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CLINICAL RESEARCH

Published Studies
Treatment of Malignant Ascites Using an Automated Pump Device (Federico Storni, Guido Stirnimann,Vanessa Banz and Andrea De Gottardi, Journal The American Journal of Gastroenterology (2018) DOIdoi:10.1038/s41395-018-0100-1)

Complete publication

Case study of treatment of a patient with malignant ascites using the alfapump.
Patient required and LVP every other week prior to implant. During the 14 months of alfapump treatment no paracentesis was necessary.

Editorial: alfapump® – an alternative to large-volume paracentesis for patients with refractory ascites?

Complete publication

This real-world study confirms the data from the randomized trial. Once again efficacy of the system has been demonstrated. With further improvements in the device characteristics, longer term follow up and introduction of routine albumin replacement, alfapump® could emerge as a real alternative to large-volume paracentesis.

Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study

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In this multicentre, open-label randomized controlled trial, subjects were randomised to receive the alfapump® (AP) or large volume Paracentesis (LVP) (27 AP, 31 SoC). The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment. As compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life.

Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis (Stirnimann et al, Alimentary Pharmacology & Therapeutics, 2017)

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Post-Marketing Surveillance Registry

Fifty-six alfapump® patients (43 males, 13 women; mean age 62 years) with a contraindication to TIPSS (transjugular intrahepatic portosystemic shunt), from centres in Germany, Switzerland, UK and Spain were followed for up to 24 months. Complications, device deficiencies, paracentesis frequency and patient survival were recorded.

In the largest reported series to-date of patients implanted with the alfapump®, the continuous drainage of ascites with the alfapump® led to a significant reduction in paracentesis frequency, with the median frequency of paracentesis dropped over 90% , from 2.17 to 0.17 per month.

Alfapump system vs. Large volume paracentesis for refractory ascites: A multicenter randomised controlled study (Bureau et al, Journal of Hepatology, 2017)

Complete publication

European Randomised Clinical Trial

This multicentre, randomized controlled trial assessed safety and efficacy of the alfapump® (AP) compared with Large Volume Paracentesis (LVP or SoC) in 58 patients (27 AP, 31 SoC, mean age 61.9 years, mean MELD 11.7).

The study demonstrated that in patients with refractory ascites, the alfapump®:

• significantly reduces the requirement for LVP compared to standard of care
• significantly improves Health-Related Quality of Life compared to standard of care
• shows nutritional benefits compared to standard of care

Automated low-flow ascites pump for the treatment of cirrhotic patients with refractory ascites (Stirnimann et al, Therapeutics Advances in Gastroenterology, 2017)

Complete publication

Patient Selection and Management

Review of the currently available data about patient selection, effiacacy and safety of the alfapump® and provides recommendations for the management of patients treated with this new method

Automated low flow pump system for the treatment of refractory ascites: A multi-center safety and efficacy study (Bellot et al, Journal of Hepatology, 2013)

Complete publication

PIONEER Study

Forty alfapump patients at 9 centres were followed for 6 months; primary outcome was safety and secondary outcomes included recurrence of tense ascites and pump performance. The alfapump was an efficacious tool to moves out ascites from the peritoneal cavity to the bladder.