Prospective Evaluation of the PleurX Catheter When Used to Treat Recurrent Ascites Associated with Malignancy

Purpose: To prospectively assess the safety of the PleurX catheter in the management of recurrent ascites in patients with advanced abdominal malignancy and the consequent quality of life among these patients. Materials and Methods: This was a multicenter, prospective study of PleurX catheters implanted between March 2004 and April 2005 for control of nonhepatic abdominal ascites associated with malignancy. A total of 34 subjects were included (age range, 40-81 years; mean age, 64.3 y) who underwent 440 drainage sessions. Subjects kept records of volume and frequency of ascites drainage and recorded any difficulties encountered with use of the device. Subjects assessed symptoms before device insertion and weekly for as long as 12 weeks. Serum laboratory values reflecting overall volume status were tracked. Results: All catheter insertions were successful without major procedural complications. Twenty-nine (85%) required no catheter intervention or separate therapeutic paracentesis during 12 weeks observation or until the patient's death. Three needed a total of 13 interventions to restore catheter function. Before 12 weeks, 26 subjects died. Five discontinued catheter use as a result of catheter function despite the presence of ascites. Ascites resolved in five patients. Bloating and abdominal discomfort were significantly reduced at 2 and 8 weeks (P < .05). At weekly follow-up, 83%-100% of subjects reported their ascites to be well controlled. There were no significant changes in blood chemistry results between baseline and 12 weeks. One case of peritonitis at 10 weeks resolved with antibiotic treatment. Conclusions: In terminally ill patients, PleurX catheter use resulted in improvement of ascites-related discomfort and was associated with low rates of serious adverse clinical events and catheter failure.