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Ascites pump reduces need for large volume paracentesis

A new low-flow ascites pump significantly reduced paracentesis frequency in patients with a contraindication to transjugular intrahepatic portosystemic shunt, or TIPS, according to a recently published study.

“The management of refractory ascites in patients with cirrhosis is challenging and novel therapies are an unmet need in hepatology, due to the important limitations of both large volume paracentesis and TIPS,” Guido Stirnimann, MD, from the University Hospital of Bern, Switzerland, said in a press release. “The results of this largest reported series to-date of alfapump patients, demonstrates that in real life subjects alfapump provides an innovative and effective treatment option.”

Alfapump (Sequana Medical AG) is a fully implantable, automated low-flow ascites pump system developed to transfer ascitic fluid from the abdominal cavity to urinary bladder catheters. When the pump cannot access sufficient fluid, pumping ceases immediately.

The researchers enrolled 56 patients with cirrhosis and refractory ascites. All patients presented a contraindication for TIPSS procedure.

During follow-up, 37 patients did not require large volume paracentesis after system implantation and the overall frequency of large volume paracenteses decreased from 2.17 (95% CI, 1.45-4.34) in the first 48 participants to 0.17 per month (95% CI, 0.0-0.41) among the whole cohort.

Of the 127 post-implant paracenteses, 55 were related to issues such as clogging of the pump or obstruction of the catheter, and the rest were due to technical issues with the charger or insufficient charging (10%), programmed pump volume set too low (27%), or unknown reasons (20%).

Mean patient survival was 12.8 months (95% CI, 10-15.7) and 23 patients died. Seven additional patients died after withdrawal from the study due to serious adverse events that required pump removal.

Twenty-seven pumps were explanted, most often due to adverse events such as infection (n = 14) or receipt of an orthotopic liver transplantation (n = 9). Seventeen patients required reinterventions without a pump exchange or explantation.

“Optimization of the system is ongoing, and preliminary results of a new version of the peritoneal catheter show a markedly decreased rate of catheter-related complications. Remaining open issues include the effects on quality of life and liver function and the role of albumin replacement with its effect on relative volume status.” – by Talitha Bennett

Disclosure: Stirnimann reports he has served as a speaker, consultant and advisory board member for Sequana Medical AG. Please see the full study for the other authors’ relevant financial disclosures.