Pollak, J.S., Burdge, C.M., Rosenblatt, M., Houston, J.P., Hwu, W.J., & Murren, J. (2001). Treatment of malignant pleural effusions with tunneled long-term drainage catheters. Journal of Vascular and Interventional Radiology: JVIR, 12(2), 201-208.

The objective of the study was to assess the effectiveness of tunneled pleural catheters in the treatment of malignant pleural effusions.

Initial enrollment of the first one-third of patients (n = 9) involved 2:1 randomization to the newly available and not U.S. Food and Drug Administration (FDA)-licensed PleurX^® catheter or chest tube-administered chemical pleurodesis with doxycycline. The remaining 19 patients after October 1997 all were treated with the PleurX^® catheter.

• The study reported on a sample of 28 patients with malignant pleural effusion for a total of 31 hemithoraces (three patients had bilateral hemothoraces) who entered on the study over 53 months.
• The mean age was 60 years, with a range of 31–85 years.
• Of the sample, 46% were males and 54% were females.
• All patients had a moderate-sized, free-flowing pleural effusion without contralateral effusion or previous sclerotherapy or local radiation therapy.
• Patients must have shown previous improvement with thoracenteses, adequate performance scale (Karnofsky at least 50), absence of chylous effusion, HIV positivity, mediastinal shift, infection in pleural space, prior lobectomy or pneumonectomy on affected side, and presence of hemostatic disorder.
• Inclusion criteria were loosened to include anyone with symptomatic effusion after the randomization stopped and the Denver PleurX catheter was commercially available.
• Two patients who had attempted chemical pleurodesis previously and two with loculated effusions were allowed to participate after the Denver PleurX catheter was licensed by the FDA.

• The single-site study was conducted in both the inpatient and outpatient setting.
• All patients were treated by the Interventional Radiology Department.
   

• Patients were underging the transitional phase of care after initial treatment.
• The study has clinical applicability for end-of-life and palliative care.
   

The study had a prospective convenience sample, with randomization of the initial one-third of patients. The study for the remaining two-thirds of the patients had a nonrandomized prospective design.

• Measurement of the type, extent, and response of pleural effusion was validated by computed tomography or frontal, lateral, and decubitus chest radiographs.    
• Assessment of dyspnea is described, but the instrument or measurement criteria are not described.
• Complication rate was calculated based upon a researcher-designed list of complications.
• Need for hospitalization related to placing the catheter was measured.
• Catheter-related discomfort was measured by patient report of pain.
   

• All catheters were placed successfully without procedural complication; however, two patients (10.7%) had three late complications. They included external catheter migration (1), tumor tracking along catheter route (1), and infection (1).
• Follow-up time with catheters ranged from 3–618 days, with a median of 51 days.
• Dyspnea improvement was seen in 26 of 28 patients (93%), and when including patients with more than one procedure, improvement was 93%. This symptom improvement was enduring and present in 20 of 22 patients (91%) alive at 30 days post-procedure.
• Persistent control of pleural effusions with a defined drainage regimen based upon the prior drainage was effective in 90% of catheters placed.
• Spontaneous pleurodesis was achieved in 42% of hemithoraces, with a median time of 19 days (range 7–96 days). Only one patient developed recurrent pleural effusion, and this patient had only one locule of his effusion treated with catheter insertion.
• Five of 28 patients required additional pleural interventions (successful treatment in 23 of 28 patients [82%]).
• Five patients required additional procedures to achieve control of the pleural effusion, but the number of complex, chylous, or loculated effusions was limited.

This small, single-site, prospective study of the effectiveness of tunneled pleural catheters showed effective pleural drainage, spontaneous pleurodesis equivalent to chest catheter pleurodesis, reduced days of hospitalization (as the procedure can be safely performed outpatient), reduced distressing symptoms, and rare complications.

• The study had a small sample size of less than 30 patients.
• Short survival after catheter insertion did not permit complete evaluation of efficacy.

Its use in patients with refractory effusions could be advantageous, as it represents patients who have received other therapies prior to catheter insertion. The average life expectancy of patients with malignant pleural effusions is only 6–12 months, with as many as half of patients dying within 30 days. Patients with malignant pleural effusions represent a group who experience significant symptoms that affect quality of life. Interventions that are low-intensity, can be performed quickly and with limited recovery time, and can be managed in the ambulatory or home setting are optimal. Nurses can act as advocates for innovative management of malignant pleural effusions that enhance patient independence. Nurses are key patient and family educators who provide guidance, support, and hands-on instruction in management of tunneled pleural catheters. Their follow-up with patients and caregivers assist in the detection of complications, as well as evaluation of efficacy. Follow-up nursing assessment for symptom relief and spontaneous pleurodesis or the need for additional interventions may be especially important for these patients receiving end-of-life care with limited contact with physicians.