TrueFusion™ Echo-Fluoro Guidance - Software 5.1 (USA)

Welcome to the Siemens Healthineers *TrueFusion™ course.   *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.     Within this course is a high-level overview on the workflow and connectivity between the ACUSON SC2000™ PRIME ultrasound system and the Artis fluoroscopy system.  This process takes advantage of the eSie Sync™ automatic registration.  There will be a review on how these two imaging devices communicate.   This course has more information in the form of links placed on the pages.  To successfully complete this course, please view all available content.   We hope you enjoy our course.      *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.   Congratulations!  You have completed the *TrueFusion echo-fluoro guidance course. Listed below are the key points presented in this course. Take time to review the material before you try the final quiz.   Download and print a copy of the detailed Course Review   In this course you have reviewed the:   The principles of *TrueFusion workflow How to identify the efficacy of clinical uses for *TrueFusion ​ Connection of the ACUSON SC2000™ PRIME ultrasound system with the Artis fluoroscopy system How to activate, place and map targets     *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.     Interventional treatment of structural heart disease (SHD) can present with many challenges.  The Interventional Cardiologist will orchestrate how the procedure will be performed in advance to bring about the best outcome.  One of the decisions in pre-planning the procedure is to choose the use of a single or multiple imaging modalities.   A few of the more common imaging devices utilized are the fluoroscope C-arm as well as transesophageal echocardiogram (TEE).  Each device has specific advantages, but in the past, there was no communication available between these devices.  The challenge is to merge the results of these two devices. Accurate coordination of anatomical structures between the ultrasound system and the fluoro device are needed to be viewed in detail with accurate points of reference identifying anatomy.   The use of *TrueFusion has accomplished this task ,and has the potential to reduce fluoro time, decrease contrast use as well as reduce and streamline procedure times; thus improving clinical outcomes.   We will discuss how this is accomplished in further detail within this course.    *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.  Equipment and Software Learn More About Equipment and Software Within this course we will discuss the fundamental principles and advantages of utilizing the *TrueFusion workflow. For this discussion the following equipment is needed or is compatible with the *TrueFusion procedure.  For clarification in this course we will use the generic term of Artis fluoro system, but see below for a list of systems and software currently compatible or needed for communication:   Artis fluoroscopy systems Artis zee (software at or higher than VD11C) Artis Q (software at or higher than VD11C) Artis Q zen, (software at or higher than VD11C) **ARTIS pheno (software at or higher than VE10) ​syngo® Application software of VD 20 or higher with syngo 3D engine, syngo® Fusion package, syngo *TrueFusion ACUSON SC2000 PRIME system ACUSON SC2000™ PRIME volume imaging ultrasound system with software 5.1 or higher 4D volume software Z6Ms ultrasound TEE transducer *TrueFusion™ echo-fluoro guidance software license eSie Valves™ advanced analysis technology   *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.    **The products/features are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details. Fluoro Advantages and Disadvantages Learn More About Fluoroscopic Advantages and Disadvantages The use of a fixed C-arm fluoroscope system allows an infinite amount of static X-ray images as well as real-time fluoro during the procedure.   Coordinates obtained from the C-arm orientation and positioning as well as the patient table position is known and useful data available for coordinate compilation.    The ability to view multiple X-ray images from the rotation of the C-arm can cause challenges in communication, as the heart and other structures are viewed from different perspectives.  Fluoro images are viewed as tissue borders and outlines with no fine tissue detail. Radiopaque contrast is used to show more anatomy detail. Also, there is always a consensus to reduce radiation time, as well as contrast used during a procedure. TEE Advantages and Disadvantages Learn More About TEE Advantages and Disadvantages   The use of TEE during the interventional procedure delivers high resolution, real-time, tissue detail, hemodynamic analysis as well as 4D volume results.    TEE allows anatomy structures and blood flow monitoring in real-time modes during the procedures. The disadvantages of utilizing only TEE within the procedure are:  The position of the TEE transducer within the esophagus is not known​   The imaging window can sometimes give a limited view TrueFusion Guidance Learn More About "Why *TrueFusion Guidance" The use of *TrueFusion negates many of the disadvantages discussed previously,  Because *TrueFusion allows communication between the Artis fluoro system and the ACUSON SC2000 PRIME ultrasound system.  *TrueFusion merges or fuses relevant imaging information into a single image to provide common orientation for navigation as well as clear communication during the interventional procedure.   In addition, relevant anatomical landmarks established on the TEE images can be identified and mapped.  These coordinates and landmarks are then communicated and displayed on the fluoro images. All of these results are delivered and communicated onto a single image for clear communication during the procedure.  Additionally, this information is updated every time the interventionist steps on of the fluoro footswitch for the most up-to-date information.    *TrueFusion has proven valuable in the treatment of many structural heart disease (SHD) procedures.  A few of these are:                                                                                           Aortic Valve Implantation                                     Paravalvular Leak Closure Septal Puncture Mitral Valve Repair Left Atrial Appendage Occlusion Tricuspid Interventions   *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.   As mentioned previously, the C-arm orientation position on the Artis fluoro system is known.   The patient table position is known, with the assumption that the patient does not move during the procedure.  This information helps contribute to the resulting coordinates. The unknown element in this equation is the Z6Ms TEE transducer position or pose.   Let’s first, consider the motions of the Z6Ms transducer as it is projected onto the imaging plane of the Artis system.   As you can see, there are an infinite number of poses available with the Z6Ms transducer.   “How do we identify the pose of the Z6Ms transducer within the patient for accurate anatomic identification?”   The continual detection of the Z6Ms transducer pose is achieved  utilizing many factors.  One important element is the use of eSie Sync™ co-registration.  This enables accurate location and identification to be accomplished with the eSie Sync co-registration software.    eSie Sync co-registration utilizes complex algorithms to track the pose of the Z6Ms transducer in real-time.   The Z6Ms transducer was designed to provide unique built-in markers.  These markers along with the eSie Sync co-registration deliver accurate continual detection of the transducer pose.   See the links below to learn more about the Z6Ms design. Holes Detection Z6Ms Transducer Pose and Detection Instructions:Flash File:HTML5 File:/content/generator/Course_90022751/TF_Holes_Spheres/index.htmlPDF File: ACUSON SC2000 PRIME System​   ​Ensure that the patient information is entered either using the modality worklist or manually entering patient data    Ensure Z6Ms transducer is connected and activated.     Tips and Trouble Shooting Tips and Trouble Shooting the Connection Multiple ACUSON SC2000 PRIME systems can be configured for easy connection.  When choosing a previously configured ACUSON SC2000 PRIME system, ensure the correct system has been chosen by hovering arrow over system ID to view the IP address. Entry is unique for each ACUSON SC2000 PRIME system   If the Connect icon is grayed out there may be two patient files open in the syngo Application Software.   To check the patient registered, press the Patient Exam folder in the ribbon.  If there are two different patient folders displayed, choose the folder with correct patient demographics.  Icon should now be available.   ACUSON SC2000 PRIME  A pop-up is displayed to Accept or Reject connection. User must confirm Accept message on ultrasound system within 30 seconds or connection must be re-established.   When a new patient registration occurs on the ACUSON SC2000 PRIME, the system will automatically disconnect.   With communication established between the two systems, the registration process is now available. Note: Before starting registration, both the Echocardiographer and the Artis operator should agree on a time to start the registration workflow step.   This is important because the Echocardiographer must hold the Z6Ms TEE transducer motionless during acquisition of both fluoroscopy images.   On the ACUSON SC2000 PRIME system ensure the anatomical view to be used for fusion is displayed on the ultrasound system screen.   This image should be a 4D volume data set.   Select the Start TrueFusion icon on the ACUSON SC2000 PRIME Image Menu. Upon completion of this course, the learner will be able to:   Understand the principles of *TrueFusion workflow   Identify the efficacy of clinical uses for *TrueFusion   Connect the ACUSON SC2000™ PRIME ultrasound system with the Artis fluoroscopy system Activate, place and map targets     *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.   On the Artis display there are two windows for registration, each window represents one of the two angles required.  The active window is highlighted by a blue outline. When fluoro is briefly activated for the first projection it will appear in the highlighted segment. After completion of the first image, the second window should be automatically selected displaying with the blue highlighted area.  If not click into that segment to activate. The C-arm is rotated to the opposing positioned at ≥30 degrees angulation between the first and second image.  Fluoroscopy is again briefly performed. The registration results improve with an increased angle difference.  The best registration results are achieved with a 90 degree angle difference.   The Z6Ms transducer tip should be included within the center of both images.   The tableside imaging zoom factor is set to 25cm.     Once registration has been completed the TEE transducer tip is shown with an overlay of color.  This color overlay is seen on both the fluoro control room and ACUSON SC2000 PRIME displays.   At initial registration the transducer symbol can be displayed in red or green. A green TEE icon indicates a good registration.        A red transducer symbol at the initial registration can indicate a possible registration error.                                           Consider repeating registration procedure if a red transducer symbol is seen at this time.   The syngo Application Software as well as the ACUSON SC2000 PRIME can display icons that help with orientation of the C-arm, TEE transducer projection as well as the 4D volume data orientation.  Let’s review these icons:   From the ACUSON SC2000 PRIME system (at 5.1 software release) The ACUSON "  ” (a), icon is replaced by a cube marked AP, or Anterior-Posterior on the volume image This icon rotates with the position of the volume so that orientation can be quickly determined   The C-arm orientation icon is available on the ultrasound screen       Landmark Overlays are a very useful tool that can be used to mark anatomical structures.  There are multiple landmarks that can be used and placed on the echo image and ported over to the live fluoro image.  These include Dots, Circles, and models of the Aortic and Mitral Valves. (Valve modeling is available with the use of AI-Powered algorithms and the eSie Valve package.) The system defaults to Dot landmarks but the user can toggle with the soft key to Circle if preferred. The following landmarks can be placed on any of the MPR images but cannot be placed on the volume image.   This includes: Up to 15 Landmarks Naming or editing the name of Landmarks Location of Landmarks can be edited Circles can be resized,  and location edited The syngo Application Software allows activation of Landmark Overlays to be automatically selected.  If not automatically selected, choose the 4D Application on the system console to select the Workflow. Landmark identification and placement is performed on the ACUSON SC2000 PRIME system and can be communicated and overlaid on the live fluoro image. syngo Application Software Press New Patient key on workstation keyboard and enter patient demographics in required fields   Select 4D / 4D syngo Tab   Select *TrueFusion from the drop-down menu   Select ACUSON SC2000 PRIME system ID name (this field will turn blue if ready to proceed)   Select the Connect icon If the Connect icon is grayed and not available check the Tips and Trouble Shooting information for suggestions to resolve.    The syngo® Workplace will display a Connecting message until connection is achieved. *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.  Connections between Systems Example of Connecting Systems Instructions:Flash File:HTML5 File:/content/generator/Course_90022751/syngo_conn_good012_avi.mp4PDF File: Final Step Important Final Step After these steps have been successfully completed one last step needs to be completed on the ACUSON SC2000 PRIME system.  A pop-up is displayed to Accept or Reject the connection. User must confirm Accept message on ultrasound system within 30 seconds or connection must be re-established.   After initial connection between systems is achieved, the ACUSON SC2000 PRIME system will automatically attempt to re-connect if the connection is lost. Note:  Entering a new patient into the ACUSON SC2000 PRIME system will automatically disconnect from the syngo Application Software. Transducer movement may cause the transducer symbol to appear red on the displays. A red transducer symbol after a successful registration, does not necessarily impact the accuracy of the fusion and landmarks. The landmarks and fusion are based on the ultrasound image at the time the image is frozen.  Remembering co-registration is implemented every time fluoro is performed.  Transducer movements between fluoro acquisitions can result in a red transducer symbol.             The user can choose to place and send landmark overlays to the fluoro image; even with a red display, if there is confidence in the positioning.  Red Indicator Learn More about a Red Indicator There can be several occurrences that cause a red indicator signal.  The following discussion should be considered when the red indicator signal is shown:   Movement During Registration – If there is any movement of the Z6Ms TEE transducer during the two fluoro image acquisitions, a red transducer signal symbol will be shown.    There are many actions occurring within the procedure room, and not all workers within the room may realize the importance of the need for clear communication.  This is an essential step in the registration process and good communication as well as practice of this workflow is strongly advised.    It is advised, if a red transducer symbol is seen at this step of the registration process, it should be repeated.  Rotate the C-arm back to the previous angle and click the associated segment on the control room display.  It will be highlighted in blue and replaced with the new fluoro acquistion.  Ensure the Z6Ms is held motionless during both fluoro acquistions and the Freeze control is pressed on the ACUSON SC2000 PRIME system once X-ray images are re-acquired.   If the red indicator symbol persists consider the following.   Z6Ms transducer tip is not centered within the fluoro image.  If the tip of the Z6Ms transducer is on the edge of the image, a red signal can occur.  If an agreement is reached that enough of the markers are displayed to calculate good coordinates, then this image can be used for registration.    If there is any doubt, then re-register and center the Z6Ms transducer into the center of the images to receive a green signal.   Increase the image zoom.  The registration works best with a field of view close to 25cm.   It is always possible to use an alternative acquisition protocol for registration. Once both X-ray images are acquired the Echocardiographer should freeze the image on the ACUSON SC2000 PRIME system to prevent an unregistered signal from transducer motion.   The Bi-plane co-registration is an important step, and it is suggested to practice prior to the actual process. Coordination during this step takes good communication between Artis operator and Echocardiographer   These steps produce the most accurate assessment of the TEE transducer pose   With the release of the fluoro pedal after the second image, a small C-Arm icon should be displayed in green on the ACUSON SC2000 PRIME system verifying a successful registration     Single Registration Single Registration A single-plane registration occurs any time a fluoro sequence is activated.  After Biplane registration, the single plane registration: Ensures the TEE transducer is in the field of view. Constantly updates the *TrueFusion guidance workflow eSie Sync™ automatic registration and co-registration is used during this process as well Ensures the TEE transducer has not made large movements from original registration syngo Application Software The syngo Application Software enables the icons and Landmark Overlays to be viewed on the live fluoro image.   A few of these are: A blue wireframe icon indicates the volume alignment with the Z6Ms transducer      Imaging projection of the Z6Ms transducer      The C-arm icon indicates the fluoro alignment The C-arm icon position is synced automatically and updated when fluoro is activated or C-arm can be moved manually to match orientation These icons help identify orientation, projection and anatomy from each device.   The user can then align both the fluoro C-arm position and the TEE to the same projection. This can enhance communication during the procedure. System Icons System Icons Identified ACUSON SC2000 PRIME Ultrasound System 5.1 Software Release                                                                                                                                                                                                                                   The ACUSON volume orientation “   ” icon is replaced by a cube marked A,P, H, F, L, R (A-P-Anterior-Posterior, H-F-Head-Feet, L-R-Left-Right) to give more detailed orientation of the volume. ​ During TrueFusion Guidance this icon also displays the C-arm angulation parameters (Left anterior oblique - LAO, and Cranio (CRAN) :   Volume position marker before 5.1 software release              Volume position marker with 5.1 software release                                                                                                                                   syngo Application Software A blue wireframe icon indicates the volume alignment with the Z6Ms transducer                             The C-arm icon on the fluoroscopy image indicates the C-arm alignment                              ​Click Align with C-arm Orientation for a single, one-time synchronization on the Image Menu To continuously synchronize the ultrasound system with the C-arm, select the On setting for C-arm Follow.  Select Off to discontinue synchronization                        The following tasks are performed on the ACUSON SC2000 PRIME system: Rembering that all  Dots and Circles are placed on the multiplanar renderings (MPRs), and not the volume image. All Landmarks are not required to be transferred. Because of this, Dots and Circles that are viewed on the ACUSON SC2000 PRIME image may or may not have been communicated to the live fluoro image..  Explore the link below to learn more.   Dots and Circles Dots and Circle Landmarks Instructions:Flash File:HTML5 File:/content/generator/Course_90022751/LandmarksSend_C/index.htmlPDF File: All of the Landmarks placed on the MPRs, can be hidden, deleted or displayed.  The Hide, Show or Delete action will be performed on the ACUSON SC2000 PRIME system and communicated to the fluoro image. The volume can be aligned to a specific MPR image Anatomy not routinely identified with fluoro can be isolated and displayed   If new registration occurs and landmarks are displaced from original location, choose MPR with landmarks to be display and press Show on selected MPR. The ACUSON SC2000 PRIME has advanced tools that can be used as static landmarks.  One of these tools, the eSie Valves™ advanced analysis package provides robust and accurate valve modeling that can be utilized from a TEE volume rendered image.  This tool can display location of anatomy and structures of the valve as well as provide many useful measurements needed for many procedures.   After following the steps to utilize the eSie Valves package, the static modeled valve may be sent to the fluoro display.   This fluoro image can show the full valve model or be minimized in its display, depending on user needs.   The eSie Valves package can be performed on the volume data set after successful registration. Registration information is then captured and saved with the volume data set Note: Registration is valid for 1 hour after initial acquisition.  If time has expired the Send control will be dithered.  There is a timer control that can be used to keep track of time. Explore the link below to see a **mitral valve model using eSie Valves package transferred to the fluoro image.  The example below demonstrates the full model display and minimalized.   Example of eSie Valve package Example of eSie Valve package on Fluoroscopy Image Instructions:Flash File:HTML5 File:/content/generator/Course_90022751/eSieValve_Fluoro.mp4PDF File: Explore the links below for the Glossary, References, and further reading opportunities. Glossary Glossary SHD - Structural Heat Disease MPR – Multiplanar Renderings TEE – Transesophageal Echocardiogram AP Cube – Anterior, Posterior , Head, Feet, Right, Left volume orientation Cube – Cube icon used for orientation of the  volume image Ta - Tantalum LAN – Local Area Network Wi-Fi -  technology for radio wireless local area networking of devices based 4D volume– Real-time 4 dimensional volume data set The X, Y & Z axis rotation refer to the different rotations of the planes of a volume Data Set X – X axis, reference to the ability to rotate around the X plane.  This motion can be represented as a wheel rolling forward or backwards. Y – Y axis, reference to the ability to rotate around the Y plane.  This motion can be represented as a spin (pirouette) of an ice skater or ballerina. Z – Z- axis reference to the ability to rotate around the Z plane.  This motion is much like the movement around the face of a clock or a Ferris wheel. C-arm - C-shaped arm used to connect the X-ray source and X-ray detector to one another TSC - touchscreen control References References Sinclair, Kevin, Bamira, Daniel, Girard, ErinSzucs, Michael, Silker, Ryan,….(2016) Elmariah, Sammy, Feasibility of a Novel Echo/X-ray Fusion Software to Determine Implant Angulation during Transcatheter Aortic Valve Replacement. Journal of the ACC, Vol. 68, No 18, B205.   Sun, Shanhui, Miao, Shun, Heimann, Tobias, Chen, Terrence, Kaiser, Markus,…… John, Matthias (2016), Towards Automated Ultrasound Transesophageal Echocardiography and X-ray Fluoroscopy Fusion Using an Image Based Co-registration Method, ©Springer International Publishing AG 2016, Part I, LNCS 9900, pp 395-403, DOI 10.1007/978-3-319-46720-7.46. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages.   All names and data of patients, parameters and configuration dependent designations are fictional and examples only.   All rights, including rights created by patent grant or registration of a utility model or design, are reserved.   Please note that the learning material is for training purposes only!   For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training.   The Operator Manual shall be used as your main reference, in particular, for relevant safety information like warnings and cautions. Note: Some functions shown in this material are optional and might not be part of your system. The information in this material contains general technical descriptions of specifications and options as well as standard and optional features that do not always have to be present in individual cases.   Certain products, product related claims or functionalities described in the material (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information.   eSie Measure Analysis Package, is a trademark of Siemens Medical Solutions, USA, Inc.   eSie Access measurement interface is a trademark of Siemens Medical Solutions, USA, Inc.   eSie Sync™ automatic registration and co-registration is a trademark of Siemens Medical Solutions, USA, Inc.   eSie Valves™ advanced analysis package is a trademark of Siemens Medical Solutions USA, Inc.eS   ACUSON SC2000™ PRIME ultrasound system is a trademark of Siemens Medical Solutions, USA, Inc.   syngo® Application Software is a trademark of Siemens Healthcare GmbH.   Copyright © Siemens Healthcare GmbH, 2019  com   *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.   The IP Address of the ACUSON SC2000 PRIME needs to be configured onto the syngo Application Software for communication purposes with the Artis fluoro system. Multiple ACUSON SC2000 PRIME systems can be configured into the syngo Application Software for quick connection access.  If this task has been completed, choose the ACUSON SC2000 PRIME system to be used for the procedure and continue to the Connect icon. If this task has not been completed or a new system is to be added click on the other Learn More icons. To find the IP address on the ACUSON SC2000 PRIME system follow these steps: Press System Configuration from keyboard Advanced Applications Tab Connection Service IP Address is on the Network Configuration page The Port Number is fixed.   US IP Address Finding the ACUSON SC2000 PRIME IP Address Instructions:Flash File:HTML5 File:/content/generator/Course_90022751/Finding_IP_2.mp4PDF File: ID IP Address Identify Right IP Address  If one or more ACUSON SC2000 PRIME ultrasound systems have already been entered into the syngo Application Software, choose the correct system to connect.  Each system entered is assigned an identification (ID) number.  The IP address can be viewed by moving the arrow over system ID number. The internet connection needs no new cabling.  Both LAN and WiFi connections are supported, but a LAN connection is suggested for stability. Video connections are basically the same, but HDMI/DVI converters may be required depending on the monitor system needs. If your system uses a large display, before starting syngo *TrueFusion, check that the current Large Display layout includes the ultrasound segment. On Artis systems, you can change the layout by selecting the icon on the Touchscreen control (TSC) and select the layout. The use of the syngo® Application Software enables the *TrueFusion workflow to be activated from the control room. Click on the links below to learn how to establish connection between the Artis fluoro and ACUSON SC2000 PRIME system.   *TrueFusion represents a workflow consisting of syngo® TrueFusion and TrueFusion™ echo-fluoro guidance.   Connect Connecting ACUSON SC2000 PRIME  The IP Address of the ACUSON SC2000 PRIME needs to be configured onto the syngo Application Software for communication purposes with the Artis fluoro system. Multiple ACUSON SC2000 PRIME systems can be configured into the syngo Application Software for quick connection access.  If this task has been completed, choose the ACUSON SC2000 PRIME system to be used for the procedure and continue to the Connect icon. More detailed information is available on the following slides.  Close this link and click arrow below to review the next slides for more comprehensive information.