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. 2022 Mar 8;22(1):111.
doi: 10.1186/s12876-022-02173-5.

Consensus care recommendations for alfapump® in cirrhotic patients with refractory or recurrent ascites

Niels Kristian Aagaard  1 , Massimo Malago  2 , Andrea De Gottardi  3   4 , Michael Thomas  5 , Gerd Sauter  6 , Cornelius Engelmann  7 , David Aranovich  8 , Michal Cohen  9 , Thierry Thévenot  10 , Thomas Ehmann  11 , Jeroen Capel  12 , Paolo Angeli  13 , Rajiv Jalan  14 , Guido Stirnimann  15
Affiliations

Consensus care recommendations for alfapump® in cirrhotic patients with refractory or recurrent ascites

Niels Kristian Aagaard et al. BMC Gastroenterol. .

Abstract

Background: The alfapump® is an implantable class III medical device that pumps ascitic fluid from the peritoneal space to the urinary bladder from where it is excreted. The pump reduces or abrogates the need for repeated paracentesis in patients with recurrent or refractory ascites.

Aims: To improve outcomes for alfapump® implantation and pre- and post-implant patient management in both clinical trial and real-world settings by development of consensus recommendations.

Methods: The alfapump® working group consisting of hepatologists and surgeons with extensive experience in implantation of the alfapump® and patient management met on two occasions: (1) to determine the key areas where recommendations should be made; and (2) to discuss the experiences of the working group within those areas and formulate draft statements. Developed statements were submitted to the group and consensus sought on relevance and wording through a collaborative iterative approach in order to consolidate the recommendations into consensus statements. Only recommendations agreed upon unanimously were included.

Results: Twenty-three consensus recommendations were developed in the areas of pre-implantation procedure, (three statements), surgical implant procedure (11 statements), immediate post-implant care (three statements) and long-term management (six statements).

Conclusions: The consensus statements are a valuable reference resource for physicians managing patients with the alfapump® and for those considering management strategies for patients with refractory ascites.

Keywords: Alfapump; Ascites; Cirrhosis; Implantation; Long-term antibiotics; Medical device; Paracentesis; Patient management; Refractory ascites; TIPSS.

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Conflict of interest statement

All authors have received consulting fees and travel support for alfapump® working group meeting attendance. ADG has received speaker fees from and participated in a data safety monitoring board for Sequana Medical NV. RJ has research collaborations with Yaqrit and Takeda and is the inventor of OPA, which has been patented by UCL and licensed to Mallinckrodt Pharma. He is also the founder of Yaqrit Ltd. (a spin out company from University College London), Cyberliver Ltd. and Hepyx Ltd. JC is an employee of and holds shares and stock options of Sequana Medical NV. GSt has received speaker fees from Sequana Medical NV.

References

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