Top 10 Reasons To Use IVUS

Through the “eyes” of IVUS,

critical clinical data maybe gathered to
assist healthcare providers in treatment choices

90514774 Slide 1 of 71, Sept 2009

for
patient care.
Through the Eyes of IVUS

Reason #1

90514774 Slide 2 of 71, Sept 2009

Diagnostic IVUS Assessment

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#1 Diagnostic IVUS Assessment
Angiogram is the gold standard for imaging

ƒ Angio Image

90514774 Slide 3 of 71, Sept 2009

Image property of Boston Scientific Corp

Angiogram provides 2 dimensional information

similar to a “roadmap”
Results from case studies are not predictive of results in other cases. Results in other cases may vary. Case study provided by Henry Lui, MD.
#1 Diagnostic IVUS Assessment
IVUS provides 3 dimensional detail of what lies
ahead

90514774 Slide 4 of 71, Sept 2009

Image property of Boston Scientific Corp

IVUS provides additional information not visualized

on the angio “map”
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#1 Diagnostic IVUS Assessment
Impacting treatment choices

Evaluate Lesion Characteristics

Calcification, fibrous, lipid/necrotic zone, mixed plaque,
concentric, eccentric, size, length

Assessment may impact treatment choices

ƒ Pre-dilatation
ƒ Plaque modification
ƒ Stent selection, size and length
ƒ Medical management
ƒ No treatment

90514774 Slide 5 of 71, Sept 2009

 #1 Diagnostic IVUS Assessment
Morphology assessment
ƒ Fatty or soft plaque - Echolucent
May have high lipid content in a mostly
cellular lesion low echogenicity

ƒ Fibrotic plaque – Echodense

Dense fibrosed plaque that causes
attenuation of sound, intermediate
echogenicity, represent the majority of
atherosclerotic plaque

ƒ Calcific plaque – Highly Echogenic

Dense calcific lesions cause bright echoes
with acoustical shadowing

90514774 Slide 6 of 71, Sept 2009

Mintz, Gary S. Intracoronary Ultrasound. (London: Taylor & Francis, 2005), p. 35- 37. Images by Boston Scientific
Corporation. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#1 Diagnostic IVUS Assessment
Anatomic Assessment - Size, length, eccentricity,
tapering and significance
Proximal Reference Lesion Site Distal Reference

B1 B2

90514774 Slide 7 of 71, Sept 2009

B1 B2
Images courtesy Dr. Gary Mintz and Dr. Neil Weissman. Results from case studies are not predictive of results in other cases.
Results in other cases may vary.
Through the Eyes of IVUS

Reason #2
Assessment of Lesion

90514774 Slide 8 of 71, Sept 2009

Significance

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#2 IVUS Assessment - Lesion Significance

IVUS criteria for a “significant” stenosis

ƒ Based on the following studies comparing IVUS to flow wire, and
based on studies with clinical outcome, MLA (minimal lumen area)
less than 4.0 mm2 of a proximal epicardial artery is believed to be a
flow-limiting stenosis1

IVUS criteria for a “significant” LM stenosis2

ƒ Minimum lumen area <6.0 mm2
a) Muray’s Law. The cube of the radius of a parent vessel
equals the sum of the cubes of the radii of the
daughters. If each daughter vessel (LAD and LCX)
requires a MLA of 4.0 mm2, then the LM would need to
have an MLA of 6.0 mm2.

90514774 Slide 9 of 71, Sept 2009

ƒ Based on the concept of “normal” being mean +/- 2SD, the lower
limit of normal for a LM lumen cross sectional area was 7.5 mm2.2

1. Abizaid, Alexandre, Am J Cardiol 1998;82:423-428

2. Fassa et al, JACC 45, No 2, January 18, 2205:204-11
#2 IVUS Assessment - Lesion
Significance
ƒ Validation of IVUS assessment of ischemia- producing
stenosis (pressure wire)
ƒ Comparison of IVUS and pressure wire (measurement
of fractional flow reserve: FFRmyo)

Sensitivity Specificity

AS>70% 100% 68%

MLD<1.8mm 100% 66%
MLA<4.0mm2 82% 56%

90514774 Slide 10 of 71, Sept 2009

Length>10mm 41% 80%
FFR: abnormal ≤0.75 and normal >0.75

Takagi, et al. Circulation 1999;100:250; 5Brigouri, et al. AJC 2001;87:136-41

#2 IVUS Assessment - Lesion
Significance
ƒ Clinical follow-up in 357 intermediate lesions in 300 patients
deferred intervention after IVUS imaging

35 35
4
30 30
IVUS MLD (mm)

Death/MI/TLR
3 25 25 DM
20 20 No-DM

TLR
2
15 15

10 10
1
5 5
r=0.339
0 0 0
0 1 2 3 4 2-3 3-4 4-5 >5 2-3 3-4 4-5 >5
QCA MLD (mm) IVUS MLA (mm2) IVUS MLA (mm2)

90514774 Slide 11 of 71, Sept 2009

ƒ Death/MI/TLR @ (mean) 13 months = 8% overall (2% death/MI and 6% TLR)
ƒ Death/MI/TLR @ (mean) 13 months = 4.4% in lesions with MLA <4.0 mm2
ƒ Only independent predictor of death/MI/TLR was IVUS MLA (p=0.0041)
ƒ Independent predictors of TLR were DM (p=0.0493) and IVUS MLA (p=0.0042)

Abizaid AS, et al. Circulation 1999;100:256-261; Bech G, et al. Circulation

2001;103:2928-2934
#2 IVUS Assessment - Lesion
Significance
ƒ Event-free survival of patients with intermediate lesions and
deferred procedures: comparison of IVUS and physiologic
studies
100 -
90 -
Event-Free Survival (%)

MLA >4.0 mm2 92.0%

80 -
70 - FFR >0.75 89.0%

60 -
50 -
40 -
30 -
20 -

90514774 Slide 12 of 71, Sept 2009

10 -
0-
0 6 12 18 24
Months

Abizaid AS, et al. Circulation 1999;100:256-261; Bech G, et al. Circulation

2001;103:2928-2934
#2 IVUS Assessment - Lesion Significance
FAME Trial -FFR vs Angiography for Multivessel Evaluation Event-
free Survival

Absolute Difference in MACE-free Survival

FFR-guided

Angio-guided
30 days
2.9% 90 days
3.8% 180 days
4.9% 360 days
5.3%

90514774 Slide 13 of 71, Sept 2009

Tonino PAL et al. N Engl J Med 2009; 360:213-224
#2 IVUS Assessment - Lesion Significance and
Anatomical Assessments
Measurement FFR IVUS
Lesion Significance X X
MLA X
MLD X
%Stenosis X
Plaque Burden X
Plaque Tissue Type X
Stent Expansion X
Stent Apposition X

90514774 Slide 14 of 71, Sept 2009

Lesion Length X
Stent Placement X
Dissections X
Through the Eyes of IVUS

Reason #3
Assessment of Angiographically
Indeterminate Lesion

90514774 Slide 15 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#3 Assessment of Angiographically
Indeterminate Lesions
Definition
What is an angiographically indeterminate lesion?

ƒ Angiographically indeterminate lesions occur when there are

overlapping branches, bifurcations, contrast streaming, or ostial
lesions. Example: left main disease

ƒ Or, any ambiguous angiographic lesion, tortuous vessels, sites with

focal spasm, sites with plaque rupture, filling defects, or
angiographically hazy lesions

90514774 Slide 16 of 71, Sept 2009

ƒ Or, anytime the angiographic presentation does not match up with
the clinical presentation

Schoenhagen, IVUS Made Easy, Taylor and Francis 2006

#3 Assessment of Angiographically
Indeterminate Lesions
IVUS Assessment – Left Main

Angiographic challenges of the left main:

ƒ Aortic cusp opacification or streaming of contrast obscures the

ostium

ƒ Short length of the vessel leaves little normal vessel for

comparison

ƒ Distal left main artery may be concealed by the branching of the

left anterior descending and the left circumflex

90514774 Slide 17 of 71, Sept 2009

ƒ Significant inter- and intra-observer variability in the
angiographic assessment of left main

Abizaid, Andrea et al, J AM Coll Cardiol 1999;34:707-715 Slide 6 of 17

#3 Assessment of Angiographically
Indeterminate Lesions
Left Main - Poor Correlation Between Angiographic MLD
and IVUS MLD

90514774 Slide 18 of 71, Sept 2009

Abizaid et al JACC 1999;34:707-15
#3 Assessment of Angiographically
Indeterminate Lesions
Left Main – IVUS Assessment
1.0-
0.9-
0.8-

Event-Free Survival
107 patients with 0.7-
angiographically 0.6-
0.5-
normal or mildly
0.4-
diseased LM 0.3-
0.2- 1 Year Rates
0.1- 2 Year Rates
0.0-
5 10 15 20 25 30
IVUS Minimum Lumen Area

90514774 Slide 19 of 71, Sept 2009

(mm2)

Only the presence of diabetes mellitus (p=0.014) and IVUS

MLA (p=0.015) were independently associated with future
adverse events
Ricciardi et al. JACC, 2005
#3 Assessment of Angiographically
Indeterminate Lesions
Left Main Disease

ƒ LM ostial stenosis by
angiography resulting in
CABG and, even, re-do CABG
(after the grafts closed the
first time)

ƒ No significant plaque by IVUS

(performed after the grafts

90514774 Slide 20 of 71, Sept 2009

closed the second time)

Lumen CSA = 11.9 mm2

Lumen Diameter = 3.5 mm

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images provided by Washington Hospital Center.
#3 Assessment of Angiographically
Indeterminate Lesions
Intermediate Lesion

Intermediate LAD stenosis in a

symptomatic patient with a
positive stress test

90514774 Slide 21 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images provided by Washington Hospital
Center.
#3 Assessment of Angiographically
Indeterminate Lesions
Unusual Morphology
Peri-stent haziness - Double lumen

90514774 Slide 22 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images provided by Washington Hospital Center.
Slide 12 of 17
#3 Assessment of Angiographically
Indeterminate Lesions
Haziness

Stent

90514774 Slide 23 of 71, Sept 2009

Peri-stent haziness - Calcification

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images provided by Washington Hospital Center.
#3 Assessment of Angiographically
Indeterminate Lesions
Haziness

Two
Overlapping
Stents

Hazy
Segment

90514774 Slide 24 of 71, Sept 2009

ƒ Peri-stent haziness - Plaque burden

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images provided by Washington
Hospital Center. Slide 15 of 17
Through the Eyes of IVUS

Reason # 4
Guidance for Plaque Modification

90514774 Slide 25 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#4 Guidance for Plaque Modification
Vessel Prep Options
Assess Lesion Characteristics
•Calcification, fibrocalcific, fibrotic,
mixed plaque, lesion resistance
•Concentric, eccentric, size, length
Cutting Balloon

Assessment may impact treatment

choices
•Pre-dilatation
•Pre-dilatation with cutting
balloon
•Rotablator

90514774 Slide 26 of 71, Sept 2009

Rotablator

Rizik, et al Benefits of Cutting Balloon Before Stenting JINVAS CARDIOL 2003;15:624-628. Bonan, J Invasiv Cardiol, 1999; 11: 23
0Hara et al., Am J Cardiol 2002; 89: 1253-1256,Ergene et al, J Invas Cardiol 1998; 10: 70-75, Global Randomized Trial
Cutting Balloon Device Directions for Use; Data on Filenoue et al., Circulation, 1998;
97:2511-2518 (US SCI #2392),
#4 Guidance for Plaque Modification
IVUS Guidance with Rotablator Procedure
Calcific Lesion Prepped with Rotablator

90514774 Slide 27 of 71, Sept 2009

Case study provided by Ignacio Inglessis, MD. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#4 Guidance for Plaque Modification
Avoid Stent Regret

Post Stent Result:

single 2.75mm stent

Post Dilatation:
3.5x9mm non-
compliant balloon for
30 seconds @ 22atm
followed by 4.0x9mm
non-compliant balloon
for 30 seconds at 16
ATM.

90514774 Slide 28 of 71, Sept 2009

•Lesions which initially appear as either treatable with PTCA or by stenting may benefit from
IVUS assessment to identify plaque morphology.
•Asymmetrical stent expansion occurs in up to 50% of cases where calcium is not treated
before stent deployment.2

Case images courtesy of Dr. Arthur Lee, Santa Clara Valley Medical Center, San Jose, CA
Moussa, Moses, Columbo et al. Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions. Circulation 1997; 96:128-136
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Through the Eyes of IVUS

Reason #5
Guidance for Stenting

90514774 Slide 29 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Reason #5 Guidance for Stenting
In BMS Era, 10/12 Studies Supported IVUS-Guided PCI

Angio IVUS IVUS Also

Study Better Better Cheaper
Choi et al (AHJ 2001;142:112-8) x
CENIC (JACC 2002;39:54A) x
CRUISE (Circulation 2000;102:523-30) x

SIPS (Circulation 2000;102:2497-502 and AJC 2003;91:143-7) x x

AVID (Circulation 1999;100:I-234) x

Gaster et al (Scan Cardiovasc J 2001;35:80-5 & Heart 2003;89:1043-9) x x

RESIST (JACC 1998;32:320-8 & Int J Cardiovasc Intervent 2000;3:207-13) x

TULIP (Circulation 2003;107:62-7) x

90514774 Slide 30 of 71, Sept 2009

BEST (Circulation2003;107:545-551) x
OPTICUS (Circulation. 2001;104:1343-9) x
PRESTO (Am Heart J. 2004;148:501-6) x
DIPOL (Am Heart J 2007;154:669-75) x
#5 Guidance for Stenting
IVUS/DES Studies - Clinical Value of IVUS

• 2650 patients studied comparing IVUS guided

DES stenting to angiography alone

Study Clinical Application

Washington Hospital IVUS/No Roy et al. Eur Heart J
IVUS Study in DES 2008;29:1851-7
1300 patients
Constantini Study – IVUS vs Costantini et al. TCT 2008
Angio in DES
1350 patients

90514774 Slide 31 of 71, Sept 2009

Roy et al. Eur Heart J 2008;29:1851-7; Costantini et al. TCT 2008
#5 Guidance for Stenting
IVUS vs Angio-Guided Stenting-TVF Free Survival Rate

TVF Free- Survival, %

IVUS (N=952)
Log-Rank Test:
p=0.02

Angio (N=398)

Lower CL Upper CL P-value

90514774 Slide 32 of 71, Sept 2009

Age -0.38 -0.09 0.001
Diabetes -0.25 0.03 0.1
MVD -0.29 -0.11 <0.0001
Non IVUS Guidance -0.03 0.25 0.1

Costantini et al. TCT 2008 Slide USCV5689.121.0 Pg 7 of 10

S.T.L.L.R. Trial
1-Year Efficacy & Safety End-Points
Technique is a contributing factor to late events.

14 13 Geographic MissStent
(n =Thrombosis
943) (%)
10 1.5 Miss (n = 473)
No Geographic
12
Geographic Miss (n = 943) Acute SAT Late
No Geographic Miss (n = 473)
of Patients

10 P = NS for all
810 1.2%
P = 0.025 P = 0.04
Overall Geographic Miss 1.0
- 66.6%
of Patients

6 8 0.8%
5.1 Axial Geographic Miss – 35.3% 0.5
Number

6 0.2
Longitudinal Geographic Miss – 47.7%
4
4
2.5 3 2.4 0.5
%

0.5 0.6

90514774 Slide 33 of 71, Sept 2009

22 1
0.8
0 0.1
0 0.0
MI<30day MI 30d-1y
TVR MI GM No GM
Costa M MD TCT 2006
#5 Guidance in Stenting
Lesion coverage

NC, necrotic core, the “culprit of the culprit”

How often is the “culprit of the

culprit” missed during stent
positioning?
And what is the impact on:

90514774 Slide 34 of 71, Sept 2009

Tsujita et al, AHA 2008
#5 Guidance for Stenting
Importance of Stent Apposition

Clinical Evidence Supporting Importance

Objective of Complete Stent Apposition

44% TLR reduction with

TLR complete stent apposition

CRUISE Study, 2003

78% of SATs involved

SATs incomplete stent apposition
Chenau et al , 2003

DES restenosis with

Restenosis incomplete stent strut apposition

90514774 Slide 35 of 71, Sept 2009

Takebayashi , 2004

Drug Delivery Complete stent apposition

facilitates uniform drag delivery

Hwang , 2001
#5 Guidance for Stenting
Expansion - MLD/MSD Optimization

Frequency of Sub-Optimal Stent Deployment

ƒClinical by Baseline QCA Variables
evidence from
the POSTIT
Trial revealed
that when 80%
% Patients not meeting IVUS

using only the

Criteria for Optimum Stent
70% 77% 75%
stent delivery 60%
72%
69%
68%
balloon, over 66%
70% of patients 50%
Deployment

did not achieve 40%

optimal stent 30%
deployment 20%
(90% MSD).
10%

90514774 Slide 36 of 71, Sept 2009

0% <12mm >12mm >70% <70% <3mm >3mm
Lesion Length % Stenosis Average RVD

Brodie B, Cooper C, Jones M, Fitzgerald P, Cummins F, et al. Is adjunctive balloon post-dilatation

necessary after coronary stent deployment? Final results from the POSTIT Trial.
Cathet Cardiovasc Intervent 2003;59:184-192.
#5 Guidance for Stenting
Understanding Stent Expansion
Unconstrained Balloon Diameter = Labeled Diameter
Deployed Balloon Diameter = Labeled Diameter – Lesion Resistance

90514774 Slide 37 of 71, Sept 2009

MLD is dependent on the balloon’s ability to overcome lesion
resistance
Images property of Boston Scientific Corporation.
#5 Guidance for Stenting
Expansion Comparison of Angiographic and IVUS Findings
Post High Pressure Stent Post-Dilation with a
Deployment noncompliant balloon

CSA by angiography - no
difference appreciated in
angiographic views

CSA by IVUS - 40% increase

90514774 Slide 38 of 71, Sept 2009

in CSA measured after
post-dilation
CSA = CSA =
4.9mm2 6.8mm2

J. Am. Coll. Cardiol. Intv. 2008;1;22-31 Results from case studies are not predictive of results in other cases. Results in other cases
may vary.
#5 Guidance for Stenting
Comparison of Measured MSA with the Predicted
Measurements

DES Achieve on Average 66% of Predicted MSA

Final deployment pressures according to stent
type and size
IVUS Measured MSA (mm²)

ƒStent ƒSES ƒAchieved ƒPES ƒAchieved PES

size pressure SES pressure minimum
(mm) (atm) minimum (atm) diameter (mm)
diameter
(mm)

ƒ2.5 ƒ14.55 ƒ2.2 ± 0.3 ƒ14.15 ƒ2.1 ± 0.4

ƒ3.0 ƒ14.15 ƒ2.4 ± 0.3 ƒ15.00 ƒ2.6 ± 0.3

90514774 Slide 39 of 71, Sept 2009

ƒ3.5 ƒ15.00 ƒ2.7 ± 0.4 ƒ14.65 ƒ2.9 ± 0.3

Predicted MSA (mm²)

de Ribamar Costa J et al. Am Heart J. 2007;153:297-03
Through the Eyes of IVUS

Reason #6
Thrombosis and Restenosis

90514774 Slide 40 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#6 Thrombosis
Washington Hospital Center
1296 IVUS-guided, DES-treated lesions in 884 pts vs 1312 propensity-
score-matched, angio-guided, DES-treated lesions in 884 pts

IVUS-
guided Angio-guided p
30 day
MACE 2.8% 5.2% 0.01
Stent thrombosis 0.5% 1.4% 0.045
TLR 0.7% 1.7% 0.045
1 year
MACE 14.5% 16.2% 0.3
Definite stent thrombosis 0.7% 2.0% 0.014

90514774 Slide 41 of 71, Sept 2009

Probably stent thrombosis 4.0% 5.8% 0.08
TLR 5.1% 7.2% 0.06
Late definite stent thrombosis 0.2% 0.7% 0.3

Pg 4 of 10
Roy et al. Eur Heart J 2008;29:1851-7
#6 Thrombosis
Washington Hospital Center

100 IVUS
p=0.013

No-IVUS

95

Stent-Thrombosis Free
Survival Rate

90514774 Slide 42 of 71, Sept 2009

90
0 1 6 12

Months of follow-up
Slide USCV5689.121.0 Pg 5 of 10
Roy et al. Eur Heart J 2008;29:1851-7
#6 Thrombosis
Clinical Utility of IVUS Guidance in PCI 12 Month Outcomes –
Washington Hospital Center

•
• IVUS No IVUS P Value
• (N=884) (N=884)

• Major adverse cardiac events 128 (14.5%) 143 (16.2%) 0.32

• Death 50 (5.7%) 62 (7.1%) 0.23

• Cardiac death 16 (1.9%) 24 (2.8%) 0.18

• Q-wave myocardial infarction 18 (2.1%) 26 (3.1%) 0.21

• Target vessel revascularization 73 (8.5%) 77 (9.1%) 0.69

• Target lesion revascularization 43 (5.1%) 61 (7.2%) 0.06

90514774 Slide 43 of 71, Sept 2009

• Definite stent thrombosis 6 (0.7%) 18 (2.0%) 0.014

• Probable stent thrombosis 35 (4.0%) 51 (5.8%) 0.08

• Late definite stent thrombosis 2 (0.2%) 6 (0.7%) 0.29

Roy, P et al. J. Interv Card 2007 Oct.20(5) 307-13

#6 Thrombosis
Minimum Stent Area and Stent Thrombosis

90514774 Slide 44 of 71, Sept 2009

Okabe et al, Am J Cardiol 2007;15(4): 615-20
#5 Assessment of Restenosis
In-stent restenosis

Assess with IVUS

ƒ Especially if restenosis was early
and if IVUS was not performed at
implantation

ƒ For Potential Contributing

Mechanical Factors
-Expansion
-Apposition
-Geographic miss
-Stent Fracture

90514774 Slide 45 of 71, Sept 2009

-Other
#5 Restenosis
TAXUS IV,V,VI
An Integrated TAXUS IV, V, and VI Intravascular Ultrasound Analysis of the
Predictors of Edge Restenosis After Bare Metal or Paclitaxel-Eluting Stents.

A meta-analysis of 531 patients (BMS=255;

PES=276) with baseline (post-stent
implantation) intravascular ultrasound data from
TAXUS IV, V, and VI to determine predictors of
angiographic stent edge restenosis.

Edge plaque burden was the only independent

predictor of 9-month angiographic edge
restenosis with ROC analysis showing a similar
cut-off in both bare metal and TAXUS stent-
treated patients: c=0.70, p=0.0244, cut-
off=47.7% and c=0.69, p=0.0137, cut-

90514774 Slide 46 of 71, Sept 2009

off=47.1%, respectively

Liu J, Maehara A, Mintz GS, Weissman NJ, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Stone GW.
Am J Cardiology. 2009;103(4):501-506
#6 Thrombosis and Restenosis
Predictors of DES Thrombosis
and Restenosis
DES Thrombosis DES Restenosis
Under Expansion §Fujii
et al. J Am Coll §Sonoda et al. J Am Coll
Cardiol 2005;45:995-8 Cardiol 2004;43:1959-
§Okabe et al., Am J 63
Cardiol. 2007;100:615- §Hong et al. Eur Heart J
20 2006;27:1305-10
§TAXUS&ATLAS
meta-analysis
§Fujii et al. Circulation
2004;109:1085-1088
Edge problems (geographic §Fujii et al. J Am Coll §Sakurai et al. Am J
miss, secondary lesions, Cardiol 2005;45:995-8 Cardiol 2005;96:1251-3
large plaque burden, etc) §Okabe et al., Am J §Liu et al, J Am Coll

90514774 Slide 47 of 71, Sept 2009

Cardiol. 2007;100:615- Cardiol 2008;51:B92
20 §Costa et al, Am J Cardio
§Liu, JACC Intervention, 2008;101:1074-11
in press

Slide USCV5689.121.0 Pg 3 of 10
Through the Eyes of IVUS

Reason #7
Assessment of Complex

90514774 Slide 48 of 71, Sept 2009

Patients/Lesions

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#7 Assessment of Complex Patients/Lesions
Strategic Use of IVUS in Complex Cases
For High Risk Patient Subsets
ƒ Renal failure
ƒ Limitations to dual antiplatelet therapy use
ƒ Diabetes mellitus
ƒ Poor left ventricular function

For High Risk Lesion Subsets

ƒ Bifurcations
ƒ Ostial lesions
ƒ Small vessels
ƒ Long lesions
ƒ Treatment of ISR

90514774 Slide 49 of 71, Sept 2009

ƒ Left main disease given the inconsistent results and risks involved

Mintz, Gary, TCT 2008, IVUS Use in the DES Era, Routine or Selective Use
#7 Assessment of Complex Patients/Lesions
Mechanical challenges increase with lesion
complexity
Percent of patients/lesion with complex features

Small Vessels
(<2.5mm)
3% CTO LM
Single Vessel, Single
Grafts 2% 2%
Stent
ISR 6%
35%
6%

Bifurcations
8%

Ostial Lesions

90514774 Slide 50 of 71, Sept 2009

8%
Single Vessel,
AMI Long Lesions Multiple Stents*
12% (>26mm) 8%
10%

Castagna MT, Mintz GS, Leiboff BO, et al. The contribution of “mechanical” problems to in-stent restenosis: An intravascular
ultrasonographic analysis of 1090 consecutive in-stent restenosis lesions. Am Heart J 2001;142:970-974.
#7 Assessment of Complex Patients/Lesions
Bifurcation Lesions

A sizable percentage (43.5%) of bifurcation lesions have ostial (side branch) involvement1,2
• More complex than an ostial lesion because two ostial lesions or one ostial lesion and
another blocked vessel are close to each other3

90514774 Slide 51 of 71, Sept 2009

Image courtesy of Dr. M. Taniuchi. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Illustration by Boston Scientific Corporation (adapted from Topol EJ, Textbook of interventional cardiology3)
1 Van Mieghem CAG, Thury A, Meijboom WB, et al. Detection and characterization of coronary bifurcation lesions with 64-slice computed tomography

coronary angiography. Eur Heart J. 2007; 28:1968-1976 (doi:10.1093/eurheartj/ehm195).

2 Mathias DW, Mooney JF, Lange HW, Goldenberg IF, Gobel FL, Mooney MR. Frequency of success and complications of coronary angioplasty of a

stenosis at the ostium of a branch vessel. Am J Cardiol. 1991 Mar1; 67(6):491-5.

3 Topol EJ, Colombo A, Stankovic G. Chapter 20: Ostial and bifurcation lesions. Textbook of interventional cardiology. Philadelphia, PA: Saunders

Elsevier;2008:349-375.
#7 Assessment of Complex Patients/Lesions
Ostial Lesions

Ostial lesions are often

fibrotic/elastic and can cause
complications because of recoil
and spasm1

Angiographically assessment of
ostial lesion severity is
hampered by vessel overlap
with the aorta and angulation.2

90514774 Slide 52 of 71, Sept 2009

Image courtesy of Dr. M. Taniuchi. Results from case studies are not predictive of results in other cases. Results in other cases may vary.
1 Mathias DW, Mooney JF, Lange HW, Goldenberg IF, Gobel FL, Mooney MR. Frequency of success and complications of coronary angioplasty of a

stenosis at the ostium of a branch vessel. Am J Cardiol. 1991 Mar1; 67(6):491-5.

2. Tobis et al, Assessment of Intermediate Coronary Lesions, JACC Vol 49, No 8 Feb 27, 2007.
#7 Assessment of Complex Patients/Lesions
Small Vessels
Assessment on size
True vessel size
vs. “apparently” small vessels by
angio
Presence of arterial remodeling

Morphology assessment
Calcification2
Angiographically silent disease
Eccentric/Concentric

Anatomical assessment

90514774 Slide 53 of 71, Sept 2009

Lesion length
Vessel Size
Vessel tapering

1 Feldman, T., J Invas Cardiol, 1998.

2 Mintz, et al., “Patterns of Calicification in Coronary Artery Disease,” Circulation, April 1995, Vol. 91, No. 7
#7 Assessment of Complex Patients/Lesions
Multi-vessel and left main disease
The presence of a significant
left main coronary artery
stenosis or multi-vessel Dominance
Number &
location of
disease has serious clinical lesions
implications.
Left Main
Calcification
Left main lesion location has
the greatest clinical
significance (myocardium at SYNTAX 3-vessel
risk)
Thrombus
Score™
Use of IVUS complements other
Total
tools in assessing the patient

90514774 Slide 54 of 71, Sept 2009

Occlusion
Bifurcation
for optimum treatment
planning, especially in the left
Tortuosity
main.

EuroInterv 2005;1:219-227. Syntax Score has been made possible by support from Boston Scientific Corp and Cardialysis Page 12 of 57
Through the Eyes of IVUS

Reason #8
Assessment For Complications

90514774 Slide 55 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#8 Assessment For Complications
Assess Complications - Dissection

Minor stent edge

dissection

90514774 Slide 56 of 71, Sept 2009

Dissection
0 1.5 mm 7.5 mm

Hermiller, James, MD, May 2008. Results from case studies shown in this slide presentation are not predictive of results in other cases.
Results in other cases may vary
#8 Assessment For Complications
Assess Complications - Dissection

Major stent
edge dissection

90514774 Slide 57 of 71, Sept 2009

Dissection
Pg 34 of 41
Hermiller, James, MD, May 2008. Results from case studies shown in this slide presentation are not predictive of results in other cases.
Results in other cases may vary
#8 Assessment For Complications
Dissections
Calcified Dissection IVUS Superficial
plaque arm catheter calcium

Blood Dissection
IVUS speckle arm: calcified

90514774 Slide 58 of 71, Sept 2009

catheter plaque

Horseshoe Dissection of Fibrous Horseshoe Dissection of

Plaque Extending into the Media Calcified Plaque

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Images porperty of Boston
Scientific Corp.
#8 Assessment For Complications
Assess Complications - Hematomas

0 1.25 mm 7.5 mm

90514774 Slide 59 of 71, Sept 2009

0 2 mm 8 mm

Pg 35 of 41
Hermiller, James, MD, May 2008. Results from case studies shown in this slide presentation are not predictive of results in other cases.
Results in other cases may vary.
Through the Eyes of IVUS

Reason #9
Guidance in Peripheral

90514774 Slide 60 of 71, Sept 2009

Interventions

Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#9 Guidance in Peripheral Interventions
Common Utilization PV IVUS

ƒ IVC Filter Placement

ƒ Visualization of AV Shunts
ƒ Renal Artery Imaging
ƒ Aortic and Arterial Dissections
ƒ Venous Imaging
ƒ EVAR/ TEVAR
ƒ Peripheral Angioplasty (eg. AOID, Iliac, Thrombus)

90514774 Slide 61 of 71, Sept 2009

ƒ Iliac Vein Compression Syndrome

Slide 9 of 24
#9 Guidance in Peripheral Interventions
Aortic Imaging

90514774 Slide 62 of 71, Sept 2009

Results from case studies are not predictive of results in other cases. Results in other cases may vary. Slide 13 of 24
#9 Guidance in Peripheral Interventions
Dissections

90514774 Slide 63 of 71, Sept 2009

Slide 15 of 24
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#9 Guidance in Peripheral Interventions
Venous Imaging
Normal Iliac Vein

90514774 Slide 64 of 71, Sept 2009

Slide 17 of 24
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#9 Guidance in Peripheral Interventions
Venous Imaging
Iliac Vein Compression

90514774 Slide 65 of 71, Sept 2009

Slide 18 of 24
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Through the Eyes of IVUS

Reason #10
Additional Clinical Applications

90514774 Slide 66 of 71, Sept 2009

With IVUS
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
#10 Additional Clinical Applications

ƒ IVUS Assessment in Disease

Progression/Regression

ƒ IVUS Assessment in SVG’s

ƒ IVUS Assessment in Cardiac Transplants

ƒ IVUS use in Clinical Studies/Research

90514774 Slide 67 of 71, Sept 2009

Summary
Top 10 Reasons to Use IVUS

1. Diagnostic IVUS Assessment

2. Assessment of Lesion Significance
3. Assessment of Angiographically Indeterminate Lesion
4. Guidance for Plaque Modification
5. Guidance for Stenting
6. Thrombosis and Restenosis
7. Assessment of Complex Patients/Lesions
8. Assessment For Complications
9. Guidance in Peripheral Interventions
10. Additional Clinical Applications With IVUS

90514774 Slide 68 of 71, Sept 2009

ƒ IVUS Assessment in Disease Progression/Regression
ƒ IVUS Assessment in SVG’s
ƒ IVUS Assessment in Cardiac Transplants
ƒ IVUS use in Clinical Studies/Research
 Thank You

90514774 Slide 69 of 71, Sept 2009

©2009 Boston Scientific Corporation or its affiliates. All rights reserved.
Directions For Use
AtlantisTM SR Pro Imaging Catheter
Intended Use/Indications:
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging
is indicated in patients who are candidates for transluminal coronary interventional procedures.
Contraindications:
Use of this imaging catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety.
Contraindications include: Bacteremia or sepsis, Major coagulation system abnormalities, Patients disqualified for CABG surgery,
Patients disqualified for PTCA, Severe hemodynamic instability or shock, Patients diagnosed with coronary artery spasm, Total
occlusion.
Complications:
The following complications may occur as a consequence of intravascular ultrasound imaging: Arterial dissection, injury or
perforation; Total occlusion; Death; Abrupt closure; Acute myocardial infarction; Ventricular fibrillation; Unstable angina; Air
embolism.
Warnings:
Do not advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower
than the catheter body or forced through a tight stenosis. If resistance is met upon withdrawal of the catheter, verify resistance
using flouroscopy, then remove the entire system simultaneously.
Precautions:
Contents supplied sterile using a gamma radiation (Cobalt 60) process. Do not use if sterile barrier is damaged. If damage is
found call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in
patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or death of the patient. Store in a cool, dark place. During the
procedure, inspect the catheter carefully for any damage which may have occurred during use. The catheter has no user
serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Do not attempt to

90514774 Slide 70 of 71, Sept 2009

connect the catheter to electronic equipment other than the designated systems. Never attempt to attach or detach the catheter
while the motor is running. To do so may damage the connector. Avoid any sharp bends, pinching or crushing of the catheter.
Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. An insertion angle greater than 45
degrees is considered excessive. Care should be taken when a guidewire is exposed in a stented vessel. Catheters that do not
encapsulate the guidewire may engage the stent between the junction of the catheter and guidewire. Care should be taken when
readvancing a guidewire after stent deployment. A guidewire may exit between stent struts when recrossing a stent that is not
fully opposed to the vessel wall. Subsequent advancement of the catheter could cause enlargement between the catheter and the
stent. Care should be taken to slowly remove the catheter from a stented vessel. Turn the MDU “off” before withdrawing the
imaging catheter.
Caution:
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on order of a physician.
Directions For Use
ILAB™ ULTRASOUND IMAGING SYSTEM
INDICATIONS: The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology.
Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as
angioplasty and atherectomy. Refer to the Directions for Use provided with all Boston Scientific ultrasound imaging catheters
to determine compatibility with the iLab System. The imaging catheters generate ultrasound images and are intended for
patient examination of vascular and cardiac anatomies. Boston Scientific manufactures a wide variety of imaging catheters for
different applications. The recommended use of each of these catheters may vary depending on the size and type of catheter.
INDICATIONS FOR AUTOMATIC PULLBACK USE: Automatic Pullback is indicated when the following occurs: The
physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented:
procedure-to-procedure, operator-to-operator. • The physician/operator wants to make linear distance determinations post-
procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed. • Two-dimensional,
longitudinal reconstruction of the anatomy is desired.
CONTRAINDICATIONS: Use of Automatic Pullback is contraindicated where introduction of any catheter would constitute a threat
to patient safety. Use of the imaging catheter is contraindicated where introduction of any catheter would constitute a threat
to patient safety. This instrument is contraindicated for fetal imaging. The contraindications include the following patient
characteristics: • Bacteremia or sepsis • Coronary artery spasm • Intra-arterial or intra-ventricle thrombosis • Life-
threatening rhythmic disorders • Major coagulation system abnormalities • Mechanical heart valves that would be crossed by
the imaging catheter • Myocardial infarction • Severe hemodynamic instability or shock • Total occlusion • Unsuitability for
balloon angioplasty (PTCA) • Unsuitability for coronary artery bypass surgery.
COMPLICATIONS OF VASCULAR IMAGING: The risks and discomforts involved in vascular or cardiac imaging include those
associated with all catheterization procedures. These risks or discomforts may occur at any time with varying frequency or
severity. Additionally, these complications may necessitate additional medical treatment including surgical intervention and, in
rare instances, may result in death: Abrupt closure • Angina • Cardiac arrhythmias including, but not limited to, ventricular
tachycardia, ventricular fibrillation and complete heart block • Catheter/guide wire/pressure wire entrapment • Embolism •
Emergent coronary artery bypass graft (CABG) surgery • Infection • Myocardial infarction, ischemia and/or perforation • Stent
strut damage • Stroke (including cerebral vascular accident and transient ischemic attack) • Thrombus formation • Total

90514774 Slide 71 of 71, Sept 2009

vessel occlusion • Valvular injury • Vessel dissection, injury, spasm or perforation.
WARNINGS/CAUTIONS/PRECAUTIONS: Federal law restricts this device to sale by or on the order of a physician. For further
information, please consult the iLab Ultrasound Imaging System Users Guide.