Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

Refractory ascites is one of the complications associated with portal hypertension in the cirrhotic patient. To date, its treatment consists of evacuating punctures, performed in day hospitalisation, whose frequency is adapted to the rate of ascites synthetis. Paracentesis, which does not affect the mechanisms of ascites formation, contributes to protein catabolism and undernutrition. They also have an inconvenience linked to the gesture, making frequent hospital stays necessary. For all these reasons, the patient's quality of life is diminished. The Alfapump® system is a new method for the treatment of refractory ascites. It is a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder, where ascites is eliminated by urinary tract.

Inclusion criteria

• Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.
• Patient with an estimated life expectancy of at least 6 months on the day of inclusion.
• Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS
• Patient affiliated with or in receipt of social security
• Informed and written consent signed by the patient.

Exclusion criteria

• Local or systemic infection in the month preceding the procedure
• Hepatocellular carcinoma with palliative care
• MELD Score > 18
• Child Pugh C Score > 10
• Creatinine Clearance < 50 ml/mn
• Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion
• Contraindication to general anesthesia
• Contraindication to implant surgery of the device:

• Obstructive urological impairment
• Partitioning of ascites
• Coagulopathy
• Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure).
• Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.