By Trevor Bromley
Liver biopsy has been the cornerstone technique for the diagnosis of liver disease staging for decades. However, complications to the patient are known to result. One of the most serious is excessive bleeding post-liver biopsy that would require rehospitalization and additional care. According to the journal Hepatology, between 2% and 3% of liver biopsied patients are hospitalized due to an adverse event.
Any interventional procedure like biopsy presents risk. But for liver disease patients, risk can run high. If a patient has advanced fibrosis or cirrhosis in the liver, they tend to bleed more easily, making needle insertion a risky option. It’s also easier to puncture vessels in liver disease patients and cause hemostasis because vessels are often obscured by the liver, which is swollen when it is in a diseased state.
Besides problems a patient might encounter, such complications also present a cost burden to the healthcare system. The median direct cost of hospitalization for complications from biopsy procedures is $4,579, with a range of $1,164-$29,641.*
But complications can be avoided, or at least greatly reduced, with noninvasive alternatives. Hepatitis C virus patients at Baylor Health Care System in Dallas have been part of the clinical trials for Sovaldi, currently the only drug on the market that is said to cure the hepatitis C virus. James Trotter, MD, medical director for general and transplant hepatology at Baylor, used ultrasound with shear wave elastography to follow several hundred HCV patients on the drug and assess the stiffness of their livers through the treatment. He has reduced the biopsy rate in HCV patients by 90%. Trotter now uses the technology on a routine basis to help make clinical decisions for his patients.
Ultrasound with shear wave elastography technology pioneered by SuperSonic Imagine can assess liver disease noninvasively using a quantifiable method that evaluates tissue elasticity. It does this through an ultrasound wave as well as a shear wave, which can measure and display tissue stiffness in real time.
Over 3 million Americans have chronic liver disease, and with a drug treatment now available for the first time, and others expected to come to market, the routine evaluation of drug therapy in HCV patients could be more efficient and cost-effective with a noninvasive method, not to mention make for a more pleasant patient experience.
A noninvasive technique like ultrasound with shear wave elastography technology also can help clinicians stage fibrosis noninvasively as well as differentiate adenomas from fibrous nodular hyperplasia, help distinguish hepatocellular carcinomas and cholangiocarcinomas, and improve the identification of hepatocellular carcinomas in cirrhotic livers.
Since the liver is a large organ, liver biopsy can often be misleading as well. A sample from one area may not give an accurate reading of the entire liver. According to the American Association for the Study of Liver Diseases, parenchymal abnormalities are irregularly distributed and sampling variability is almost inevitable in nearly all liver disease.
Such variability can lead to additional sampling, which is not an ideal situation for the patient or provider due to the costs as well as the risks of adverse side effects each time a follow-up biopsy is needed. In some cases, such as assessing therapeutic progress or monitoring fibrosis, several biopsies are performed. A noninvasive method for these particular cases would be a welcome tool for clinicians.
Studies are still ongoing to evaluate ultrasound with shear wave technology as a more effective method than liver biopsy, but the broader economic context of what it can bring to the table is worth considering and examining further, even if it’s simply the fact that the noninvasive technique avoids risk to the patient, and, in essence, could lead to more efficient clinical management and better patient outcomes.
(*SOURCE: Myers RP, Fong A, Shaheen AA. Utilization rates, complications and costs of percutaneous liver biopsy: a population-based study including 4275 biopsies. Liver Int. 2008;28(5):705-12, and reproduced in NIH PubMed)
Trevor Bromley is a UK-based freelance medical writer. He can be reached at [email protected].