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; von Schaewen, Markus; 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; ... (2013). Automated low flow pump system for the treatment of refractory ascites: A multi-center safety and efficacy study. Journal of hepatology, 58(5), pp. 922-927. Elsevier 10.1016/j.jhep.2012.12.020

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BACKGROUND & 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-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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Gastroenterology

UniBE Contributor:

Wiest, Reiner

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0168-8278

Publisher:

Elsevier

Language:

English

Submitter:

Lilian Karin Smith-Wirth

Date Deposited:

16 Jun 2014 13:16

Last Modified:

06 Nov 2015 09:51

Publisher DOI:

10.1016/j.jhep.2012.12.020

Uncontrolled Keywords:

Cirrhosis, Ascites, Refractory, Liver, Failure

BORIS DOI:

10.7892/boris.53113

URI:

https://boris.unibe.ch/id/eprint/53113

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