Is a Liver Dialysis Device on the Horizon?
A new liver dialysis device might soon be able to save patients on the edge of death from liver failure, early clinical trial results show.
The DIALIVE device safely improved organ function and alleviated symptoms in patients with acute-on-chronic liver failure, compared with others receiving standard care, the researchers reported.
If the device proves out in a larger trial, it could provide patients with liver failure a lifeline at a time of immediate danger, said senior researcher Dr. Rajiv Jalan, a professor of hepatology at University College London (UCL), in the United Kingdom.
“Liver failure is potentially reversible as the liver has enormous capacity for regeneration,” Jalan said. “Therefore, the aim of a liver dialysis machine is to try and create a conducive environment for regeneration to occur and keep the patient alive until this is achieved. In case of overwhelming liver failure, liver dialysis would bridge the patient to a liver transplant.”
A larger trial is also needed to prove the device can actually save lives, noted Dr. Meena Bansal, a gastroenterologist and professor of liver disease with the Icahn School of Medicine at Mount Sinai, in New York City.
Although DIALIVE did improve liver function in this small pilot group of 32 patients, the device did not provide any survival benefit over standard care, said Bansal, who was not involved with the study.
“Equal numbers of patients died at the end of four weeks in either arm,” Bansal said. “If your blood markers look better, that's wonderful, but if you still die it's really not that great. That doesn't mean it's not promising. It just means that the study was too small to really show a potential survival benefit.”
Acute-on-chronic liver failure occurs in people with cirrhosis. Liver function suddenly declines, liver cells begin to die, and the gut begins to leak bacteria into the bloodstream, the researchers said.
“It's this overwhelming inflammatory storm,” Bansal said, adding that patients can suffer multiple organ failures and die within a month after developing acute-on-chronic liver failure.
About 100 million people around the world live with cirrhosis of the liver, and 3 million go on to develop acute-on-chronic liver failure, the study authors said in background notes.
Researchers have been trying for the past couple of decades to develop a liver dialysis device similar to kidney dialysis, Bansal said.
But the liver does a lot more than simply filter out toxins, Jalan said. It's a complex organ that performs more than 500 functions that include producing important blood proteins, manufacturing bile needed to digest food, helping the body store sugars, and processing fats.
The DIALIVE device involves a two-step process aimed directly at helping people survive acute-on-chronic liver failure, Jalan said. The device was invented by researchers at UCL's Institute for Liver and Digestive Health.
A healthy liver produces albumin, a blood protein that keeps fluid from leaking out of your blood vessels. But in acute-on-chronic liver failure, the liver starts to produce bad albumin that doesn't function as needed, Bansal said.
The new device filters out the bad albumin and replaces it with functioning albumin, Bansal said.
DIALIVE also filters out bacterial toxins that accumulate in the blood and liver, contributing to inflammation, Bansal said.
The device isn't a long-term cure, but instead gives the battered liver some breathing room to recover, Bansal said. If it doesn't recover, the device would keep the patient alive long enough for a transplant
“They're just trying to get people out of this very tumultuous acute situation, to bridge them to transplant,” Bansal said. “Can I just survive this acute insult and get to the point where I can get my liver transplant, or do I die in four weeks?”
Jalan and his colleagues tested DIALIVE in 32 patients with alcohol-related acute-on-chronic liver failure, who were randomly assigned to either be treated with the device or receive regular medical care.
The patients assigned to DIALIVE received at least three sessions on the device lasting 8 to 12 hours.
All patients were then followed for 28 days, to see how well they did.
The results showed the device provided significantly faster reversal of acute-on-chronic liver failure, the researchers reported.
It also reduced circulating levels of bacterial toxins and promoted better albumin function in patients. Inflammatory markers improved as well.
“The device was able to resolve liver failure significantly faster and in about twice the number of patients compared with patients only receiving standard of care,” Jalan said.
However, there was no significant difference in deaths between the two groups at 28 days, the results showed.
The next, larger trial will aim to confirm DIALIVE's safety and effectiveness, and also will assess its impact on survival, the researchers said.
If the trial is positive, DIALIVE could be available to treat patients in two to three years, Jalan said.
“This is an important development in the field of liver failure. Given the fact that the device is safe, it could be available very rapidly to start impacting on the lives of patients,” Jalan said. “The impact of DIALIVE on the underlying molecular mechanisms that drive liver failure opens up the possibility of developing other types of treatment for the future.”
The new study was published online May 31 in the Journal of Hepatology.
The Cleveland Clinic has more about liver failure.
SOURCES: Rajiv Jalan, MBBS, MD, PhD, professor, hepatology, University College London, United Kingdom; Meena Bansal, MD, gastroenterologist and professor, liver disease, Icahn School of Medicine at Mount Sinai, New York City; Journal of Hepatology, May 31, 2023, online