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

From the 2006 SIR Annual Meeting.
https://doi.org/10.1016/j.jvir.2008.09.002Get rights and content

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.

Section snippets

Materials and Methods

This was a prospective study conducted at four institutions; the local institutional review board at each institution approved the study protocol. During the study period (March 2004 through April 2005), all patients who were potential candidates for the study based on the stated inclusionary/exclusionary criteria were asked to participate. We did not record the number of patients who declined to participate. Informed consent for the procedure and participation in the study was obtained in 36

Results

There were five patients who consented to and entered into the study who, in retrospect, represented protocol deviations. Four had undergone only one paracentesis in the previous 30 days rather than two. All four had symptomatic ascites and had relief of symptoms after drainage. Each patient continued to drain fluid after insertion of the catheter. Additionally, one patient who had multiple loculations and poor performance status was entered. All five are included in the analysis in the Results

Discussion

The main findings of the present work indicate that the PleurX catheter is a feasible approach to treat recurrent ascites associated with malignancy without significant rates of complication, failure, discomfort, or electrolyte abnormality. Specifically, we treated 34 subjects and demonstrated that all but five could use the catheter without failure. Also, of the 34, five had resolution of their ascites. Use of this device in these patients is, of course, palliative. All subjects had terminal

References (22)

  • F.F. Hussain et al.

    Peritoneovenous shunt insertion for intractable ascites: a district general hospital experience

    Cardiovasc Intervent Radiol

    (2004)
  • Cited by (60)

    View all citing articles on Scopus

    This study was funded by Denver Biomedical, Inc. (Golden, Colorado). A.C. and S.R. have received consulting fees from Denver Biomedical and Cardinal Health (McGaw Park, Illinois). None of the other authors have identified a conflict of interest.

    View full text