A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

Inclusion criteria

• patients ≥ 21 years of age
• recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months
• cirrhosis of any etiology
• failure to respond to or intolerance to high dose diuretics
• expected survival of greater than 3 months (MELD score ≤ 21)
• screened for varices and on optimal management
• diagnostic paracentesis with neutrophil count < 250 / µl within 24 hours of implantation
• written informed consent
• ability to comply with study procedures and ability to operate the device
• women of childbearing potential should use adequate contraception

Exclusion criteria

• more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
• presence of any current cancer
• evidence of extensive ascites loculation
• serum creatinine > 1.5 mg/dl
• serum bilirubin > 5 mg/dl
• eGFR < 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
• gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
• hepatic encephalopathy > stage II in the two weeks prior to implant
• presence of a patent TIPS or surgical portosystemic shunt
• presence of Budd-Chiari syndrome
• previous solid organ transplant
• obstructive uropathy (bladder residual volume > 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi)
• International Prostate Symptom Score (I-PSS) ≥20
• thrombocytopenia < 45,000 X106/l
• patient undergoing therapeutic anticoagulation
• recent (<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition.
• history (>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis.
• any non-liver disease with life expectancy < 1 year
• patients eligible for TIPS (unless they have refused TIPS placement).
• presence of any active implantable or body-worn devices that cannot be removed
• pregnancy
• patients being in another therapeutic clinical study