ShearWave™ Elastography in Chronic Liver Diseases: Clinical Research Literature Review

1 /27 SWE™ in Chronic Liver Diseases Published Results from Clinical Research
ShearWave™ Elastography
in Chronic Liver Diseases
CLINICAL RESEARCH LITERATURE REVIEW
BY JOEL GAY, CLINICAL MANAGER
SUPERSONIC IMAGINE

Preamble
• Clinical information is presented along with the
source references for informational purposes only.
This information is available in peer-reviewed
published journals and represents the findings of
the third-party and not of SuperSonic Imagine.
Research findings do not represent any claims by
SuperSonic Imagine.
• This presentation contains information and images
which are provided as an information resource
only, and are not to be used or relied on for any
diagnostic or treatment purposes.
• None of the Company, Managers of affiliates,
members, directors, officers or employees accepts
liability for any loss arising from the use of this
presentation or contents arising in connection
therewith.
• Third-party or customers quotes represent the
opinion of the third-party and are not to be
considered as claims nor the opinion of
SuperSonic Imagine.
• This presentation is not to be used as a source of
patients education.
• Aixplorer® is an ultrasound imaging equipment for
diagnostic use, allowing to perform anatomical and
morphological imaging, blood flow imaging, and
elasticity imaging of soft tissue.
• Aixplorer® must be operated by experienced & trained
personnel, in order to collect information that will be
interpreted by a medical doctor (radiologist or
clinician), while taking into account all clinical
information available in the patient’s file.
• Aixplorer® is NOT providing a diagnosis, but important
and relevant information to enable a medical doctor to
make a diagnosis.
• Aixplorer® is a CE-marked Class IIa medical device
(CE Certificate #26415).
• Current Intended Use cleared by the FDA
• “The SuperSonic Imagine AIXPLORER® ultrasound
system and transducer are intended for general purpose
pulse echo ultrasound imaging, Doppler fluid flow analysis
of the human body, and tissue elasticity imaging of soft
tissues.” (K132274; K161999)
• “Diagnostic ultrasound imaging or fluid flow analysis of the
human body.” (K132274; K142100)

Agenda
#1
Liver Stiffness
Measurement
•Technical Landscape
•Confounders
#2
SWE™ Success
Rate, Reliability and
Reproducibility
•Healthy subjects
•Chronic hepatopathies
•Cirrhotic patients
•Protocol
#3
Evaluation of Liver
Fibrosis
•Stiffness of healthy liver
•Correlation of SWE with
liver fibrosis
•Diagnostic
performances
#4
Prognostic
Information
•Cirrhosis severity
•Portal hypertension
•Esophageal varices
#5
Treatment Planning
and Follow-up
•Liver transplantation
•Anti-viral treatments
•Monitoring of portal
hypertension

Shear Wave-based Elastography:
Technical Landscape
SWE
External
Mechanical piston
Transient
elastography
1D
No SW propagation image
PQ
elastography LiveFrozen
External
Mechanical vibrator
A posteriori 2D MRE
2D
SW propagation imaging
Transient
vibration
Continuous
vibration
Continuous
Supersonic Shear ImagingComb-pushARFIndividual ARF
Internal
Acoustic Radiation Force
MRIUltrasound

Network of Confounding Factors of Liver
Fibrosis Assessment with Liver Stiffness
Cui XW et al. World J Gastroenterol. 2013 Oct 14;19(38):6329-47.
Liver
stiffness
Liver fibrosis
Breathing
Device /
Technology
Gender
Blood
pressure
BMI
Fasting
Lobe
Patient's
position
Steatosis
Congestion
Necro-inflammatory
activity
Age
Albumin
Cytolysis
Etiology
?
Prothrombin
Time
Platelets count
Total Bilirubin

Confounding Factors of Liver Stiffness
Measurement Failure
Cassinotto C et al. J Hepatol. 2014 Sep;61(3):550-7
Practice Patient
Failure of
breath control
Ultrasound
reverberation
Diabetes
BMI
Sub-optimal
acoustic window
Liver lobe
Patient's
positioning
Steatosis
Haptoglobin
Arterial
hypertension
Alkaline
Phosphatase
Ascites +++
Cardiac
pulsatility
Intercostal
wall thickness

SWE™ Technical Success Rates
(TSR) Reported in 12 Studies
Author, Journal Year
Nb
Subjects
Liver Disease TSR (%)
Ferraioli, EJR 2012 46 Healthy 91.3
Ferraioli, Hepatol 2012 121 HCV 97.5
Huang, WJG 2014 112 HBV 100
Leung, Radiol 2013 454 HBV 98.9
Cassinotto, Hepatol 2016 291 NASH 87
Gerber, UMB 2015 120 CLD 100
Guibal, Diag Interv Imaging 2016 170 CLD 89.5
Choi, Ultrasonics 2016 380 CLD 91.1
Yoneda, Clin Gastroenterol Hepatol 2015 124 CLD; BMI 25 kg/m² 94.6
Elkrief, Radiol 2014 77 Cirrhosis 99
Procopet, J Hepatol 2015 88 Cirrhosis 99
Cassinotto, Dig Liv Dis 2015 401 Cirrhosis 93.8

SWE™ Measurements Reliability
and Applicability
• Reliability criteria used/defined
• Image stability over 3-5 seconds (Cassinotto)
• Emin ≥ 0.2 kPa (Poynard)
• SD < 1.75 kPa and Q-Box™ > 18 mm (Thiele)
• SD3/Median3 < 10% or Depth of measurement < 5.6 cm (Elkrief)
• IQR/Median ≤ 30% (Yoon) or SD/Mean < 30% (Bota)
Author, Journal Year Nb Patients Liver Disease
Reliability or
Applicability (%)
Bota , UMB 2015 * 127 CLD 99.2
Poynard, PLosOne 2016 * 2251 CLD 89.6
Yoon, JUM 2014 454 CLD 83.7
Cassinotto, J Hepatol 2014 349 CLD 89.6
Cassinotto, Hepatol 2016 291 NASH 79.7
Elkrief, Radiol 2014 77 Cirrhosis 83
* No biopsy performed

Optimal Conditions for Liver
SWE Measurements
Determination of Conditions
• Elastometry Experience feedback
• Several published works:
• Depth of measurements:
− Wang CZ et al. Ultrasound Med Biol. 2014
Mar;40(3):461-9.
• Liver lobe / segments:
− Hudson JM et al. Ultrasound Med Biol. 2013
Jun;39(6):950-5.
− Gerber et al. Ultrasound Med Biol. 2015 Sep;41(9):2350-
9.
− Yoneda M et al. Clin Gastroenterol Hepatol. 2015
Aug;13(8):1502-9.e5.
− Samir A et al. Radiology. 2015 Mar;274(3):888-96.
− Beland MD et al. AJR Am J Roentgenol. 2014
Sep;203(3):W267-73.
• Patient’s positioning:
− Ferraioli G et al. Hepatology. 2012 Dec;56(6):2125-33.
− Cassinotto C et al. J Hepatol. 2014 Sep;61(3):550-7.
• Number of measurements:
− Choi SH et al. Ultrasonics 2016;72:158-164
− Huang ZP et al. World J Gastroenterol 2014 July 28;
20(28): 9578-9584
− Vilgrain V et al. ESGAR 2015
• Other factors:
− Huang Z et al. Ultrasound Med Biol. 2014
Nov;40(11):2549-55
Imaging Protocol
• Patient in supine position
• Right arm in maximal abduction
• Suspended breath (3-5 s)
• Right liver lobe (Segment 6-8)
• Intercostal approach
• SWE Box 3.5 x 2.5 cm
• 3 to 5 cm from the probe surface
• 1 to 2 cm below the liver capsule
• Q-Box™ diameter: 20 mm
• Pressure +++ on thoracic wall
• Maximize probe contact and ultrasound
transmission (ultrasound gel)
• Orthogonal to liver capsule
• At least 3 independent measurements

SWE Measurements
Reproducibility
Author, Journal
Year
Nb
Meas.
Nb
Op.
Nb
Sess.
Nb Subj. Intra-Op ICC
Inter-Session
ICC
Inter-Operator
ICC
Ferraioli, EJR 2012 10 2 2 42 healthy
Expert: 0.95
Novice: 0.93
Expert: 0.84
Novice: 0.65
0.88
Hudson, UMB
2013
5 2 2
15 healthy
Segt 6
Op1: 0.91
Op2: 0.92
Op1: 0.63
Op2: 0.84
0.83
Yoon, JUM 2014 15 1 2
454
patients
2 meas: 0.93
6 meas: 0.96
0.95
Fatty liver: 0.83
CLD: 0.88
Cirrhosis: 0.96
Cassinotto, Dig
Liver Dis 2015
5 2 1
401
cirrhotic
patients
Liver: 0.95
Spleen: 0.96
N/A
Liver: 0.94
Spleen: 0.87
Thiele, EJU 2016 5 1 1 142 0.95 N/A N/A

Stiffness Value of Healthy Liver
• Experience reported in 18 peer-reviewed publications, from January 2009 until
September 2015
• Publications with kPa values
• Healthy volunteers: 9 articles
• F0-F1 patients with chronic liver diseases: 8 articles
• Reported values
• Healthy liver: Emean= 4.99+/-1.39 kPa
• F0-F1 : Emean= 6.74+/-1.95
3
4
5
6
7
8
9
Status
Average
CLD HLT
Median values, IQR and extreme
values in healthy subjects (HLT)
and F0-F1 patients with chronic
liver diseases (CLD)

References
SWE Values (kPa) in healthy
subjects
1. Quantitative assessment of the elasticity values of liver with shear wave ultrasonographic
elastography. Arda K, Ciledag N, Aribas BK, Aktas E, Köse K. Indian J Med Res. 2013
May;137(5):911-5.
2. Reproducibility of real-time shear wave elastography in the evaluation of liver elasticity. Ferraioli G,
Tinelli C, Zicchetti M, Above E, Poma G, Di Gregorio M, Filice C. Eur J Radiol. 2012
Nov;81(11):3102-6.
3. Feasibility and Diagnostic Accuracy of Supersonic Shear-Wave Elastography for the Assessment of
Liver Stiffness and Liver Fibrosis in Children: A Pilot Study of 96 Patients. Franchi-Abella S, Corno L,
Gonzales E, Antoni G, Fabre M, Ducot B, Pariente D, Gennisson JL, Tanter M, Corréas JM.
Radiology. 2016 Feb;278(2):554-62.
4. Inter- and intra-operator reliability and repeatability of shear wave elastography in the liver: a study in
healthy volunteers. Hudson JM, Milot L, Parry C, Williams R, Burns PN. Ultrasound Med Biol. 2013
Jun;39(6):950-5.
5. Quantitative elastography of liver fibrosis and spleen stiffness in chronic hepatitis B carriers:
comparison of shear-wave elastography and transient elastography with liver biopsy correlation.
Leung VY, Shen J, Wong VW, Abrigo J, Wong GL, Chim AM, Chu SH, Chan AW, Choi PC, Ahuja AT,
Chan HL, Chu WC. Radiology. 2013 Dec;269(3):910-8.
6. Determination of normal hepatic elasticity by using real-time shear-wave elastography. Suh CH, Kim
SY, Kim KW, Lim YS, Lee SJ, Lee MG, Lee J, Lee SG, Yu E. Radiology. 2014 Jun;271(3):895-900.
7. Influence of measurement depth on the stiffness assessment of healthy liver with real-time shear
wave elastography. Wang CZ, Zheng J, Huang ZP, Xiao Y, Song D, Zeng J, Zheng HR, Zheng RQ.
Ultrasound Med Biol. 2014 Mar;40(3):461-9.
8. Staging of hepatic fibrosis: comparison of magnetic resonance elastography and shear wave
elastography in the same individuals. Yoon JH, Lee JM, Woo HS, Yu MH, Joo I, Lee ES, Sohn JY,
Lee KB, Han JK, Choi BI. Korean J Radiol. 2013 Mar-Apr;14(2):202-12.
9. Shear wave elastography for liver stiffness measurement in clinical sonographic examinations:
evaluation of intraobserver reproducibility, technical failure, and unreliable stiffness measurements.
Yoon JH, Lee JM, Han JK, Choi BI. J Ultrasound Med. 2014 Mar;33(3):437-47.
SWE Values (kPa) in patients with
F0-F1 CLD
1. Non-invasive assessment of liver fibrosis with impulse elastography: comparison of Supersonic Shear
Imaging with ARFI and FibroScan®. Cassinotto C, Lapuyade B, Mouries A, Hiriart JB, Vergniol J,
Gaye D, Castain C, Le Bail B, Chermak F, Foucher J, Laurent F, Montaudon M, De Ledinghen V. J
Hepatol. 2014 Sep;61(3):550-7.
2. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a
pilot study. Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Filice G, Filice C; Liver Fibrosis Study
Group. Hepatology. 2012 Dec;56(6):2125-33.
3. Assessment of liver fibrosis with 2-D shear wave elastography in comparison to transient
elastography and acoustic radiation force impulse imaging in patients with chronic liver disease.
Gerber L, Kasper D, Fitting D, Knop V, Vermehren A, Sprinzl K, Hansmann ML, Herrmann E, Bojunga
J, Albert J, Sarrazin C, Zeuzem S, Friedrich-Rust M. Ultrasound Med Biol. 2015 Sep;41(9):2350-9.
4. Normal liver stiffness in healthy adults assessed by real-time shear wave elastography and factors
that influence this method. Huang Z, Zheng J, Zeng J, Wang X, Wu T, Zheng R. Ultrasound Med Biol.
2014 Nov;40(11):2549-55.
5. Real time shear wave elastography in chronic liver diseases: accuracy for predicting liver fibrosis, in
comparison with serum markers. Jeong JY, Kim TY, Sohn JH, Kim Y, Jeong WK, Oh YH, Yoo KS.
World J Gastroenterol. 2014 Oct 14;20(38):13920-9.
6. Shear-wave elastography for the estimation of liver fibrosis in chronic liver disease: determining
accuracy and ideal site for measurement. Samir AE, Dhyani M, Vij A, Bhan AK, Halpern EF, Méndez-
Navarro J, Corey KE, Chung RT. Radiology. 2015 Mar;274(3):888-96.
7. Supersonic Shear Imaging and Transient Elastography With the XL Probe Accurately Detect Fibrosis
in Overweight or Obese Patients With Chronic Liver Disease. Yoneda M, Thomas E, Sclair SN, Grant
TT, Schiff ER. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1502-9.e5.
8. Diagnostic accuracy of two-dimensional shear wave elastography for the non-invasive staging of
hepatic fibrosis in chronic hepatitis B: a cohort study with internal validation. Zeng J, Liu GJ, Huang
ZP, Zheng J, Wu T, Zheng RQ, Lu MD. Eur Radiol. 2014 Oct;24(10):2572-81.

Correlation of SWE™ Values with METAVIR
Stages in Chronic HBV Patients
Zeng J et al. Eur Radiol. 2014 Oct;24(10):2572-81.
Validation cohort
Development cohort
• 372 patients recruited, of which 310
finally included
• 206 in development cohort
• 104 in validation cohort
• SWE™ Protocol
• Patients in supine position, with right
arm in maximum abduction
• SWE acquisitions and measurements
on the right liver via intercostal
access
• Breath hold during 5 seconds
• SWE Box of 4 cm×3 cm size, placed
1 cm below the capsule
• Q-Box™ with the largest diameter
possible, avoiding vessels
• 5 measurements per patient
• Technical success rate: 306/310
(98.7%)

Diagnostic Performances (AUROC) in
HBV Patients
Zeng J et al. Eur Radiol. 2014 Oct;24(10):2572-81.

AUROCs in Patients with Mixed
Etiologies in Comparative Studies
Cassinotto C et al. J Hepatol. 2014 Sep;61(3):550-7.
Gerber L et al. Ultrasound Med Biol. 2015 Sep;41(9):2350-9. (Per protocol assessment)
Yoneda M et al. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1502-9. (Patients with BMI > 25 kg/m²)
Herrmann et al. J Hepatol 2015 Apr;62:S187–S212. (Oral presentation at EASL 2015, manuscript submitted)
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
Yoneda, 2015 Herrmann, 2015 Cassinotto, 2014 Gerber, 2015 Yoneda, 2015 Herrmann, 2015 Cassinotto, 2014 Gerber, 2015 Yoneda, 2015 Herrmann, 2015 Cassinotto, 2014 Gerber, 2015
≥F2 ≥F3 F4
Mixed etiologies SWE0.86

AUROCs in Patients with Chronic
HCV in Comparative Studies
Bavu E et al. Ultrasound Med Biol. 2011 Sep;37(9):1361-73.
Ferraioli G et al. Hepatology. 2012 Dec;56(6):2125-33.
Yoneda M et al. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1502-9. (Patients with BMI > 25 kg/m²)
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
Bavu, 2011 Ferraioli, 2012 Yoneda, 2015 Herrmann, 2015 Bavu, 2011 Ferraioli, 2012 Yoneda, 2015 Herrmann, 2015 Bavu, 2011 Ferraioli, 2012 Yoneda, 2015 Herrmann, 2015
≥F2 ≥F3 F4
HCV SWE0.86

AUROCs in Patients with Chronic
HBV in Comparative Studies
Leung VY et al. Radiology. 2013 Dec;269(3):910-8.
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
Leung, 2013 Herrmann, 2015 Leung, 2013 Herrmann, 2015 Leung, 2013 Herrmann, 2015
≥F2 ≥F3 F4
HBV SWE0.88

AUROCs in Patients with NAFLD and
NASH in Comparative Studies
Cassinotto et al. Hepatology. 2016 Jun;63(6):1817-27.
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
Herrmann, 2015 Cassinotto, 2016 Herrmann, 2015 Cassinotto, 2016 Herrmann, 2015 Cassinotto, 2016
≥F2 ≥F3 F4
NAFLD SWE0.86

3 Meta-analyzes on SSI-SWE
Published in 2016
Authors, Journal Year Search date QUADAS
Nb
articles
Nb
patients
≥ F2
AUROC (95% CI)
Sensitivity (%; 95%CI)
Specificity (%; 95%CI)
F4
AUROC (95% CI)
Sensitivity (%; 95%CI)
Specificity (%; 95%CI)
Feng, JUM 2016 February 28, 2015 Yes 12 1635
0.85 (0.81-0.88)
84 (81-86)
81 (74-87)
0.93 (0.90-0.95)
88 (82-91)
86 (81-90)
Jiang, PLosOne 2016 May 13, 2016 Yes 13 2303
0.87 (0.84-0.90)
84 (81-86)
83 (77-88)
0.94 (0.92-0.96)
89 (84-92)
88 (84-92)
Li, Med Sci Monit 2016 N/A Yes 8 934
0.88 (0.85-0.91)
85 (82-88)
81 (71-88)
0.92 (0.89-0.94)
87 (80-92)
88 (80-93)

Multicenter Retrospective Analysis
Results Presented at EASL 2015
Submitted data
• Information collected retrospectively from 13
sites in Europe and Asia, having used or using
SWE™ for liver fibrosis assessment
• 1650 patients
• “Real-life” conditions corresponding to routine
practice
• Statistical analysis performed independently by
Prof Eva Herrmann, Univ Frankfurt, taking into
account the heterogeneity of data between
sites.
• EASL 2015 #RS-3186: 2D-Shear Wave
Elastography is Equivalent or Superior to
Transient Elastography for Liver Fibrosis
Assessment: Results from an Individual Patient
Data Based Meta-analysis
• 1340 patients with SWE
• 972 patients in a comparative sub-study
• Objective: To assess the diagnostic
performances of SWE to evaluate
severity of liver fibrosis, depending on
liver disease etiology
• Etiologies
• HCV: n=470
• HBV: n=420
• NAFLD/NASH: n=172
• Others: n=278
Fibrosis
severity
HCV HBV
NAFLD
/NASH
METAVIR
≥ F2
AUROC (%) 86.3 91.6 85.9
Cutoff (kPa) 7.1 7.1 7.1
METAVIR
= F4
AUROC (%) 96.1 97.1 95.5
Cutoff (kPa) 13.5 11.5 13.5

3 3,5 4 4,5 5 5,5 6 6,5 7 7,5 8 8,5 9 9,5 10 10,5 11 11,5 12 12,5 13 13,5 14 14,5 15 15,5 16 16,5 17
3 3,5 4 4,5 5 5,5 6 6,5 7 7,5 8 8,5 9 9,5 10 10,5 11 11,5 12 12,5 13 13,5 14 14,5 15 15,5 16 16,5 17
SWE™ Liver Stiffness Cutoff Values for the
Assessment of Liver Fibrosis Severity and
their Performances
HCV Patients
References :
1. Reproducibility of real-time shear wave elastography in the evaluation of liver elasticity. Ferraioli G et al. Eur J Radiol. 2012 Nov;81(11):3102-6.
2. Inter- and intra-operator reliability and repeatability of shear wave elastography in the liver: a study in healthy volunteers. Hudson JM et al. Ultrasound Med Biol. 2013 Jun;39(6):950-5.
3. Staging of hepatic fibrosis: comparison of magnetic resonance elastography and shear wave elastography in the same individuals. Yoon JH et al. Korean J Radiol. 2013 Mar-Apr;14(2):202-12.
4. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a pilot study. Ferraioli G et al. Hepatology. 2012 Dec;56(6):2125-33
5. Supersonic Shear Imaging and Transient Elastography With the XL Probe Accurately Detect Fibrosis in Overweight or Obese Patients With Chronic Liver Disease. Yoneda M, Thomas E, Sclair SN, Grant
TT, Schiff ER. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1502-9.e5.
6. Quantitative Elastography of Liver Fibrosis and Spleen Stiffness in Chronic Hepatitis B Carriers: Comparison of Shear-Wave Elastography and Transient Elastography with Liver Biopsy Correlation. Leung
VY et al. Radiology. 2013 Dec;269(3):910-8.
7. Diagnostic accuracy of two-dimensional shear wave elastography for the non-invasive staging of hepatic fibrosis in chronic hepatitis B: a cohort study with internal validation. Zeng J, Liu GJ, Huang ZP,
Zheng J, Wu T, Zheng RQ, Lu MD. Eur Radiol. 2014 Oct;24(10):2572-81.
8. Liver stiffness in nonalcoholic fatty liver disease: A comparison of Supersonic Shear Imaging, FibroScan and ARFI with liver biopsy. Cassinotto C, Boursier J, De Ledinghen V, Lebigot J, Lapuyade B,
Cales P, Hiriart JB, Michalak S, Le Bail B, Cartier V, Mouries A, Oberti F, Fouchard-Hubert I, Vergniol J, Aube C. Hepatology. 2015 Dec 13. doi: 10.1002/hep.28394.
9. Transient and 2-Dimensional Shear-Wave Elastography Provide Comparable Assessment of Alcoholic Liver Fibrosis and Cirrhosis. Thiele M, Detlefsen S, Sevelsted Møller L, Madsen BS, Fuglsang
Hansen J, Fialla AD, Trebicka J, Krag A. Gastroenterology. 2016 Jan;150(1):123-33.
Se: 83.9%
Sp: 83.3%
Se: 90.7%
Sp: 88.9%
Se: 72.5%
Sp: 96.4%
Se: 75.8%
Sp: 83.3%
Se: 87.5%
Sp: 96.8%
Se: 97.3%
Sp: 95.1%
Se: 90.0%
Sp: 87.5%
No disease1-3 F2 F3 F4F0-F1Color legend:
Unspecified BMI [4]
BMI > 25 kg/m² [5]
HBV Patients[6-7] Se: 91.9%
Sp: 89.7%
Se: 91.9%
Sp: 85.7%
Se: 86.4%
Sp: 86.9%
Se: 83.5%
Sp: 91.2%
NAFLD Patients[8]
Se: 90%
Sp: 72%
Se: 91%
Sp: 71%
Se: 90%
Sp: 50%
Se: 58%
Sp: 90%
Se: 71%
Sp: 90%
Se: 71%
Sp: 90%
Sensitivity ≥ 90%
Specificity ≥ 90%
ALD Patients[9*] Se: 100%
Sp: 96%
Se: 92%
Sp: 81%
* Cut-off values in a high-risk population, with a prevalence of significant fibrosis > 50% and a prevalence of cirrhosis > 25% would be 10,1 kPa dna 16,4 kPa, respectively.
F1

Prognostic Information in
Cirrhotic Patients
• Prediction of liver failure in HBV/HCV
patients
Grgurevic I et al. Eur Radiol. 2015 Nov;25(11):3214-21.
• 123 patients
• SWE Protocol
− Right liver, intercostal access
− 5 measurements performed
• Liver stiffness > 27 kPa
− Sensitivity: 90.5%
− Specificity: 96.2%
• Spleen stiffness (measured via left intercostal
access) can be used as well, but is more
challenging with higher failure rate (~40%)
Cassinotto, Dig Liver Dis. 2015 Aug;47(8):695-701.
Correlation between liver stiffness and cirrhosis clinical
severity
Cutoff values defined to provide a NPV ≥ 90%
Cassinotto, Dig Liver Dis. 2015 Aug;47(8):695-701.

Non-Invasive Diagnosis of Clinically
Significant Portal Hypertension (CSPH)
Author
Nb
pts
Nb
Meas
Organ Correl coef AUROC Cutoff value (kPa)
Sensitivity
(%)
Specificity
(%)
Elkrief 77 3 Liver 0.578 (p<0.0001) 0.79 24.5 81 88
Procopet 88 3 Liver 0.611 (p<0.0001) 0.72 2-cutoff strategy N/A N/A
Elkrief 77 3 Spleen 0.604 (p=0.088) 0.86 34.7 40 100
Procopet 88 3 Spleen 0.514 (p<0.0001) 0.73 N/A N/A N/A
• Proposal for clinical implementation by Procopet et al.:
• Liver stiffness < 14.1 kPa can exclude CSPH
• Liver stiffness >25.8 kPa can predict CSPH
• 65% of patients would be classified, of which 89% correctly
• Spleen stiffness measurements can be considered in addition to liver stiffness,
but technique is more challenging with technical success rates between 60%
and 70%.

Algorithm to Rule Out CSPH
Jansen et al. Gut. 2016 Jun;65(6):1057-8.
Jansen et al. Liver Int. 2016 Aug 29. doi: 10.1111/liv.13243
• Objective was to define an
algorithm to diagnose non-
invasively patients with and without
CSPH
• Algorithm using
• Liver SWE stiffness
• Spleen SWE stiffness
• 158 patients with mixed etiologies
• 56% ASH
• 17% NASH
• 8% HBV
• 19% Others Sensitivity Specificity PPV NPV Accuracy
98.6% 70.3% 86.6% 96.3% 89%

Prediction of Esophageal Varices
Kim et al. JUM 2016;35:1373-1381
• Retrospective study on 103 patients with
compensated cirrhosis recruited for upper
endoscopy
• SWE acquisitions and measurements protocol
• Fasting patients for 8 hours
• Supine position with right arm in maximum
abduction
• SWE Box located 2 cm below the liver capsule
• Suspended expiration for 5 seconds
• Adjusted Q-Box™ up to a max diameter of 20
mm
• 5 acquisitions and 5 measurements (median,
IQR and IQR/median)
• Prediction of varices
• Prediction of high-risk varices
Parameter
AUROC
(95% CI)
Cutoff
Sens
(%)
Spec
(%)
Platelets
(103/mm3)
0.845
(0.761-0.909)
89 85 81
Spleen size
(cm)
0.722
(0.625-0.806)
13.7 54 93
Platelets/Spleen size
(N/mm3/mm)
0.841
(0.755-0.905)
824 85 80
Liver SWE
(kPa)
0.880
(0.801-0.936)
16.1 85 86
Parameter
AUROC
(95% CI)
Cutoff
Sens
(%)
Spec
(%)
Platelets
(103/mm3)
0.765
(0.672-0.843)
104 70 76
Spleen size
(cm)
0.692
(0.594-0.780)
10.7 68 68
Platelets/Spleen size
(N/mm3/mm)
0.770
(0.677-0.848)
860 63 83
Liver SWE
(kPa)
0.887
(0.809-0.941)
13.9 75 89

Transplantation Planning and
Monitoring
• Objective: To compare liver stiffness
values measured with SWE™ and MRE
in patients with chronic liver diseases
Yoon et al. Korean J Radiol. 2013 Mar-Apr;14(2):202-12.
• Subjects:
• 94 pre-transplantation patients
• 114 living donors
• SWE Measurements protocol
• Right liver via intercostal access
• 5 measurements
• Depth between 25 and 45 mm
• EMean < 5.6 kPa seemed to be a good
indicator to exclude the very early stages
of fibrosis (F0)
• Sensitivity=100%
• Specificity=90%
• Possible utility to select living donors
• Objective: To evaluate liver graft failure or
post-transplantation recurring disease
with SWE™.
Yoon et al. Eur Radiol. 2013 Jun;23(6):1729-37
• Subjects:
• 216 pre-transplantation patients
• 37 living donors
• SWE Measurements protocol
• 5 measurements
• 15 to 20 mm below the capsule
• Liver graft failure/rejection or post-
transplantation recurring disease could
be predicted with SWE™ measurements.
• Liver transplant stiffness should be
measured 4 weeks after transplantation
• EMean < 8 kPa could exclude the
hypothesis of a graft failure or of recurring
disease (specificity=87%)

Therapeutic Monitoring and
Follow-up
• Monitoring of portal hypertension (PH)
Choi SY et al. Radiology. 2014 Dec;273(3):917-26.
• 105 patients with portal hypertension, of
which 23 were followed-up (average
follow-up duration was 174+/-19 days)
• SWE Protocol
• Normal breath hold
• 5 measurements with Q-Box™ of 20 mm
diameter
• Strong correlation between D SWE liver
stiffness and D HVPG: (r=0.863)
• Increase in SWE values was highly
predictive of PH worsening
(AUROC: 0.925)
• Prediction of hepatocellular carcinoma
(HCC) in HCV patients who reached
sustained virological response (SVR)
Imai et al. J Med Ultrason (2001). 2015 Jul;42(3):341-7.
• 42 HCV patients treated with interferon-
based therapy, of which 6 presented with
HCC during follow-up.
• SWE™ Protocol
• Breath hold
• 3 measurements, with Q-Box™ of 10 mm in
diameter
• EMean could predict the presence of HCC
• AUROCs
− EMean: 0.963
− g-globulin: 0.888
− Age: 0.778
• Emean ≥ 6.5 kPa
− Sensitivity: 83%
− Specificity: 83%

Conclusions
#1
Liver Stiffness
Measurement
•Technical Landscape
•Confounders
#2
SWE™ Success
Rate, Reliability and
Reproducibility
•Healthy subjects
•Chronic hepatopathies
•Cirrhotic patients
•Protocol
#3
Evaluation of Liver
Fibrosis
•Stiffness of healthy liver
•Correlation of SWE with
liver fibrosis
•Diagnostic
performances
#4
Prognostic
Information
•Cirrhosis severity
•Portal hypertension
•Esophageal varices
#5
Treatment Planning
and Follow-up
•Liver transplantation
•Anti-viral treatments
•Monitoring of portal
hypertension

Thank you for your attention.
Questions?
webinar@supersonicimagine.com

ShearWave™ Elastography in Chronic Liver Diseases: Clinical Research Literature Review

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