Challenges for Calcified Complex SFA lesion assessed by IVUS

Masahiko Fujihara, MDKishiwada Tokushukai Hospital

Osaka, Japan

Disclosure

Speaker name :

Mashiko Fujihara

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Background

• Ballooning for SFA disease is becoming most preferred approach in drug-coated balloon era

• However calcified lesions are prevalent in SFA disease

• Current endovascular devices are unable to cope with these calcified lesions

• To obtain optimal dilatation is the most important to keep a long term patency

How to evaluate the vessel calcification?

X-ray CT(enhanced） CT(plain） MRA

How to evaluate the vessel calcification?Intravascular evaluation

60mHz IVUS OCT Angioscopy

≧5

cm

< 5cm

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4

no visible calcium

Calcification < 5cmUnilateral

Calcification ≥ 5cmUnilateral

Calcification < 5cmBilateral

Calcification ≥ 5cmBilateral

Calcification Validation based on PACSS

Rocha-Singh, Catheterization and Cardiovascular Interventions 2014

Severe

< 5cm

≧5

cm

None

a

0-90°

b

91-180°

c

181-270°

d

271-360°

e

Calcium arc assessment by IVUSbased on Calcium Burden Assessment Circumferential grade

Severe

Fanelli F . Cardiovasc Interventional Radiology 2014

Is there a role for DCB in calcified lesions?

90°

180°270°

360°

Grade 1 Grade 2 Grade 3 Grade 4

Little Calcification Severely Calcification

100% 100% 100%

90% 90% 87.5%

50% 50%

0,45 0,460,52

0,590,68 0,66

0,72 0,75

0

0,2

0,4

0,6

0,8

1

0%

20%

40%

60%

80%

100%

1a 1b 2a 2b 3a 3b 4a 4b

Primary patency Late Lumen Loss(PP) (LLL)

a< 3cm

b≥ 3cm

1. Reported criteria for calcification may not be applicable in real world cases?

2. Why are the clinical outcomes after EVT in calcified lesions poor?

3. How to define the predictive factor of a poor clinical course in calcified lesion?

Clinical Questions

Study Design

A multicenter, Cross Sectional investigation (UMIN000023703)

Inclusion Criteria Exclusion Criteria

•Age >20 years old•Rutherford category 2-6•Successfully EVT for SFA lesions•de novo lesions

•CFA,POPA lesions•In stent restenosis

Endpoint

Lesion dilatation depend on calcification severity

Imaging Modality Center

1.Fluoroscopy 2.Angiography (QVA)3. Intra vascular ultrasound (IVUS)

Kishiwada Tokushukai HospitalSaiseikai Nakatsu HospitalJapanese Red Cross Kyoto Daini HospitalShin-Koga HospitalMorinomiya HospitalOsaka General Medical Center Miyazaki Medical Association Hospital

CODE-study Material and Method

8 cases were excluded for protocol violation

13 cases were excluded for not cross or poor visualization of IVUS

150 patients Enrolled in this study

143 patients Angio and IVUS analysis

130 patients Primary analysis

( 32 patients PTA alone/ 98 cases Stent implanted )

111 patients adequate post-procedural IVUS findings

CODE study- Study Scheme

Age (years old) 73±8 eGFR (ml/min) 46.5±28.4

Male (%) 66.1) Serum Ca (mg/dl) 9.01±0.5

Hypertension(%) 94.6 Serum P (mg/dl) 3.6±1.0

Diabetes (%) 54.6 Intact PTH (mg/dl) 89.8±88.1

Dyslipidemia (%) 59.2 Alb (mg/dl) 3.9±0.5

Obesity(%) 23.8

Current Smoking (%) 35.3 PTA alone (%) 24.6

Chronic Kidney Disease (%) 58.9 Scoring/Cutting PTA 13

Hemodialysis (%) 23.8 Stent (%) 75.4

Coronary Artery Disease (%) 57.7

Stroke (%) 27.7

Critical Limb Ischemia (%) 26.1

Ankle Brachial Index 0.6 ±0.3

Patient and Procedural Characteristics (N=130)

QA analysisLesion Length (mm) 146.7

Ref vessel size (mm) 5.2

Minimum Vessel D (mm) 0.95

TASC CD (%) 45.4

% stenosis 81.8

CTO (%) 33.0

BTK run-off 1.4

Calcification length 64.3

Calcification/lesion ratio 0.48

NoneUnibilateral (%)

25.420.054.6

Lesion and Calcification Characteristics (N=130)

IVUS analysisDistal lumen area (mm2) 19.3

Proximal lumen area (mm2) 23.5

Minimum lumen area (mm2) 2.31

Calcified Nodule (%) 25.4

Calcification (%) 78.4

Maximum Calcification site (N=102)

-Lumen Area (mm2) 6.2

-Vessel Area 27.3

-Angle (degree) 193.2

-smooth/irregular (%) 68.6/31.3

-concave凹/convex凸 (%) 29.4/70.1

≧5

cm

< 5cm

Grade 0 Grade 1 Grade 2 Grade 3 Grade 4

no visible calcium

Calcification < 5cmUnilateral

Calcification ≥ 5cmUnilateral

Calcification < 5cmBilateral

Calcification ≥ 5cmBilateral

Calcification Validation based on PACSSSevere

< 5cm

≧5

cm

22% 20% 5% 15% 39%

None

a

0-90°

b

91-180°

c

181-270°

d

271-360°

e

Calcium arc assessment by IVUSbased on Calcium Burden Assessment Circumferential grade

Severe

22% 16% 23% 18% 23%

Dilatation pattern assessed by IVUS-Pre and Post procedural MLA-

Post-procedural minim lumen area (MLA), in-stent area if stent implanted

Pre MLA

Post MLA

(PTA alone group) Pre MLA

Post Minimum Stent Area

(Stent implanted group)

No calcification（n=20）

Calcification（n=91）

Post-procedural minimum lumen area (mm2) 17.8 ± 5.2 14.1 ± 4.4

Association of calcification with post-procedural MLA

0

5

10

15

20

25

Post-

pro

cedura

l M

LA

(m

m2

) P<0.001

Relation between calcification arc more 180°and post-procedural MLA

Characteristics of calcification

Crudedifference (mm2)

Adjusteddifference (mm2)Model 1

Adjusteddifference (mm2)Model 2

Calcification -3.7 [-5.9, -1.5]* -3.6 [-5.1, -2.0]* -2.3 [-4.2, -0.3]*Calcification>5cm -2.1 [-3.8, -0.3]* -1.8 [-3.0, -0.5]* 0.4 [-1.2, 2.0]Bilateral Calcification -2.9 [-4.6, -1.2]* -2.3 [-3.6, -1.0]* 0.0 [-1.7, 1.6]Intimal type calcification -2.3 [-4.0, -0.5]* -2.6 [-3.9, -1.4]* -0.8 [-2.4, 0.8]Calcification>180° -3.6 [-5.3, -2.0]* -3.3 [-4.5, -2.2]* -2.2 [-3.8, -0.5]*Calcified Nodule -2.9 [-4.7, -1.0]* -2.5 [-3.9, -1.1]* -0.6 [-2.1, 0.9]

Model 1: Adjusted by (Distal vessel area・with or without stent implanted)

Model 2: Adjusted by (Distal vessel area・with or without stent implanted・calcification・>5cmcalcification・bilateral calcification・intima type

calcification・>180°calcification・calcified nodule

←Small vessel Large vessel→

Post Procedural MLAAdjusted by Distal lumen area

Relation between post-procedural MLAand calcification arc more than 180°

No calcification（n=20）

<180° calcification（n=46）

≥ 180° calcification（n=45）

Post-procedural MLA (mm2) 17.7 [16.4, 19.0] 15.4 [14.6, 16.3] 12.8 [11.9, 13.7]

P value（vs. non calcification） P = 0.006 P < 0.001

P value（vs. <180° calcification） P < 0.001

Adjusted by (Distal vessel area・with or without stent implanted)

10

11

12

13

14

15

16

17

18

19

Post-

pro

cedura

l M

LA

(m

m2

)

Predictive factors of more than 180°Calcification arc - multi-variate analysis -

Unadjusted Odds ratio Adjusted Odds ratioMale 0.7 [0.4, 1.4] (p = 0.350) N/I≥75 years old 0.7 [0.4, 1.4] (p = 0.370) N/ICurrent smoking 0.7 [0.3, 1.3] (p = 0.247) N/IHypertension 3.2 [0.8, 13.5] (p = 0.113) N/IDyslipidemia 1.2 [0.6, 2.3] (p = 0.559) N/IDiabetes Mellitus 3.0 [1.5, 5.8] (p = 0.001) 2.2 [1.1, 4.3] (p = 0.028)Chronic Kidney Disease 4.4 [2.0, 9.4] (p = 0.000) 3.4 [1.6, 7.6] (p = 0.002)

Days 0 180 360 540

at risks (None Calc) 28 26 18 11% 0 4.0 28.0 28

at risks (Calc <180°) 51 42 34 17

% 0 14.6 27.8 44.9at risks (Calc ≥180°) 49 35 24 10

% 0 27.7 43.7 55.1

Days 0 180 360 540

at risks (None Calc) 28 26 22 17% 0 3.8 11.5 11.5

at risks (Calc <180°) 51 46 40 20

% 0 6.3 12.9 15.3at risks (Calc ≥180°) 49 43 31 19

% 0 6.4 16.6 19.6

DAYSDAYSTLR

rate

Resten

osis

Rate

P=0.47 log-rankP=0.032* log-rank

Calcification≥180°Calcification<180°None Calcification

Clinical Outcomes by vessel calcification severity

Calcification≥180°Calcification<180°None Calcification

• The calcification pattern of symptomatic SFA disease were analyzed

• In our study, 80% of cases showed calcifications

• On either previous reported criteria, 40-55% of patients were classified in severe calcification.

• Calcified lesion showed smaller MLAcompared to non-calcified group

• Calcified arc more than 180°were related to incomplete expansion and predict the poor clinical outcomes

Result of CODE study

• Assessment of calcified arc by IVUS could predict post dilatation pattern

• To cope with more than ≥180°calcified arc, vessel modification by atherectomy device could be needed to obtain full expansion of the calcified vessel

• Predictive factors related to more than 180°calcified arc were diabetes and chronic kidney disease

• Vessel preparation with the other device is the key for vessel calcified lesion dilatation before DCB or also stent.

Lesson From CODE study

Thank you for your attention

JET2018 Osaka, Japan

February 23(Fri)-25(Sun) 201810th Anniversary JET 2018