Papatheodoridi Margarita, Hiriart Jean Baptiste, Lupsor-Platon Monica, Bronte Fabrizio, Boursier Jerome, Elshaarawy Omar, Marra Fabio, Thiele Maja, Markakis Georgios, Payance Audrey, Brodkin Edgar, Castera Laurent, Papatheodoridis George, Krag Aleksander, Arena Umberto, Mueller Sebastian, Cales Paul, Calvaruso Vincenza, de Ledinghen Victor, Pinzani Massimo, Tsochatzis Emmanuel A
UCL Institute for Liver and Digestive Health, Royal Free Hospital and UCL, London, UK.
INSERM U1053, Bordeaux University, Bordeaux, France.
J Hepatol. 2021 May;74(5):1109-1116. doi: 10.1016/j.jhep.2020.11.050. Epub 2020 Dec 9.
The Baveno VI consensus proposed a dual liver stiffness (LS) by transient elastography threshold of <10 and >15 kPa for excluding and diagnosing compensated advanced chronic liver disease (cACLD) in the absence of other clinical signs. Herein, we aimed to validate these criteria in a real-world multicentre study.
We included 5,648 patients (mean age 51 ± 13 years, 53% males) from 10 European liver centres who had a liver biopsy and LS measurement within 6 months. We included patients with chronic hepatitis C (n = 2,913, 52%), non-alcoholic fatty liver disease (NAFLD, n = 1,073, 19%), alcohol-related liver disease (ALD, n = 946, 17%) or chronic hepatitis B (n = 716, 13%). cACLD was defined as fibrosis stage ≥F3.
Overall, 3,606 (66%) and 987 (18%) patients had LS <10 and >15 kPa, respectively, while cACLD was histologically confirmed in 1,772 (31%) patients. The cut-offs of <10 and >15 kPa showed 75% sensitivity and 96% specificity to exclude and diagnose cACLD, respectively. Examining the ROC curve, a more optimal dual cut-off at <7 and >12 kPa, with 91% sensitivity and 92% specificity for excluding and diagnosing cACLD (AUC 0.87; 95% CI 0.86-0.88; p <0.001) was derived. Specifically, for ALD and NAFLD, a low cut-off of 8 kPa can be used (sensitivity=93%). For the unclassified patients, we derived a risk model based on common patient characteristics with better discrimination than LS alone (AUC 0.74 vs. 0.69; p <0.001).
Instead of the Baveno VI proposed <10 and >15 kPa dual cut-offs, we found that the <8 kPa (or <7 kPa for viral hepatitis) and >12 kPa dual cut-offs have better diagnostic accuracy in cACLD.
The term compensated advanced chronic liver disease (cACLD) was introduced in 2015 to describe the spectrum of advanced fibrosis and cirrhosis in asymptomatic patients. It was also suggested that cACLD could be diagnosed or ruled out based on specific liver stiffness values, which can be non-invasively measured by transient elastography. Herein, we assessed the suggested cut-off values and identified alternative values that offered better overall accuracy for diagnosing or ruling out cACLD.
巴韦诺VI共识提出，在无其他临床体征的情况下，通过瞬时弹性成像测定的肝脏硬度（LS）双阈值<10 kPa和>15 kPa用于排除和诊断代偿期晚期慢性肝病（cACLD）。在此，我们旨在通过一项真实世界的多中心研究验证这些标准。
我们纳入了来自10个欧洲肝脏中心的5648例患者（平均年龄51±13岁，53%为男性），这些患者在6个月内进行了肝活检和LS测量。我们纳入了丙型肝炎（n = 2913，52%）、非酒精性脂肪性肝病（NAFLD，n = 1073，19%）、酒精性肝病（ALD，n = 946，17%）或乙型肝炎（n = 716，13%）患者。cACLD定义为纤维化分期≥F3。
总体而言，分别有3606例（66%）和987例（18%）患者的LS<10 kPa和>15 kPa，而1772例（31%）患者经组织学证实为cACLD。<10 kPa和>15 kPa的阈值分别显示出75%的敏感性和96%的特异性来排除和诊断cACLD。通过检查ROC曲线，得出了一个更优的双阈值<7 kPa和>12 kPa，排除和诊断cACLD的敏感性为91%，特异性为92%（AUC 0.87；95%CI 0.86 - 0.88；p<0.001）。具体而言，对于ALD和NAFLD，可使用8 kPa的低阈值（敏感性=93%）。对于未分类的患者，我们基于常见患者特征推导了一个风险模型，其判别能力优于单独的LS（AUC 0.74对0.69；p<0.001）。
我们发现，与巴韦诺VI提出的<10 kPa和>15 kPa双阈值相比，<8 kPa（病毒性肝炎为<7 kPa）和>12 kPa双阈值在cACLD诊断中具有更好的准确性。
代偿期晚期慢性肝病（cACLD）这一术语于2015年引入，用于描述无症状患者的晚期纤维化和肝硬化谱。还提出可根据特定的肝脏硬度值诊断或排除cACLD，这些值可通过瞬时弹性成像进行无创测量。在此，我们评估了建议的阈值，并确定了在诊断或排除cACLD方面具有更好总体准确性的替代值。
