Novel Liver Assist Device Safe for Patients With Cirrhosis

A novel liver dialysis device for patients with acute on chronic liver failure (ACLF) was safe compared to standard of care, a small randomized study found.

In a European multi-center trial of 32 patients, serious adverse events occurred in 11 patients treated with the Dialive extracorporeal liver assist device versus in eight patients receiving standard of care. Deaths in both groups were also comparable (four and three, respectively), reported Banwari Agarwal, MD, of Royal Free Hospital in London.

While efficacy was not the purpose of the study, data from this small group also found that the intervention was associated with improvements in organ function, and ACLF-free survival compared to standard of care.

At the virtual European Association for the Study of the Liver (EASL) annual meeting, EASL scientific committee member, Tobias Boettler, MD, who moderated the press conference, but was not involved in the research, characterized the findings as "promising early results."

"It's very early, but we're really desperate in finding something to bridge to transplantation," he said. "I think this is very hopeful."

Agarwal noted how cirrhosis affects thousands of patients around the world, who "come into the hospital with acute decompensation ... and some of these patients go on to progress to other organ failure."

"The short-term outcome for these patients is abysmal with the current standard of care," he said.

Previous trials on mechanical liver devices carried out detoxified albumin in the liver through a dialysis system where it was then recirculated. But Agarwal noted albumin molecules are largely pro-inflammatory.

"We just want to remove them completely and discard [them] and infuse fresh albumin into the patient," he said.

This preliminary safety study was conducted at eight European hospitals. Patients were included if they had history indicative of alcohol-related cirrhosis, history of an acute decompensation event, or had ACLF grade 1, 2, or 3a. The primary endpoint was safety at 10 days after three to five sessions of 8 to 12 hours of the Dialive device.

There were 17 patients randomized to the intervention, while 15 were randomized to receive standard of care. Patients had a mean age of 49, about three-quarters were men, and all had alcoholic cirrhosis. Dialive therapy was administered for a median of three sessions in the first 3 days for a median of 8 hours each.

Three patients in the Dialive group had an unexpected serious device adverse event, such as anemia, septic shock, or hypotension, and one patient discontinued the device due to thrombocytopenia.

Though the trial was not designed to look at efficacy, Agarwal touted the preliminary clinical outcomes. At 28 days, 10 of 15 evaluable patients (66%) in the Dialive group remained alive with complete resolution of ACLF as compared to five of 15 (33%) in the control arm. Patients in the Dialive group also had better brain function, he said, which "translated into ongoing improvement."

When asked if there were plans to compare Dialive with other mechanical artificial liver devices in head-to-head studies, Agarwal noted other devices have previously failed in randomized trials for patients with acute on chronic liver failure, and that there are no data from an efficacy trial here.

"There seems little point in comparing something that is currently evolving," he said. "This would only be done if there was a similar story with all these devices, then maybe a one-to-one comparison would [help] inform [the] choice for clinicians."

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