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Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study.

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|June 25, 2017
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The automated alfapump® significantly reduces the need for large volume paracentesis in patients with refractory ascites, improving quality of life. While serious adverse events were more frequent, they did not impact survival.

Keywords:
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Area of Science:

  • Hepatology
  • Gastroenterology
  • Medical Devices

Background:

  • Refractory ascites (RA) significantly impacts patient quality of life, necessitating frequent large volume paracentesis (LVP).
  • Current standard of care (SoC) for RA involves repeated LVPs, leading to hospital visits and reduced well-being.
  • Novel therapeutic approaches are needed to manage RA effectively and improve patient outcomes.

Purpose of the Study:

  • To evaluate the safety and efficacy of the automated, low-flow alfapump® (AP) system compared to LVP as SoC.
  • To assess the impact of AP on paracentesis requirements, quality of life, and survival in RA patients.
  • To investigate the effects of AP on nutritional status, hemodynamics, and renal injury biomarkers.

Main Methods:

  • A randomized controlled trial was conducted across seven centers with a six-month follow-up period.
  • The primary outcome was the time to the first LVP, with secondary outcomes including paracentesis frequency, safety, and health-related quality of life (HRQoL).
  • A sub-study assessed nutritional parameters, hemodynamics, and renal injury biomarkers at three months.

Main Results:

  • The alfapump® group demonstrated a significant reduction in LVP requirement, with the median time to first LVP not reached compared to 15.0 days in the SoC group (HR 0.13; p<0.001).
  • AP patients showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores and nutritional parameters, including hand-grip strength and body mass index.
  • While the AP group reported more adverse events (AEs) and serious AEs (SAEs), predominantly acute kidney injury and pump-related issues, these were generally treatable and did not affect survival.

Conclusions:

  • The alfapump® system is effective in reducing paracentesis frequency and enhancing quality of life for cirrhotic patients with RA.
  • Despite a higher incidence of SAEs, the alfapump® offers a viable alternative to repeated LVPs without compromising patient survival.
  • The AP system represents a significant advancement in managing refractory ascites, improving patient well-being and reducing healthcare burdens.