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.
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.
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.
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
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
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.
