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Prediction of the debulking effect of rotational atherectomy using optical frequency domain imaging

Tanimura, Kosuke Otake, Hiromasa Kawamori, Hiroyuki Toba, Takayoshi Nagasawa, Akira Sugizaki, Yoichiro Takeshige, Ryo Nakano, Shinsuke Matsuoka, Yoichiro Takahashi, Yu Fukuyama, Yusuke Hirata, Kenichi 神戸大学

2021.04.08

概要

Whether predicting the rotational atherectomy (RA) effect based on the position of optical frequency domain imaging (OFDI) is accurate remains uncertain. The aim of this study was to evaluate the predictive accuracy of OFDI in identifying RA location and area. Twenty-five patients who underwent RA with OFDI were included. On pre-RA OFDI images, a circle with the dimension of a Rota burr was drawn at the center of the OFDI catheter. The area where the circle overlapped with the vessel wall was defined as the predicted ablation area (P-area), and the actual ablated area (A-area) was measured. The predictive accuracy of OFDI was evaluated as follows: overlapped ablation area (O-area: overlapping P- and A-areas) divided by P-area = %Correct-area, and A-area − O-area divided by A-area = %Error-area. Cross-sections were separated into four categories based on the median values of %Correct- and %Error-area. Among 334 cross-sections, RA effects were confirmed in the predicted location in 87% of them. The median %Correct- and %Error-areas were 43.1% and 64.2%, respectively. Floppy wire, narrow lumen area, OFDI catheter close to the intima, and large arc of calcium were independently associated with good prediction (high %Correct-/low %Error-areas). Non-left anterior descending lesions, OFDI catheter far from the wire, and OFDI catheter and wire far from the intima were associated with irrelevant ablation (low %Correct-/ high %Error-areas). The accuracy of the OFDI-based predictions for RA effects was acceptable with regard to location, but not high with regard to area. Wire types, target vessels, and OFDI catheter and wire positions are important determinants for accurately predicting RA effect using pre-procedural OFDI.

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参考文献

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21

Figure Legends

Figure 1. Definition process of predicted and actual ablation according to OFDI

before and after rotational atherectomy and a representative case of OFDI

findings following rotational atherectomy.

(A) Definition process of the predicted and actual ablation areas. Cross-sectional

OFDI image (1) before and (2) after RA. (3, 4) Superimposed OFDI images of

before and after RA. The blue dotted line area indicates the predicted ablation area

(P-area). The yellow dotted line indicates the actual ablation area (A-area). White

circle indicates the Rota burr size circle (1.75 mm). (3) The red dotted line indicates

where the P-area and A-area overlapped (O-area). (4) Blue, yellow, and red angles

indicate the P-, R-, and O-angles, respectively. (B) Deep vessel wall injury extending

beyond the media before (1) and after RA (2). Blue area indicates P-area. Yellow

area indicates A-area. White circle indicates the Rota burr size circle (1.50 mm).

Asterisks show deep vessel wall injury extending beyond the media following RA on

above image. (C) Intimal flap outside of P-area (1) before and (2) after RA. White

arrowhead indicates intimal flap outside of the P-area following RA. White circle

indicates the Burr size circle (2.00 mm). OFDI, optical frequency domain imaging;

RA, rotational atherectomy.

Figure 2. Distribution of %Correct-angle.

Figure 3. Distribution of %Correct- and %Error-areas in all cross-sections.

All cross-sections were plotted according to %Correct- and %Error-areas. The

median %Correct- and %Error-areas were 43.1% and 64.2%, respectively. %Correct-

22

area, the ratio of correctness area; %Error-area, the ratio of error area.

Figure 4. Representative angiography and OFDI of good prediction and

irrelevant ablation cases.

(A) Good prediction. (B) Irrelevant ablation. Angiography images with (upper left)

and without contrast (lower left) are shown. OFDI results before and after rotational

atherectomy are shown (right). White double-head arrow indicates target lesions.

White triangles indicate wire position. White circles indicate the circle with Rota

burr dimensions. Blue dotted line indicates the predicted ablation area (P-area).

Yellow dotted line indicates the actual ablation area (A-area). The green dotted area

indicates the P-area with wire-based prediction. (A) In the leftmost cross-sections, Pand A-area were measured as 0.89 mm2 and 0.86 mm2, respectively, and O-area

(where overlapped P- and A-area) was 0.86 mm2. The %Correct- and %Error-area

were calculated to be 96.6% (O-area / P-area×100) and 0% ([A-area − O-area / Aarea]×100), respectively. After conducting similar measurement and calculation on

each cross-section, the mean %Correct-and %Error-area for each lesion were

calculated by the sum of %Correct-and %Error-area for each cross-section divided

by the number of cross-sections of the lesion. The mean %Correct- and %Error-area

were calculated to be 55% and 8%, respectively. (B) The mean %Correctand %Error-areas were 29% and 74%, respectively. OFDI, optical frequency domain

imaging; RA, rotational atherectomy; P-area, predicted ablation area; A-area, real

ablation area.

23

Table 1. Patient, lesion, and procedural characteristics

Overall

Patients, n

Age, yrs

Male, n (%)

Comorbidities

Hypertension, n (%)

Diabetes mellitus, n (%)

Dyslipidemia, n (%)

Chronic kidney disease, n (%)

25

70.5 ± 10.1

20 (80)

20 (80)

14 (56)

19 (76)

15 (60)

Hemodialysis, n (%)

Diagnosis

Stable angina pectoris, n (%)

Acute coronary syndrome, n (%)

Lesion, n

Cross-section, n

Target vessel

LAD, n (%)

LCx, n (%)

RCA, n (%)

6 (24)

25 (100)

0 (0)

26

334

15 (58)

6 (23)

5 (19)

Target lesion

Proximal, n (%)

Mid, n (%)

Distal, n (%)

Approach site

Transfemoral, n (%)

Transradial, n (%)

Guiding catheter type

Judkins, n (%)

Extra back up, n (%)

Amplatzer, n (%)

13 (50)

11 (42)

2 (8)

17 (65)

9 (35)

6 (23)

13 (50)

7 (27)

Rotawire type

Floppy wire, n (%)

Extra-support wire, n (%)

Burr size

1.50 mm, n (%)

16 (62)

10 (38)

15 (58)

24

1.75 mm, n (%)

2.00 mm, n (%)

2.15 mm, n (%)

QCA analysis

Lesion length, mm

Reference diameter, mm

MLD, mm

%Diameter stenosis, %

Burr-to-artery ratio

9 (34)

1 (4)

1 (4)

19.9 (17.5–22.8)

2.77 (2.20–3.18)

1.06 (0.83–1.26)

60.5 (47.5–67.1)

0.47 (0.39–0.53)

Values are expressed as median (interquartile range) or n (%). Abbreviations:

LAD, left anterior descending; LCx, left circumflex; MLD, minimum lumen

diameter; RCA, right coronary artery.

25

Table 2. OFDI measurements before and after rotational atherectomy according

to cross-section-based analysis

Overall

Pre/post-operative lumen measurements

n=334

Pre minimum lumen diameter, mm

1.62 (1.19–2.08)

Pre mean lumen diameter, mm

1.90 (1.53–2.48)

Pre lumen area, mm²

2.84 (1.84–4.88)

Burr/pre lumen ratio

0.88 (0.65–1.09)

Post minimum lumen diameter, mm

2.01 (1.67–2.28)

Post mean lumen diameter, mm

2.39 (2.01–2.71)

Post lumen area, mm²

4.48 (3.17–5.76)

Morphology of calcification

n=334

Arc of calcium, °

154.9 (97.3–257.4)

Minimum depth of calcium, µm

800 (540–1080)

Circumferential calcification, n (%)

104 (31.1)

Eccentric calcification, n (%)

123 (36.8)

Nodular calcification, n (%)

107 (32.0)

Location of myocardial site, n (%)

157 (68.2)

Location of pericardial site, n (%)

73 (31.8)

RA-related measurement

Angle-based analysis

n=311

P-angle, ˚

127.1 (65.3–218.7)

A-angle, ˚

102.9 (70.6–142.3)

O-angle, ˚

64.6 (23.9–118.1)

%Correct-angle, %

55.3 (22.6–90.1)

Area-based analysis

n=334

P-area, mm²

0.47 (0.20–0.74)

A-area, mm²

0.54 (0.28–0.99)

O-area, mm²

0.18 (0.05–0.35)

%Correct-area, %

43.1 (14.9–69.4)

%Error-area, %

64.2 (31.4–90.4)

OFDI and wire position

n=334

Minimum distance between the OFDI catheter and intima, mm

0.001 (0–0.155)

Minimum distance between the wire and intima, mm

0.20 (0.10–0.33)

Minimum distance between the OFDI catheter and wire, mm

26

0.02 (0–0.05)

OFDI findings following RA

n=334

Deep vessel wall injury extending beyond media, n (%)

14 (4.2)

Intimal flap outside of the P-area, n (%)

26 (7.8)

Values are expressed as median (interquartile range) or n (%). Burr/lumen ratio was calculated

by dividing the Rota burr size by the mean lumen diameter. %Correct-angle was calculated as

O-angle divided by P-angle. %Correct-area was calculated as O-area divided by P-area. %Errorarea was calculated as A-area minus O-area divided by A-area. Abbreviations: RA, rotational

atherectomy; OFDI, optical frequency domain imaging; P-area, predicted ablation area; A-area,

actual ablation area; O-area, overlap ablation area; P-angle, angle of predicted ablation area; Aangle, angle of actual ablation area; O-angle, angle of overlap ablation area; %Correct-angle

(area), percentage of correct ablation angle (area); %Error-area, percentage of error ablation

area.

27

Table 3. Univariate and multivariate logistic regression analyses according to the good prediction group

Variables

Univariate

Multivariate

OR

95% CI

P value

OR

95% CI

P value

LAD

Floppy wire

1.99

1.86

1.21 – 3.29

1.12 – 3.09

0.007

0.016

2.59

1.45 – 4.62

0.001

Judkins type guiding catheter

Pre lumen area

Burr / lumen ratio

Distance between the OFDI catheter and intima

Distance between the wire and intima

Distance between the OFDI catheter and wire

Myocardial site calcification

0.89

0.70

8.17

0.00

0.18

0.03

0.69

0.49 – 1.61

0.60 – 0.81

3.61 – 18.5

0.00 – 0.03

0.05 – 0.65

0.001 – 0.61

0.43 – 1.08

0.692

<0.001

<0.001

<0.001

0.008

0.024

0.104

4.12

0.01

1.71 – 10.1

0.00 – 0.16

0.002

0.001

Arc of calcium

Thickness of calcium

1.00

0.72

1.00 – 1.01

0.43 – 1.22

0.006

0.22

1.00

1.00 – 1.01

0.006

Abbreviation: LAD, left anterior descending; OFDI, optical frequency domain imaging.

28

Table 4. Univariate and multivariate logistic regression analyses according to the irrelevant ablation group

Variables

Univariate

Multivariate

OR

95% CI

P value

OR

95% CI

P value

LAD

Extra-support wire

0.49

1.38

0.31 – 0.79

0.86 – 2.21

0.003

0.18

0.54

0.33 – 0.89

0.016

Judkins type guiding catheter

Pre lumen area

Burr / lumen ratio

Distance between the OFDI catheter and intima

Distance between the wire and intima

Distance between the OFDI catheter and wire

Myocardial site calcification

1.25

1.26

0.13

154.7

7.46

206.7

0.97

0.70 – 2.23

1.12 – 1.42

0.05 – 0.31

19.6 – 1221

2.36 – 23.5

11.5 – 3279

0.62 – 1.53

0.45

<0.001

<0.001

<0.001

0.001

<0.001

0.903

30.4

4.05

44.3

2.92 – 316.4

1.15 – 14.3

3.67 – 534.1

0.004

0.03

0.003

Arc of calcium

Thickness of calcium

1.00

1.47

0.99 – 1.003

0.87 – 2.49

0.53

0.15

Abbreviation: LAD, left anterior descending; OFDI, optical frequency domain imaging.

29

Figure 1.

30

Figure 2.

31

Figure 3.

32

Figure 4.

33

Supplementary Table 1. OFDI measurements before and after rotational

atherectomy according to lesion-based analysis.

n=26

Pre/post-operative lumen measurements

Pre minimum lumen diameter, mm

0.97 (0.83–1.19)

Pre minimum lumen area, mm2

1.59 (1.30–2.15)

Post minimum lumen diameter, mm

1.61 (1.45–1.77)

Post minimum lumen area, mm2

1.98 (1.87–2.16)

Morphology of calcification

Length of calcification, mm

21.9 (14.8–33.6)

Circumferential calcification, n (%)

9 (34.6)

Eccentric calcification, n (%)

9 (34.6)

Nodular calcification, n (%)

8 (30.8)

RA-related measurement

Angle-based analysis

P-angle, ˚

120.0 (78.0–174.6)

A-angle, ˚

80.4 (62.4–139.4)

O-angle, ˚

49.6 (32.0–112.4)

%Correct-angle, %

43.0 (28.0–51.0)

Volume-based analysis

P-volume, mm3

6.08 (3.52–10.59)

A-volume, mm3

6.39 (3.54–12.36)

O-volume, mm3

2.11 (1.14–4.55)

%Correct-volume, %

50.3 (29.0–57.0)

%Error-volume, %

67.0 (50.0–77.0)

OFDI and wire position

Minimum distance between the OFDI catheter and intima, mm

0.08 (0.04–0.13)

Minimum distance between the wire and intima, mm

0.25 (0.22–0.29)

Minimum distance between the OFDI catheter and wire, mm

0.04 (0.01–0.07)

Values are expressed as median (interquartile range) or n (%). All variables were calculated as

averages at each cross-section per lesion. %Correct-angle was calculated as O-angle divided by

P-angle. %Correct-area was calculated as O-area divided by P-area. %Error-area was calculated

as A-area minus O-area divided by A-area. P-, A-, and O-volume was calculated by integrating

P-, A-, and O-area each cross-section, respectively. %Correct-volume was calculated as Ovolume divided by P-volume. %Error-volume was calculated as A-volume minus O-volume

34

divided by A-volume. Abbreviations: RA, rotational atherectomy; OFDI, optical frequency

domain imaging; P-area (volume), predicted ablation area (volume); A-area (volume), actual

ablation area (volume); O-area (volume), overlap ablation area (volume); P-angle, angle of

predicted ablation area; A-angle, angle of actual ablation area; O-angle, angle of overlap ablation

area; %Correct-angle (volume), percentage of correct ablation angle (volume); %Error-volume,

percentage of error ablation volume.

35

Supplementary Table 2. Multiple linear regression analyses for %Correct- and %Error-volume

Variables

%Correct-volume

%Error-volume

Standard B

95% CI

P value

Standard B

95% CI

P value

Age

0.08

-0.86 – 1.10

0.790

-0.08

-1.47 – 1.10

0.760

Male

-0.04

-21.3 – 17.8

0.849

0.19

-14.1 – 37.3

0.346

LAD

0.13

-15.2 – 23.7

0.646

-0.27

--38.5 – 12.6

0.291

Floppy wire

-0.12

-21.3 – 13.2

0.617

-0.36-

-40.3 – 5.11

0.117

Judkins type guiding catheter

0.13

-15.3 – 25.1

0.607

0.15

-18.1 – 35.0

0.501

Pre minimum lumen area

-0.01

-14.6 – 14.1

0.968

0.23

-10.2 – 27.5

0.338

Burr / artery ratio

-0.07

-57.2 – 45.9

0.817

-0.20

-91.3 – -44.4

0.465

Mean distance between the OFDI catheter and intima

0.21

-118.1 – 221.8

0.519

-0.26

-315.1 – 131.9

0.390

Mean distance between the wire and intima

-0.17

-114.9 – 62.2

0.529

-0.34

-193.5 – 39.3

0.175

Mean distance between the OFDI catheter and wire

-0.66

-147.6 – 6.0

0.068

0.41

-37.0 – 164.9

0.193

Mean arc of calcium

0.23

-0.08 – 6.69

0.381

0.10

-0.14 – 0.21

0.667

Mean thickness of calcium

-0.38

-46.7 – 6.69

0.128

0.31

-10.7 – 59.6

0.156

Abbreviation: LAD, left anterior descending; OFDI, optical frequency domain imaging.

36

Supplementary Table 3. Univariate and multivariate logistic regression analyses according to the over ablation group

Variables

Univariate

Multivariate

OR

95% CI

P value

OR

95% CI

P value

LCx

Extra-support wire

2.52

2.80

1.24 – 5.01

1.53 – 5.11

0.01

0.001

2.21

1.17 – 4.16

0.014

Judkins type guiding catheter

Pre lumen area

Burr / lumen ratio

Distance between the OFDI catheter and intima

Distance between the wire and intima

Distance between the OFDI catheter and wire

Myocardial site calcification

1.13

1.23

0.16

7.81

0.24

0.11

2.01

0.53 – 2.41

1.07 – 1.41

0.05 – 0.52

0.78 – 78.6

0.04 – 1.33

0.003 – 3.87

1.10 – 3.68

0.747

0.003

0.002

0.081

0.103

0.23

0.024

Arc of calcium

Thickness of calcium

1.00

1.92

1.00 – 1.001

0.96 – 3.84

0.183

0.065

Abbreviation: LCx, left circumflex; OFDI, optical frequency domain imaging.

37

Supplementary Figure 1. Patient flowchart.

38

Supplementary Figure 2. Distributions of OFDI findings following rotational

atherectomy.

(A) Presence of deep vessel wall injury extending beyond the media following

rotational atherectomy. The cross-section with deep vessel wall injury was more

frequently observed in the over ablation group (9.6% of cross-sections, 5 of 52 crosssections, χ² test: P = 0.60). (B) Presence of intimal flap outside of the P-area following

rotational atherectomy. Cross-sections with intimal flap outside the P-area were more

frequently observed in the irrelevant ablation group than the other groups (18.1% of

cross-sections, 21 of 116 cross-sections, χ² test: P <0.001). OFDI, optical frequency

domain imaging.

39

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