based on article published in japi

2. VALIDATION OF BAVENO VI CRITERIA FOR SCREENING OF
ESOPHAGEAL VARICES IN A COHORT OF SOUTH ASIAN
PATIENTS WITH COMPENSATED
CHRONICLIVERDISEASE
-DR. RESHMI HARIKUMAR PILLAI
-GUIDE:DR. NEERA SAMAR MAÁM
RNT MEDICAL COLLEGE AND MB GOVT HOSPITAL
DEPARTMENT OF MEDICINE
JOURNAL CLUB

4. OVERVIEW
OBJECTIVE
THE BAVENO VI CONSENSUS
TRANSIENT ELASTOGRAPHY
MATERIALS AND METHODS
INCLUSION CRITERIA
EXCLUSION CRITERIA
PROCEDURE
STATISTICAL ANALYSIS
RESULTS
DISCUSSION
LIMITATION
CONCLUSION

5. OBJECTIVE
(i) PRIMARY AIM- validation of the the Baveno VI Consensus statement regarding
esophageal variceal screening in a cohort of Indians with cACLD(compensated
advanced chronic liver disease)
(ii) To determine whether alternate noninvasive parameters (not including Transient
elastography) would be equally or more predictive than the Baveno statement in
ruling out HRV(High risk varices).

6. BAVENOVICRITERIA
-Patients with cACLD(compensated advanced chronic liver disease) having a liver
stiffness measurement (LSM) less than 20 kPa (determined by Transient
elastography) and a platelet count >150 000/mm3 are unlikely to have HRV(High
risk varices) requiring treatment.
-HRV- Medium or large varices/ small varices with red wale marking / small varices
in Child C patients

10. TRANSIENTELASTOGRAPHY
-Marketed as FIBROSCAN
-Noninvasive -> Uses Ultrasound waves to measure liver stiffness
-FibrosisIncreased stiffness of hepatic tissue
-Shear wave propagates faster through stiff material than through elastic material
-Window = 1x4 cm(100x area of an average liver biopsy)
-More accurate in identification of higher degrees of Fibrosis

12. MATERIALSANDMETHOD
-STUDY DESIGN: CROSS-SECTIONAL STUDY.
-Included patients with chronic liver disease that attended the OP at the Department
of Medical Gastroenterology,Government medical college, Trivandrum between
September 2016 and August 2017 in whom TE was performed.

13. INCLUSION CRITERIA
-LSM (Liver Stiffness Measurement ) ≥ 10 k Pa
-Laboratory tests and upper endoscopy performed within 6 months of TE.

14. The the cutoff of 10 Kpa was kept because, according to Baveno VI The
probability of having cACLD is very low if LSM is <10 Kpa. Also, it mentions
that patients with LSM in between 10 to 15 Kpa are likely to have cACLD.

15. EXCLUSION CRITERIA
-Decompensated cirrhosis (defined as the history or presence of overt ascites,
overt encephalopathy or variceal haemorrhage and jaundice)
-Portal or splenic vein thrombosis
-History of splenectomy or liver transplantation.

16. TE was performed using Fibroscan© (Echosens, Paris) after at least 4 hours of
fasting and the Mean value of two fibroscan reading in fasting in two different days
were taken.
LSMs were performed in the right lobe of liver and 10 successful measurements were
obtained in each patient and the mean value was taken.

17. -Patients also underwent OGD scopy and grading of varices was done by standard
criteria. All oesophageal varices described as grade 3 esophageal varices, grade 2
varices with red wale markings, or gastric varices, were defined as HRV.
-Data pertaining to etiology, LFT, RFT, CBC, INR was noted for all patients.

18. PROCEDURE

20. STATISTICALANALYSIS

21. -Statistical analysis was performed using SPSS package v.22 (SPSS Inc., Chicago,IL,
USA).
-Sensitivity, specificity, positive predictive value and negative predictive value was
calculated.
-Comparisons between groups were performed using Mann-Whitney U test for non-
parametric tests and Fisher’s exact test for proportions.
-AUROC was constructed for validation study.

22. RESULTS
-Among all patients who underwent Transient elastography 382 patients had LSM
values > 10 Kpa. Of these, 7 patients were excluded because endoscopy report was
not analysed.
-Demographic and clinical characteristics of these patients were tabulated.
-Main etiology of compensated cirrhosis was Hepatitis B (42 %) followed by
Hepatitis C (39%), NAFLD (9.1%) and alcohol (9%) in our study. In hepatitis B and
C, TE was done before starting antivirals.

24. -Endoscopically, 246 (65.6%) patients had no gastroesophageal varices, 45 (12 %)
had small varices and 84 (22%) had medium/large varices (HRV).
-266 patients fulfilled Baveno criteria to rule out HRV i.e. they had LSM< 20 Kpa
and platelet count >150000/mm3. Among those, 262 did not have HRV while 4
patients had HRV. 109 patients were out of Baveno criteria and among those, 80
patients had HRV.

25. -The sensitivity, specificity, Positive predictive value (PPV) and negative predictive
value (NPV) was 96%, 90%, 74% and 99% respectively.
-AUROC for compensated cirrhosis was 0.91.

27. DISCUSSION

28. -The Criteria was validated in the study population with cACLD (defined
as a liver stiffness ≥10 kPa and no decompensating events).
-Only 4 patients out of 266 who satisfied Baveno criteria had HRV needing treatment.
(Sensitivity= 96%, NPV= 99%). Percentage of endoscopies that could have been
circumvented by Baveno criteria were 70%, but it incorrectly classified 2% of
patients (This may delay prophylaxis against variceal bleeding with non-selective
beta-blockers in this small proportion of patients).

29. -Careful consideration must be given to comorbidities which may impact the validity
of the proposed platelet cut-off(E.g Blood dyscrasias).
-Reassuringly, only 4/266 (0.15 %) cases meeting BAVENO criteria had HRV,
therefore the annual risk to a patient counselled in clinic based on a bleeding rate
from varices of 15% per year would be just 0.3%.
-The guidelines hence advise annual assessment of TE and platelet count, followed
by endoscopic surveillance of patients who move out of the low risk category.

30. -Etiologically, applying Baveno criteria in Hep B patients had a sensitivity of 93%
and NPV of 98% to rule out HRV. In patients with Hep C as etiology, Baveno criteria
could rule out HRV with a sensitivity of 95% and NPV of 98%.
-Patients with alcohol and NAFLD etiology had a sensitivity of 100% and NPV of
100%.

31. -The study suggests that there is a role for non- invasive markers in identifying
patients at low risk of having clinically significant varices who can safely avoid
screening endoscopy.
-The poor PPV show these non- invasive tests cannot replace endoscopy in the
diagnosis of varices and deciding which patients warrant treatment with primary
prophylaxis.

32. -TE is not widely available in India ,expensive , needs a skilled operator .
-TE –measures stiffness and not fibrosis per se; affected by
inflammation/edema/hepatocyte necrosis/intrasinusoidal activity
-At present mild to moderate disease activity can be detected only by liver biopsy

33. -A strategy was developed excluding TE and including platelet count and MELD
-No patient with MELD of 6 showed HRV irrespective of platelet count. (sensitivity
and NPV= 100%) No patient with MELD = 7 and platelet count > 150000/mm3 had
HRV (sensitivity and NPV= 100%).
-This criteria can be used to determine patients who can safely avoid screening
endoscopy. The number of endoscopies that could have been circumvented by this
criteria using MELD=6 or MELD < 8 and platelet >150000/mm3was 67% which is
comparable to the number of endoscopies that could have been circumvented using
Baveno criteria (70%).

34. LIMITATION
-The retrospective design : limitations of bias.
-Usage of the presence of varices as an endpoint is limited by variable
and subjective reporting of their size.

35. CONCLUSION
-Validation of Baveno VI consensus statement for endoscopic screening
of esophageal varices in a cohort of Indian population.
-Long-term follow-up with annual TE and platelet count to initiate
timely endoscopic surveillance in suitable patients.

36. -New strategy : MELD 6 or MELD < 8 and platelet > 150000/mm3 which can be
used when TE is not available to screen patient who can avoid endoscopy in
resource constrained settings.

37. In clinical practice, initiation of primary prophylaxis is based on the endoscopic
evidence of high risk varices given the impractical nature of routinely measuring
HVPG. Therefore, identification of non-invasive techniques to identify patients
without varices is relevant.

38. ALTERNATIVE NON INVASIVE TESTS

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41. Thankyou 