4.3 Article

Consensus care recommendations for alfapump(R) in cirrhotic patients with refractory or recurrent ascites

Journal

BMC GASTROENTEROLOGY
Volume 22, Issue 1, Pages -

Publisher

BMC
DOI: 10.1186/s12876-022-02173-5

Keywords

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

Funding

  1. Sequana Medical NV

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The study aimed to improve outcomes for alfapump(R) implantation and patient management by developing consensus recommendations. Through two meetings, 23 consensus recommendations were developed, covering areas such as pre-implantation procedure, surgical implant procedure, immediate post-implant care, and long-term management. These consensus statements serve as a valuable reference resource for physicians managing patients and considering management strategies for refractory ascites.
Background The alfapump(R) 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(R) implantation and pre- and post-implant patient management in both clinical trial and real-world settings by development of consensus recommendations. Methods The alfapump(R) working group consisting of hepatologists and surgeons with extensive experience in implantation of the alfapump(R) 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(R) and for those considering management strategies for patients with refractory ascites.

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