The templates that comprise the Quantitative Arterial Analysis SR are interconnected as in Figure A-4:

[pic]

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Figure A-4: Quantitative Arterial Analysis Report SR IOD Template Structure
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The Quantitative Arterial Analysis Template consists of a CONTAINER with a structure for reporting the result of the quantitative arterial analysis process.

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TID 3213
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QUANTITATIVE ARTERIAL ANALYSIS
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Type: Extensible Order: Significant
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NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINER | EV (122291, DCM, “Quantitative Arteriography Report”) | 1 | M | ||||

2 | > | HAS CONCEPT MOD | INCLUDE | DTID (1204) Language Of Content Item And Descendants | 1 | M | ||

3 | > | HAS OBS CONTEXT | INCLUDE | DTID (1002) Observer Context | 1-n | M | ||

4 | > | CONTAINS | INCLUDE | DTID (3602) Cardiovascular Patient Characteristics | 1 | U | ||

5 | > | HAS OBS CONTEXT | TEXT | EV (111001, DCM, “Algorithm Name”) | 1 | M | ||

6 | > | HAS OBS CONTEXT | TEXT | EV (111003, DCM, “Algorithm Version”) | 1 | M | ||

7 | > | HAS OBS CONTEXT | TEXT | EV (122405, DCM, “Algorithm Manufacturer”) | 1 | M | ||

8 | > | CONTAINS | INCLUDE | DTID (3214) Analyzed Segment | 1-n | M |

Row 5 | Identifies the Arterial Analysis program |

Row 6 | Identifies the Arterial Analysis program version |

Row 7 | Identifies the Arterial Analysis program manufacturer |

The Analyzed Segment Template consists of a CONTAINER providing quantitative arterial analysis measurements derived from the angiographic images.

TID 3214ANALYZED SEGMENTType: Extensible Order: Significant

NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINER | EV (121070, DCM, “Findings”) | 1 | M | ||||

2 | > | HAS CONCEPT MOD | CODE | EV (G-C0E3, SRT, “Finding Site”) | 1 | M | DCID (3604) Arterial lesion locations | |

3 | > | CONTAINS | IMAGE | EV (121112, DCM, “Source of Measurements”) | 1 | M | ||

4 | > | CONTAINS | INCLUDE | DTID (3205) Calibration | 1 | M | ||

5 | > | HAS ACQ CONTEXT | INCLUDE | DTID (3520) Hemodynamic Clinical Context | 1 | U | ||

6 | > | HAS ACQ CONTEXT | CODE | EV (G-72BB, SRT, “Catheterization Procedure Phase”) | 1 | U | DCID (3651) Hemodynamic Measurement phase | |

7 | > | CONTAINS | SCOORD | EV (122507, DCM, “Left Contour”) | 1 | M | GRAPHIC TYPE = POLYLINE | |

8 | >> | R-SELECTED FROM | IMAGE | 1 | M | Must reference Row 3 | ||

9 | > | CONTAINS | SCOORD | EV (122508, DCM, “Right Contour”) | 1 | M | GRAPHIC TYPE = POLYLINE | |

10 | >> | R-SELECTED FROM | IMAGE | 1 | M | Must reference Row 3 | ||

11 | > | CONTAINS | INCLUDE | DTID (3219) Segment Values | 1 | M | ||

12 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = (R-404FB, SRT, “Minimum”) $Unit = DT (mm, UCUM, “mm”) | |

13 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation =(G-A437, SRT, “Maximum”) $Unit = DT (mm, UCUM, “mm”) | |

14 | > | CONTAINS | CONTAINER | EV (122509, DCM, “Diameter Graph”) | 1 | U | ||

15 | >> | CONTAINS | NUM | EV (122511, DCM, “Graph Increment”) | 1 | M | Value = 1 Units = DT ({pixels}, UCUM, “pixels”) | |

16 | >> | CONTAINS | INCLUDE | DTID (300) Measurement | 1-n | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Unit = DT (mm, UCUM, “mm”) | |

17 | > | CONTAINS | NUM | EV (122382, DCM, “Site of Luminal Minimum ”) | 1 | U | Units = DT ({pixels}, UCUM, “pixels”) | |

18 | > | CONTAINS | NUM | EV (122516, DCM, “Site of Luminal Maximum”) | 1 | U | Units = DT ({pixels}, UCUM, “pixels”) | |

19 | > | CONTAINS | INCLUDE | DTID (3215) Angiographic Lesion Analysis | 1-n | U | ||

20 | > | CONTAINS | INCLUDE | DTID (3217) Sub-Segmental Data | 1-n | U | ||

21 | > | CONTAINS | IMAGE | No purpose of reference | 1 | U |

Row 1 | Observation DateTime (0040,A032) of container needs to be flagged with the time of the analysis |

Row 6 | Numeric coordinates (x,y) identifying the contour points from proximal to distal of left contour. Left is relative to the direction of the blood flow. |

Row 9 | Numeric coordinates (x,y) identifying the contour points from proximal to distal of right contour. Right is relative to the direction of the blood flow. |

Row 12,13 | Positions are relative to the midpoint between the first left and right contour points and measured along the midline between the left and right contour. |

Row 14 | The X-axis represents the pixel points of the midline of the vessel from proximal to distal. The points on the midline are not necessarily equidistant. |

Row 16 | For each point of the midline of the vessel a measurement value for the diameter is calculated. |

Row 17,18 | The positions in the graph are related to the points on the midline of the vessel. |

Row 21 | Secondary Capture image with Arterial Analysis contour. |

Definition of Left and Right defined by the direction of the blood flow:

[pic]

The Angiographic Lesion Analysis Template consists of a CONTAINER providing quantitative arterial analysis measurements derived for an obstruction in a total analyzed segment.

TID 3215ANGIOGRAPHIC LESION ANALYSISType: Extensible Order: Significant

NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

2 | > | CONTAINS | TEXT | EV (121151, DCM, “Lesion Identifier”) | 1 | M | ||

3 | >> | HAS PROPERTIES | CODE | EV (G-C0E3, SRT, “Finding Site”) | 1 | M | DCID (3604) Arterial lesion locations | |

4 | >>> | HAS CONCEPT MOD | CODE | EV (G-A1F8, SRT, “Topographical modifier”) | 1 | U | DCID (3019) Cardio-vascular Anatomic Location Modifiers | |

5 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation =(R-404FB, SRT, “Minimum”) $Unit = DT (mm, UCUM, “mm”) | |

6 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1-n | U | $Measurement = EV (G-0366, SRT, “Vessel Lumen Cross-Sectional Area”) $Method = DCID (3470) Vessel Lumen Cross-Sectional Area Calculation Methods $Derivation =(R-404FB, SRT, “Minimum”) $Unit = DT (mm2, UCUM, “mm^2”) | |

7 | > | CONTAINS | CODE | EV (122430, DCM, “Reference Method”) | 1 | M | DCID (3465) QA Reference Method | |

8 | > | CONTAINS | CONTAINER | EV (122438, DCM, “Reference Points”) | 1 | U | ||

9 | >> | CONTAINS | NUM | EV (122337, DCM, “Relative Position”) | 1-n | M | $Unit = DT (mm, UCUM, “mm”) | |

10 | >>> | HAS PROPERTIES | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Unit = DT (mm, UCUM, “mm”) | |

11 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $TargetSite = (122382, DCM, ”Site of Luminal Minimum”) $Unit = DT (mm, UCUM, “mm”) | |

12 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (G-0366, SRT, “Vessel Lumen Cross-Sectional Area”) $Derivation = EV (122404, DCM, “Reconstructed”) $TargetSite = (122382, DCM, ”Site of Luminal Minimum”) $Unit = DT (mm2, UCUM, “mm^2”) | |

13 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = EV (R-41D2D, SRT, “Calculated”) $TargetSite =EV (122481, DCM, “Contour Start”) $Unit = DT (mm, UCUM, “mm”) | |

14 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = EV (R-41D2D, SRT, “Calculated”) $TargetSite = EV (122482, DCM, “Contour End”) $Unit = DT (mm, UCUM, “mm”) | |

15 | > | CONTAINS | INCLUDE | DTID (3218) Position in Arterial Segment | 1 | M | ||

16 | > | CONTAINS | CONTAINER | EV (122517, DCM, “Densitometric Luminal Cross-sectional Area Graph”) | 1 | U | ||

17 | >> | CONTAINS | NUM | EV (122511, DCM, “Graph Increment”) | 1 | M | Value = 1 Units = DT ({pixels}, UCUM, “pixels”) | |

18 | >> | CONTAINS | INCLUDE | DTID (300) Measurement | 1-n | M | $Measurement = EV (G-0366, SRT, ”Vessel Lumen Cross-Sectional Area”) $Unit = (mm2, UCUM, “mm^2”) | |

19 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (G-0366, SRT, “Vessel Lumen Cross-Sectional Area”) $Derivation = EV (R-41D2D, SRT, “Calculated”) $Method = EV(122474, DCM, “Densitometric method”) $TargetSite =EV (122481, DCM, “Contour Start”) $Unit = (mm2, UCUM, “mm^2”) | |

20 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (G-0366, SRT, “Vessel Lumen Cross-Sectional Area”) $Derivation = EV (R-41D2D, SRT, “Calculated”) $Method = EV(122474, DCM, “Densitometric method”) $TargetSite = EV (122482, DCM, “Contour End”) $Unit = (mm2, UCUM, “mm^2”) | |

21 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (R-101BC, SRT, “Lesion Length”) $Unit = DT (mm, UCUM, “mm”) | |

22 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (R-101BB, SRT, “Lumen Diameter Stenosis”) $Unit = DT (%, UCUM, “%”) | |

23 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1-n | U | $Measurement = EV (R-101BA, SRT, “Lumen Area Stenosis”) $Method = DCID (3470) Vessel Lumen Cross-Sectional Area Calculation Methods $Unit = DT (%, UCUM, “%”) | |

24 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1-n | U | $Measurement = EV (122372, DCM, “Lumen Volume”) $Method = DCID (3470) Vessel Lumen Cross-Sectional Area Calculation Methods $Unit = DT (mm3, UCUM, “mm^3”) | |

25 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122542, DCM, “Plaque Area”) $Unit = DT (mm2, UCUM, “mm^2”) | |

26 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122376, DCM, “Total Plaque Volume”) $Unit = DT (mm3, UCUM, “mm^3”) | |

27 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122544, DCM, “Diameter Symmetry”) $Unit = DT ({ratio}, UCUM, “ratio”) | |

28 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122545, DCM, “Area Symmetry”) $Unit = DT ({ratio}, UCUM, “ratio”) | |

29 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122546, DCM, “Inflow Angle”) $Unit = DT (deg, UCUM, “degrees”) | |

30 | > | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122547, DCM, “Outflow Angle”) $Unit = DT (deg, UCUM, “degrees”) | |

31 | > | CONTAINS | INCLUDE | DTID (3216) Stenotic Flow Reserve | 1 | U | ||

32 | > | CONTAINS | IMAGE | No purpose of reference | 1 | U |

Row 8 | Set of user defined reference position for method that requires local reference position. |

Row 9 | Distance of local reference position from an arbitrary landmark. |

Row 10 | Diameter at a local reference position. |

Row 11 | The reference diameter for the arterial lesion calculated with the applicable reference method |

Row 12 | The reference area for the arterial lesion calculated with the applicable reference method |

Row 13 | The diameter measurement at the start of the reconstruction line in the diameter graph (TID 3214 Row 14) |

Row 14 | The diameter measurement at the end of the reconstruction line in the diameter graph (TID 3214 Row 14) |

Row 15 | The positions of the lesion, borders of the lesion, etc. |

Row 16 | The graph with the calculated cross sectional area results based on the densitometric method |

Row 18 | The cross sectional area measurements calculated based on the densitometric method |

Row 19 | The cross sectional area measurement at the start of the reconstruction line in the area graph |

R0w 20 | The cross sectional area measurement at the end of the reconstruction line in the area graph |

Row 21 | Measured along the midline of the left and right contour |

Row 22 | The diameter stenosis is calculated as follows: (Reference Luminal Diameter – Minimum Luminal Diameter / Reference Luminal Diameter) * 100% |

Row 23 | The circular and the densitometric area stenosis are calculated respectively as: (Reference Vessel Lumen Cross-Sectional Area – Minimum Luminal Circular Area / Reference Vessel Lumen Cross-Sectional Area) * 100% (Reference Vessel Lumen Cross-Sectional Area – Minimum Luminal Densitometric Area / Reference Vessel Lumen Cross-Sectional Area) * 100% |

Row 24 | Estimated lumen volume between proximal border and distal border of lesion (TID 3218, row 1 and 2) |

Row 32 | Secondary Capture image with obstruction analysis contour |

The Stenotic Flow Reserve Template consists of a CONTAINER providing quantitative arterial analysis measurements derived for an obstruction in a total analyzed segment.

TID 3216STENOTIC FLOW RESERVEType: Extensible Order: Significant

NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122548, DCM, “Stenotic Flow Reserve”) $Unit = DT ({ratio}, UCUM, “ratio”) | ||

2 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122549, DCM, “Poiseuille Resistance”) $Unit = DT (mm[Hg].s/cm, UCUM, “mmHG.s/cm”) | ||

3 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122550, DCM, “Turbulence Resistance”) $Unit = DT (mm[Hg].s2/cm2, UCUM, “mmHG.s^2/cm^2”) | ||

4 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122555, DCM, “Estimated Normal Flow”) $Unit = DT (ml/s, UCUM, “ml/s”) | ||

5 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (122551, DCM, “Pressure Drop at SFR”) $Unit = DT (mm[Hg], UCUM, “mmHg”) | ||

6 | CONTAINS | IMAGE | No purpose of reference | 1 | U |

Row 6 | Secondary Capture image with SFR analysis contour |

The Sub-segmental Data Template consists of a CONTAINER providing quantitative arterial analysis measurements derived for a sub-segment in a total analyzed segment.

TID 3217SUB-SEGMENTAL DATAType: Extensible Order: Significant

NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINER | EV (121070, DCM, “Findings”) | 1 | M | ||||

2 | > | HAS CONCEPT MOD | CODE | EV (G-C0E3, SRT, “Finding Site”) | 1 | M | DCID (3604) Arterial lesion locations | |

3 | >> | HAS CONCEPT MOD | CODE | EV (G-A1F8, SRT, “Topographical modifier”) | 1 | U | DCID (3019) Cardio-vascular Anatomic Location Modifiers | |

4 | > | CONTAINS | CODE | EV (122554, DCM, “Segmentation Method”) | 1 | M | DCID (3456) Sub-segment Methods | |

5 | > | CONTAINS | INCLUDE | DTID (3219) Segment Values | 1 | U | ||

6 | > | CONTAINS | INCLUDE | DTID (3218) Position in Arterial Segment | 1 | M | ||

7 | > | CONTAINS | IMAGE | No purpose of reference | 1 | U |

Row 7 | Secondary Capture image with obstruction analysis contour |

The Position in Arterial Segment Template consists of the position content items common for the Angiographic Lesion Analysis and Sub-Segmental Data.

TID 3218POSITION IN ARTERIAL SEGMENTType: Extensible Order: Significant

NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122528, DCM, “Position of Proximal Border”) $Unit = DT (mm, UCUM, “mm”) | ||

2 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122529, DCM, “Position of Distal Border”) $Unit = DT (mm, UCUM, “mm”) | ||

3 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122382, DCM, “Site of Luminal Minimum”) $Unit = DT (mm, UCUM, “mm”) | ||

4 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122516, DCM, “Site of Luminal Maximum”) $Unit = DT (mm, UCUM, “mm”) | ||

5 | CONTAINS | NUM | EV (122528, DCM, “Position of Proximal Border”) | 1 | UC | IFF TID 3214 Row 14 is present | Units = DT ({pixels}, UCUM, “pixels”) | |

6 | CONTAINS | NUM | EV (122529, DCM, “Position of Distal Border”) | 1 | UC | IFF TID 3214 Row 14 is present | Units = DT ({pixels}, UCUM, “pixels”) | |

7 | CONTAINS | NUM | EV (122382, DCM, “Site of Luminal Minimum”) | 1 | UC | IFF TID 3214 Row 14 is present | Units = DT ({pixels}, UCUM, “pixels”) | |

8 | CONTAINS | NUM | EV (122516, DCM, “Site of Luminal Maximum”) | 1 | UC | IFF TID 3214 Row 14 is present | Units = DT ({pixels}, UCUM, “pixels”) |

Row 1,2,3,4 | Positions are relative to the midpoint of the first left and right contour points and measured along the midline of the left and right contour |

Row 5,6,7,8 | The positions are relative to the measurement locations of the Diameter Graph of TID 3214 row 14. |

The Segment Values Template consists of content items providing quantitative arterial analysis measurements for a total analyzed segment or sub segment.

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TID 3219
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SEGMENT VALUES
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Type: Extensible Order: Significant
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NL | Rel with Parent | VT | Concept Name | VM | Req Type | Condition | Value Set Constraint | |

1 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (122510, DCM, “Length Luminal Segment”) $Unit = DT (mm, UCUM, “mm”) | ||

2 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = (R-404FB, SRT, “Minimum”) $Unit = DT (mm, UCUM, “mm”) | ||

3 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation =(G-A437, SRT, “Maximum”) $Unit = DT (mm, UCUM, “mm”) | ||

4 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | M | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = (R-00317, SRT, “Mean”) $Unit = DT (mm, UCUM, “mm”) | ||

5 | CONTAINS | INCLUDE | DTID (300) Measurement | 1 | U | $Measurement = EV (G-0364, SRT, “Vessel Luminal Diameter”) $Derivation = (R-10047, SRT, “Standard Deviation”) $Unit = DT (mm, UCUM, “mm”) |

Row 1 | Measured along the midline of the left and right contour. |