Vibration-controlled transient elastography scores to predict liver-related events in steatotic liver disease
Open accessAbstract
Importance: Metabolic dysfunction-associated steatotic liver disease (MASLD) is currently the most common chronic liver disease worldwide. It is important to develop noninvasive tests to assess the disease severity and prognosis. Objective: To study the prognostic implications of baseline levels and dynamic changes of the vibration-controlled transient elastography (VCTE)-based scores developed for the diagnosis of advanced fibrosis (Agile 3+) and cirrhosis (Agile 4) in patients with MASLD. Design, Setting, and Participants: This cohort study included data from a natural history cohort of patients with MASLD who underwent VCTE examination at 16 tertiary referral centers in the US, Europe, and Asia from February 2004 to January 2023, of which the data were collected prospectively at 14 centers. Eligible patients were adults aged at least 18 years with hepatic steatosis diagnosed by histologic methods (steatosis in ≥5% of hepatocytes) or imaging studies (ultrasonography, computed tomography or magnetic resonance imaging, or controlled attenuation parameter ≥248 dB/m by VCTE). Main Outcomes and Measures: The primary outcome was liver-related events (LREs), defined as hepatocellular carcinoma or hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy, or hepatorenal syndrome), liver transplant, and liver-related deaths. The Agile scores were compared with histologic and 8 other noninvasive tests. Results: A total of 16 603 patients underwent VCTE examination at baseline (mean [SD] age, 52.5 [13.7] years; 9600 [57.8%] were male). At a median follow-up of 51.7 (IQR, 25.2-85.2) months, 316 patients (1.9%) developed LREs. Both Agile 3+ and Agile 4 scores classified fewer patients between the low and high cutoffs than most fibrosis scores and achieved the highest discriminatory power in predicting LREs (integrated area under the time-dependent receiver-operating characteristic curve, 0.89). A total of 10 920 patients (65.8%) had repeated VCTE examination at a median interval of 15 (IQR, 11.3-27.7) months and were included in the serial analysis. A total of 81.9% of patients (7208 of 8810) had stable Agile 3+ scores and 92.6% of patients (8163 of 8810) had stable Agile 4 scores (same risk categories at both assessments). The incidence of LREs was 0.6 per 1000 person-years in patients with persistently low Agile 3+ scores and 30.1 per 1000 person-years in patients with persistently high Agile 3+ scores. In patients with high Agile 3+ score at baseline, a decrease in the score by more than 20% was associated with substantial reduction in the risk of LREs. A similar trend was observed for the Agile 4 score, although it missed more LREs in the low-risk group. Conclusions and Relevance: Findings of this study suggest that single or serial Agile scores are highly accurate in predicting LREs in patients with MASLD, making them suitable alternatives to liver biopsy in routine clinical practice and in phase 2b and 3 clinical trials for steatohepatitis.
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In longitudinal studies with serial VCTE measurements, changes in LSM (20% increase, stable, 20% decrease) correlated with the risk of liver-related events including HCC and liver-related death.
“In longitudinal studies with serial VCTE measurements, changes in LSM (20% increase, stable, 20% decrease) correlated with the risk of liver-related events (including HCC) and liver-related death. 184,185”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [184]
The Serial model section reports that changes in LSM were associated with liver-related event risk, and the paper defines those events to include HCC and liver-related death. However, it does not report the claimed 20% increase/stable/20% decrease categories: the Serial model discusses a decrease of at least 10% and gives 30% as an example, while the Discussion attributes a 20% threshold to prior studies. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSeveral observational studies showed that LSM had good accuracy for liver-related events, liver-related and overall mortality.
“Several observational studies showed that LSM had good accuracy for liver-related events, liver-related and overall mortality. 178,183,184”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [184]
The Discussion reports that LSM predicts liver-related events with performance only marginally below the Agile scores. The Outcomes section includes liver-related death in the composite event measure, but the paper does not establish LSM’s accuracy for liver-related mortality separately or for overall mortality. It is also one multicenter study, rather than evidence by itself for several studies. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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Is liver steatosis a disease or the emperor’s new clothes?
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A Pragmatic Management Approach for Metabolic Dysfunction-Associated Steatosis and Steatohepatitis
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Biomarkers in Metabolic Dysfunction-Associated Steatotic Liver Disease
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- Authors
- Lin, H., Lee, H. W., Yip, T. C.-F., Tsochatzis, E., Petta, S., Bugianesi, E., Yoneda, M., Zheng, M.-H., Hagström, H., Boursier, J., Calleja, J. L., Goh, G. B.-B., Chan, W.-K., Gallego-Durán, R., Sanyal, A. J., de Lédinghen, V., Newsome, P. N., Fan, J.-G., Castéra, L., Lai, M., Harrison, S. A., Fournier-Poizat, C., Wong, G. L.-H., Pennisi, G., Armandi, A., Nakajima, A., Liu, W.-Y., Shang, Y., de Saint-Loup, M., Llop, E., Teh, K. K.-J., Lara-Romero, C., Asgharpour, A., Mahgoub, S., Chan, M. S.-W., Canivet, C. M., Romero-Gomez, M., Kim, S. U., Wong, V. W.-S., & VCTE-Prognosis Study Group
- Affiliations
- Chinese University of Hong Kong (HK)
- Yonsei University (KR)
- The Royal Free Hospital (GB)
- University of Palermo (IT)
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Yokohama City University (JP)
- First Affiliated Hospital of Wenzhou Medical University (CN)
- Karolinska University Hospital (SE)
- Centre Hospitalier Universitaire d'Angers (FR)
- Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
- Singapore General Hospital (SG)
- University of Malaya (MY)
- Digestive Diseases Unit and CIBERehd, Virgen Del Rocío University Hospital, Seville, Spain
- Virginia Commonwealth University (US)
- Centre d’Investigation de la Fibrose Hépatique, Haut-Lévêque Hospital, University Hospital of Bordeaux, Pessac, France
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Shanghai Jiao Tong University (CN)
- Inserm (FR)
- Beth Israel Deaconess Medical Center (US)
- University of Oxford (GB)
- Echosens, Paris, France
- Karolinska Institutet (SE)
- Hepato-Gastroenterology and Digestive Oncology Department, Angers University Hospital, Angers, France
- Hospital Universitario Puerta de Hierro Majadahonda (ES)
- Echosens (France) (FR)
- Corresponding author
- Kim, Seung Up
- Wong, Vincent Wai-Sun
- ORCID
- Lin, Huapeng
- Lee, Hye Won
- Yip, Terry Cheuk-Fung
- Tsochatzis, Emmanuel
- Petta, Salvatore
- Bugianesi, Elisabetta
- Yoneda, Masato
- Zheng, Ming-Hua
- Hagström, Hannes
- Boursier, Jérôme
- Goh, George Boon-Bee
- Chan, Wah-Kheong
- Sanyal, Arun J.
- Newsome, Philip N.
- Fan, Jian-Gao
- Castéra, Laurent
- Lai, Michelle
- Harrison, Stephen A.
- Wong, Grace Lai-Hung
- Pennisi, Grazia
- Armandi, Angelo
- Nakajima, Atsushi
- Liu, Wen-Yue
- Shang, Ying
- Llop, Elba
- Teh, Kevin Kim-Jun
- Asgharpour, Amon
- Kim, Seung Up
- Wong, Vincent Wai-Sun
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2024-04-16
- Volume
- 331
- Issue
- 15
- Pages
- 1287
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W4393037494
- Cited by
- 250
- References
- 32
- Citations by year
- 2026: 106 · 2025: 98 · 2024: 46
- FWCI
- 76.29
- Type
- journal article
- Language
- en
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Funders
- Pfizer
- AstraZeneca
- Gilead Sciences
- Kowa Company
- Novo Nordisk
- Siemens Healthineers
- Japan Society for the Promotion of Science (21K08012)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Keywords
- vibration-controlled transient elastography, non-alcoholic fatty liver disease, liver-related events, liver fibrosis, liver cirrhosis, noninvasive fibrosis assessment, outcome prediction, hepatic decompensation, hepatocellular carcinoma, liver transplantation, controlled attenuation parameter, hepatic steatosis, natural history (disease)
- MeSH terms
- Adolescent, Adult, Esophageal and Gastric Varices, Fatty Liver, Female, Gastrointestinal Hemorrhage, Carcinoma, Hepatocellular, Humans, Liver, Liver Cirrhosis, Liver Neoplasms, Male, Middle Aged, Vibration, Cohort Studies, Elasticity Imaging Techniques
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