GE Healthcare; funding received from Siemens AX.; M. Gounis, consultant for Codman Neurovascular and Stryker Neurovascular; Holds stock in InNeuroCo Inc, research grants: NIH, Medtronic Neurovascular, Microvention/Terumo, Cerevasc LLC, Gentuity, Codman Neurovascular, Philips Healthcare, Stryker Neurovascular, Tay Sachs Foundation, and InNeuroCo Inc.; S. Rudin, Supported in part by NIH Grant R01EB002873 and the Toshiba Medical System Corp.

60 APPLIED LIFE SCIENCES↗

WE-DE-207A-04: Advances in Radiological Neuro-Endovascular Interventional Imaging

1. Parallels in the evolution of x-ray angiographic systems and devices used for minimally invasive endovascular therapy Charles Strother - DSA, invented by Dr. Charles Mistretta at UW-Madison, was the technology which enabled the development of minimally invasive endovascular procedures. As DSA became widely available and the potential benefits for accessing the cerebral vasculature from an endovascular approach began to be apparent, industry began efforts to develop tools for use in these procedures. Along with development of catheters, embolic materials, pushable coils and the GDC coils there was simultaneous development and improvement of 2D DSA image quality and the introduction of 3D DSA. Together, these advances resulted in an enormous expansion in the scope and numbers of minimally invasive endovascular procedures. The introduction of flat detectors for c-arm angiographic systems in 2002 provided the possibility of the angiographic suite becoming not just a location for vascular imaging where physiological assessments might also be performed. Over the last decade algorithmic and hardware advances have been sufficient to now realize this potential in clinical practice. The selection of patients for endovascular treatments is enhanced by this dual capability. Along with these advances has been a steady reduction in the radiation exposure required so that today, vascular and soft tissue images may be obtained with equal or in many cases less radiation exposure than is the case for comparable images obtained with multi-detector CT. Learning Objectives: To understand the full capabilities of today’s angiographic suite To understand how c-arm cone beam CT soft tissue imaging can be used for assessments of devices, blood flow and perfusion. Advances in real-time x-ray neuro-endovascular image guidance Stephen Rudin - Reacting to the demands on real-time image guidance for ever finer neurovascular interventions, great improvements in imaging chains are being pursued. For the highest spatial and temporal resolution, x-ray guidance with fluoroscopy and angiography although dominant are still being vastly improved. New detectors such as the Micro-Angiographic Fluoroscope (MAF) and x-ray source designs that enable higher outputs while maintaining small focal spots will be highlighted along with new methods for minimizing the radiation dose to patients. Additionally, new platforms for training and device testing that include patient-specific 3D printed vascular phantoms and new metrics such as generalized relative object detectability for objectively inter-comparing systems will be discussed. This will improve the opportunity for better evaluation of these technological advances which should contribute to the safety and efficacy of image guided minimally invasive neuro-endovascular procedures. Learning Objectives: To understand the operation of new x-ray imaging chain components such as detectors and sources To be informed about the latest testing methods, with 3D printed vascular phantoms, and new evaluation metrics for advanced imaging in x-ray image guided neurovascular interventions Advances in cone beam CT anatomical and functional imaging in angio-suite to enable one-stop-shop stroke imaging workflow Guang-Hong Chen - The introduction of flat-panel detector based cone-beam CT in clinical angiographic imaging systems enabled treating physicians to obtain three-dimensional anatomic roadmaps for bony structure, soft brain tissue, and vasculatures for treatment planning and efficacy checking after the procedures. However, much improvement is needed to reduce image artifacts, reduce radiation dose, and add potential functional imaging capability to provide four-dimensional dynamic information of vasculature and brain perfusion. In this presentation, some of the new techniques developed to address radiation dose issues, image artifact reduction and brain perfusion using C-arm cone-beam CT imaging system will be introduced for the audience. Learning Objectives: To understand the clinical need of one-stop-shop stroke imaging workflow To understand to technical challenges in cone beam CT perfusion To understand the potential technical solutions to enable one-stop-shop imaging workflow Recent advances in devices used in neuro--interventions Mattew Gounis - Over the past two decades, there has been explosive development of medical devices that have revolutionized the endovascular treatment of cerebrovascular diseases. There is now Level 1, Class A evidence that intra-arterial, mechanical thrombectomy in acute ischemic stroke is superior to medical management; and similarly that minimally invasive, endovascular repair of ruptured brain aneurysms is superior to surgical treatment. Stent-retrievers are now standard of care for emergent large vessel occlusions causing a stroke, with a number of patients need to treat for good clinical outcomes as low as 4. Recent technologies such as flow diverters and disrupters, intracranial self-expanding stents, flexible large bore catheters that can reach vessels beyond the circle of Willis, stent-retrievers, and super-compliant balloons are the result of successful miniaturization of design features and novel manufacturing technologies capable of building these devices. This is a rapidly evolving field, and the device technology enabling such advancements will be reviewed. Importantly, image-guidance technology has not kept pace in neurointervention and the ability to adequately characterize these devices in vivo remains a significant opportunity. Learning Objectives: A survey of devices used in neurointerventions, their materials and essential design characteristics Funding support received from NIH and DOD; Funding support received from GE Healthcare; Funding support received from Siemens AX; Patent royalties received from GE Healthcare; G. Chen, Funding received from NIH; funding received from DOD; funding received from GE Healthcare; funding received from Siemens AX.; M. Gounis, consultant for Codman Neurovascular and Stryker Neurovascular; Holds stock in InNeuroCo Inc, research grants: NIH, Medtronic Neurovascular, Microvention/Terumo, Cerevasc LLC, Gentuity, Codman Neurovascular, Philips Healthcare, Stryker Neurovascular, Tay Sachs Foundation, and InNeuroCo Inc.; S. Rudin, Supported in part by NIH Grant R01EB002873 and the Toshiba Medical System Corp.

60 APPLIED LIFE SCIENCES↗