Liver Stiffness by Transient Elastography Predicts Liver-Related Complications and Mortality in Patients with Chronic Liver Disease

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Abstract

Background

Liver stiffness measurement (LSM) by transient elastography (TE, FibroScan) is a validated method for noninvasively staging liver fibrosis. Most hepatic complications occur in patients with advanced fibrosis. Our objective was to determine the ability of LSM by TE to predict hepatic complications and mortality in a large cohort of patients with chronic liver disease.

Methods

In consecutive adults who underwent LSM by TE between July 2008 and June 2011, we used Cox regression to determine the independent association between liver stiffness and death or hepatic complications (decompensation, hepatocellular carcinoma, and liver transplantation). The performance of LSM to predict complications was determined using the c-statistic.

Results

Among 2,052 patients (median age 51 years, 65% with hepatitis B or C), 87 patients (4.2%) died or developed a hepatic complication during a median follow-up period of 15.6 months (interquartile range, 11.0–23.5 months). Patients with complications had higher median liver stiffness than those without complications (13.5 vs. 6.0 kPa; P<0.00005). The 2-year incidence rates of death or hepatic complications were 2.6%, 9%, 19%, and 34% in patients with liver stiffness <10, 10–19.9, 20–39.9, and ≥40 kPa, respectively ( P<0.00005). After adjustment for potential confounders, liver stiffness by TE was an independent predictor of complications (hazard ratio [HR] 1.05 per kPa; 95% confidence interval [CI] 1.03–1.06). The c-statistic of liver-stiffness for predicting complications was 0.80 (95% CI 0.75–0.85). A liver stiffness below 20 kPa effectively excluded complications (specificity 93%, negative predictive value 97%); however, the positive predictive value of higher results was sub-optimal (20%).

Conclusions

Liver stiffness by TE accurately predicts the risk of death or hepatic complications in patients with chronic liver disease. TE may facilitate the estimation of prognosis and guide management of these patients.

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Most cited references 29

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Comorbidity measures for use with administrative data.

A Elixhauser, C. Steiner, D Harris … (1998)

This study attempts to develop a comprehensive set of comorbidity measures for use with large administrative inpatient datasets. The study involved clinical and empirical review of comorbidity measures, development of a framework that attempts to segregate comorbidities from other aspects of the patient's condition, development of a comorbidity algorithm, and testing on heterogeneous and homogeneous patient groups. Data were drawn from all adult, nonmaternal inpatients from 438 acute care hospitals in California in 1992 (n = 1,779,167). Outcome measures were those commonly available in administrative data: length of stay, hospital charges, and in-hospital death. A comprehensive set of 30 comorbidity measures was developed. The comorbidities were associated with substantial increases in length of stay, hospital charges, and mortality both for heterogeneous and homogeneous disease groups. Several comorbidities are described that are important predictors of outcomes, yet commonly are not measured. These include mental disorders, drug and alcohol abuse, obesity, coagulopathy, weight loss, and fluid and electrolyte disorders. The comorbidities had independent effects on outcomes and probably should not be simplified as an index because they affect outcomes differently among different patient groups. The present method addresses some of the limitations of previous measures. It is based on a comprehensive approach to identifying comorbidities and separates them from the primary reason for hospitalization, resulting in an expanded set of comorbidities that easily is applied without further refinement to administrative data for a wide range of diseases.

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Assessing validity of ICD-9-CM and ICD-10 administrative data in recording clinical conditions in a unique dually coded database.

Hude Quan, Bing Li, L. Duncan Saunders … (2008)

The goal of this study was to assess the validity of the International Classification of Disease, 10th Version (ICD-10) administrative hospital discharge data and to determine whether there were improvements in the validity of coding for clinical conditions compared with ICD-9 Clinical Modification (ICD-9-CM) data. We reviewed 4,008 randomly selected charts for patients admitted from January 1 to June 30, 2003 at four teaching hospitals in Alberta, Canada to determine the presence or absence of 32 clinical conditions and to assess the agreement between ICD-10 data and chart data. We then re-coded the same charts using ICD-9-CM and determined the agreement between the ICD-9-CM data and chart data for recording those same conditions. The accuracy of ICD-10 data relative to chart data was compared with the accuracy of ICD-9-CM data relative to chart data. Sensitivity values ranged from 9.3 to 83.1 percent for ICD-9-CM and from 12.7 to 80.8 percent for ICD-10 data. Positive predictive values ranged from 23.1 to 100 percent for ICD-9-CM and from 32.0 to 100 percent for ICD-10 data. Specificity and negative predictive values were consistently high for both ICD-9-CM and ICD-10 databases. Of the 32 conditions assessed, ICD-10 data had significantly higher sensitivity for one condition and lower sensitivity for seven conditions relative to ICD-9-CM data. The two databases had similar sensitivity values for the remaining 24 conditions. The validity of ICD-9-CM and ICD-10 administrative data in recording clinical conditions was generally similar though validity differed between coding versions for some conditions. The implementation of ICD-10 coding has not significantly improved the quality of administrative data relative to ICD-9-CM. Future assessments like this one are needed because the validity of ICD-10 data may get better as coders gain experience with the new coding system.

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Determination of reliability criteria for liver stiffness evaluation by transient elastography.

Sandrine Bertrais, Jean-Pierre Zarski, … (2013)

Liver stiffness evaluation (LSE) is usually considered as reliable when it fulfills all the following criteria: ≥10 valid measurements, ≥60% success rate, and interquartile range / median ratio (IQR/M) ≤0.30. However, such reliable LSE have never been shown to be more accurate than unreliable LSE. Thus, we aimed to evaluate the relevance of the usual definition for LSE reliability, and to improve reliability by using diagnostic accuracy as a primary outcome in a large population. 1,165 patients with chronic liver disease from 19 French centers were included. All patients had liver biopsy and LSE. 75.7% of LSE were reliable according to the usual definition. However, these reliable LSE were not significantly more accurate than unreliable LSE with, respectively: 85.8% versus 81.5% well-classified patients for the diagnosis of cirrhosis (P = 0.082). In multivariate analyses with different diagnostic targets, LSE median and IQR/M were independent predictors of fibrosis staging, with no significant influence of ≥10 valid measurements or LSE success rate. These two reliability criteria determined three LSE groups: "very reliable" (IQR/M ≤0.10), "reliable" (0.10 0.30 with LSE median 0.30 with LSE median ≥7.1 kPa). The rates of well-classified patients for the diagnosis of cirrhosis were, respectively: 90.4%, 85.8%, and 69.5% (P < 10(-3) ). According to these new reliability criteria, 9.1% of LSE were poorly reliable (versus 24.3% unreliable LSE with the usual definition, P < 10(-3) ), 74.3% were reliable, and 16.6% were very reliable. The usual definition for LSE reliability is not relevant. LSE reliability depends on IQR/M according to liver stiffness median level, defining thus three reliability categories: very reliable, reliable, and poorly reliable LSE. (HEPATOLOGY 2013). Copyright © 2012 American Association for the Study of Liver Diseases.

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Author and article information

Contributors

Seung Up Kim: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2014

Publication date (Electronic): 22 April 2014

Volume: 9

Issue: 4

Electronic Location Identifier: e95776

Affiliations

[1 ]Liver Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada

[2 ]Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada

[3 ]Medical Services, Alberta Health Services, Calgary, Alberta, Canada

Yonsei University College of Medicine, Republic of Korea

Author notes

* E-mail: rpmyers@ 123456ucalgary.ca

Competing Interests: The authors have declared that no competing interests exist.

Conceived and designed the experiments: RPM. Performed the experiments: JXQP SZ SN PC JT FP AAS RPM. Analyzed the data: JXQP RPM. Contributed reagents/materials/analysis tools: JXQP SZ SN PC JT FP AAS CSC SH GGK MGS RPM. Wrote the paper: JXQP RPM. Revised the manuscript for important intellectual content: JXQP SZ SN PC JT FP AAS CSC SH GGK MGS RPM.

Article

Publisher ID: PONE-D-14-09449

DOI: 10.1371/journal.pone.0095776

PMC ID: 3995722

PubMed ID: 24755824

SO-VID: 59a1446a-3ef3-4509-bfbd-b254e99174f2

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 4 March 2014

Date accepted : 29 March 2014

Page count

Pages: 9

Funding

Drs. Myers, Coffin, and Kaplan are supported by awards from the Canadian Institutes for Health Research (CIHR). Dr. Kaplan is also supported by Alberta Innovates-Health Solutions (AIHS). Dr. Swain is supported by the Cal Wenzel Family Foundation Chair in Hepatology. This study was supported in part by grants from CIHR, AIHS, and the Canadian Liver Foundation, and is based in part on data provided by Alberta Health. The interpretation and conclusions are those of the researchers and do not necessarily represent the views of the Government of Alberta. Neither the Government nor Alberta Health expresses any opinion in relation to this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Liver Stiffness by Transient Elastography Predicts Liver-Related Complications and Mortality in Patients with Chronic Liver Disease

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Abstract

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Conclusions

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Most cited references 29

Comorbidity measures for use with administrative data.

Assessing validity of ICD-9-CM and ICD-10 administrative data in recording clinical conditions in a unique dually coded database.

Determination of reliability criteria for liver stiffness evaluation by transient elastography.

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