A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

Inclusion Criteria: * Female or male patients ≥ 18 years of age * Removal of at least 10 L of ascites in the preceding 2 months for symptom relief * Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects * Dietary sodium restriction \<90 mcg/d. * Serum creatinine levels of less than 1.8 mg/dL for at least 7 days before study entry. * Total bilirubin levels of less than 3 mg/dL. * Expected survival of greater than 6 months * Written informed consent Exclusion Criteria: * Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection. * Presence of peritoneal carcinomatosis * Evidence of extensive ascites loculation * Obstructive uropathy * Coagulopathy that could not be corrected to a prothrombin time INR \<1.8, * Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3 * Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator * Any condition requiring emergency treatment * Pregnancy * Inability to obtain informed consent