Press release

Use of LiMAx test leads to reduction in post-hepatectomy liver failure and related mortality

Retrospective analysis of 1170 patients shows improved outcomes of partial liver resections after the determination of the patient’s individual operative risk with the LiMAx test.

Post-operative liver failure is a severe complication after partial liver resections. Pre-existing hepatic dysfunction therefore remains a major concern when considering patients for liver resection. We need selection criteria that accurately identify patients in whom a surgical intervention can be safely performed. Humedics’ LiMAx test has been demonstrated to accurately and reliably assess liver function in both healthy subjects and patients with cirrhosis. It furthermore has been shown to be unaffected by age, gender or obesity.

In a retrospective study at the Department of General, Visceral and Transplantation Surgery, Charité – Universitätsmedizin Berlin, Campus Virchow Hospital, 1170 patients undergoing elective hepatectomy between January 2006 and December 2011 were analyzed. The aim of this study was to investigate the impact of the LiMAx test on patient selection and outcome. Propensity score matching was used to compare the effects on morbidity and mortality of the integration of the LiMAx algorithm into clinical practice.

Study results showed that even with more cirrhotic patients were selected to undergo liver surgery (6.9% in 2006 to 11.3% in 2011), the post-operative liver failure rate were dramatically decreased by 54.4% after the full implementation of LiMAx algorithm. Besides, the liver failure-related mortality dropped from 4% to 0.9% regardless of the increase in complex hepatectomy cases (including extended right hepatectomies and resections with concomitant biliary and/or vascular reconstruction).

The analysis of data for the propensity score-matched cohort suggests that the integration of the LiMAx algorithm was a major factor contributing to the improved outcomes. In conclusion, the integration of the LiMAx algorithm seems to have played an important role in optimizing risk assessment prior to hepatic surgery.

Investigator PD Dr. Martin Stockmann said: “We saw an increasing number of complex hepatectomies over the study period and at the same time a decline in postoperative liver failure and in particular a reduction in the number of postoperative liver failure related deaths. In my opinion the improved outcomes are associated with the integration of the LiMAx test in our routine work-up.”

A major strength of this study is that the analysis is based on all consecutive and unselected patients over 6 years that received partial hepatic resection of one or more segments in an attempt to overcome a potential selection bias.

Erwin de Buijzer, CEO of Humedics GmbH, stated: “We are very pleased that this retrospective study demonstrates once more the usefulness of our LiMAx test and its benefits for patients considered for liver surgery. For us, this study is especially interesting because the long study period covers the time of the introduction of the LiMAx test into the work routine at the Charité and clearly demonstrates the improvements in clinical outcomes over six years.”

The LiMAx test, together with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery.

Original publication:
HPB 2015, 17, 651–658

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About Humedics

Humedics has developed a breath test based in vivo diagnostic system (the LiMAx® test), which comprises a CE-marked medical device, breathing masks and a diagnostic drug. The LiMAx® test enables the clinician to quantitatively determine the individual liver function capacity of a patient within minutes. This allows for selection of treatment strategies and disease monitoring optimally adapted to the individual patients’ liver status. Current clinical applications, studies of which have already been published in highly respected peer-reviewed scientific journals, include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of acute liver failure) and assessment of diseases such as liver fibrosis and cirrhosis. Over 20 trials in new indications such as the diagnosis of chronic liver diseases like non-alcoholic steatohepatitis (NASH) and the improvement of treatment decisions in liver oncology are ongoing. These investigator initiated trials impressively demonstrate the further potential of the LiMAx® test. The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and more than 20,000 tests have already been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.

LiMAx® Test

Based on the specific metabolic action of the liver enzyme CYP1A2, which is expressed in all functioning hepatocytes, performing the LiMAx® test is a simple procedure. The diagnostic drug solution is administered intravenously, and the liver immediately starts to metabolize the drug into low dose paracetamol and 13CO2 (non-radioactive). The latter is exhaled in the breath, collected via a respiratory mask and guided to the LiMAx® system where, within 1-2 minutes following the injection, the LiMAx® IR laser spectroscopy system allows real-time and very precise quantification of the increase in 13CO2 content. The resulting LiMAx® value, measured in micrograms per kilo body weight per hour, is a reliable and repeatable measure of the maximum functional capacity of the liver. 

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Erwin de Buijzer MD MBA

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