Jon Gingrich, CEO, Echosens North America writes ….
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder in the word, impacting 25% of the world’s population. More than 90% of people with obesity, 60% of people with diabetes and up to 20% of people with normal weight develop the disease.
A key factor in the development of NAFLD is the accumulation of fat in the liver, which can progress to a more aggressive form of NAFLD called non-alcoholic steatohepatitis (NASH). NASH leads to inflammation and fibrosis, which can then develop into liver cirrhosis, primary liver cancer, and sometimes death. Prevalent NASH cases are expected to increase 63% from 16.52 million to 27 million cases by 2030. Because liver fibrosis is a strong predictor of long-term mortality in patients with NAFLD, a growing number of healthcare executives, primary care physicians, and specialists are adopting non-invasive tools to battle the liver disease epidemic.
High Costs of Liver Disease
The prevalence and associated costs of underdiagnosed liver disease is now linked to over $100 billion in annual direct costs. Experts estimate that approximately 24% of U.S. adults have NAFLD and about 1.5-6.5% of U.S. adults have NASH, which can lead to advanced fibrosis, liver cancer, liver transplantation, increased risk of cardiovascular events and all-cause mortality. Costs per patient and overall costs per year of chronic liver disease stem from inpatient hospitalization and outpatient appointments, emergency department visits, organ transplantation, medical procedures or new diagnoses, new medications or changes to existing medications, and mortality.
In one study, patients with NASH were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635. Patients with advanced fibrosis have the highest costs, which suggests that reducing fibrosis progression is important for reducing future health care costs.
With early diagnosis, intervention and monitoring, however, liver disease can often be reversed. Disease progression is typically slow, and patients can be managed well by primary care physicians.
New guidelines from the European Association for the Study of the Liver (EASL), a professional association for individuals researching liver disease, points to the effectiveness of non-invasive tests (NITs).
These important guidelines represent a critical advance for the non-invasive management of patients with liver diseases and an unprecedented level of recommendation for 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.
NIT Technology: High-Value Liver Health Management
NIT technology measures and monitors liver disease across the liver care continuum for all population groups. As the VCTE of reference, FibroScan 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.
EASL guidelines recommend VCTE technology 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), as well as in at-risk populations, such as patients with metabolic risk factors and/or harmful use of alcohol. All recommended cut-off values are clearly specified for LSM by TE.
VCTE technology represents a promising and cost-effective way to comprehensively manage liver health.
Lifestyle Change Can Reverse Liver Disease
The staggering rise in adult obesity in the United States and worldwide has led to more people experiencing liver damage and correlating health issues. In 2000, 30.5% of American adults had obesity—a body mass index of 30 or higher. That rate increased through 2015-2016, helping to spike other related health issues, such as diabetes, cardiovascular disease, and some cancers.
In 2018, the obesity rate reached 42.4%, surpassing 40% for the first time. Obesity can have a devastating impact on vital organs, especially the liver, causing insulin resistance and the buildup of blood sugar, increasing the amount of free fatty acids circulating in the blood and liver cells. This buildup of fat is very common in those with Type 2 diabetes and increases the risk of liver fibrosis, cirrhosis, liver cancer, and death.
Because NAFLD and NASH are so tightly intertwined with obesity, diabetes, and lifestyle, a more proactive approach to patient engagement is required to support behavioral changes that will result in better outcomes across the co-morbid conditions affecting the individual patient.
For many patients, a 3% reduction in body weight through diet and exercise has been associated with reversal of steatosis and a reduction of greater than 7% may resolve NASH in many patients.
Bottom line: VCTE is a simple, painless, and rapid way for clinicians to quantify the stiffness of liver tissue and estimate liver fat at the point of care—and likely to become a standard care option in the near future.
About Jon Gingrich, CEO, Echosens North America
With more than 20 years of global medical device and health care sales, marketing and general management experience at AxoGen, Inc., Hologic, Inc., Boston Scientific Corporation and Unilever, N.V, Gingrich now leads the development and execution of the Echosens U.S. strategy for expanding the utilization of FibroScan® technology in the assessment of chronic liver disease. As a member of the broader global executive leadership team, he works to implement the Company’s transformation plan and shape the future of Echosens.