Innovative Clinical Tool Helps Endocrinologists Quickly and Non-Invasively Diagnose, Manage and Treat Patients with Fatty Liver Disease

closeup of female doctor explain disease treatment solution for patient in clinic. selective focus photo.

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By Dr. Martin M. Grajower, M.D., FACP, FACE, a Clinical Professor of Medicine, Division of Endocrinology, at Albert Einstein College of Medicine

The United States and the entire world now face an epidemic of liver disease tied to the rise in obesity. Almost one-third of Americans have asymptomatic liver disease, also known as fatty liver disease (FLD), a chronic health condition caused by fatty deposits that become trapped in the liver. FLD stems primarily from an unhealthy diet, being overweight or heavy, long-term alcohol consumption. Except when due to alcohol, FLD is considered the liver manifestation of insulin resistance, or a pre-diabetic state.

FLD causes the liver to make inflammatory chemicals (cytokines) that cause inflammation all over the body.  These cytokines are a major reason obesity was associated with the high COVID mortality during the early years of the pandemic and remains a major risk factor for morbidity from COVID.  FLD also impedes the liver’s ability to process toxins and, if left untreated, can lead to a complete shut-down of the liver. From 2000 to 2014, the proportion of obese individuals went up by 44.9%. By 2030, this number is projected to drive a 55% annual increase in the number of people with nonalcoholic steatohepatitis cirrhosis (NASH) waiting for a liver transplant. NASH is the more severe form of non-alcoholic fatty liver disease (NAFLD), the accumulation of liver fat in people who drink moderate or no alcohol. 

Many endocrinologists, other health care providers, hospitals and health plans are seeing more individuals than ever before who are overweight (defined as a BMI of 25-29) or have obesity (BMI 30 or higher), which puts them at risk for NAFLD and NASH. In the absence of drugs to effectively treat FLD, it is crucial for these specialists to identify the disease early and help patients manage the disease through lifestyle changes, and then monitor the disease progression or improvement over time using non-invasive exams at the point of care. 

Importance of Early Detection  

Typical approaches for identifying NAFLD and NASH are either complicated, expensive and potentially harmful, such as liver biopsy, or not adequately sensitive. Fortunately, an innovative, non-invasive solution is now available. Powered by liver stiffness measurement assessed by vibration-controlled transient elastography (LSM by VCTE™), controlled attenuation parameter (CAP™) and spleen stiffness measurement (SSM by VCTE™), this quick and painless exam is performed in less than 10 minutes to provide immediate results at the point-of-care.

LSM by VCTE produces several measurements for simplified and consistent interpretation, rather than images which cannot be easily quantified. This enables clinicians to share the results with the patient at point-of-care and to monitor changes in liver fat content and fibrosis over time. In particular, this tool provides reliable, early identification of patients with FLD for proactive intervention aiming for behavioral changes. 

In addition to identifying patients with FLD who should be encouraged to make lifestyle changes, these patients also have double the risk of cardiovascular disease (heart attacks and strokes). The presence of FLD will therefore trigger the physician to be more aggressive in treating other risk factors like diabetes, blood pressure and cholesterol. 

Lifestyle Changes

LSM by VCTE serves as an ideal complement to lifestyle modifications, weight loss and strict control of obesity and Type 2 diabetes for effectively treating NAFLD. Greater reductions in body weight have been shown to reverse fibrosis. In many patients, as little as a 5-7% decrease in body weight is associated with a reduction in liver fat and inflammation. This helps to slow progression of, or even reverse, the liver disease. What’s more, screening and early detection with LSM by VCTE, can help to prevent more serious conditions, such as liver cancer. 

The liver stiffness measure can be used to non-invasively identify patients at high risk of active fibrotic NASH from among those with high suspicion of NAFLD. Since the degree of hepatic fibrosis is an extremely important prognostic indicator, this information can be used by primary care physicians and non-hepatologist specialists, such as endocrinologists, to inform whether a referral should be made to a hepatologist, or if the patient can continue to be followed in the current setting and treated with lifestyle intervention and aggressive management of cardiovascular risk factors.

Helping Payers Cut Costs

An independent assessment conducted by Santa Barbara Actuaries Inc. to evaluate from the payer’s perspective the cost effectiveness of deploying LSM by VCTE/CAP technology for detecting and monitoring FLD found that early identification of patients with FLD through broad placement of LSM by VCTE/CAP devices offers cost savings to payers. The model relied on administrative claims data consisting of 5 million commercial members and 3 million Medicare members to inform baseline statistics on disease prevalence, health care cost and utilization, and disease progression associated with different severities of liver disease. 

Across a five-year time span, researchers estimated net savings up to $2.64 per member per month (PMPM) for Medicare payers and up to $1.91 PMPM for commercial payers. The study concluded that deploying LSM by VCTE/CAP devices is a financially advantageous solution to address the FLD epidemic. 

One economic model involving high device penetration for a Medicare payer with 100,000 members deploying devices at specialists, produced an estimated five-year cumulative gross savings of $10.1 million and a net savings (subtracting device rental) of $8.8 million. This corresponds to a five-year 6.5:1 ROI and a net savings of $1.46 PMPM.

Stakeholders should look for LSM by VCTE tools that are small and portable, making them easy to use in the office or outpatient setting. They can be used by a trained operator, including a nurse, doctor or technician, with results available immediately for interpretation by the healthcare professional. Given the ongoing obesity epidemic beginning in childhood, and the rise in diabetes incidence, the prevalence of NAFLD, as well as the proportion of those with advanced liver disease, the need for LSM by VCTE is projected to grow.