title: Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study.
abstract: OBJECTIVE
  Refractory ascites (RA) affects 10% of patients with advanced cirrhosis and ascites. Usual therapy includes large volume paracentesis, and in selected patients, a transjugular portosystemic shunt (TIPS). These therapies may be associated with increased morbidity: paracentesis may induce circulatory dysfunction and impair quality of life and TIPS may induce encephalopathy and is associated with increased mortality in patients with severe liver dysfunction. We present the results of a multicenter, non-randomized trial to assess the safety and efficacy of a new automated pump system for treatment of RA.
  
  
  METHODS
  Forty patients at 9 centers (February 2010-June 2011) received an implanted pump for the automated removal of ascites from the peritoneal cavity into the bladder, from where it was eliminated through normal urination. Patients were followed-up for 6months. The primary study outcome was safety. Secondary outcomes included recurrence of tense ascites and pump performance.
  
  
  RESULTS
  Surgical complications occurred early in the study and became less frequent. The pump system removed 90% of the ascites and significantly reduced the median number of large volume paracentesis per month [3.4 (range 1-6) vs. 0.2 (range 0-4); p <0.01]. Cirrhosis-related adverse events decreased along follow-up.
  
  
  CONCLUSIONS
  The automated pump seems an efficacious tool to move out ascites from the peritoneal cavity to the bladder. Its safety is still moderate, but a broad use in different countries will improve the surgical technique as well as the medical surveillance. A prospective randomized clinical trial vs. large volume paracentesis is underway to confirm these preliminary results.
authors: Liver Unit, Hospital General Universitario de Alicante and Universidad Miguel Hernández, Elche, Alicante, Spain.
authors: Pablo
authors: P
authors: Bellot
authors: Martin-Walter
authors: MW
authors: Welker
authors: German
authors: G
authors: Soriano
authors: Markus
authors: M
authors: von Schaewen
authors: Beate
authors: B
authors: Appenrodt
authors: Reiner
authors: R
authors: Wiest
authors: Steven
authors: S
authors: Whittaker
authors: Radin
authors: R
authors: Tzonev
authors: Stoyan
authors: S
authors: Handshiev
authors: Chris
authors: C
authors: Verslype
authors: Christian
authors: C
authors: Moench
authors: Stefan
authors: S
authors: Zeuzem
authors: Tilman
authors: T
authors: Sauerbruch
authors: Carlos
authors: C
authors: Guarner
authors: Ekart
authors: E
authors: Schott
authors: Noel
authors: N
authors: Johnson
authors: Assen
authors: A
authors: Petrov
authors: Krum
authors: K
authors: Katzarov
authors: Frederik
authors: F
authors: Nevens
authors: Pedro
authors: P
authors: Zapater
authors: Jose
authors: J
authors: Such
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001201:Ascites / Q000453:epidemiology* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D007668:Kidney / Q000098:blood supply; D008099:Liver / Q000098:blood supply; D008297:Male; D026901:Membrane Transport Proteins / Q000009:adverse effects*; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D026901:Membrane Transport Proteins