Automated Low Flow Pump System for the treatment of Refractory Ascites: a multi-center safety and efficacy study
Bellot, Pablo × Welker, Martin-Walter Soriano, German Schaewen, Markus von Appenrodt, Beate Wiest, Reiner Whittaker, Steven Tzonev, Radin Handshiev, Stoyan Verslype, Chris Moench, Christian Zeuzem, Stefan Sauerbruch, Tilman Guarner, Carlos Schott, Ekart Johnson, Noel Petrov, Assen Katzarov, Krum Nevens, Frederik Zapater, Pedro Such, Jose #
Elsevier Science Publishers
Journal of hepatology vol:58 issue:5 pages:922-7
BACKGROUND AND AIMS: 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 to 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 6 months. 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 is an efficacious tool to move out ascites from the peritoeal 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.