WASHINGTON, DC — Liver fibrosis was detected in more than one-third of people with no known liver disease who underwent transient elastography in a primary care clinic, new research shows.
“In the community setting, there is no reliable diagnostic test for early liver disease,” said Tarek Hassanein, MD, from Southern California GI and Liver Centers in San Diego.
In fact, blood chemistry was normal in more than 90% of the patients in this cohort, which suggests that the serum alanine transaminase (ALT) assays commonly used to screen for fatty liver disease might be insufficient.
“We are well aware that more than 50% of patients with fatty livers have normal ATL values,” he pointed out. And interoperator variability and “poor predictive ability for diagnosis of fibrosis and steatosis” limit the utility of ultrasonography, which is also commonly used to evaluate patients for liver disease. Liver biopsies are more accurate, but they are invasive, he added.
However, transient elastography is “quick, simple, and validated across a range of liver diseases for assessment of fibrosis and steatosis,” Dr Hassanein said here at The Liver Meeting 2017, where he presented initial findings from a study of 958 patients.
Correlation With Biopsy Findings
For their study, Dr Hassanein and his colleagues implemented a 16-week transient elastography screening program at a primary care clinic in Chula Vista, California. They offered screening to 1298 consecutive patients, and ended up with 958 evaluable scans.
Operators used a hand-held FibroScan probe, from Echosens, to assess liver stiffness, an indication of fibrosis, and a controlled attenuation parameter (CAP) score to detect steatosis.
Results are still being analyzed but, so far, 53 primary care patients have been referred to a liver specialist and 21 have undergone a full evaluation, including liver biopsy.
Biopsy results correlated well with transient elastography findings of steatosis, and have confirmed 19 of the 21 positive scans.
For fibrosis, however, the correlation between biopsy results and the transient elastography liver stiffness measurement was less striking. Although biopsy confirmed all patients without fibrosis — those with a transient elastography liver stiffness score below 7 — biopsy only confirmed significant fibrosis in five of the 13 patients with a liver stiffness score of at least 7.
In the study, 36% of patients had a CAP score of at least 290, indicating steatosis. “That’s a significant proportion of patients,” said Dr Hassanein. And transient elastrography detected significant stiffness in 18% of the patients.
But close to 93% of these patients had normal liver tests and 98% had normal platelet counts, “so those are not very helpful in looking at these patients,” he added.
Ready for Primary Care?
On the basis of these results, Dr Hassanein said he believes that screening for fatty liver should be conducted in the primary care clinic.
But not everyone is convinced.
“It’s a very important study, but I disagree with the conclusion. I think more data will need to come out of their paper,” said session comoderator Naga Chalasani, MD, from the Indiana University School of Medicine in Indianapolis.
The investigators might want to look at lowering the ALT threshold — from 40 to 30 IU/L — for example, he told Medscape Medical News.
Cost might be an issue, and “you’re going to have false positives and biopsies,” he added. The results are going to require further scrutiny “in terms of how we interpret them,” he added.
After the presentation, the line at the microphone was long and generated a lot of discussion.
One member of the audience mentioned the limited availability of transient elastography in the primary care setting, and noted that such routine screening might not be reimbursed.
“The goal of the screening program is to develop an algorithm for the primary care setting,” Dr Hassanein reported, adding, “I hope that the FibroScan becomes more available as a screening tool.”
Another audience member asked whether it is appropriate to recommend screening in a primary care clinic “even if we don’t have data showing a difference in outcome.”
“I think the opposite is true,” Dr Hassanein replied, saying that the study supports the use of transient elastography. “We need to stress lifestyle changes, diet, exercise, and expending the effort,” he pointed out, not just “waiting for the patient’s criteria to change.”
“I’d like to remind the audience that the AASLD guidance updated in 2017 does not recommend screening for fatty liver in the primary care setting,” said Dr Chalasani, who is lead author of the guidelines (Hepatology. Published online July 17, 2017). “It’s not because the disease is not prevalent, it’s more about lack of effective treatment that will change the outcome.”
“Detection is not the same as finding something that can change the natural history of the condition,” he explained.
Another member of the audience asked if it might be more cost-effective to reserve transient elastography for patients with higher body mass indexes.
“We have not found a significant number with advanced fibrosis, but I don’t want to speculate before we further analyze the data,” Dr Hassanein said. But, he added, almost 80% of the population in this study was overweight, obese, or morbidly obese.
Referral Follow-up Needs Improvement
“I’m disappointed because 25% of your patients did not accept the FibroScan, and 30% of the patients did not show up,” said another person. In addition to the 326 people who declined screening or did not meet inclusion criteria, 46 people who were referred to a specialist did not make an appointment, and 44 others were no-shows.
“Some people when screened say they don’t want to know if they have a liver condition,” said Dr Hassanein. “We are very interested in that group,” he noted, and want to understand “why some people reject and prefer not to be screened.”
The investigators are still evaluating the reasons people did not follow through on their appointments.” Patients who do not follow through often say, “I feel great. I have no problems,” he explained.
“Education and awareness are very important. They have to target primary care physicians because they have a better connection with patients than our team showing up and offering the FibroScan.”
Dr Hassanein and Dr Chalasani have disclosed no relevant financial relationships.
The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD): Abstract 58. Presented October 22, 2017.