HEARTWARE, INC - UCalgary



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User’s Manual

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Users Manual

heartware, inc

HeartView User’s Manual

( HeartWare, Inc

© Copyright 1999 by HeartWare, Inc. All Rights Reserved.

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Printed and bound in the United States of America.

The information in this document is furnished for informational use only, is subject to change without notice, and does not represent a commitment on the part of HeartWare Incorporated. HeartWare, Inc. assumes no liability or responsibility for any errors or inaccuracies that may appear in either this document or the software. The software described in this document is furnished under a license agreement, and may be used or copied only in accordance with the terms of the agreement.

HeartWare is a trademark of HeartWare, Inc. HeartView is a registered trademark of HeartWare, Inc.

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Table of Content

Introduction 3

Introduction 3

Contents of Distribution Kit 3

System Requirements 4

Hardware requirements 4

Software requirements 4

Installation 5

Installing HeartView 5

Starting HeartView 5

HeartView Password 5

Using HeartView 6

Using Windows and the Mouse 6

HeartView Help 6

Sample Patient 8

Loading an Existing Record 8

Adding Lesions to the Coronary Tree 8

Modifying a Branch Vessel on the Tree 9

Indicating TIMI Flow 9

Using the Interventional Page 10

Using the Grafts Page 10

Leaving the Coronary Tree 11

Saving the Tree 11

Quitting the Program 11

Setting up the Database 11

Overview 11

Adding a New M.D. 12

Getting Started 12

Quick Start Tutorial 13

Tutorial 13

Starting a New Tree 13

Modifying the Coronary Anatomy 15

Entering Diagnostic Procedure Results 15

Adding Lesions to the Tree 15

Adding Collaterals 16

Entering Lesion Morphology 17

Adding Bypass Grafts 18

Entering Interventional Procedure Results 18

HeartView Menus 20

Overview 20

Tree Load 20

Creating a New Exam 20

Adding A New Patient 21

Starting a New Coronary Tree Diagram 21

Page Menu 22

Diagnostic 23

Intervention 23

HeartView Tools 23

Customizing the Tree 23

Undo Function 23

Native Coronary Anatomy Tools 24

Change Vessel Size 25

Remove Vessels 26

Restore Removed Vessels 26

Add Optional Branch 26

Remove Optional Branch 26

Add Lesions 26

Add Stent 27

Lesion Type 27

Remove Lesion 27

Modify Lesion Size 28

Add Collaterals 28

Remove Collaterals 28

Modify TIMI Flow 28

Lesion Morphology 29

Graft Tools 29

Adding Grafts 30

Removing Grafts 31

Modify TIMI Flow 31

Add Lesions 31

Interventional Page Tools 32

Post Intervention Lesion Severity 32

Modify TIMI Flow 33

Add Lesions 33

Post Intervention Lesion Morphology 33

Additional Tools 34

Add Comment 34

Undo Command 34

Printing the Tree Diagram 34

Saving the Tree Diagram 35

File Menu 35

Database Menu 35

Adding New M.D.'s 35

Modifying Data 35

Modify MD 35

Modify Exam 35

Modify Patient 36

Modify Tree 36

Deleting an Exam & Tree 36

HeartView Definitions 37

Coronary Artery Nomenclature 37

Dominance 37

Coronary Artery Segments 37

Right Coronary System (RCA) 37

Left Main Coronary System 38

Left Anterior Descending Artery (LAD) 38

Left Circumflex Artery (LCX) System 39

Anomalous Coronary Arteries 39

Coronary Artery Sizing 40

Coronary Artery Bypass Grafts 40

Grafts 40

Left Aortic Graft Origins 41

Right Aortic Graft Origins 41

Left Internal Mammary Artery (LIMA) 41

Right Internal Mammary artery (RIMA) 41

Coronary Artery Vessel Descriptors 41

Lesion Type 41

Distal Flow TIMI Criteria 41

Lesion Morphology Descriptors 42

Lesion Length 42

Contour 42

Lesion Eccentricity 42

Branch involvement 43

Lesion Angulation 43

Lesion Calcification 43

Total occlusion 43

Proximal Tortuosity 43

Ostial in Location 44

Thrombus 44

Post PTCA Morphology Descriptors 44

Distal Embolization 44

Dissection 44

Thrombus 44

Coronary Origin & Dominance 45

Chapter

1

Introduction

Introduction

HeartView is a computer program for reporting the anatomic results of a coronary angiography procedure. An easy-to-use graphical interface allows the operator to quickly generate a patient specific representation of the coronary arteries. Locations of coronary artery stenoses are indicated along with the results of the visual interpretation of the severity of each stenosis. The extent of each lesion and the qualitative morphologic characteristics can be entered as well. From the morphologic characteristics, an AHA/ACC morphology class can be automatically calculated for identification of complex lesion morphology relevant to coronary interventional procedures.

In addition to the diagnostic page where the entire coronary anatomy can be entered, a post-interventional page is available for focusing on the results of an interventional procedure for each relevant lesion. Additional pages are available for the graphical depiction of coronary artery bypass grafts for both diagnostic and interventional procedures.

After the completion of the graphical representation of the coronary anatomy or "tree", a hard copy can be printed out for inclusion in a patient record, along with a brief text report summarizing the visual interpretation. The final version of the "tree" is stored in a searchable database for future access, including retrieval, printout and modification.

HeartView simplifies the reporting procedure, allowing the user to quickly and intuitively generate a report on the catheterization procedure at their personal computer. Storage of the report on the local computer provides desktop access to the records for multiple patients, limited only by the amount of disk storage space available.

Contents of Distribution Kit

• HeartView is distributed on 3 1/2" 1.44MB disk or CD-ROM and contains:

• Installation program - setup.exe.

• HeartView executable files.

• Readme file.

• Database files.

• Coronary Tree Template files.

• Configuration file.

System Requirements

Hardware requirements

To use HeartView, you will need the following hardware:

• A personal computer using the Intel Pentium processor.

• A hard disk drive with a minimum of 10 MB of free space.

• A 3 1/2-inch (1.44MB) floppy disk drive or CD-ROM drive.

• A color SVGA video graphics adapter and monitor running in the 1024 x 768 graphics mode.

• A minimum of 32 MB of RAM.

• A Microsoft Mouse.

• A Microsoft© Windows compatible laser printer and printer driver with a minimum of 2 megabytes of memory.

Software requirements

To use HeartView, you will need to have the following software installed

• Microsoft Windows NT 4.0 or Windows 95/98.

• Microsoft ODBC Driver for Access version.

Chapter

2

Installation

Installing HeartView

To install the HeartView software:

• Microsoft Windows NT or 95/98 must be installed prior to installing HeartView.

• Insert either the CD-ROM or 3 1/2-inch disk in to drive.

• Start the installation program (a:setup.exe) from the Start->run… button.

Starting HeartView

To start HeartView select the Start->Programs->HeartWare->HeartView item from the start button.

HeartView Password

To prevent unauthorized access to HeartView patient and procedure data, HeartView requires that every user enter the site password that is provided with your copy of HeartView. Following the startup of the HeartView application, the user will see the Password Dialog Box. Type the site password and click on OK or press Enter to start the program, click on Quit to exit the program.

[pic]

Login Screen

Chapter

3

Using HeartView

Using Windows and the Mouse

HeartView uses a graphical user interface to quickly and easily create a coronary tree diagram depicting a patient's coronary anatomy as determined from angiography. HeartView presents the user with a series of pulldown menus and dialog boxes to allow the user to navigate through the program. After starting HeartView, along the top left of the HeartView window, you will see a menu containing several options (File,View,Page,Database,Help) - this is the "Main Menu Bar." Menu items are selected from the Main Menu Bar by moving the mouse pointer to the desired menu heading, then pressing and holding down on the left mouse button. A menu item is selected by moving the cursor to the desired option and releasing the mouse button.

HeartView also presents and request information through the use of dialog boxes - windows that combine text, push buttons, and entry fields to perform specific tasks. The task of a dialog box may be to make a statement and request an acknowledgment to it or to request a response to a yes or no question. Alternatively, a dialog box may prompt for information such as first name, last name, and date of birth. Buttons are selected by pressing and releasing ("clicking") on the desired button in the dialog box. Some buttons can also be selected by pressing the "Return" key. These buttons, known as default buttons, are highlighted with a wide border. Entry fields can be selected by clicking in the desired field. The cursor can be moved within an entry field by using the left and right arrow keys on the keyboard. Some dialog boxes which contain several fields of information, allow you to move from field to field using the "Tab" key. By pressing the "Shift" key along with the "Tab" key you may move in the opposite direction.

HeartView Help

Most of the actions in HeartView are performed by clicking on icons in any one of a number of boxes. The selection of the icon is done by clicking the left mouse button as described above. To get a brief description of the function of an icon, pass the cursor over the icon and a banner will appear describing its actions. Detailed help can be found by selecting the Help Topics from the Help menu.

[pic]

HeartView Help

[pic]

HeartView Window

Sample Patient

Loading an Existing Record

An example patient with a tree record is included with the HeartView program. To load, select the "Tree Load" option from the "File" Menu or the "Open File" icon. Enter the Exam ID "99999" and click on "OK" or press the "Enter" key. Since a record exists for this patient, the previously entered Tree is loaded and displayed and should look like sample shown with a patient name of "Test Patient" and a Patient ID Z99999. This record contains a single lesion - a total occlusion in the distal right coronary

Adding Lesions to the Coronary Tree

Additional coronary artery stenoses can be added to the existing record. A detailed explanation of the menu options is provided in Chapter 5. For now, add a tubular lesion by clicking on the Add Lesion icon which is the upper left-most icon in the Tool Box. Selection of the icon will result in the icon being highlighted. Select both a lesion severity button from the Lesion Severity Box and a shape from the Lesion Type Box, e.g. the first icon on the Lesion Type Box represents a discrete lesion. For example, to add a 95% tubular lesion, choose the value 95 from the Lesion Severity Box and the tubular lesion type from the Lesion Type Box. Using the mouse, position the cursor in a vessel to locate one end of the desired stenosis and click, using the left mouse button.

Move the cursor down the vessel segment and click again to designate the end of the stenosis. If this is not what you had in mind, move the cursor to the Undo icon in the lower left part of the screen and the stenosis will be removed. At any time successive selection of the Undo icon will reverse the action one step backward at a time.

Modifying a Branch Vessel on the Tree

The size of a vessel can be classified as "small", "normal", or "large" to reflect its visual assessment. All vessels are initially classified as normal but can be changed with the use of the Change Vessel Size icon. The example patient has a combination of all three vessel sizes. A normal vessel can be changed in either direction by first clicking on the change icon: the up arrow to indicate increased size and the down arrow to indicate reduced size. Once the icon is selected, select the vessel segment that is to be changed. At any time, the labels of every vessel segment can be displayed by selecting the Label icon in the lower left-hand corner of the Main Menu screen. A small or large vessel can be changed to normal using the Normal Vessel Size icon that is designated by a two-headed arrow.

Indicating TIMI Flow

The qualitative assessment of antegrade coronary perfusion can be indicated on the Tree diagram using one of the TIMI Flow icons. By clicking on one of the icons and pointing to a vessel segment, the tree is modified to indicate the TIMI flow beyond that point. The TIMI 3 icon - the upper left icon of the four - can be used to increase the perfusion flow characterization to TIMI 3 flow.

Using the Interventional Page

A separate page is available for generating a Tree diagram that focuses on an interventional catheterization procedure. The interventional page is selected by using the mouse to pull down options from the Page Menu at the top of the Main Menu. Releasing the mouse button with the cursor on the Native Coronary Anatomy option results in the display of a new Tree diagram which carries forward the previous diagnostic results (if they have been entered) and provides a template to designate the interventional results. In addition to a subset of the icons present on the Diagnostic Page, there is also available a Post Intervention Tool Box which provides the ability for indicating a change in lesion severity due to an interventional procedure. This is done by first clicking on the Post Intervention Lesion Severity icon, then selecting a "New" lesion severity, and, last, clicking on an existing stenosis. Notice that the post-intervention severity is displayed beside the pre-intervention severity. Many of the options available in the Diagnostic Page are available on this page as well to provide a means for indicating changes in flow characteristics, additional lesions, etc.

[pic] [pic]

Using the Grafts Page

Additional tree pages are also available for indicating the location and types of coronary artery bypass grafts visualized during the catheterization procedure. This option is selected from the Page Menu that offers both a Diagnostic and an Interventional Grafts Page. Selection of the Diagnostic Grafts results in the display of the diagnostic Tree page in a "ghosted" format. The origin and destination of bypass grafts can be added by first selecting the type of graft using one of the tree Graft icons, and clicking first on the insertion point in the vessel, then moving the cursor to the graft origin and clicking again. The types of grafts available are Single, Jump, and Y-Graft. Any type of graft can be removed by first clicking on the Remove Graft icon and then on the desired graft.

[pic]

Leaving the Coronary Tree

Printing the Results of a Tree Session

Once the desired changes have been made to the Coronary Tree Diagram, the diagram can be saved and/or printed. Optional comments can be entered by first clicking on the Comment icon in the lower left-hand corner of the Main Menu and typing in the desired comment in the Dialog Box which will appear. After clicking on OK or pressing the Return key, a brief text summary can be displayed on the Tree page selecting the Report item from the View menu. The vessel names can be toggled on or off using the View Label menu item. The Tree can be printed by selecting the File->Print menu item or selecting the Print icon.

Saving the Tree

At the end of a session, the results must be saved in order to be accessible in the future and so that previous data can be retrieved for update. Select the Save Tree option from the Tree menu to save all the work that has been done during the above session. This action will change the example Tree; if you do not wish to do so, select Abandon instead and the original data will not be changed.

[pic]

Icons (from left to right) Close, Open, Save, Print, Help, Context Help

Quitting the Program

If no more procedures are to be added during a session, you can exit the program by selecting the File->Exit menu item.

Setting up the Database

Overview

The HeartView Database is capable of indefinitely storing all the coronary tree diagrams entered into it, as long as there is free disk space. The basic unit record in HeartView is a procedure, identified by an Exam ID - a unique number up to 10 digits long that corresponds to a catheterization procedure. Each patient is identified with a Patient ID (medical record number) for which there may be multiple Exam IDs, corresponding to each catheterization procedure. The date of the procedure and the attending clinicians' names are stored along with the Exam ID information. Patient demographic information is stored separately and needs only to be entered once. When a Patient ID is entered, HeartView either retrieves an existing patient's record or asks for new information. In a similar manner, physician demographics are stored separately and need be entered only once. Physician information is referenced by a unique code assigned to each clinician. Before beginning to enter patients and procedure records into HeartView, it is only necessary to set up a table of physicians from which to choose.

Adding a New M.D.

Code numbers and information about clinicians can be entered by selecting the Add M.D. function from the Database menu of the Main Menu Bar. A dialog box is displayed requesting that you enter a physician Code number, First Name, and a Last Name. A unique code must be assigned to each physician. The codes can contain up to ten alphanumeric characters. It is recommended that you use either a number (i.e. starting with 100,101,102...) or the physician's initials (i.e. TST) for the code.

[pic]

Physician Information Dialog

Getting Started

You are now ready to start entering new patients and procedures into HeartView. A QuickStart session is provided in the following chapter to enable a new user to become familiar with the functions most frequently used in a routine application. A detailed explanation of the functions of every menu is provided as well in Chapter 5. For entering a new patient into the HeartView database, the steps involved are:

• Enter New Procedure - The cine number, attending physician, and base coronary anatomy are entered into the database.

• Enter New Patient - If the procedure record belongs to a patient not already in the database, the Patient ID, name, date of birth need to be entered first.

• Generate Coronary Tree(s) - The HeartView Tools and Menus are used to modify the base anatomy in one or more pages to represent the results of the coronary procedure(s).

• Save Record - At the conclusion of the Tree session, a hardcopy may be printed and a complete record is saved in the database for future reference.

• Exit - If no further procedures need to be entered, the user can exit the program and return to the operating system.

Chapter

4

Quick Start Tutorial

Tutorial

Welcome to the QuickStart Tutorial! In the next several pages, you will have the opportunity to try out most of the items contained in the HeartView icon driven tool box for the two principal operating modes - diagnostic and interventional procedures - along with the corresponding native coronary and bypass graft pages.

Starting a New Tree

The starting point for generating a new coronary tree diagram is choosing the template format for the patient's coronary anatomy. This is done whenever you enter a new procedure, whether or not a previous procedure already exists for a patient. For the purposes of this tutorial, we will add a "new" procedure to the record for the patient "Test Patient", whose Patient ID is "Z99999". Select the File->Tree Load menu item from the main menu. Without releasing the mouse button, move the cursor down to the Tree Load option and release the mouse button. A box will pop up, asking you to enter an Exam ID - try entering "99998" and click on OK to dismiss the box. A second box should appear, checking with you to see whether you would like to create a new procedure - click on Yes or press Enter.

The dialog box is used to enter the procedure information before you go on to generate a Tree. In the field labeled Patient ID, enter "Z99999", then use the Tab key or the mouse to move into the M.D. #1 field and either enter "TST" or use the mouse to select the arrow beside the box, displaying the available M.D. codes. Click on one, M.D. #1 for example, and release. Click on OK to dismiss the box. (Only one M.D. field is required - a second can be entered if desired).

[pic]

Exam Information Dialog

After the new procedure is entered in the database, the template for the patient-specific anatomy can be entered. This is done using the Tree Information dialog box.

[pic]

Tree Information Dialog

A number of options are available for the individual procedure: which arteries were injected (invaluable for interventional procedures in which typically the right coronary artery (RCA) or left coronary system only are visualized); coronary artery dominance; the presence of coronary artery anomalies; the location of the sino-atrial (SA) and atrio-ventricular (AV) nodes.

Illustrations of the printed output for each coronary artery dominance are shown in Appendix A to help guide you and to demonstrate what form the printed output will take. The coronary artery segments are also labeled and follow the Coronary Artery Surgery Study (CASS) nomenclature. Also included in the Appendix is a representative output for each of the additional templates of available coronary anomalies including a single coronary artery, separate ostia for the left circumflex and left anterior descending artery (LAD) and the left circumflex artery (LCX) arising from the right coronary artery (or cusp). For the purposes of this example, we will assume that all the vessels are injected; this is done by clicking in each of the choices, i.e. RCA, Main, LAD and LCX. Move on through the remaining boxes using the mouse or the Tab key and choose Right for dominance, Normal anatomy (i.e., no anomalous origin), select Right for the locations of the SA and AV nodal arteries. Once you have entered this data in the dialog box, accept the choices by either pressing the Enter key or clicking on Ok. An outline of the coronary artery tree should appear.

Modifying the Coronary Anatomy

With the HeartView tools, you can now further individualize the anatomy to match the catheterization results. For example, let us say that, during the procedure, it was noted that the patient had only one diagonal and two marginals. The first diagonal is a large bifurcating vessel, while the first marginal is small and the second is large. (If you are having difficulty distinguishing the coronary artery segments, select the view->labels item from the main menu. Labels for each coronary artery segment will appear). To delete the third diagonal, first find the Remove Vessel icon and depress it. Move the cursor to D3 and select it. The screen will be redrawn and the diagonal will disappear. Repeat this sequence for the second diagonal. Now, select the Optional Branch icon and then click on the first diagonal. A branch should now appear attached to this segment. Now, you need to make the changes to the marginals. Go ahead and delete the third marginal (OM3). Now, to indicate the first marginal as small, select the icon that appears as a downward arrow (Small Vessel Size) and then click on the first marginal. The baseline anatomy for this patient has now been defined.

Entering Diagnostic Procedure Results

Adding Lesions to the Tree

After the baseline anatomy has been drawn, you can address the coronary lesions which were visualized during the procedure. Let's say that this patient has a 90% discrete lesion in the proximal LAD, a 70% tubular lesion in the first diagonal before the bifurcation, a 70% diffuse lesion in the mid LCX between the first and second marginals. The RCA has an 80% discrete lesion in its mid portion with TIMI 2 flow distal to the lesion. The PDA and the three posterolaterals have collaterals from the septals and distal LAD. Find the Add Lesion icon and click on it.

Two additional toolboxes will appear along the bottom, the one on the right allowing you to designate the stenosis severity in terms of percent diameter reduction and the one on the left to indicate the lesion type (from left to right - discrete, tubular, diffuse, discrete aneurysm and diffuse ectasia).

Move the cursor to the box labeled 90 and depress the left mouse button and move to the left toolbox and choose the leftmost icon (discrete lesion type). Now move the cursor to the proximal LAD and click with the left mouse button. You have now placed the proximal LAD lesion. Move back to the lesion severity box and choose the box labeled 70. Select the icon for a tubular lesion (second from left) and move the cursor to the first diagonal, before the bifurcation of the branch from the diagonal, and click. The cursor changes to a cross, allowing you to designate the length of the lesion. Extend the lesion to beyond the bifurcation and click. As you review the diagram, assume that you realize the lesion is actually longer than you indicated. At the bottom of the screen is the Undo icon. Find it and depress the icon. This icon allows you to undo any previous action in reverse order.

The lesion will disappear and the screen will be redrawn. Repeat the actions to insert a lesion by selecting the Add Lesion icon followed by the lesion severity and tubular lesion type. Again, place the lesion but make it longer.

Let's re-select the lesion type and choose the third icon from the left (diffuse). If necessary, also re-select a severity of 70. Place the lesion in the body of the left circumflex between the first and second marginals. Let's now turn our attention to the right coronary artery. Select 80 for lesion severity, choose the discrete lesion type and place the lesion in the mid-RCA. We can now indicate that flow distal to the lesion is TIMI 2. Let's go back up to the main toolbox and choose the TIMI 2 Icon.

Below the lesion in the RCA, depress the left mouse button. The contour of the artery distal to the lesion will change and the tree will be redrawn.

Adding Collaterals

The only remaining task now is to indicate the presence of collaterals - this is done with the Add Collaterals icon. Collaterals are indicated on the tree in a from - to fashion. The collaterals originate from the septals and end in the PDA. Move the cursor to the tip of the septal and depress the left mouse button. Now move the cursor to the tip of the PDA and again depress the left mouse button. A collateral vessel will appear with a herringbone pattern indicating the direction of blood flow. Repeat this sequence for designating collaterals from the other septal and the distal LAD and ending in the PDA.

[pic]

Tree Diagram With Modified TIMI Flow

Entering Lesion Morphology

The information for describing the results of the diagnostic catheterization has now been entered. Additional features include the ability to enter the descriptors that comprise the American Heart Association/American College of Cardiology lesion classification system. This feature is accessed by depressing the Lesion Morphology icon and selecting a lesion which has already been placed into the Tree diagram.

A dialog box appears with a series of questions. You must answer each question for the AHA/ACC classification to be calculated.

[pic]

Morphology Dialog

Adding Bypass Grafts

We will briefly examine some of the features of HeartView for dealing with bypass grafts. In an effort to make the software as intuitive as possible, we have included a page for describing the anastomoses and lesions which may appear in bypass grafts. Let's go back to the top of the Main Menu bar and choose the Page option with the left mouse button. Move down the displayed menu and choose grafts. The toolbox will change to reflect the utilities available for bypass grafts. Once can see that there are several types of bypass grafts available indicated by a combination of letters and graphics. Choose the jump graft icon. Place the cursor on the final anastomosis (the mid LAD) and depress the left mouse button, move the cursor to the intervening anastomosis (the large first diagonal) and depress the left mouse button again. Then move the cursor to the top of the box and select the graft origin which is oriented vertically (left internal mammary proximal anastomosis). The graft outline will appear, linking the LIMA to the first diagonal and then terminating in the mid LAD. Facilities exist for altering the TIMI flow and adding lesions into the grafts. Other graft types also exist including single proximal and distal anastomoses (either saphenous vein grafts or internal mammaries) and Y-grafts).

Entering Interventional Procedure Results

Let's turn our attention now to interventional procedures. Again, return to the Page menu and choose Native under the interventional section. The toolbox once again changes to reflect the facilities that are available for the individual page. To enter the results of an interventional procedure, choose the Post Intervention Lesion Severity icon. Once again, similar to the procedure described above for entering a lesion, the toolboxes appear along the bottom of the main window.

Select the post procedure stenosis severity with the number 10 in it and move the mouse cursor to the mid-RCA lesion and click on it. The stenosis severity will change and the post procedure results will be indicated alongside the lesion. We will say that, since the lesion has been dilated, TIMI 3 flow has been restored. Select the TIMI 3 icon and move to a point just proximal to the lesion in the mid RCA and depress the left mouse button. You may either save the tree without printing or save the tree and print as many copies as necessary. You have now successfully completed the QuickStart Tutorial. For more detailed information on any of the features discussed in the tutorial, please refer to the detailed descriptions of the HeartView Menus in Chapter 5. Definitions for coronary artery segments, stenosis severity, lesion type, etc are also available in the following chapters.

Chapter

5

HeartView Menus

Overview

HeartView can store coronary tree diagrams indefinitely - the only limit is the amount of disk space available for storage. Because individual patients may undergo more than one procedure on a given day, HeartView tracks the Tree diagrams via their Exam IDs. Exam IDs are grouped by Patient ID, which is the number used to identify a given patient to the system. When a new Patient ID is entered, HeartView prompts the user for demographic information. HeartView provides the recorded information for an existing Patient ID.

Tree Load

In order to enter a new Coronary Tree record or to load an existing Coronary Tree record, select the Tree Load option from the File menu. Enter the Exam ID for the record and click on "OK" or press "Enter" on the keyboard. "OK" is a default button in this dialog box. If a record already exists for that Exam ID, then the stored Tree diagram will be loaded and displayed.

If no previous record exists for that Exam ID, then you will be given the option of creating a new one. If you press "Cancel" then no new record will be started. By pressing "OK" a window will be displayed asking for new catheterization procedure information.

Creating a New Exam

The Exam Information Dialog box is used to enter information that the database requires for each catheterization procedure. A unique number up to ten digits long identifies the Exam, referred to as the Exam ID. The entry fields also include Patient ID, Exam date, and M.D. codes. The patient's name will be entered later. You must answer all these questions and click on the "OK" button when finished. You can move from question to question by either using the mouse to click in the desired box or by pressing the "Tab" key. Patient ID is the patient's medical record number and is unique for each and every patient. This field may contain up to ten alphanumeric characters (see Adding a New Patient). M.D. # 1 and M.D. # 2 are codes for the physicians performing the catheterization procedure. A distinct code must be assigned to each physician. The codes can contain up to ten alphanumeric characters. It is recommended that you use either the physician's initials (TST) although a numeric code (e.g. starting with 100) is acceptable. By pressing on the arrow button located next to these fields, a list of available physician codes will be displayed. You may select a code from this list by clicking on the desired code. If a physician's code is not present, you may add the appropriate code using the "Add M.D." option from the "Database" menu (see Adding New M.D's.). HeartView will prevent you from continuing if the code number for the M.D. is invalid. A second M.D. # is allowed if two physicians are involved in the procedure.

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Adding A New Patient

Once you have finished entering the catheterization information, a New Patient dialog box will be displayed asking for information about the patient if the Patient ID had not been previously entered. You can move from field to field clicking in the desired field with the mouse or by using the "Tab" key. Their Patient ID identifies a patient in the database. The Patient ID is the patient's medical record number and should be unique for each and every patient. The Patient ID may contain up to ten alphanumeric characters ("AB12345Z", "123567890"). If you use a patient's social security number, remove the dashes to adhere to the ten-character limit. The remaining entry fields include the patient's first and last name, date of birth (DOB) and sex. The date must be entered in the format of "MM/DD/YYYY" (12/14/1965 for December 14, 1965). Once you have finished entering this information, press "OK" to continue or "Cancel" to go back to the previous window.

Starting a New Coronary Tree Diagram

After both the catheterization and patient information have been entered into the database, a dialog box prompts for more specific information regarding the coronary anatomy.

INJECTED: The coronary arteries injected during the catheterization procedure are indicated with the use of this selection. The default mode assumes that both the right coronary artery (RCA) and the left are injected during the procedure. Individual injection of either the left main (MAIN), left circumflex (LCX), or the left anterior descending (LAD) coronary arteries can be selected instead. The results of this selection determines which vessels are displayed on the initial coronary tree diagram. Selections are made by clicking on the respective boxes to select or deselect a vessel.

CORONARY DOMINANCE: The dominance is defined based on the origin of the posterior descending coronary artery. It is right dominant if the posterior descending arises from the right coronary and there are also posterolateral branches distal to the posterior descending supplying the left ventricle. There is mixed dominance if the posterior descending arises from the right coronary with no further branches to the LV from the right coronary artery. Posterolateral branches arise from the left circumflex in this instance. It is left dominant if the posterior descending vessel and the majority of posterolaterals arise from the left circumflex coronary artery.

ANATOMY: allows one to select common coronary anomalies should they exist. Normal implies that the left main is normally located from the left coronary cusp and gives rise to both the left anterior descending and left circumflex. This is the default setting. Crx.Off Rt. implies the circumflex artery arises from the proximal right coronary. Sep. Ost. implies separate origins for the LAD and left circumflex, i.e. no discernable left main. Single Cor. implies all vessels arise from the right cusp. Other less common anomalies can be added to a comment box later if need be. The origins of the AV Nodal artery and SA Nodal artery must be coded at this time by selecting the appropriate buttons. The default setting assumes that both arise from the right coronary artery system. Once all data regarding the basic tree construction has been satisfactorily entered, click on the "OK" button.

After the patient-specific coronary tree template is complete, a graphical representation is displayed, incorporating all of the specific characteristics enter in the above menu.

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Page Menu

Once a tree record has been loaded or initialized, a diagram is displayed on the screen. At this point, the user has the option to select what type of Tree will be created from the Page Menu. There are four different page options for each coronary tree diagram: a Diagnostic Page for both Native Coronary anatomy and Bypass Graft anatomy; and Interventional Pages for either Native Coronary anatomy or Bypass Graft anatomy. Each page is used to convey different information about the coronary anatomy and provides a different set of tools necessary for its modification. Selecting the appropriate page from the Page menu on the Main Menu Bar can change the page. The page currently selected is marked with a check mark.

Diagnostic

The Diagnostic Pages are used to show all the information about the coronary anatomy visualized through contrast injection of the native coronaries or coronary artery bypass grafts. Selection of the Native option results in the display of the native coronary artery anatomy determined during the procedure creation. Selection of the Grafts option results in a "ghosted" display of the native coronary anatomy and lesions visualized. The origin and termination of either saphenous venous or internal mammary grafts are displayed. In addition, that portion of the coronary tree supplied by these grafts can then be highlighted.

Intervention

The Intervention Pages bring the diagnostic tree forward and allow modification of the baseline anatomy to reflect the results of coronary interventional procedures. Both a Native and Grafts option are available as in the Diagnostic Pages.

HeartView Tools

Customizing the Tree

The Coronary Tree Diagram may be customized in many different ways. Vessels can be removed and resized. Vessels can be made to reflect perfusion. Lesions of varying types and sizes may be added. Collaterals and grafts can be diagrammatically displayed. Modifications to the Tree diagram are carried out by selecting the appropriate functions from the Tool Box and "clicking" on the desired vessels or vessel locations where the change is desired Once a function is selected from the tool box, it remains in effect until another function is selected. This latter feature allows one to modify the tree more rapidly, for instance, by quickly modifying all small vessels, adding all lesions of a certain magnitude and morphology, etc.

An assortment of tools is available for the modification of the coronary anatomy, both in the generation of the patient-specific template and for the location of coronary lesions and bypass grafts.

Undo Function

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HeartView stores all modifications made to a Tree Diagram in a buffer and allows those modifications to be removed a single action at a time with the use of the Undo icon in the lower left-hand corner of the screen. Every time the undo icon is selected the last modification made to the tree diagram will be undone. By repeated pressing this button you can remove all the modifications in reverse sequence. For instance, if a lesion was added to the wrong location, it can be removed by pressing the undo button. If you added a lesion and then performed some other modification, Undo will modify the last change before the lesion is removed. It is advisable that you use the undo button immediately following a mistaken action rather than using some other modify/remove function. You will always be able to modify any information that is added to the tree diagram through the use of the Tools.

Native Coronary Anatomy Tools

The native anatomic coronary tree can be readily modified with HeartView to conform to the patient's actual angiography. The startup configuration includes all the major branches in the tree and designates them all as "normal" size and an absence of optional branches. Since the anatomy for all patients is different from this basic anatomy, modification of the startup template is required in order to have the tree record accurately represent the actual patient anatomy. To make these changes, the Native Coronary Toolbox is used. It should be noted that the total number of changes that can be made to the startup template is limited in order to save space in the database. Each use of an Add or Delete tool is counted as a modification while, in contrast, use of the Undo tool does not and actually reduces the number of modifications for each use. If a mistake is made, it is better to use the Undo tool rather than to repeatedly use add/delete tools. A warning will apear when there are only 5 more modifications possible. In general, this has not been a problem for the majority of trees that may be generated in a clinical setting.

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Native Coronary Tool Box

Change Vessel Size

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The size of most vessels in the tree can be designated as Small, Normal, or Large (normal is the default). This is done by selecting either the up arrow to increase the size from that display or the down arrow to decrease a vessel's size. The two-headed arrow is used to return the vessel to an indication of normal size, regardless of its present designation. The size of the vessel is independent of flow and is meant to represent the native anatomic size and distribution. The effect of flow is selected using the perfusion tool below. In general, vessels should be considered normal if they are of sufficient size to warrant an intervention (CABG, PTCA). Large size is used to indicate a greater than normal myocardial distribution; small size indicates a less than normal myocardial distribution. After selecting the appropriate function from the tool box, click on the desired vessels to change. Changing all vessels of similar size at the same time facilitates rapid construction of the native tree diagram.

Remove Vessels

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Typically, not all the vessels in the startup tree template are actually present in a specific patient. These vessels may beo removed from the patient's tree diagram by selecting the Remove Vessel icon from the tool box and clicking on the desired vessel. All but a few of the vessels can be removed; some are assumed to be always present.

Restore Removed Vessels

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When the Restore Vessel icon is selected from the tool box, all vessels which have been removed are redisplayed in green. If you wish to restore the vessel back to the diagram, clicking on the appropriate vessel will cause it to be restored to its previously visualized status.

Add Optional Branch

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Certain vessels have large branches which are important and those can be added by selecting the Add Optional Branch icon from the tool box and clicking on the appropriate vessel. This feature may be used to indicate that the optional branch is of sufficient size such that, if a lesion is present in the vessel, the vessel is large enough to be considered for intervention. Only certain vessels have this feature (see Chapter 6).

Remove Optional Branch

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Optional branches may be removed by first selecting theRemove Optional Branch icon and then clicking on the vessel which contains the optional branch. The size of the vessel will remain unchanged.

Add Lesions

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Lesions of varying severity and type may be added anywhere in the coronary tree diagram by first selecting the Add Lesion icon, then the Lesion Type icon and then selecting a lesion severity (if required). All lesions with that set of characteristics can then be quickly added to the diagram by clicking on the desired locations in the coronary tree where the lesions are to be placed. The available lesions severity designations range from 10% to 100% in intervals of 10%; these values are intended to indicate visually assessed percent diameter stenosis. The use of these predefined cutoffs facilitates data queries later. A lesion severity less than 50% implies minimal stenosis, while a severity greater than 60% is meant to imply visually "significant" lesion. The available lesion morphologic choices include discrete, tubular, diffuse, aneurysmal, or ectasia. Some lesions, like discrete, or aneurysmal are focal and require only a single location to be specified for them to be added. Lesions which are spread out, such as tubular, diffuse, and ectasia require both a beginning and an ending location to be specified. Note that both the severity and the morphology are displayed on the coronary tree diagram to graphically indicate what was visualized angiographically.

Add Stent

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A Stent may be added anywhere in the coronary tree diagram by first selecting the Add Stent icon. Stents can then be quickly added to the diagram by clicking on the desired locations in the coronary tree where the stents are to be placed.

Lesion Type

The Lesion Type icon bar at the bottom of the screen is used to select the morphology for a lesion to be added to the tree diagram. The Lesions types are: Discrete, Tubular, Diffuse, Discrete Aneurysm, Diffuse Ectasia.

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Lesion Type Box

Remove Lesion

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Any lesion can be removed by selecting the Remove Lesion icon and clicking on the lesion to be removed. You must click on the lesion itself and not on the lesion identifier (i.e. the percent stenosis). Alternatively, a lesion can be removed by using the Undo tool immediately after it was placed into the tree diagram.

Modify Lesion Size

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The size of any lesion may be changed by selecting the Modify Lesion Size icon from the tool box and then selecting the desired size for the lesion to be changed to. Once these options are selected, any lesion you click on will be changed to reflect this new size. The lesion morphology is not changed by this modification.

Add Collaterals

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Collaterals may be added by clicking first on the origin of the collateral, then on the termination point on the tree diagram. The arrows on the collateral indicate flow direction. Multiple collaterals may be added by repeatedly selecting origin and termination points.

Remove Collaterals

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Any collateral may be removed by selecting the Remove Collateral icon and then clicking on the desired collateral. The Undo tool may be used to remove collaterals as well.

Modify TIMI Flow

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The antegrade coronary perfusion at any point in the coronary tree may be modified using one of the four perfusion functions which may represent: Normal perfusion (TIMI 3); Reduced perfusion (TIMI 2); Minimal perfusion (TIMI 1); No perfusion (TIMI 0). These functions will alter the appearance of the relevant vessel for all points distal to the selection point, reflecting the changed flow characteristics beyond the designated point. You may continue to modify the vessel perfusion distal to the initial point to reflect changing perfusion. We recommend that you DO NOT change the perfusion grade proximal to a previous perfusion change; unpredictable results may occur. If you make a mistake with one of these perfusion functions, remember to use the Undo function rather than applying an additional perfusion modification.

For a detailed explanation of the various perfusion grades, please see Chapter 6.

Lesion Morphology

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HeartView provides a way to further characterize any lesion using a number of qualitative morphological characteristics. Clicking on the Lesion Morphology icon in the Diagnostic Native Coronary Tool box and then on the desired lesion results in the display of the Lesion Morphology Screen. Individual lesion morphology can be described in accordance with the AHA/ACC Task Force report on coronary angioplasty This feature allows the user to select each of the lesion descriptors that are needed to define the Type A, B, or C lesions in accordance with the definitions provided in chapter 6. Each individual dialog box in the Morphology Screen must be answered completely before the morphologic descriptors can be coded and stored in the database. After all the boxes have been completed, the Screen is closed by clicking on OK. The type of lesion is automatically calculated using the results of the data entry in the Morphology Screen dialog boxes. The number of characteristics of each type is also reported, e.g. if the lesion is a Type B and includes 4 Type B characteristics, the lesion is described as a B4.

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Lesion Morphology Screen

Graft Tools

Selection of the Grafts Diagnostic option from the Page Menu brings forward the diagnostic tree in "ghosted" form and the replacement of the Tool Box with the Grafts Tool Box. With these tools, one can accurately depict the origin and destination of coronary bypass grafts and their perfusion. Lesions that occur within the grafts can also be placed.

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Graft Tool Box

Adding Grafts

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There are three types of grafts available: Single graft, Jump graft, and Y-graft. All graft types require that the sites of insertion onto the coronaries be selected first, followed by the graft origin site. There are a variety of graft origin sites available. Three left and three right aortic origins can be utilized as well as one left and one right internal-mammary site. To enter a Single graft, first select the sites where the graft is to be inserted and then select the origin of the graft from either the aortic root or the respective mammary. For a Jump graft, first select each of the insertion sites one at a time in sequence, then select the graft origin. A Y-graft is entered by first selecting the two insertion sites and then selecting the graft origin. If you incorrectly specify the graft sequence, a message box requesting a repeat selection will appear.

Eight origin sites - three each for the left and right sides of the aortic root and two for the right and left internal mammary artery - can be selected from their respective graphical representations.

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Coronary Artery Bypass Graft Origins

Removing Grafts

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Any graft may be removed by selecting the Remove Graft icon from the tool box and then by clicking on any part of the desired graft to be removed. Alternatively, the Undo function can be used to delete a graft after it is entered by mistake.

Modify TIMI Flow

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The visualization and perfusion of the native coronary anatomy assessed following injection of the coronary artery bypass grafts can be indicated through the use of this tool. The antegrade coronary perfusion at any point in the coronary tree may be modified using one of the four perfusion functions which may represent: Normal perfusion (TIMI 3); Reduced perfusion (TIMI 2); Minimal perfusion (TIMI 1); No perfusion (TIMI 0). The "ghosted" coronary tree is used to display the native vessels and the location of native stenoses. Clicking on the desired perfusion icon results in display of the portion of the coronary tree that is visualized by contrast through the coronary graft. This visualizaion, indicated by solid line outlining of the vessels, will extend to any part of the vessel in either a retrograde or antegrade manner and allows accurate representation of graft perfusion of the native coronary anatomy. If you make a mistake with one of these perfusion functions, remember to use the Undo function rather than applying an additional perfusion modification.

Add Lesions

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Lesions of varying sizes and types may also be added on the Grafts Page. Lesions can be added to either the grafts themselves or to areas of the native coronaries perfused by the grafts.

Interventional Page Tools

Also available from the Page Menu are interventional forms of the tree pages that result in the display of dedicated sets of tools. The post intervention pages are used to bring forward the diagnostic page information for either the native coronary anatomy or the bypass grafts to allow for modification of the lesions following a coronary interventional procedure. The basic procedures have been described above - a variation on the tool box is displayed depending on the selected page option.

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Post Intervention Tool Box

Post Intervention Lesion Severity

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The change in the severity of a lesion following a coronary interventional procedure may be entered by selecting the Post Intervention Lesion Severity icon from the tool box, selecting an appropriate lesion stenosis size from the lesion severity box, and then clicking on the desired lesion. Both the pre-intervention and post-intervention sttenosis severity are displayed and the graphical representation of the lesion severity is changed automatically as well.

Note that this will not change the representation of this stenosis severity in the original Diagnostic tree record.

Modify TIMI Flow

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The perfusion of the vessel following the coronary interventional procedure can be selected to reflect changes in flow after the procedure. The same perfusion grades and representative display are used as in the Diagnostic pages.

Add Lesions

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Lesions of varying severity and types may also be added on the Interventional Native Coronary Page. This option may be used to indicate lesions that were not seen before the interventional procedure or that occurred as a result of the procedure.

Post Intervention Lesion Morphology

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The qualitative morphological characteristics of a lesion following an intervention can be characterized and recorded by clicking on the Lesion Morphology icon in the Post Intervention Tool Box and then on the desired lesion. This results in the display of the Post Intervention Lesion Morphology Screen. Each individual dialog box in the Morphology Screen must be answered completely before the morphologic descriptors can be coded and stored in the database. After all the boxes have been completed, the Screen is closed by clicking on OK

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Post Intervention Morphology Screen

Additional Tools

Add Comment

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A comment may be entered by selecting the Comment icon from the lower left screen. When you select this option, a dialog box will appear allowing you to add or modify a comment that will be displayed when the tree diagram is printed. Select the "OK" button when you have completed entering the comment. Selecting the "Cancel" button will cause the comment modifications not to be stored. Comments of up to 250 characters in length can be stored.

Undo Command

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HeartView stores all modifications made to a Tree Diagram in a buffer and allows those modifications to be removed a single action at a time with the use of the Undo icon in the lower left-hand corner of the screen. Every time the undo icon is selected the last modification made to the tree diagram will be undone. By repeated pressing this button you can remove all the modifications in reverse sequence. For instance, if a lesion was added to the wrong location, it can be removed by pressing the undo button. If you added a lesion and then performed some other modification, Undo will modify the last change before the lesion is removed. It is advisable that you use the undo button immediately following a mistaken action rather than using some other modify/remove function. You will always be able to modify any information that is added to the tree diagram through the use of the Tools

Printing the Tree Diagram

HeartView works with most laser printers that are supported under Microsoft Windows. It is recommended that you use a laser printer capable of supporting a minimum of 150 dot per inch resolution, with 300 DPI preferred. This may required additional memory in some laser printers. A printer that supports Postscript will give the best results. You can print the coronary tree diagram by selecting the "Print" option from the File Menu. A dialog box will be displayed informing you that printing is in progress and that you may cancel at any time by pressing the "Cancel" button. Printing can take as little as 15 seconds if you use a Postscript laser printer and as much as five minutes using slower laser printers.

Saving the Tree Diagram

The coronary tree diagram can be saved by selecting the "Save" option from the File Menu. Once the tree diagram is saved, it may be recalled at any time using the "Tree Load" option from the File Menu. If you do not wish to save the changes you have made to the tree diagram since that last time it was saved, you should select the "Close" option from the File Menu and choose the No button when the program ask if you want to save the Tree. If you select not to save the Tree, any changes you have made on the current tree diagram will not be stored. Any previous information you have stored will not be affected.

File Menu

You can quit HeartView at any time by selecting the "Exit" option from the File Menu. If you are currently modifying a tree diagram then any changes you have made will not be stored. You should save any changes made before exiting the program if you wish them stored for future use.

Database Menu

The HeartView database can be modified using the Modify functions accessible through the Database Menu.

Adding New M.D.'s

Code numbers and information about clinicians can be entered by selecting the "Add M.D." function from the Database Menu. A dialog box is displayed requesting that you enter a physician Code number, First Name, and a Last Name. A unique code must be assigned to each physician. The codes can contain up to ten alphanumeric characters. It is recommended that you use either a number (i.e. starting with 100,101,102...) or the physician's initials (i.e. TST) for the code.

Modifying Data

Any of the information which has been entered into the database can be modified using one of the appropriate modify options from the Database Menu. After selecting one of these options, a dialog box appears asking you for an appropriate identifier for the information you wish to modify; the specific procedure varies with the selected option.

Modify MD

Names of clinicians can be changed by selecting this option and entering the desired Code number at the resulting dialog box. If the Code number is not known, a list of existing codes can be displayed by clicking on the Search button. Clicking on OK after a Code number is selected will result in a display of the Physician Information Box where any of the name information can be changed. Click on OK to store the changes or click on Cancel to leave the data as it is.

Modify Exam

Selection of this option allows the user to change the procedure identification for a given Exam ID. After the option has been selected, a Modify Exam Dialog Box will be displayed which will prompt the user to enter the desired Exam ID. If the number is known, enter it into the Exam ID box and click on OK; this will result in the display of the Exam Information Box. At this point, any data other than the Exam ID can be changed, including the Patient ID, Exam Date, or physicians. Click on OK to save the changes or click on Cancel to leave the data as it is.

If the number is not known, the database can be searched by clicking on the Search button with the mouse - this results in the display of the Search For Exam Dialog Box. The Database can be searched by entering any known information in either of the Exam ID or the Exam Date boxes and clicking on the Search button. For example, entry of the first three digits "999" results in a listing of all exams which contain that combination of numbers. If the desired Exam is displayed, it is selected by first clicking on it with mouse and then clicking on Select. This results in the display of the Modify Exam box discussed above and the Modify procedure from this point is identical to that described above.

Modify Patient

This option allows a user to change the patient demographic information including the name, date of birth and sex. The procedure to modify the patient information is similar to that used to Modify Exam. Selection of the option from the Database Menu results in display of a Modify Patient Dialog Box which prompts for the Patient ID; if known, enter and click on OK, otherwise click on the Search button. In the Search For Patient window, entry of any known information in the Patient Name or the Patient ID boxes results in a listing of matching entries in the database. NOTE: The Search for Patient is sensitive to the case of all characters in the Name fields or the Patient ID field. Select the desired patient by using the mouse to highlight the desired patient and clicking on Select. This returns the user to the Modify Patient Box - click on OK to change the record or Cancel to exit the modify procedure. Selecting OK results in the display of the Patient Information Box - edit fields as desired and click on OK to save the changes or click on Cancel to leave the existing data.

Modify Tree

This option allows a user to change the Tree Information used to create the patient-specific template of the coronary anatomy that serves as the starting point for the generation of the Tree diagram.

WARNING - Modifying a Tree will result in the deletion of all recorded anatomy results for that Exam and will require that a new Tree diagram be entered.

The procedure for modifying a Tree is very similar to the Modify Exam procedure described above including the use of the Search For Exam function if the Exam ID is unknown. After the desired Exam ID has been determined and OK has been selected on the Modify Tree Dialog Box, the user will be allowed to change the information in the Tree Template Dialog Box which was discussed in Chapter 4. Click on OK when finished to store the changes.

Deleting an Exam & Tree

This function is available for the complete removal of an Exam record from the database and should be used with caution. After deletion of the Exam record, the Exam ID will be available for assignment to a different procedure.

Chapter

6

HeartView Definitions

Coronary Artery Nomenclature

The labels used to construct the patient specific tree template and to identify the vessels in the coronary tree diagram have been selected in attempt to follow common clinical practice. A list of the definitions of the terms used in HeartView for the coronary anatomy follows.

Dominance

• Right: If the posterior descending artery (PDA) arises from the right coronary artery and at least one other branch extends past the PDA into the atrioventricular groove, giving off one or more posterolateral branches to the inferior surface of the ventricle, the circulation is termed right dominant.

• Left: The circulation is considered left dominant if the posterior descending artery and all the posterolateral branches to the inferior surface of the left ventricle arise from the left circumflex artery.

• Mixed: The right coronary artery terminates as the posterior descending artery. Posterolateral branches to the left ventricle arise from the left circumflex.

Coronary Artery Segments

Right Coronary System (RCA)

• Proximal right coronary artery (Prox RCA): The proximal RCA extends from the right coronary ostium up to and including the anterior right ventricular (RV) branch.

• Mid right coronary artery (Mid RCA): Extends from the anterior RV branch to and including the origin of the acute marginal branch.

• Distal right coronary artery (Dist RCA): Begins at the level of the acute marginal branch and extends through the bifurcation of the posterior descending artery and to the distal right coronary artery continuation.

• Right posterior descending artery (R PDA): Begins at the bifurcation of itself and the distal right coronary artery segment. This artery is involved in supplying the inferoposterior portion of the left ventricle. If two posterior descending arteries are present (i.e., one arising from the RCA and the other from the left circumflex), only the larger one is described. The circulation will be continued to be called mixed. The inferior and posterolateral branches of this larger artery are to be identified, as well.

• Right posterior descending septal branch (R PDA Septal)

• Distal right coronary artery continuation segment (R PAV): The terminal portion of the right coronary artery in a right dominant circulation. This segment lies in or near the atrioventricular (AV) groove and gives rise to a variable number of right posterolateral segments. This segment is the terminal portion of the right coronary artery and begins at the bifurcation of the distal RCA and PDA and gives rise to the AV nodal artery as well.

• Anterior right ventricular artery branches (Ant R Vent)

• Acute marginal branches (Acute Marg.): This segment may in some cases give rise to a true posterior descending artery directly.

• First right posterolateral branch (R PL1): This segment arises from the R PAV and supply the inferobasal aspect of the left diaphragm.

• Second right posterolateral branch (R PL2): This segment arises from the R PAV and supply the inferobasal aspect of the left diaphragm.

• Third right posterolateral branch (R PL3): This segment arises from the RPAV and supply the inferobasal aspect of the left diaphragm.

• Right sinoatrial artery (R SA Nodal): This segment is the nutrient artery for the sinus node.

• Conus (Conus)

• Right atrioventricular nodal (R AV Node)

Left Main Coronary System

• Left main coronary artery (L Main): This segment extends from the left coronary ostium to the bifurcation of this vessel into the left anterior descending (LAD) and circumflex artery (LCX).

Left Anterior Descending Artery (LAD)

• Proximal LAD (Prox LAD): This segment extends from the bifurcation of the left main coronary artery up to and including the first visible septal perforator. Acceptance of this definition may result in an extremely short proximal segment. The first septal perforator is often preceded by several tiny branches.

• Mid LAD: Extends from the first septal perforator up to and including the level of the third diagonal.

• Distal LAD (Dist LAD): Extends from the third diagonal branch to the termination of the LAD.

• First diagonal (anterolateral) branch (D1): The first diagonal branch is defined as the diagonal vessel arising from the proximal portion of the LAD.

• Second diagonal branch (D2): If the first diagonal branch visualized arises in the mid-LAD, it is to be designated the second diagonal (re: the first diagonal arises in the proximal LAD). The first diagonal will be coded as "absent".

• Third diagonal branch (D3)

• First septal perferator (1st Septal): This segment delineates the termination of the proximal LAD and is meant to represent the first large septal readily visualized.

• Second septal perforator (2nd Septal)

Left Circumflex Artery (LCX) System

• Proximal circumflex artery (Prox LCX): Extends from the origin of the circumflex artery from the left main artery to and including the origin of the first obtuse marginal branch.

• Mid circumflex artery (Mid LCX): Originates at the level of the first obtuse marginal branch and extends to and includes the third obtuse marginal.

• Distal circumflex artery (Dist LCX): The distal circumflex is that portion of the artery that lies in the atrioven- tricular groove, originating at the level of the third obtuse marginal. In a right dominant circulation, the distal circumflex may be very small or absent. In a left or mixed circulation, the distal circumflex and the left atrioventricular arteries are arbitrarily defined as the proximal and distal halves of the circumflex artery below the origin of the first marginal branch. All branches arising from the circumflex artery are termed mar- ginal branches and those arising from the left circumflex artery continuation segment (L PAV) are termed left posterolateral branches.

• First obtuse marginal artery (OM1): This is the first significant branch from the left circumflex artery.

• Second obtuse marginal artery (OM2): This is the second branch from the left circumflex artery.

• Third obtuse marginal artery (OM3): This is the third branch from the left circumflex artery.

• Distal left circumflex artery continuation segment (L PAV): In right dominant circulation, this segment may be absent altogether or present as a terminal branch. In mixed or left dominant circulation, it is present as a conduit segment. See distal circumflex artery.

• First left posterolateral branch (L P1): Present in mixed or left dominant circulation only.

• Second left posterolateral branch (L PL2): Present in mixed or left dominant circulation only.

• Third left posterolateral branch segment (L PL3): Present in mixed or left dominant circulation only.

• Left posterior descending artery segment ( L PDA): Present in mixed or left dominant circulation only .

• Ramus intermedius segment (Optional Diagonal) (Ram Int): Extends from its origin off the left main coronary artery to the medial termination. Occasionally, there is a true trifurcation of the left main artery, resulting in the presence of an "intermediate" artery.

• Left atrioventricular nodal (L AV Node): Present in mixed or left dominant circulation only

• Left posterior descending septal artery(L PDA Septal): Present in left dominant circulation only

Anomalous Coronary Arteries

When a new procedure is entered in with the use of the Tree Template Dialog Box, the user has the option of indicating common coronary anomalies that may be present. Several common coronary anomlaies are avaiable as templates. These include:

• Circumflex Artery Aising From the Right Coronary Artery (Crx. Off Right): This selection is made if the circumflex artery arises from the proximal right coronary artery. The origin of the left circumflex artery arises from either the right coronary cusp, as a separate ostium or from the body of the proximal right coronary artery. In this instance, the left main is absent, since no common trunk for the left anterior descending and left circumflex arteries exists.

• Separate Ostia for Left Anterior Descending and Left Circumflex Arteries (Sep. Ost.): The LAD and left circumflex arteries have separate origins, i.e. no left main coronary artery. The origins of the left anterior descending and left circumflex artery arises from their separate ostia respectively. In this instance, the left main is absent, since no common trunk for the left anterior descending and left circumflex arteries exists.

• Single Coronary Artery (Single Cor.): This selection is used to indicate that all three major coronary arteries arise from the right cusp. The origin of the left main coronary artery arises from either the right coronary cusp, as a separate ostium or from the body of the proximal right coronary artery. The usual bifurcation of the left main into the left anterior descending artery and the left cirucmflex arteries occurs in its usual fashion.

Coronary Artery Sizing

Recommended criteria for assigning the size of coronary artery segments using the Change Branch Size functions are listed below.

• Normal: A vessel with a large enough diameter and perfusion bed to warrant a revascularization procedure if one would be required. Generally, this implies a diameter greater than 1.5 mm.

• Large: A vessel with a large enough diameter and perfusion bed to warrant a revascularization procedure if one would be required. This vessel has a diameter which is larger than would be expected and serves to indicate those arteries which appear angiographically as larger than average.

• Small: A vessel with either a lumen diameter or perfusion bed of insufficient size to warrant a revascularization procedure (< 1.5 mm diameter).

Coronary Artery Bypass Grafts

Grafts

Proximal anastomosis site lesions involve the aortic anastomosis, while distal anastomosis site lesions involve the coronary artery segment into which they are inserted. Included in the description of the graft type should be a determination of the location of the proximal anastomosis (see below) and a judgment as to the location of the distal anastomosis. The location of the distal anastomosis should be in accord with the previously described coronary artery segments. (See Coronary Artery Segments)

Left Aortic Graft Origins

This pertains only to saphenous vein grafts. This should indicate any graft with a proximal anastomosis located on the left side of the aorta.

Right Aortic Graft Origins

This pertains only to saphenous vein grafts. This should indicate any graft with a proximal anastomosis located on the right side of the aorta.

Left Internal Mammary Artery (LIMA)

This designation pertains to those grafts arising from the left internal mammary artery with a distal insertion into any of the major coronary artery circulations.

Right Internal Mammary artery (RIMA)

This designation pertains to those grafts arising from the right internal mammary artery with a distal insertion into any of the major coronary artery circulations.

Coronary Artery Vessel Descriptors

Lesion Type

The Lesion Type Tool Box is used to designate general characteristics of a visualized artery lesion. Each of the icons in the Tool Box are used to indicate one of the following characterizations.

• Discrete: Discrete lesions are assumed to be less than or equal to 10 mm and are mapped as a single location.

• Diffuse: Diffuse lesions are assumed to be longer than 10 mm, possess an irregular contour but at no point in the length of lesion does the luminal diameter reduction become normal. This is to be mapped as a single lesion.

• Tubular: Tubular lesions are assumed to be longer than 10 mm, possess an smooth contour, with the luminal diameter reduction remaining approximately constant for the length of the lesion. In addition, at no point in the course of the lesion does the luminal diameter reduction become normal. This is to be mapped as a single lesion.

• Discrete Ectasia: This represents a localized area of ectasia (aneurysmal dilatation), whose length should not be longer than 10 mm.

• Diffuse ectasia: Should be reserved for diffuse coronary ectasia, with a length longer than 10 mm.

Distal Flow TIMI Criteria

• TIMI Grade 3 (complete perfusion): Antegrade flow into the terminal coronary artery segment distal to a stenosis is as prompt as antegrade flow into a comparable segment proximal to the stenosis. Contrast clears as rapidly from the distal segment as from an uninvolved bed in the same vessel or the opposite artery, within 3 cardiac cycles.

• TIMI Grade 2 (partial perfusion): The contrast material passes across the obstruction and opacifies the coronary bed distal to the obstruction. However, the rate of entry of contrast material into the vessel distal to the obstruction or its rate of clearance from the distal bed (or both) are perceptibly slower than its entry into or clearance from comparable areas not perfused by the previously occluded vessel - e.g., the opposite coronary artery or the coronary bed proximal to the obstruction.

• TIMI Grade 1 (penetration without perfusion): The contrast material passes beyond the area of obstruction but 'hangs up' and fails to opacify the entire coronary bed distal to the obstruction for the duration of the cineangiographic filming sequence.

• TIMI Grade 0 (no perfusion): There is no antegrade flow beyond the point of occlusion.

Lesion Morphology Descriptors

Lesion Length

This is to be performed using visual estimation of stenosis severity, with the adjacent normal vessel diameter to serve as a "yardstick" or unit. The length is to be expressed as encompassing:

• 0 - 10 mm 20 mm > 1 balloon length

using standard 20 mm angioplasty balloon devices for comparison.

Contour

• Smooth: A stenosis is judged to be smooth if its edge is smooth. Luminal edge is judged only if antegrade flow visualizes the vessel edge well. Care should be taken so as not to mistake small vessel crossings for irregularities. If there is a question as to the nature of the lesion, it is to be judged as smooth.

• Irregular/Ulcerated: A stenosis is judged to be irregular/ulcerated if its luminal edge is irregular, or has a "sawtooth" component, but there is no evidence of a "crater" being present or if a discrete luminal widening in the area of a coronary stenosis in the form of a "crater" is seen. If the widening exceeded the diameter of the normal lumen, it is to be judged as an area of ectasia, not an ulcer.

Lesion Eccentricity

Eccentric lesions are asymmetrically positioned in one or more views. The degree of asymmetry will require evaluation of which quartile of vessel diameter the center of the lesion lies in. Lesion should be designated as either concentric or eccentric. Useful guidelines for determining whether eccentricity exists include:

• Concentric lesions: Concentric lesions typically have a symmetric, hourglass coronary artery narrowing; the borders are smooth or only slightly irregular.

• Smooth convex eccentric: These lesions represent asymmetric narrowings in the form of a convex intraluminal obstruction with smooth borders and a wide neck or any asymmetric narrowing with smooth borders. This would correspond to Type I lesions in the scheme proposed by Ambrose.

• Irregular convex eccentric: These lesions represent eccentric stenoses in the form of a convex intraluminal ob-struction with a narrow neck due to one or more overhanging edges or scalloped borders, or both. These lesions correspond to Ambrose Type II lesions.

Branch involvement

In the treatment of primary lesions, in the presence of a bifurcation or side branch lesion involving a normal or large-sized branch and/or territory as depicted above, one must consider whether during the interventional procedure if there is a high probability of occlusion of the side branch. If the lesion involves a normal or large-sized branch, you must decide whether that branch requires protection, and if so, to what extent protection is possible. This may include diagonals, marginals, ramus, posterior descending and proximal left anterior descending or left circumflex vessels coded as normal or large.

Lesion Angulation

Refers to the amount of "bend" in the lesion, in the projection which best minimizes foreshortening of the angle. Lesion angle is formed by the intersection of a centerline through the artery lumen proximal to the center of the stenosis and extended beyond it and a second center line in the straight portion of the artery distal to the center of the stenosis. Angulation is mild or absent if the angle is less than or equal to 45 degrees, moderate if between 45 and 89 degrees and excessive if greater than or equal to 90 degrees. It does not refer to the amount of pivoting or "kinking" of the vessel at the stenosis.

Lesion Calcification

Calcification involving a portion of adjacent artery not involved in the stenosis is graded as none, light, or heavy.

Total occlusion

This group will include all lesions determined to have TIMI grade 1 or 0 flow. An estimation of duration of occlusion will be made (to be determined from medical review) and expressed in hours or days (whichever is the more appropriate time frame). For lesions graded as TIMI 0, no assessment of morphology is possible (except for entry point descriptors) and these parameters are scored as unknown - TIMI grade 0.

Proximal Tortuosity

The number and severity of bends between the origin of the coronary artery system and the lesion, is to be used as a measure of the degree of difficulty in mechanically accessing a coronary stenosis. A "bend" is a vessel segment with at least 60 degrees angulation in the projection which best opens up the vessel profile for visualization at end-diastole. Lesions distal to one bend are considered to be located in mildly tortuous vessels. Lesions distal to two bends lie in moderately tortuous vessels, and those distal to three or more bends lie in severely tortuous vessels.

Ostial in Location

A lesion is "ostial" if the proximal shoulder is located a distance of less than 5 mm from the origin of any medium or large sized coronary artery segment. This may include, but is not restricted to the proximal right coronary artery, the left main coronary artery, proximal LAD artery, proximal circumflex artery or ramus intermedius (optional diagonal).

Thrombus

Thrombus is judged to be absent or present, depending on the presence or absence of a discrete intraluminal filling defect, haziness of the opacified vessel lumen or contrast "staining" (persistence of contrast in the vessel lumen after the remainder of the vessel clears contrast) in the area of the stenosis.

Post PTCA Morphology Descriptors

Distal Embolization

A notation as to whether thrombus migrates distally should include be made. Also required is whether or not there was occlusion of a normal or large-sized branch as a result of the embolization. A notation as to whether the material results in a discrete intraluminal filling defect, haziness of the opacified vessel lumen or contrast staining (persistence of contrast in the vessel lumen after the remainder of the vessel clears contrast) should also be made.

Dissection

Classification of this complication of PTCA will require a notation as to the character and location of the rent in the target vessel. The presence of one type of dissection does not preclude the presence of other types. Each type present should be indicated. Three choices are available to characterize the severity and extent of the dissection:

• None

• Minor: The dissection extends for a distance of less than one balloon length.

• Major: The length is greater than one balloon in length and appears to result in threatened or actual compromised blood flow.

Thrombus

Thrombus is judged to be absent or present, depending on the presence or absence of a discrete intraluminal filling defect, haziness of the opacified vessel lumen or contrast "staining" (persistence of contrast in the vessel lumen after the remainder of the vessel clears contrast) in the area of the stenosis.

Appendix

A

Coronary Origin & Dominance

Left Dominance

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Right Dominance

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Mixed Dominance

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Circumflex Off Right

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Single Coronary

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Separate Ostiums

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Main Menu

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Lesion Morphology

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