Diagnostic performance of Baveno IV criteria in cirrhotic patients with upper gastrointestinal bleeding: analysis of the F7 liver-1288 study population.
OBJECTIVE
The definition of failure to control bleeding agreed upon at the Baveno IV consensus meeting, included the Adjusted Blood Requirement Index [ABRI: number of blood units/(final-initial hematocrit+0.01)]. ABRI ≥0.75 denotes failure. However, timing for hematocrit measurements was not defined. The aims of this study were: (1) to assess the Baveno IV criteria performance to classify treatment success or failure to control bleeding at 5 days, (2) to determine the appropriate timing for hematocrit.


METHODS
Two hundred and forty-two cirrhotic patients with gastrointestinal bleeding were independently classified by three clinical experts according to the Baveno IV criteria, by analysis of the database of a randomized trial. ABRI was calculated by using the closest hematocrit to the 5 day time point from the first trial product administration (ABRI-1) or after the latest transfusion within the 5-day period (ABRI-2). The gold standard for success/failure for 5-day control of bleeding was the clinical judgment of the three independent observers based on all the clinical and follow-up data.


RESULTS
Inter-observer agreement for the final outcome assessment was 0.82 and a final consensus was obtained in 236/242 patients. Inter-observer agreement on patient classification with Baveno IV criteria was 0.70 with ABRI-1 and 0.84 with ABRI-2. c-statistics for correct patients classification were 0.86 for ABRI-1, 0.84 for ABRI-2, and 0.88 for Baveno IV criteria without ABRI. ABRI-1 caused misclassification of 27 patients and ABRI-2 of 39.


CONCLUSIONS
Baveno IV criteria are accurate to assess outcome of patients with variceal bleeding. There is a substantial observer variability linked to timing of hematocrits for ABRI calculation. With the current definition ABRI does not add to the performance of the other criteria.
Thabut
D
D
UPMC, AP-HP, Service d'Hépato-Gastroentérologie, Hôpital Pitié-Salpêtrière, Paris, France.
D'Amico
G
G
Tan
P
P
De Franchis
R
R
Fabricius
S
S
Lebrec
D
D
Bosch
J
J
Bendtsen
F
F
D000328:Adult; D001803:Blood Transfusion; D004932:Esophageal and Gastric Varices / Q000150:complications; D015942:Factor VIIa / Q000627:therapeutic use; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000097:blood / Q000150:complications* / Q000175:diagnosis* / Q000628:therapy; D006400:Hematocrit; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications; D008103:Liver Cirrhosis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa