Phillip J Bendick, PhD FSDMS William Beaumont Hospital Royal ...

Phillip J Bendick, PhD FSDMS
William Beaumont Hospital
Royal Oak, Michigan

Disclosures
No relevant disclosures
Speaker for -
Gulfcoast Ultrasound
GE Ultrasound

What’s New
Accreditation
Screening
Markers for CV Disease
Plaque Characterization
CCSVI
Physiologic testing for CVI
3-D Vascular Ultrasound
. . .

What’s New
Accreditation
All Technical Staff
members must be
credentialed by Jan, 2017

What’s New
Accreditation
IAC granted deeming
status by CMS,
which has led to . . .

What’s New
Accreditation
Audits and random
site visits (once per
cycle)

What’s New
Accreditation
Provisional accreditation
Required conference call

What’s New
Accreditation
60 day comment period
for any Standards change

What’s New
Screening
How to screen ??
Whom to screen ??

What’s New
§ Deal with the easy question first:
How to screen

What’s New
• How to screen
ICAVL Standards –
Appropriate equipment
Qualified personnel
Adequate protocols
Appropriate criteria

What’s New
Screening is NOT a diagnostic study !
A typical diagnostic examination may
have 30-40 images or more
A typical screening study
will have 4-8 images

What’s New

What’s New
Screening is minimal sampling !
As with any sampled system,
it is subject to diagnostic
“aliasing”
The fewer the samples,
the greater the aliasing !

What’s New
Screening is minimal sampling !
Requires:
Skilled sonographer
Knowledgable interpretation

What’s New
Screening should be highly
sensitive !
Participants will not go directly to
intervention based on screening.

What’s New
Screening should be highly
sensitive !
Diagnostic thresholds for significant
positive findings should be low –
e.g.
ICA PSV > 125 cm/sec

What’s New
Which leaves the more
difficult question:
Whom to screen ??

What’s New
Whom to screen
Everyone § Impractical
§ Cost prohibitive
§ Ineffective

What’s New
Whom to screen
Everyone
Nobody

What’s New
Whom to screen
Everyone
Nobody
Even if this were the correct
answer,

What’s New
Whom to screen
Everyone
Nobody
Even if this were the correct
answer, it can be done

What’s New
Whom to screen
Everyone
Nobody
Even if this were the correct
answer, it can be done
è it will be done

What’s New
§ Whom to screen:
What is the goal of screening?

What’s New
§ Whom to screen:
What is the goal of screening?
Identify candidates for intervention

What’s New
• Identify candidates for intervention
Prevalence of significant carotid
stenosis for cost-effectiveness*
Derdeyn 1996 > 20%
Lee 1997 > 40%
Yin 1998 > 4.5%
* In an otherwise perfect world

What’s New
Pre-operative screening:
1990s literature showed prevalence
in CABG/PVD patients of 5-10%
Prevalence approaches 20% if
carotid bruit present

What’s New
General population (Colgon, 1988) ~ 1%
è US Preventive Services Task Force:
There is inadequate evidence to
support carotid screening at this time

What’s New
§ Whom to screen:
What is the goal of screening?
Identify candidates at risk for CHD

What’s New
If Framingham RS Low, 59% have
carotid plaque
If FRS Intermediate / High, 87% have
carotid plaque
Naqvi JASE 2010

What’s New
If Framingham RS Low, 59% have
carotid plaque
If FRS Intermediate / High, 87% have
carotid plaque
So simply reverse engineer the problem!

What’s New
Unfortunately, if carotid plaque used as a
marker for CHD –
The detection rate is only 62%
The false positive rate is 30%
Wald J Med Screen 2009

What’s New
Carotid plaque does not have a screening
performance that is sufficiently discriminatory
between affected and unaffected individuals
to be a worthwhile screening test.
Wald J Med Screen 2009

What’s New
§ Whom to screen:
What is the goal of screening?
Identify candidates for aggressive
preventive medicine measures

What’s New
200 million in US between 20 – 80 years
75% eligible for risk reduction
20% eligible for statins
Cost: $60-80B / year

What’s New
Anecdotes from a vascular screening program
15-20% with carotid plaque
~ 40% with carotid plaque in selected
screenings

What’s New
Identify candidates for preventive
measures -
There is no evidence that outcomes
ultimately are improved!

What’s New
In the evidence-based world of
medicine, carotid screening
does not occur

What’s New
In our world (the real world), carotid
screening occurs, but evidence is
lacking at this time to define the
appropriate population to be
screened which will make it a
cost-effective means of preventive
medicine.

What’s New
34 th Bethesda Conference (2002):
Recommended an individualized approach
to noninvasive atherosclerosis testing
“based on physician recommendation and
referral,

What’s New
34 th Bethesda Conference (2002):
“… only after a careful consideration of
known medical history and evaluation of
major standard cardiovascular risk factors
by office-based techniques”
Redberg JACC 2003

What’s New
§ Whom to screen:
What is the goal of screening?
Refine “risk status” using
markers for CV disease

What’s New
Markers of CV Disease:
ABI
Flow mediated dilation (FMD)
Intima – Media Thickness (IMT)

What’s New
Markers of CV Disease:
Ankle – Brachial Index
Survival
Years

What’s New
Markers of CV Disease:
Ankle – Brachial Index
Significant existing disease

What’s New
Markers of CV Disease:
Flow mediated dilation

What’s New
Markers of CV Disease:
Flow mediated dilation
Berry Clinical Science 2000

What’s New
Markers of CV Disease:
Flow mediated dilation
Significant existing
endothelial dysfunction

What’s New
Markers of CV Disease:
Intima – Media Thickness

What’s New
Clinical Outcomes: MI / Stroke
O’Leary NEJM 1999

What’s New
Clinical Outcomes: Event Rate

What’s New
Automated Measurements
Trace

What’s New
Standardized Measurements
Ø CCA vs Bifurcation vs ICA
ICA
CCA

What’s New
Standardized Measurements
Ø CCA vs Bifurcation vs ICA
Ø Max IMT vs Mean IMT
Ø Near wall vs Far wall
Ø Absolute IMT vs Progression rate

What’s New
Protocol:
Patient supine
Straight lateral, +/- 45 o approaches

What’s New
Protocol:
Patient supine
Straight lateral, +/- 45 o approaches
Distal CCA, far wall, 1cm segment
R-wave gated hi-res digital images
Triplicate measures, each view
Measure mean IMT, Right & Left
Stein et al, JASE 21(2):93-111 (Feb, 2008)

What’s New
Protocol:
Note – Extensive protocols with
measurements from multiple
sites are required for the precision
necessary to observe a treatment
effect

What’s New
Simplified Protocol:
Patient supine, facing up
Straight lateral approach
Distal CCA, 1-2cm segment
Measure far wall, mean IMT
Greater of Right vs Left

What’s New
Standardized Measurements
Typical values:
Young healthy adults < 0.6 mm
Adults, 45-55: Mod risk 0.7 – 1.0 mm
High risk 1.0 – 1.5 mm
Adults, > 55: Mod risk 0.8 – 1.1 mm
High risk 1.1 – 1.5 mm
Plaque > 1.5 mm
Data Tables available in Stein et al, JASE 21:93-111 (Feb, 2008)

What’s New
Markers of CV Disease:
Intima – Media Thickness
An indicator of future
dysfunction / disease

What’s New
Framingham Risk Score
Female, 62 yrs 9
Tot Cholesterol 228 3
HDL Cholesterol 40 1
SBP (treated) 134 3
(+) Smoker 3
Non-diabetic 0
25% 10 yr. Risk

Using IMT Measurements
Refining the FRS
Vascular Age:
“A man is as old as his arteries.”
Thomas Sydenham, English physician, 1624-1689

Using IMT Measurements
Refining the FRS
Vascular Age:
Measure IMT, assign age
that has that value as the median,
use that vascular age to
calculate FRS

Vascular
Age: IMT
Trigger for
aggressive
risk factor
Using IMT Measurements
Refining the FRS
management

What’s New
Using IMT Measurements
Framingham Risk Score
Female, 62 yrs 9
Tot Cholesterol 180 0
HDL Cholesterol 45 1
SBP (treated) 122 0
(-) Smoker 0
Non-diabetic 0
9% 10 yr. Risk

What’s New
Using IMT Measurements
Framingham Risk Score
Female, 62 yrs
IMT
1.0mm
Vasc Age 80
10 yr. Risk 15%

What’s New
Using IMT Measurements
Framingham Risk Score
Female, 62 yrs
IMT
1.0mm
Vasc Age 80
10 yr. Risk 15%
Potential for more aggressive Rx:
BP, Lipids, Fitness level

What’s New
Using IMT Measurements
Framingham Risk Score
Female, 62 yrs
IMT
0.6mm
Vasc Age 45
10 yr. Risk 4%

What’s New
Using IMT Measurements
Framingham Risk Score
Female, 62 yrs
IMT
0.6mm
Vasc Age 45
10 yr. Risk 4%
Current Rx may be adequate

What’s New
Markers of CV Disease:
Existing plaque
Today’s problem

What’s New
Cardiovascular Disease –
Historically, the clinical significance
of CV disease has been based on the
severity of blockage (stenosis)

What’s New
Stenosis assessment:
Contrast angiography
CTA
MRA
The new “non-invasive”

What’s New
All of these techniques are
image-based and provide
anatomic information only –
but is that the important data ??

What’s New
Atherosclerotic Disease – Carotid
Stroke Risk:
Asymptomatic, > 70%
5% / yr
Symptomatic, > 70%
15% / yr

What’s New
Atherosclerotic Disease – Carotid
Which implies NO stroke risk:
Asymptomatic, > 70%
95% / yr
Symptomatic, > 70%
85% / yr

What’s New
Atherosclerotic Disease –
Besides stenosis, what are the lesion
characteristics that will identify
the atherosclerotic plaque likely
to become symptomatic?

What’s New
Plaque Characterization:
Not a new concept -
Dixon S 1982
Lusby RJ 1982
Reilly LM 1983
Johnson JM 1985
Bendick PJ 1986
Bluth EI 1986
. . .

What’s New
Atherosclerotic Disease –
Early efforts at plaque characterization
Identification of ulceration
Plaque echogenicity

What’s New
Atherosclerotic Disease – Ulceration
Ultrasound criteria
Heterogeneous lesion
Sharp, irregular borders
> 2mm crater

What’s New
Atherosclerotic Disease – Ulceration

What’s New
Atherosclerotic Disease – Ulceration
Sx Patient, > 70% stenosis
Non-ulcerated ~ 15% / yr
Ulcerated
~ 40% / yr

What’s New
Atherosclerotic Disease – Echogenicity
It’s what’s inside
that counts

What’s New
Atherosclerotic Disease – Echogenicity
Plaque type using Ultrasound
I
II
III
IV
Predominantly anechoic
Heterogeneous, partly anechoic
Heterogeneous, mostly echogenic
Homogeneous, echogenic

What’s New
Atherosclerotic Disease – Echogenicity
Type I
Type IV
Need for objective plaque evaluation

What’s New
Gray Scale Median (GSM)
Ø Normalize image echogenicity

What’s New
Gray Scale Median (GSM)
Ø Use histogram feature

What’s New
Gray Scale Median (GSM)
Ø Clinical correlation
Asymptomatic plaque:
GSM 38 +/- 26
Symptomatic plaque:
GSM 21 +/- 15 p = .002
Elatrozy Int Angiol 1998

What’s New
Gray Scale Median (GSM)
Ø Clinical correlation
Echorich plaque: 50-79% 80-99%
Relative stroke risk – 1.0X 3.1X
Echolucent plaque: 50-79% 80-99%
Relative stroke risk – 4.2X 7.9X
Gronholdt Circulation 2001

What’s New
Gray Scale Median (GSM)
Ø Clinical correlation – ICAROS Study
Complications of carotid stenting –
GSM25
Asx pts. 6.1% 0.6%
Sx pts. 9.8% 3.3%
Biasi Circulation 2004

What’s New
Plaque Characterization:
Where are we headed ?

What’s New
The unstable plaque
Metabolic activity
è Inflammation
è Collagen reduction
è Thinning of fibrous cap
è Plaque rupture
è Heart attack / Stroke

What’s New
New technologies -
MSCT tissue characterization
MRI / MRS
PET / PET-CT
IVUS / CE ultrasound
OCT

What’s New
Next generation ultrasound -
Intravascular Ultrasound
- Virtual histology
Okubo et al
Circ J 2008

What’s New
Next generation ultrasound -
Intravascular Ultrasound
Okubo et al
Circ J 2008

What’s New
Next generation ultrasound -
Contrast Enhanced Ultrasound **
Plaque neovascularity
Giannonni
Eur J Vasc Endovasc Surg 2009
** Off label use of ultrasound contrast;
not FDA approved for this application

What’s New
Next generation ultrasound -
Contrast Enhanced Ultrasound **
Plaque neovascularity
Feinstein
Radiology 2010
** Off label use of ultrasound contrast;
not FDA approved for this application

What’s New
Next generation ultrasound -
Contrast Enhanced Ultrasound **
Plaque
neovascularity
Feinstein
Radiology 2010

What’s New
l
CCSVI – Chronic CerebroSpinal
Venous Insufficiency
Identify hemodynamic
/ anatomic abnormalities
in the cerebro-spinal
venous drainage system
of patients with MS

What’s New
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CCSVI
Protocol – IJV (Rt + Lt)
Supine and Upright
Image sagittal and transverse
Measure lumen diameter, crosssectional
area (End expiration)
Proximal, Mid and Distal

What’s New
l
CCSVI - IJV
Supine: Dilated, good venous
emptying, respiratory
phasicity
Upright: Collapsed, diminished
venous emptying and
respiratory phasicity

What’s New
l CCSVI
IJV - Supine
CDI Sagittal

What’s New
l
CCSVI
IJV - Supine
B-mode
Sagittal

What’s New
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CCSVI
IJV - Upright
CDI Sagittal

What’s New
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CCSVI
IJV - Upright
B-mode
Sagittal

What’s New
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CCSVI – IJV Supine

What’s New
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CCSVI – IJV Upright

What’s New
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CCSVI – Vertebral Veins
Supine: Normal lumen,
good venous emptying,
respiratory phasicity
Upright: Normal lumen, good /
enhanced venous emptying,
some loss of respiratory
phasicity

What’s New
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CCSVI – Intracranial Veins
Transtemporal Window:
Deep Middle Cerebral Vein
Basal Vein (Rosenthal)
Occipital Window:
Internal Cerebral Vein
Great Cerebral Vein(Galen)

What’s New
l
CCSVI – Intracranial Veins
Evaluate for reflux flows
with respiration

What’s New
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CCSVI – Abnormal Findings

What’s New
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CCSVI – Abnormal Findings

What’s New
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CCSVI – Abnormal Findings
Scale 5
Scale 30

What’s New
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CCSVI – Abnormal Findings
Results are very preliminary
Unverified by other centers
Venous drainage abnormalities seen in
up to 60-70% of patients with MS
No long term followup after intervention

What’s New
Evaluation
for DVT

What’s New
Use augmentation maneuvers for
venous testing
1975: “Blind” CW Doppler;
no imaging capability
2013: High resolution
imaging groin to
ankle

What’s New
High resolution imaging groin to ankle

What’s New
Augmentation maneuvers:
Venous testing for DVT
Provide no additional
diagnostic information –
“Augmentation … rarely
provides additional
information.”
Lockhart et al AJR 2005

What’s New
Augmentation maneuvers:
Venous testing for DVT
Provide no additional
diagnostic information
Are not required
by ICAVL
Waste time

What’s New
Venous testing for DVT: ICAVL
Spectral Doppler waveforms from
the CFV and Popliteal Vein

What’s New
Physiologic
evaluation
of CVI

What’s New
Physiologic evaluation of CVI
The Calf
Muscle
Pump

What’s New
The calf muscle pump

What’s New
Physiologic evaluation of CVI
Primary / secondary VV

What’s New
Physiologic evaluation of CVI

What’s New
Physiologic evaluation of CVI

What’s New
Physiologic evaluation of CVI

What’s New
Physiologic evaluation of CVI
Limitations:
Operator / Technique dependent
Patient compliance dependent
Lack of reproducibility
Time consuming

What’s New
Physiologic evaluation of CVI
Automated
Quantitative

What’s New
Physiologic evaluation of CVI
Venous Outflow
Venous Filling

What’s New
Physiologic evaluation of CVI
Multiphasic Testing

What’s New
3-D Vascular Ultrasound
Ultrasound Imaging – 1950s
Bistable ultrasound
Persistance oscilloscope images
Water bath coupling (Patient and transducer)
è Stereoscopic viewing

What’s New
Ultrasound Imaging – 1990s

What’s New
2011: In the time it takes to acquire
a single 2-D image, we can now
collect a complete
volume set of data

What’s New

What’s New

What’s New
l
3-D Vascular Ultrasound

What’s New

What’s New
3-D Vascular Ultrasound
+
ICA
+
ECA
+
+
CCA
ICA

What’s New
ICA
Automate
using
Macros
ECA
CCA

What’s New
Tomographic Ultrasound Imaging (TUI)

What’s New
Tomographic Ultrasound Imaging (TUI)

What’s New
3-D Plaque characterization
+
ICA
+
ICA

What’s New
3-D Plaque characterization

What’s New
3-D Plaque characterization

What’s New
3-D Plaque characterization

What’s New
3-D Plaque characterization

What’s New
The future
of Ultrasound -
is Now

What’s New
You are only limited by your imagination !

What’s New