SHAPE Society

1. IntroductionIntroductionJacques Barth M.D., Ph.D, FACC, FAHAJacques Barth M.D., Ph.D, FACC, FAHA
Professor at W.M Keck School of MedicineProfessor at W.M Keck School of Medicine
University of Southern California, LosUniversity of Southern California, Los
Angeles, CaliforniaAngeles, California
• Expert in preventive cardiology ,Expert in preventive cardiology ,
endocrinology and image processingendocrinology and image processing
Pioneer in the development of ultrasoundPioneer in the development of ultrasound
technology to assess cardiovascular risktechnology to assess cardiovascular risk
Senior Scientist for NASA’s NationalSenior Scientist for NASA’s National
Research Council at the Jet PropulsionResearch Council at the Jet Propulsion
LaboratoryLaboratory
Involved in Image Laboratories inInvolved in Image Laboratories in
Amsterdam, Rotterdam, Vancouver andAmsterdam, Rotterdam, Vancouver and
Los AngelesLos Angeles
CORE Laboratory for Pharma, State ,CORE Laboratory for Pharma, State ,
Federal and International studiesFederal and International studies

2. Evolution IMTEvolution IMT
measurement 1986-2005.measurement 1986-2005.
Vulnerable PlaquesVulnerable Plaques
Myths and issuesMyths and issues
Reporting 2005Reporting 2005

4. Normal Arterial WallNormal Arterial Wall
Tunica adventitia
Tunica media
Tunica intima
Endothelium
Subendothelial connective
tissue
Smooth muscle cell
Internal elastic membrane
Elastic/collagen fibres
External elastic membrane

5. Blood Flow Features atBlood Flow Features at
Carotid BifurcationCarotid Bifurcation
 This figure depicts the region of
flow separation with formation of
secondary vortices.
 While flow remains laminar and
mainly unidirectional in the high-
shear flow-divider area, a very
low-shear area is present on the
lateral wall of the internal carotid
artery.
 This area is where plaques are
most likely to form and where
blood flow accelerates with each
cardiac cycles.

7. 19861986

12. 19921992
Edge-Contour DetectionEdge-Contour Detection

15. Intima-Medial Thickness ChangeIntima-Medial Thickness Change
Colestipol-Niacin Therapy and Placebo over 48 m - CLAS StudyColestipol-Niacin Therapy and Placebo over 48 m - CLAS Study
Time (months)
• Placebo •Active medication
Intima
Media
Thickness
(mm)

19. IMT HeartScan vs. Caliper IMTIMT HeartScan vs. Caliper IMT
Observer 1
1.00
0.5
1.000 0.5
0
n=50
r =.95
Standard Deviations: Observer 1 = 4.05 Observer = 12.45 p < 0.01
Observer 1
Observer2IMTThickness
r =.63
Observer2IMTThickness
1.000 0.5
n=50

20. 1997 Prosound (PCI)1997 Prosound (PCI)
Patient StudiesPatient Studies

22. IMT Triage - Utah ProjectIMT Triage - Utah Project
N = 556
A 137 (25 %) B 206 (37%) C 105 (19%)
D 82 (15%)
Of the 556
E 13 (4%)
AA p<50 Percp<50 Perc BB p=75-95 Percp=75-95 Perc CC >ULN>ULN RR 2-3RR 2-3 (Average Risk 1.5)(Average Risk 1.5)
DD RR 4-6RR 4-6 EE RR 6-10RR 6-10 (Average Risk 2.7)(Average Risk 2.7)

23. Patient Compliance:Patient Compliance:
An Illusion?An Illusion?

24. Personal Image N=210Personal Image N=210
Hypertension(n)Hypertension(n)
HypercholesterolemiaHypercholesterolemia
Smoking (n)Smoking (n)
Weight Loss (kg)Weight Loss (kg)
QIMT values (mm)QIMT values (mm)
±± SD;SD; *p<0.05,*p<0.05, **p<0.01 ;**p<0.01 ;
Barth JD , Am J Cardiol 2001Barth JD , Am J Cardiol 2001
IMT HeartscanIMT Heartscan
Efficacy StudyEfficacy Study
Baseline 1 2 months
Y N
88 14 /44** 21/44
108 10/54 ** 18/54
42 13/21** 19/21
87 9.5 1
0.790 0.777** 0.790
±0.070 ± 0.062 ± 0.067

25. Impact of Picture on ComplianceImpact of Picture on Compliance
 Cap test with microchipsCap test with microchips
 30 tablets, once a day; after 30 days a pill count;30 tablets, once a day; after 30 days a pill count;
Results:Results:
without picturewithout picture with picturewith picture
40%40% 76%76%

26. C h i l d r e n :C h i l d r e n :
VulnerableVulnerable
and oftenand often
forgotten groupforgotten group

28. Ultrasound Imaging AssessmentUltrasound Imaging Assessment
Carotid Artery as a Predictor of Diabetes Susceptibility inCarotid Artery as a Predictor of Diabetes Susceptibility in
Adolescent Ethnic Population GroupsAdolescent Ethnic Population Groups
PARAMETERPARAMETER HispanicHispanic CaucasianCaucasian
 Males and femalesMales and females N=118N=118 N=94N=94
 Average age yearsAverage age years 15.015.0 15.915.9
 % E from Fat (>30%)% E from Fat (>30%) 89 %89 % 77%77%
 % Dietary Cholesterol(>300 mg/d)% Dietary Cholesterol(>300 mg/d) 51%51% 53%53%
 Serum LDL- Cholesterol(>100 mg/dl)Serum LDL- Cholesterol(>100 mg/dl) 37%37% 19%19%
 HDL-Cholesterol(<40 mg/dl)HDL-Cholesterol(<40 mg/dl) 18%**18%** 10%10%
 Glucose (>100 mg/dl)Glucose (>100 mg/dl) 8%**8%** 4%4%
 BMI (>30 kg/m²)BMI (>30 kg/m²) 53%*53%* 36%36%
 QIMT (μ±sd)QIMT (μ±sd) 522±017* 539±021522±017* 539±021
 Plaques in Diabetics (n)Plaques in Diabetics (n) 4/7**4/7** 0/50/5
E = Energy BMI = Body Mass Index ** p<0.01, * p<0.05E = Energy BMI = Body Mass Index ** p<0.01, * p<0.05

29. IMT HeartScanIMT HeartScan::
TheThe mostmost sensitive Marker of Insulinsensitive Marker of Insulin
ResistanceResistance
BMI>30 (n=27;7-17 y)BMI>30 (n=27;7-17 y) BMI <25 (n=13;7-17 y)BMI <25 (n=13;7-17 y)
FBSFBS 92.492.4 79.479.4 mg/dl p<0.0005mg/dl p<0.0005
HbAc1HbAc1 5.075.07 5.255.25 NSNS
InsulinInsulin 20.020.0 7.87.8 µµU/mlU/ml p<0.0005p<0.0005
HOMAHOMA 4.544.54 1.931.93 p<0.001p<0.001
[ HOMA: Homeostasis Model Assessment (IR) ][ HOMA: Homeostasis Model Assessment (IR) ]
Conclusions:Conclusions:
 IMT vs INS value r = 0.855IMT vs INS value r = 0.855 p<0.001p<0.001
 IMT vs BMI value r = 0.570IMT vs BMI value r = 0.570 p<0.01p<0.01

30. Plaque Vulnerability:Plaque Vulnerability:
What does it mean for the clinician?What does it mean for the clinician?

39. ZoeZoeXPXP
20052005 InternetInternet EnabledEnabled

40. PCIPCI HeartScanHeartScan™™
MeasurementMeasurement VariabilityVariability
 Three operators measured FAR WALL IMTThree operators measured FAR WALL IMT
using the PCI standardized procedureusing the PCI standardized procedure
 Intra-operator and inter-operator intra-classIntra-operator and inter-operator intra-class
correlations both were 0.97correlations both were 0.97
 Coefficients of variation within readers wasCoefficients of variation within readers was
3.0% and between readers was 3.1%3.0% and between readers was 3.1%

41. About the TechnologyAbout the Technology
Physician writes referral
prescription for
IMT HeartScan Certified ultrasound tech performs
15 min IMT HeartScan test.
Data is wirelessly sent to
IMT HeartScan server
Software measures the IMT
thickness. Interactive
database generates report.
Lesion assessments for size,
number and vulnerability
Physician and patient receive
IMT HeartScan report online
in less than one hour.

44.  Central Laboratory
 Satellite Offices
 US HeartScan Locations
20052005

45. Carotid IMT standardizationCarotid IMT standardization
 Image Acquisition:Image Acquisition: SOP / PCI as published in AJC;SOP / PCI as published in AJC;
Now online acquisition via DIVONow online acquisition via DIVO
 Image Transport:Image Transport: Dedicated Secured FTP; HIPAADedicated Secured FTP; HIPAA
compliantcompliant
 Image Analysis:Image Analysis: Cross-sectional and longitudinalCross-sectional and longitudinal
imaging during cardiac cycle; Automated analyses ofimaging during cardiac cycle; Automated analyses of
ROI / IMT, plus lesion imaging for carotid tree;ROI / IMT, plus lesion imaging for carotid tree;
 Data Reporting:Data Reporting: Individualized per patient for CCA,Individualized per patient for CCA,
Lesions, and Tissue typing; Interactive database andLesions, and Tissue typing; Interactive database and
automatic storage includedautomatic storage included

46. How Accurate isHow Accurate is ZoeZoeXPXP ??
 Typically the field of view (ultrasound windowTypically the field of view (ultrasound window
size) is 40x40 mm, which covers 200x200 pixels.size) is 40x40 mm, which covers 200x200 pixels.
 The system calibration is 0.2 mm/pixel and eachThe system calibration is 0.2 mm/pixel and each
pixel can be measured to a 10th.pixel can be measured to a 10th.
 Bottom line: ZoeXP can measure to an accuracyBottom line: ZoeXP can measure to an accuracy
of 0.02 mm orof 0.02 mm or 20 microns20 microns..
 The software can measure up to 1/10 of a pixel !!The software can measure up to 1/10 of a pixel !!

47. PCIPCI HeartScanHeartScan™™
Database AdvantageDatabase Advantage
 Contains over 40,000 individualsContains over 40,000 individuals
 Age range 2-90 years (incl. 2000 children)Age range 2-90 years (incl. 2000 children)
 Average follow-up ~ 6 yearsAverage follow-up ~ 6 years
 Different ethnic groups representedDifferent ethnic groups represented
 Cross-sectional & longitudinal images are savedCross-sectional & longitudinal images are saved
 Demographics are separately savedDemographics are separately saved
 Lesion images are savedLesion images are saved
 Other miscellaneous parameters are savedOther miscellaneous parameters are saved
 SQL interactive formatSQL interactive format
 Third party supervision Database monitoringThird party supervision Database monitoring

48. IMT issues still to be settled . . .IMT issues still to be settled . . .
 Acquisition / reportingAcquisition / reporting
protocol?protocol?
 Data storage?Data storage?
 Caliper vs (semi)Caliper vs (semi)
automatic analysis?automatic analysis?
 Lesions & IMT measures?Lesions & IMT measures?
 Min, max, or averageMin, max, or average
measurement?measurement?
 Normograms?Normograms?
ZoeXP SOPZoeXP SOP
HIPAA compliantHIPAA compliant
dual serversdual servers
Digital, fully automaticDigital, fully automatic
with remote capabilitywith remote capability
Both lesionsBoth lesions andand IMTIMT
Min, max,Min, max, andand averageaverage
MenMen andand women; Ethnicitywomen; Ethnicity
[ Part 1 ][ Part 1 ]
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage

49.  ReproducibilityReproducibility
requirements?requirements?
 One vs multiple frames?One vs multiple frames?
 ECG or other requiredECG or other required
add-on tests?add-on tests?
 Location in the carotid treeLocation in the carotid tree
for analyses?for analyses?
 Acceptance of procedure?Acceptance of procedure?
3% inter + 3.1% intra3% inter + 3.1% intra
Full cardiac cycleFull cardiac cycle
NoneNone
X and longit CCA,X and longit CCA,
bulb, internalbulb, internal
YesYes
YesYes
IMT issues still to be settled . . .IMT issues still to be settled . . .
[ Part 2 ][ Part 2 ]
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage
PCIPCI HeartScan™HeartScan™
AdvantageAdvantage

51. Report Print-out # 1
Report Print-out # 2

54. Additional InformationAdditional Information
www.pciheartscan.comwww.pciheartscan.com
Tel: 1-866-430-scanTel: 1-866-430-scan