Table 1. Patient and vessel characteristics.
No. of patients
|
12
|
Mean age, years (range)
|
68 (55 – 87)
|
Sex
|
Male 10 (83%). Female 2 (17%)
|
Race
|
Caucasian 92%. African-American (8%)
|
Mean weight, kg (range)
|
82 (69 – 92)
|
Mean height, cm (range)
|
176.8 (167.6 – 187.9)
|
Leg of the vessel accessed
|
Left 9 (75%). Right (25%)
|
Vessel imaged
|
SFA (64%) Popliteal (36%)
|
Mean length of target segment of vessel, cm (range)
|
24 (10 – 60)
|
Number of images containing a specific vessel characteristic to be scored
Layered structure
Nonlayered structure
Calcification
Stent
Artifact
|
24
104
40
21
120
|
Table 2. Mean ranking of the image quality of layered structure, non-layered structure, calcification, stent structure, and artifacts as rated by three readers of matched images captured by OCT and IVUS systems.
Vessel Characteristic
|
Mean score for IVUS images
|
Mean score for OCT images
|
Student’s t-Test
|
Mann-Whitney-Wilcoxon test
|
Layered structurea
|
1.61
|
1.49
|
p = 0.19
|
z = 0.82
p = 0.41
|
Non-layered structureb
|
2.70
|
1.82
|
p < 0.001
|
z = 11.04
p < 0.001
|
Calcificationc
|
2.45
|
2.11
|
p = 0.001
|
z = 2.80
p = 0.005
|
Stent structured
|
1.79
|
1.43
|
p = 0.004
|
z = 2.67
p = 0.007
|
Artifactse
|
1.87
|
1.79
|
p = 0.07
|
z= - 1.52
p = 0.12
|
Scoring: a Layered structure (1- clear differentiation of vessel wall layers, 2- differentiation of 3 wall layers, 3-differentiation of 2 wall layers, 4- no differentiation visible); b Non-layered structure (1- excellent histology-like image quality to 5- unacceptably poor image quality); c Calcification (1- excellent histology-like image quality to 5- unacceptably poor image quality); d Stent structure (1 excellent image, 2 – acceptable image, 3 – unacceptably poor image); and e Artifacts (1-none, 2- tolerable/not limiting, 3-is intense and limits image quality).
Table 3. Mean ranking of the image quality of layered structure, non-layered structure, calcification, stent structure, and artifacts as rated by three readers of matched images captured by OCT and IVUS systems.
Reader
|
Layered Structurea
|
Non-Layered Structureb
|
Calcificationc
|
Stent Structured
|
Artifactse
|
1
ICC intrareader
|
IVUS OCT
1.58 1.12
p = 0.002
0.82 0.91
|
IVUS OCT
2.97 2.08
p <0.001
0.89 0.91
|
IVUS OCT
2.28 2.05
p < 0.001
0.77 0.83
|
IVUS OCT
2.00 1.48
p < 0.001
0.82 0.93
|
IVUS OCT
2.15 1.68
p < 0.001
0.85 0.81
|
2
ICC intrareader
|
1.42 1.04
p = 0.02
0.70 0.83
|
2.55 1.54
p < 0.001
0.73 0.81
|
2.15 1.60
p < 0.001
0.91 0.85
|
1.81 1.14
p < 0.001
0.84 0.88
|
1.73 1.51
p < 0.001
0.92 0.83
|
3
ICC intrareader
|
1.83 2.29
p = 0.005
0.84 0.75
|
2.58 1.84
p < 0.001
0.89 0.77
|
2.95 2.68
p = 0.19
0.92 0.87
|
1.52 1.67
p = 0.52
0.83 0.86
|
1.22 2.33
p < 0.001
0.92 0.81
|
Scoring: a Layered structure (1- clear differentiation of vessel wall layers, 2- differentiation of 3 wall layers, 3-differentiation of 2 wall layers, 4- no differentiation visible); b Non-layered structure (1- excellent histology-like image quality to 5- unacceptably poor image quality); c Calcification (1- excellent histology-like image quality to 5- unacceptably poor image quality); d Stent structure (1 excellent image, 2 – acceptable image, 3 – unacceptably poor image); and e Artifacts (1-none, 2- tolerable/not limiting, 3-is intense and limits image quality)
Table 4. The longest and shortest luminal diameter of vessels at the distal, middle, and proximal portions of the target segments of vessels and the resultant luminal area as measured by the Pantheris OCT or Visions PV IVUS systems.
|
|
|
Proximal Location
|
|
|
|
Middle Location
|
|
|
|
Distal Location
|
|
Patient
|
Imaging Modality
|
Longest Diameter (mm)
|
Shortest Diameter (mm)
|
Luminal Area from Longest Diameter (sq mm)
|
|
Longest Diameter (mm)
|
Shortest Diameter (mm)
|
Luminal Area from Longest Diameter (sq mm)
|
|
Longest Diameter (mm)
|
Shortest Diameter (mm)
|
Luminal Area from Longest Diameter (sq mm)
|
P1
|
IVUS
|
5.4
|
4.3
|
22.9
|
|
5.1
|
4.6
|
20.43
|
|
3.5
|
3
|
9.62
|
|
OCT
|
6.1
|
3.9
|
29.22
|
|
5.7
|
4.2
|
25.52
|
|
3.8
|
3.3
|
11.34
|
P2
|
IVUS
|
4.3
|
4
|
14.52
|
|
3.8
|
3.2
|
11.34
|
|
2.9
|
2.5
|
6.6
|
|
OCT
|
3.9
|
3.3
|
11.95
|
|
4.2
|
3
|
13.85
|
|
3.2
|
3
|
8.04
|
P3
|
IVUS
|
3.9
|
3
|
11.95
|
|
4.4
|
4
|
15.2
|
|
3.1
|
2.6
|
7.54
|
|
OCT
|
4.2
|
2.9
|
13.85
|
|
4.6
|
4.3
|
16.62
|
|
3.2
|
2.7
|
8.04
|
P4
|
IVUS
|
6.4
|
5.9
|
32.17
|
|
5.2
|
4.7
|
21.24
|
|
3.4
|
3.3
|
9.08
|
|
OCT
|
5.7
|
5.3
|
25.52
|
|
4.8
|
4.4
|
18.09
|
|
3.1
|
2.9
|
7.55
|
P5
|
IVUS
|
6.7
|
5.8
|
35.26
|
|
5.9
|
5.1
|
27.34
|
|
5.9
|
5.4
|
27.34
|
|
OCT
|
5.7
|
5
|
25.52
|
|
5.5
|
4.8
|
23.76
|
|
5.5
|
5.1
|
23.76
|
P6
|
IVUS
|
4.8
|
4.1
|
18.09
|
|
3.8
|
3.1
|
11.34
|
|
3.3
|
2.8
|
8.55
|
|
OCT
|
5.4
|
4.1
|
22.9
|
|
3.6
|
2.8
|
10.18
|
|
3.5
|
3
|
9.62
|
P7
|
IVUS
|
5.3
|
4.3
|
22.06
|
|
4.6
|
4
|
16.62
|
|
3.2
|
2.8
|
8.04
|
|
OCT
|
4.6
|
4
|
16.62
|
|
4.2
|
3.5
|
13.85
|
|
3
|
2.6
|
7.06
|
P8
|
IVUS
|
5.3
|
4.3
|
22.06
|
|
5.4
|
4.8
|
22.9
|
|
4.6
|
4.2
|
16.62
|
|
OCT
|
5.6
|
4.7
|
24.63
|
|
5.1
|
4.3
|
20.43
|
|
4.9
|
4.3
|
18.86
|
S1
|
IVUS
|
3.5
|
3
|
9.62
|
|
3.6
|
2.5
|
10.18
|
|
3
|
2.3
|
7.07
|
|
OCT
|
3.8
|
3.2
|
11.34
|
|
3.8
|
2.6
|
11.34
|
|
3.1
|
2.4
|
7.55
|
S2
|
IVUS
|
2.9
|
2
|
6.6
|
|
2.2
|
1.8
|
3.8
|
|
2.3
|
2.1
|
4.15
|
|
OCT
|
2.8
|
2.5
|
6.16
|
|
2.4
|
2
|
4.52
|
|
3.2
|
2.4
|
8.04
|
S3
|
IVUS
|
3.7
|
2.9
|
10.75
|
|
3.9
|
3.4
|
11.94
|
|
3.3
|
2.7
|
8.55
|
|
OCT
|
4.1
|
2.4
|
13.2
|
|
3.4
|
2.6
|
9.08
|
|
3
|
2.5
|
7.07
|
S4
|
IVUS
|
4.6
|
4.2
|
16.62
|
|
3.9
|
3.4
|
11.94
|
|
3.1
|
2.8
|
7.55
|
|
OCT
|
4.3
|
3.9
|
14.52
|
|
3.7
|
3.1
|
10.75
|
|
2.8
|
2.5
|
6.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MEANS
|
IVUS
|
4.7
|
3.9
|
18.55
|
|
4.3
|
3.7
|
15.36
|
|
3.5
|
3
|
10.06
|
|
OCT
|
4.7
|
3.8
|
17.28
|
|
4.2
|
3.4
|
14.83
|
|
3.5
|
3
|
10.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
p = 0.80
|
p = 0.10
|
p = 0.39
|
|
p = 0.54
|
p = 0.02
|
p = 0.52
|
|
p = 0.60
|
p = 0.96
|
p = 0.74
|