Treatment of refractory ascites with an automated low‐flow ascites pump in patients with cirrhosis

Abstract

SummaryBackgroundRefractory ascites (RA) is a frequent complication of cirrhosis, requiring large volume paracentesis or placement of a transjugular intrahepatic portosystemic shunt (TIPSS). The automated low‐flow ascites pump (alfapump, Sequana Medical AG, Zurich, Switzerland) is an innovative treatment option for patients with RA.AimTo assess safety and efficacy of this treatment in patients with a contraindication to TIPSS.MethodsFifty‐six patients (43 males; mean age 62 years) from centres in Germany, Switzerland, UK and Spain were included and followed for up to 24 months. Complications, device deficiencies, paracentesis frequency and patient survival were recorded.ResultsAt the time of this analysis, 3 patients completed the 24‐month observation period, monitoring of 3 was ongoing, 9 underwent liver transplantation, 17 patients were withdrawn due to serious adverse events and 23 patients died. Most frequently observed technical complication was blocking of the peritoneal catheter. Twenty‐three pump‐related reinterventions (17 patients) and 12 pump exchanges (11 patients) were required during follow‐up. The pump system was explanted in 48% of patients (in 17 patients due to serious adverse events, in 9 at the time of liver transplantation and in 1 due to recovery from RA). Median frequency of paracentesis dropped from 2.17 to 0.17 per month.ConclusionsThe alfapump can expand therapeutic options for cirrhotic patients with RA. Continuous drainage of ascites in a closed loop automated system led to significant reduction in paracentesis frequency. Technical and procedural improvements are required to reduce the rate of adverse events and reinterventions. https://clinicaltrials.gov/ct2/show/NCT01532427

Improvement in Quality of Life and Decrease in Large‐Volume Paracentesis Requirements With the Automated Low‐Flow Ascites Pump

“…For the 17 patients who required an LVP during the study, the time to the first LVP after alfapump implantation was delayed to more than 3 months, consistent with other reports of alfapump use in the literature . The majority of the postimplantation LVPs were related to pump or catheter malfunction, which is higher than in published studies .…”

“…This is the first North American study using the alfapump as a management tool for recurrent ascites. Like the previous European studies, we encountered a significant number of technical issues, and bacterial infections occurred in at least 40% of the study patients. Despite this, we demonstrated that the insertion of the alfapump system was effective in reducing the requirement for LVP.…”

Permanent indwelling peritoneal catheters for palliation of refractory ascites in end‐stage liver disease: A systematic review

“…The ALFApump ® involves an implantable device pumping ascites from the peritoneal cavity into the bladder . Consistent with the initial European multicentre safety and efficacy study and the multicentre RCT, recent studies have corroborated complication rates of infections (11%‐56%), renal dysfunction (21%‐67%), device deficiency including catheter occlusion (9%‐33%) and explantation rates of up to 30% . Recent NICE guidance on the ALFApump ® advises use only with ‘special arrangements’ and in research settings…”

Systematic review with meta‐analysis: automated low‐flow ascites pump therapy for refractory ascites

“…We screened 309 references; 40 were selected for full‐text retrieval. Of these, nine were included in the analysis …”

“…Of these, nine were included in the analysis. 5,6,12,[20][21][22][23][24][25] Seven studies were published as full-text articles 5,6,12,[20][21][22][23] and two in abstract form. 24,25 With the exception of one randomised controlled trial, 6 all other studies were case series; only patients treated with automated low-flow ascites pump were considered in the meta-analysis (…”