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Can Non-Invasive Medical Devices Help Halt Liver Disease?

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Vibration-controlled transient elastography (VCTE) technology could be used to detect liver disease early and to monitor interventions.   

A silent liver disease epidemic is sweeping the country and the world through a rise in chronic liver diseases, such as non-alcoholic fatty liver disease (NAFLD) and its more severe form non-alcoholic steatohepatitis (NASH). NASH can lead to advanced fibrosis and liver cancer, liver transplantation, and increased risk of cardiovascular events and all-cause mortality, while NAFLD is one of the most common causes of liver disease in the United States. Experts state that about 24% of U.S. adults have NAFLD and about 1.5% to 6.5% of U.S. adults have NASH.

Fortunately, liver disease can often be reversed with early diagnosis and intervention with the help of medical devices known as non-invasive tests (NITs) to help in the management of patients with liver diseases. The most promising NIT is vibration-controlled transient elastography (VCTE) technology, including liver stiffness measurement (LSM) by transient elastography (TE), controlled attenuation parameter (CAP), and spleen stiffness measurement (SSM) as an additional NIT to further improve risk stratification and refine the risk of high-risk varices.

Studies show that detecting and monitoring liver disease using VCTE is a non-invasive, convenient, and cost-effective way for clinicians to quantify the stiffness of liver tissue and to estimate liver fat at the point of care.

Closer Look at VCTE Technology

VCTE combines standardization, clinical performance, and accessibility for early patient identification, either in primary care, diabetology clinic, or liver clinic, and for advanced liver disease patient management, portal hypertension, and hepatocellular carcinoma (HCC) risk stratification.

VCTE technology is critical for detecting and monitoring for NAFLD/NASH, alcoholic liver disease (ALD), hepatitis C virus (including post sustained virologic response [PSVR]), primary biliary cirrhosis (PBC)/primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH) in at-risk populations such as patients with metabolic risk factors and/or harmful use of alcohol. VCTE technology also offers high value for comprehensive management of liver health. This is significant, considering the prevalence and associated costs of underdiagnosed liver disease.

Prevalence and Costs of Liver Disease

Liver damage rates have been tied to the alarming rise in adult obesity in the United States and worldwide. In 2000, 30.5% of American adults had obesity—a body mass index of 30 or higher—which increased through 2015-2016 and led to a spike in diabetes, cardiovascular disease, and some cancers. In 2017-2018, the obesity rate reached 42.4%—passing 40% for the first time.

Obesity can be devastating on vital organs, causing insulin resistance that leads to buildup of blood sugar and raises the amount of free fatty acids circulating in the blood and liver cells. Common in those with Type 2 diabetes, liver fat buildup increases the risk of liver fibrosis, cirrhosis, liver cancer, and death.

Costs

Liver damage is now linked to more than $100 billion in annual direct costs. A recent study among Medicare Advantage plans found that the annual cost of NAFLD was $9,062 for a new diagnosis and $5,363 for long-term management versus $4,111 per matched control. These costs are tied to inpatient hospitalization and outpatient appointments, emergency department visits, organ transplantation, medical procedures or new diagnoses, new medications, or changes to existing medications and mortality.

Estimates reveal that 357 million people will have NASH globally by 2030. Given that NAFLD and NASH are so closely tied to obesity, diabetes, and lifestyle, a preemptive approach to patient engagement is necessary to encourage more positive lifestyle behavioral changes.

Addressing Behavioral Change with Medical Devices

For many patients, diet and exercise can make all the difference. In fact, a 3% reduction in body weight has been associated with reversal of fat in the liver, while a reduction of greater than 7%  may resolve NASH in many patients.

The progression of liver disease is typically slow, giving patients the opportunity to be managed well by primary care physicians. This has prompted a growing number of healthcare providers to adopt VCTE tools to help halt or reverse liver damage among at-risk patients.

Stakeholders could benefit from a VCTE tool that provides exam results to help monitor lifestyle modification. The tool should also offer consistent quantitative results to enable clinics to monitor fatty liver disease and provide feedback to patients about their diet and exercise modifications. It’s also important that a VCTE tool integrates with EHRs for automatic upload and storage of the exam results to save time, secure data, and improve the patient’s follow-up.

The bottom line: as a medical device, a VCTE tool can help in the battle against the liver disease epidemic, adding value to a practice, enhancing patient satisfaction, improving outcomes, and playing a role in creating a more sustainable healthcare system.

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