Pleurodesis/Pleural Catheter

Pleurodesis/Pleural Catheter

PEP Topic 
Dyspnea
Description 

Pleural effusion, the build-up of fluid surrounding the lung, can occur in patients with cancer, resulting in acute dyspnea. Pleurodesis is a procedure used to cause the layers of the pleura to stick together, eliminating the space for fluid build-up. In this procedure, a chemical or medication is inserted into the space between the pleura. The resulting inflammation causes these layers to stick together. Various medications, such as antibiotics, povidone iodine, or a slurry of talc, have been used. Another approach used to manage pleural effusion is the insertion of an indwelling pleural catheter to drain the pleural space. With an indwelling catheter, the patient or caregiver performs catheter care and drainage. Both of these approaches relieve dyspnea from pleural effusion, and each is associated with its own potential adverse events. One consideration in selection of approach is the patient’s ability to perform ongoing catheter care with an indwelling pleural catheter.

Benefits Balanced With Harm

Research Evidence Summaries

Alavi, A.A., Eshraghi, M., Rahim, M.B., Meysami, A.P., Morteza, A., & Hajian, H. (2011). Povidone-iodine and bleomycin in the management of malignant pleural effusion. Acta Medica Iranica, 49(9), 584-587.

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Study Purpose:

The objective of this study was to compare the effectiveness of bleomycin as a sclerosing agent with povidone-iodine with respect to efficacy, cost, accessibility, safety, ease of administration, and number of doses for complete response.        

Intervention Characteristics/Basic Study Process:

Forty participants were assigned into two treatment groups of bleomycin treatment or povidone-iodine treatment via block randomization. A 28Fr. chest tube was placed in all patients at the bedside under local anesthesia with opioids given for pain. The following day, both groups had a sclerosing agent instilled in the chest tube for one hour; bleomycin at 1 mg/kg in 60 mL saline in the study group and povidone-iodine 10%, which was diluted to obtain a final concentration of 2.5% povidone-iodine in the control group. Both groups had 5 mL of 2% lidocaine solution added to the sclerosing agent. In both groups, the chest tubes were clamped for one hour and then connected to water seal. All patients were admitted to the same unit in the hospital and experienced the same post-pleurodesis respiratory and pain management protocols. The chest tube remained in place until output decreased to 200 mL; if high output persisted more than 10 days, a Heimlich valve was placed and patients were discharged from the hospital. Chest x-rays were obtained post-chest tube removal and at 30 days post-procedure to evaluate size of pleural effusions. Pain and dyspnea after drainage ratings were recorded at discharge and at 30 days post-op. 

Sample Characteristics:

The sample was comprised of 39 patients.

Key disease characteristics included

  • Biopsy- or cytology-proven malignant pleural effusions with a variety of types of cancer
  • Effusions previously treated with and showing improvement with thoracenteses but recurrent or symptomatic when entered in study.

Key sample characteristics included

  • Symptomatic benefit from thoracenteses
  • Chest radiograph confirming lung expansion of 90% or more after therapeutic thoracenteses
  • Karnofsky performance status index greater than or equal to 70
  • No one with comorbidities that would exclude them from general anesthesia
  • No bleeding disorders, massive skin infiltration, or active infectious disease.
     

Setting:

This single-site study was conducted in the inpatient unit at Valiasr Hospital in Tehran, Iran.

Phase of Care and Clinical Applications:

  • Patients were undergoing long-term follow-up care.
  • The study has clinical applicability for end-of-life and palliative care.
     

Study Design:

The study was a randomized clinical trial.

Measurement Instruments/Methods:

  • Chest tube placement, +/- Heimlich valve    
  • Numeric pain scale
  • Chest x-ray
  • Dyspnea scale (1–10)
     

Results:

  • According to author reports, the groups were equivalent in demographic variables, but this data was not visible to the reviewer.
  • No significant difference was seen between groups with respect to age, duration of thoracostomy, volume of pleural effusion, dyspnea score after drainage, fever, and pleural effusion after drainage, discharge, and one month later.
  • Patients in the bleomycin group had significantly lower dyspnea scores at the one-month follow-up time compared to the povidone-iodine group.
  • Complete pleurodesis occurred in 79% of the bleomycin group and 75% of the povidone-iodine group, which is not a significant difference in treatment results.

Conclusions:

  • Bleomycin is more effective at long-term dyspnea management based on one-month follow-up reports.
  • No differences were observed between groups based on pain score following procedure, dyspnea at discharge, or reoccurrence of pleural effusion at the one-month follow-up visit. 
  • Neither method demonstrated extremely superior results and appear similar in overall effects.

Limitations:

  • The study had a small sample size of less than 100 patients.
  • Groups were not matched by age and sex.
     

Nursing Implications:

When compared with povidone-iodine, bleomycin offers the advantage of being more effective for dyspnea symptoms one month post-procedure. However, both methods appear similar in terms of pain scores, dyspnea at discharge, and recurrence of pleural effusions at one-month follow-up. For patients with concerns of iodine absorption or side effects, bleomycin would be a comparable sclerosing agent.

Davies, H.E., Mishra, E.K., Kahan, B.C., Wrightson, J.M., Stanton, A.E., Guhan, A., . . . Rahman, N.M. (2012). Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: The TIME2 randomized controlled trial. JAMA : The Journal of the American Medical Association, 307(22), 2383-2389.

doi: 10.1001/jama.2012.5535
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Study Purpose:

The objective of the study was to determine if indwelling pleural catheters (IPCs) are more effective than talc slurry pleurodesis via chest tube for relief of dyspnea.

Intervention Characteristics/Basic Study Process:

Patients with symptomatic malignant pleural effusion requiring pleurodesis were randomized to either IPC or talc pleurodesis. IPCs were inserted, initial large-volume drainage was performed, and caregivers were trained in IPC management. Drainage was advised to be done three times weekly. The IPC was removed if significant drainage stopped for at least four weeks, with no evidence of fluid reaccumulation. Patients in the talc group were hospitalized and had percutaneous chest tube insertion and talc slurry pleurodesis with 4 g sterile high-grade talc, following published treatment guidelines. Patients were followed up for 12 months after randomization. Dyspnea measurement was recorded daily for 42 days and then at 10, 14, 18, 22, and 26 weeks, and at 9 and 12 months.

Sample Characteristics:

  • The sampe was comprised of 96 patients.
  • The mean patient age was 76 years (SD = 11.5 years).
  • Of the 96 patients, 43.5% were males and 56.5% were females.
  • Various cancer types were included in the sample, but breast and lung were most frequent.
  • The average size of effusion on radiography as a hemothorax was 51% in the IPC group and 49% in the talc group.
     

Setting:

The study was conducted in multiple settings in the United Kingdom.

Phase of Care and Clinical Applications:

  • Patients were undergoing late effects and survivorship care.
  • The study has clinical applicability for palliative care.

Study Design:

The study was an unblinded, randomized controlled trial.

Measurement Instruments/Methods:

  • 100 mm Visual Analogue Scale (VAS) for dyspnea
  • EORTC - Quality of Life Questionnaire
  • Complication recording
  • Use of healthcare resources
     

Results:

  • No significant difference in dyspnea was observed between groups.
  • Dyspnea declined in both groups, with a mean decrease of 37.0 mm with IPC and 30.2 mm with talc. 
  • At 6 months, a clinically significant decrease was seen in dyspnea in the IPC group compared to the talc group ( - 14.0 mm, p = .01). 
  • Over 12 months, the IPC group spent an average of one day in the hospital for drainage or complications, compared to an average of 4.5 days in the talc group (p < .001).
  • Global quality of life improved in both groups, with no significant difference between groups at any time point.
  • In the IPC group, 40% experienced any adverse event, compared to 13% in the talc group (p = .002). 
  • No difference in serious adverse events was observed between groups. 
  • Pleural infections occurring with IPCs were asymptomatic and treated with oral antibiotics, and no IPC had to be removed for infection.

Conclusions:

  • Both talc pleurodesis and IPC were effective in reducing dyspnea in patients with malignant pleural effusion. 
  • No significant difference in effectiveness was seen between the two approaches.
  • IPCs reduce hospitalization time but are associated with more adverse events.

Limitations:

Because it was unblinded, the study had the risk of bias.

Nursing Implications:

  • Both approaches demonstrated effectiveness for reducing dyspnea in this group of patients. 
  • Patient selection for IPC use needs to include consideration of caregiving needs and capabilities to manage the catheter, given the tendency for higher adverse events with its use.

Demmy, T.L., Gu, L., Burkhalter, J.E., Toloza, E.M., D'Amico, T.A., Sutherland, S., . . . Cancer and Leukemia Group B. (2012). Optimal management of malignant pleural effusions (results of CALGB 30102). Journal of the National Comprehensive Cancer Network, 10(8), 975-982.

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Study Purpose:

The objective of the study was to compare tunneled pleural catheter drainage (TCD) to bedside talc pleurodesis (TP) via chest catheter for efficacy in controlling symptomatic unilateral malignant pleural effusions (MPE).

Intervention Characteristics/Basic Study Process:

Randomized patients received one of two methods (TP or TCD) for pleural drainage then were followed up for 60 days. For the TP procedure, a single dose of 4–5 g of sterile talc slurry in 100 mL of saline was infused into the pleural space with a chest catheter. Placement was confirmed on a chest x-ray. Talc was administered within 36 hours of tube placement. The tube remained clamped for two hours for talc distribution. When the chest drainage decreased to 150 mL/24 hours, pleurodesis was assumed and the tube was removed. TP was performed on an inpatient basis. For TCD, catheters were drained daily with drainage bottles. No more than 1,000 mL were drained at a time, other than during the initial drainage. A chest x-ray was taken within 36 hours of initial drainage and the patient, a caregiver, or a visiting nurse drained the catheter daily after that. The catheter was removed when the drainage volume was less than 30 mL each day over three consecutive days. TCD is generally an outpatient procedure.

Sample Characteristics:

  • The sample was comprised of 57 patients aged 60–67 years.
  • Of the 57 patients, 45%–55% were males and 39%–61% were females.
  • Patients had a performance status of 0 to 2 with no active pleural infection, talc allergy, or other indications to talc use.
  • Lung cancer (62%) and breast cancer (12%) were the most common malignancies.
  • The study originally planned 530 total patients for 90% power to detect differences in efficacy between the two methods of pleural drainage.
  • Trapped lung was not recommended for randomized therapy, as TCD may be a better therapy option.

Setting:

The study was conducted in 21 comprehensive cancer centers—17 cases were conducted at one instution, and 1–7 cases were conducted at each of the other institutions.

Phase of Care and Clinical Applications:

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for elder care and palliative care.

Study Design:

The study was a prospective, randomized phase III trial.

Measurement Instruments/Methods:

  • Lung re-expansion was determined by the treating physician using serial chest x-rays.
  • Condensed Memorial Symptom Assessment Scale form (specific elements: performance status, dyspnea scale, physical function, social life, and overall quality of life) measured quality of life and specific symptoms or functionality.

Results:

  • No statistical differences in lung expansion were noted between the two treatment arms, but it improved from baseline in both cases.
  • The odds ratio for TCD success was five times higher than TP, and patients with good expansion experienced better success (odds ratio, 5; 95% CI, 1–25; P = .053).
  • Pleurodesis occurred in 86.2% of patients treated with TP, compared with 68.0% of those treated with TCD (P = .1883).
  • Therapy-related complications were low but were higher in the TCD arm.
  • Recurrent dyspnea was seen only in TP cases, and dyspnea was statistically better in patients treated with TCD (8.7 vs. 5.9; P = .036) even after adjusting for baseline dyspnea score, initial drainage, gender, inpatient status, and performance status at baseline.
  • No relationship was seen between baseline dyspnea score and lung expansion at any of the three points; however, 30-day dyspnea-free exercise and all quality-of-life measures correlated significantly with lung expansion.

Conclusions:

  • TCD is preferred for patients with complicated effusions or when the lung may be trapped.
  • Although TCD prolongs therapy, this added duration may maintain lung expansion and improve quality-of-life parameters.
  • Lung expansion may be an unreliable indicator of the benefits of pleural drainage.
  • TCDs in this study may more predictably relieve dyspnea.
  • The study had to be closed early because patients had a strong preference for treatment (inpatient vs. outpatient) and refused randomization.

Limitations:

  • The study had a small sample size of less than 100 patients.
  • The study had a risk of bias because of no blinding and its sample characteristics.
  • Accrual was far less than anticipated due to patient preferences interfering with patient consent to randomization.
  • Refusals to participate may have influenced the final study population, as evidenced by lower-than-anticipated success of talc pleurodesis intervention.
  • The study does not describe that “malignant effusion” was validated cyopathologically.

Nursing Implications:

  • TCD and TP are both common strategies to manage malignant pleural effusion.
  • Similar lung expansion appears to be able to be achieved with both techniques in patients with uncomplicated pleural effusion, and the selection of method may be based upon patient preference.
  • Nurses should ensure that patients are thoroughly informed of therapeutic options to make the best decision for their circumstances.
  • In cases in which patients experience distress form dyspnea at baseline, they may experience better symptom relief with the TCD method of managing malignant pleural effusions.

Mohsen, T.A., Zeid, A.A., Meshref, M., Tawfeek, N., Redmond, K., Ananiadou, O.G., & Haj-Yahia, S. (2011). Local iodine pleurodesis versus thoracoscopic talc insufflation in recurrent malignant pleural effusion: A prospective randomized control trial. European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery, 40(2), 282-286.

doi: 10.1016/j.ejcts.2010.09.005
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Study Purpose:

The objective of the study was to compare the efficacy and safety of 10% povidone-iodine and thoracoscopic talc insufflation for pleurodesis of recurrent malignant pleural effusions due to metastatic breast cancer.

Intervention Characteristics/Basic Study Process:

Forty-two participants were randomized into two groups. Patients assigned to Group A received video-assisted thoracoscopic (VATS) drainage, mechanical adhesiolysis, and 4 g of talc poudrage, while the 20 patients assigned to Group B received VATS drainage, mechanical adhesiolysis, bedside pleurodesis with 20 mL of 10% povidone-iodine diluted in 30 mL of normal saline. Therapeutic thoracentesis was performed in all participants, and pleural fluid volume was recorded and sent for biochemical (pH, LDH, glucose), bacteriologic, and cytologic evaluation. All patients were scheduled for a follow-up every three months at which symptoms and chest x-rays were evaluated, and efficacy of pleurodesis was gauged on three levels: complete (absence of pleural fluid reaccumulation), partial (residual pleural fluid or reaccumulation that remained asymptomatic and not requiring thoracentesis), or failed (necessitating pleural procedures). Success was defined as a normal chest x-ray or radiologic reaccumulation of pleural fluid without recurrence of dyspnea or need for thoracentesis. Repeated ultrasound-guided thoracentesis was provided for patients with failed pleurodesis and reaccumulation of effusion at weekly intervals, and a PleurX® catheter was offered for home management of effusions when required.

Sample Characteristics:

  • The study reported on a sample of 42 patients.
  • In Group A, the mean age was 48 years (SD = 9 years), and the range was 29–64 years.
  • In Group B, the mean age was 50.2 years (SD = 7 years), and the range was 32–62 years.
  • Data were not available to determine the percentage of males and females.
  • Participants had malignant pleural effusion secondary to metastatic breast cancer.
  • All patients either had either metastasis as their first presentation or had relapsed after chemotherapy during their follow-up.
  • Patients were excluded from the study if they had a performance status greater than three, known allergies to iodine, a trapped lung, no change in the Medical Research Council (MRC) dyspnea scale after thoracentesis, pleural fluid pH less than 7.2 or glucose less than 60 mg/dL, and an extrathoracic metastasis.
  • Both groups received the same protocol for adjuvant chemotherapy (i.e., 5FU, Adriamycin®, and chlophosphamide (FAC), or docetaxel).
  • No difference in preoperative demographic and clinical details between the two groups were noted.
     

Setting:

This single-site study was conducted in an outpatient setting in the Department of Chest Medicine and Cardiothoracic Surgery in Cairo University Hospitals.
 

Phase of Care and Clinical Applications:

  • Patients were in the transition phase after initial treatment.
  • The study has clinical applicability for end-of-life and palliative care and late effects and survivorship.
     

Study Design:

The study was a prospective, randomized controlled trial.

Measurement Instruments/Methods:

  • Medical Research Council (MRC) dyspnea scale to assess breathlessness
  • Performance status scale (ECOG) to assess functional ability
  • Diagnostic thoracentesis
     

Results:

Dyspnea and cough symptoms were improved in all patients after drainage and pleurodesis, and no mortality related to the procedure or perioperative mortality were observed. Survival rates between the two groups and totally at follow-up were 32 patients (76%) at eight months, 22 patients (52%) at two years, and 10 patients (23%) at four years. All had good outcomes with no bleeding complications and were discharged when both radiologic and clinical evidence confirmed complete resolution of pleural effusion. Group B experienced a significantly lesser post-procedural hospital stay (mean 5.7 days [SD = 2 days]) than Group A (mean 4.5 days [SD = 1.1 days]) (p = 0.009). During early follow-up in Group A, successful/complete response was achieved in 19 patients (87%), failure in 2 patients (9%), and partial response with radiologic reaccumulation at two months post-procedure but remaining asymptomatic during the 14 months’ follow-up. Early follow-up in Group B resulted in 17 (85%) complete response, no partial response, and three failures (15%) with recurrence of dyspnea at 33, 41, and 49 days respectively. No loculations were observed in Group B, thus a small-bore chest tube was placed and iodine was used again. In Group A, observed loculations were repeatedly aspirated with an ultrasound guide, and when repeated reaccumulation was experienced, an ultrasound-guided PleurX® catheter was offered. No recurrence was detected at more than six months during follow-up, and no statistical difference between long-term success (four years) rates in Groups A (91%) and B (85%) were observed. Complications of pleuritic pain were observed in four participants of Group A (18%) but none in Group B, and fever was observed in four participants (18%) in Group A, and one participant (5%) in Group B.

Conclusions:

Authors concluded that povidone-iodine pleurodesis is a safe and effective alternative to talc pleurodesis in the prevention of recurrent malignant pleural effusion at 30 days post-procedure. Additionally, while chest pain and fever are the most common adverse effects of pleurodesis, those in the iodine-povidone population (Group B) experienced less analgesic requirements and reports of fever, albeit at no statistical significance. Authors also emphasized that the dose of 10% povidone-iodine was administered in dilute form, thereby significantly increasing povidone safety with decreased toxicity when compared to other studies.

Limitations:

  • The study had a small sample size, with less than 100 participants.
  • The study results are only significant to a population of patients with malignant pleural effusion secondary to metastatic breast cancer; more research is warranted for efficacy among other population types.
  • The clinical practice of providing mechanical adhesiolysis through the VATS procedure may have contributed to successful pleurodesis in both groups; true translation of this evidence would require performing a VATS procedure prior to the instillation of povidine-iodine, which is an uncommon practice. (Patients usually have a VATS procedure with talc insufflations or a chest catheter bedside procedure but not a surgical procedure followed by a bedside procedure.)
  • Statistical analysis was limited by a lack of computed confidence intervals to safely exclude clinically relevant differences, as well as a lack of survival analysis.
     

Nursing Implications:

Given its good success rate and fewer complications, povidone-iodine appears to be a successful, safe, and cost-effective alternative to talc pleurodesis for palliative management of malignant pleural effusion stemming from metastatic breast cancer.

Musani, A.I., Haas, A.R., Seijo, L., Wilby, M., & Sterman, D.H. (2004). Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration; International Review of Thoracic Diseases, 71(6), 559-566.

doi: 10.1159/000081755
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Study Purpose:

The objective of the study was to retrospectively examine whether recurrent malignant pleural effusions (MPEs) could be managed on an outpatient basis using small-bore tunneled pleural catheters (PCs) and without the use of sclerosing agents.

Intervention Characteristics/Basic Study Process:

The study was a retrospective analysis of 24 patients who underwent placement of PCs to manage recurrent dyspnea symptoms due to MPEs.

Patients chosen were experiencing symptomatic MPEs and

  • Had an advanced primary malignancy
  • Had a predicted life expectancy of at least three months
  • Had prior experience with dyspnea symptom relief post-thoracentesis
  • Had radiographic evidence of an accessible, free-flowing pleural effusion.

PC placement took place in an outpatient clinic under local anesthesia or conscious sedation. Written and oral instructions were given to the patients and caregivers, including details on how to care for the catheter and perform drainage at home. Patients and their caregivers also received home visits from a home health nurse to reinforce these instructions. Patients were evaluated in the outpatient center weekly for the first two weeks and then as needed clinically. In each post-placement visit, patients were evaluated for subjective findings such as dyspnea, chest discomfort, and exercise intolerance. Objective evaluations included pulse oximetry, blood pressure, heart rate, respiratory rate, and weight measurement. In addition, patients were evaluated for pulmonary and/or catheter complications, including chest radiographs and computed tomography scans (if indicated).

Once the PC output was less than 50 mL on three consecutive days, the PC was removed using only local anesthesia in the Pulmonary Outpatient Center, and patients were periodically followed by the Interventional Pulmonology outpatient practice for evaluation of symptom recurrence or effusion.

Sample Characteristics:

  • The study reported on a sample of 24 patients aged 47–89 years.
  • Of the sample, 33% were males and 67% were females.
  • Key disease characteristics were breast (11), lung (5), colon (1), mesothelioma (3), renal (1), melanoma (1), and adenocarcinoma of unknown primary (2).
  • Patients who were extremely ill and had the potential to be admitted for the treatment of MPEs were excluded from this study.
     

Setting:

This single-site study was conducted in an outpatient clinic in Philadelphia, PA, for both insertion and removal of the PC catheter.

Phase of Care and Clinical Applications:

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for end of life, palliative care, and quality of life . 
     

Study Design:

The study was a retrospective chart analysis.

Measurement Instruments/Methods:

The dyspnea assessment instrument was not identified, but the presence and absence of dyspnea was implied.

Results:

A total of 27 PCs were placed. Three patients had bilateral PC placement, and one patient had two ipsilateral catheter placements (accounting for the extra catheter placements). All catheters were placed in an outpatient setting, and patients were sent home on the same day without any immediate complications. Five patients died during the study; four of these patients had fully functioning and patent catheters. The fifth patient developed cardiac tamponade, and the PC was removed and replaced by a chest tube. The indwelling time for these five patients prior to passing was 26.3 days.

Complications related to catheter placement included cellulitis, bacterial super-infection, and incisional tumor growth. These complications were managed with antibiotics, removal of the PC, and increases in anti-neoplastic medication.

Nineteen patients survived to catheter removal or to the time the analysis took place. Out of the 19 patients, 10 patients reached spontaneous pleurodesis after using daily PC drainage over a median time of 39 days. One patient achieved pleurodesis in 15 days after PC placement for a total of 11 out of 19 (58%) patients achieving either complete or partial pleurodesis without chest tubes or the use of sclerosing agents.

Conclusions:

Small-bore tunneled pleural catheters are offered as an alternative, more palliative, less invasive treatment for MPEs. The number of patients in this study that reported relief of dyspnea symptoms and were able to achieve complete or partial pleurodesis after PC placement is comparable to those who undergo more invasive procedures.

Limitations:

  •  The study had no appropriate control group
  •  The study had a small sample size.
  • The authors themselves recognized the potential bias of the study by excluding those patients who were extremely ill with a significant risk of being admitted for the management of MPEs.

Nursing Implications:

The outpatient small-bore tunneled catheter method does not seem to be an appropriate method for patients with recurrent, symptomatic MPEs  who have weeks or days to live.

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.

doi: 10.1016/S1051-0443(07)61826-0
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Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

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 Instruments/Methods:

  • 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.
     

Results:

  • 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.

Conclusions:

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.

Limitations:

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

Nursing Implications:

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.

Schneider, T., Reimer, P., Storz, K., Klopp, M., Pfannschmidt, J., Dienemann, H., & Hoffmann, H. (2009). Recurrent pleural effusion: Who benefits from a tunneled pleural catheter? The Thoracic and Cardiovascular Surgeon, 57(1), 42-46.

doi: 10.1055/s-2008-1039109
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Study Purpose:

The objective of this study was to report on the effectiveness of tunneled indwelling pleural catheters (TIPC) in patients with recurrent malignant pleural effusion (MPE) and impaired lung dilatability.

Intervention Characteristics/Basic Study Process:

TIPC placement was performed on three groups of patients: those with a trapped lung who were not candidates for pleurodesis, those with recurrent pleural effusion after failed attempts at pleurodesis, and those with poor physical condition/limited lifespan who were not candidates for VATS procedure. Prior to TIPC placement, diagnostic or therapeutic interventions (i.e., pleuracenteses or pleurodesis) were performed on 54 patients to treat the pleural effusion. TIPC placement was performed by a thoracic surgeon as an inpatient procedure for 98 patients in an operating room via local anesthesia or VATS procedure. Following placement, patients and relatives or home care nursing staff were instructed in TIPC care and drainage through specific training, and subsequent drainage of the catheter system was performed three times weekly and afterward based on symptoms (pain or dyspnea) or fluid volume. TIPCs ultimately were removed as an outpatient procedure under local anesthesia when volume at three sequential drainage procedures was less than 50 mL and were drained once a week in an expanded lung by x-ray. Patients were then followed up until February 2008.

Sample Characteristics:

  • The study reported on a sample of 100 patients.
  • The mean age was 64 years, with a range of 30-91 years.
  • Of the sample, 52% were males and 48% were females.
  • Key disease characterstics included underlying cancer disease: lung (23), breast (20), mesothelioma (11), ovarian (4), pancreatic (5), cancer of unknown primary (5), other malignant disease (19), nonmalignant due to liver cirrhosis or chronic exudative pleurisy (13).
  • Of the 107 patients undergoing TIPC procedures, 88 patients had malignant disease and 12 had nonmalignant effusions. Seven additional procedures included six contralateral procedures and one ipsilateral procedure.
  • Patients with malignant pleural effusion and fully expandable lungs in good clinical condition were given talc poudrage during VATS procedure instead of TIPC. Also, intraoperative suspicion of pleural empyema was a contraindication for TIPC.

Setting:

This single-site study was conducted in an inpatient setting (for TIPC insertion) and outpatient setting (for TIPC removal) in an operating room in Germany.

 

Phase of Care and Clinical Applications:

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for end-of-life and palliative care.

 

Study Design:

The study was a retrospective analysis.

Measurement Instruments/Methods:

  • Diagnostic VATS procedure prior to TIPC placement (54 patients)
  • X-ray performed prior to TIPC removal to assess lung re-expansion
     

Results:

Median residence time of TIPC was 70 days (range 2-384 days) in all patients. In 52 procedures, TIPC remained indwelling until patients’ death (median 47 days; range 2-319 days). In these particular patients, further relief of recurrent effusion was achieved by a drainage system, such that no one required repeated investigations (via pleuracenteses or surgical interventions). Sixteen TIPCs remained at the end of the observation period with a median indwelling time of 87 days (range 30-389 days) because they still required relief for recurrent pleural effusion. Thirty-nine TIPCs were removed after a median indwelling time of 80 days after decreased drainage and lung re-expansion. Patients with carcinoma of unknown primary and pancreatic cancer had the worst outcome. Nine patients had their catheters removed following TIPC-related complications (empyema [4], pain [1], accidental dislodgement by patient [2], bronchopleural fistula [1], occlusion of drainage [1], and recurrent effusion requiring TIPC replacement [2]). Six patients died during hospitalization following TIPC placement due to rapid progressive malignant disease.

According to the authors, the three groups that appear to benefit the most are patients with an intraoperative find of a trapped lung in a diagnostic VATS procedure who are not candidates for talc pleurodesis; patients with a history of repeated pleuracenteses or past failed attempts at pleurodesis; and patients with limited life expectancy and reduced clinical condition due to underlying disease.

Conclusions:

Tunneled indwelling catheters are useful in the palliative treatment of patients with recurrent malignant and nonmalignant pleural effusions.

Limitations:

  • The study had no appropriate control group.
  • Due to the nature of the study, authors were unable to control for patient death during the hospitalization and observation period.
  • Only patients unable to tolerate VATS procedures were included, so results can only be generalized to patients with refractory pleural effusion in the setting of poor physical health.
  • Authors suggest that the insertion of a “not-tunneled pleural mini-catheter” be considered as an alternative intervention. This point, however, seems to contradict the authors’ original conclusion that TIPC will be beneficial for patients with limited lifespan and reduced clinical condition due to underlying disease.

     

Nursing Implications:

Though TIPC placement under local anesthesia is less invasive and offers the advantage of very low postoperative mortality rate, it may not be an appropriate intervention for patients with a “very limited lifespan” based on underlying disease. Hence, its use in this population should be considered cautiously, given the procedure's aggressive or semi-aggressive, invasive nature. Patient/caregiver capacity to care for the catheter and perform drainage may influence the appropriateness of this intervention.

Suzuki, K., Servais, E.L., Rizk, N.P., Solomon, S.B., Sima, C.S., Park, B.J., . . . Adusumilli, P.S. (2011). Palliation and pleurodesis in malignant pleural effusion: The role for tunneled pleural catheters. Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer, 6(4), 762-767.

doi: 10.1097/JTO.0b013e31820d614f
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Study Purpose:

The objective of the study was to evaluate tunneled pleural catheters for efficacy of palliation and the rate and predictors for spontaneous pleurodesis.

Intervention Characteristics/Basic Study Process:

The study was a retrospective review of all patients (no matter who or where inserted) with at least tunneled pleural catheter inserted at a single institution from September 2007 to September 2009. Catheters were placed by pulmonologists, interventional radiologists, and thoracic surgeons in interventional radiology or bedside. All catheters were placed by Seldinger technique, unless during a video-assisted thoracoscopic procedure (VATs).

A total of 418 tunneled pleural catheters were placed. Forty-two patients had additional contralateral pleural catheters, 13 patients had an additional ipsilateral pleural catheter, and 4 patients had both a contralateral and secondary ipsilateral catheter.

Sample Characteristics:

  • The study reported on a sample of 355 patients.
  • The median age was 63 years, with a range of 16-90 years.
  • Of the sample, 42% were males and 58% were females.
  • Of the sample, 106 patients (30%) had lung cancer, 62 (17%) had breast cancer, 36 (10%) had gynecologic cancer, 24 (7%) had urologic cancer, 21 (6%) had upper gastrointestinal cancer, 18 (5%) had sarcoma, 18 (5%) had lower gastrointestinal cancer, 18 (5%) had hepatobiliary, and 52 (15%) had other disease.
  • Two hundred fifty-three patients (61%) had right effusions, and 165 patients (39%) had left effusions.
  • Sixty-nine patients (17%) had undergone previous procedures, and 349 patients (83%) had undergone no previous procedures.
  • One hundred and ten patients (26%) had loculated pleural effusions, and 308 patients (74%) had simple, non-loculated pleural effusions.


 

Setting:

The single-site study was conducted in both the inpatient and outpatient settings. Two hundred sixty-one patients (62%) were treated in interventional radiology, 107 patients (26%) were treating in the operating room, 37 patients (9%) were treated at the bedside, and 13 patients (3%) were treated in a clinic.

Phase of Care and Clinical Applications:

  • Patients were undergoing long-term follow-up care.
  • The study has clinical applicability for end-of-life and palliative care.
     

Study Design:

The study was a retrospective review.

Measurement Instruments/Methods:

  • Radiographic evaluation of effusions pre- and post-catheter placement
  • Computed tomography (CT) scan preferred; chest x-ray when CT not available
  • Measured presence/absence of pleural fluid and presence/absence of spontaneous pleurodesis     
  • Dyspnea was measured as “absence of symptoms” and “no need for subsequent effusion-directed drainage,” but the exact instrument or method of measurement was not described.
     

Results:

Median survival in this series from the time of the first catheter insertion was 3.7 months (range 2.9-4.5 months, confidence interval 95%). Median follow-up was 2.4 months, with a range of 1.0-6.4 months. Three hundred eighty of 418 catheters inserted (91%) did NOT need additional effusions-directed therapies. The successful palliation rate in patients who lived longer than 30 days was 89% (28 of 322 insertions). Spontaneous pleurodesis was achieved in 110 catheters (26%), and accounting for those who died, the probability of successful pleurodesis during the study time was 34%. The catheter complication rate was 4.8% (20 catheters; 5 grade II, 15 grade III).

Conclusions:

  • Tunneled pleural catheters were considered more cost-effective than talc pleurodesis for patients living less than six weeks. They had complication rates of 4.8% and were less severe than with talc pleurodesis (severe respiratory distress in 1%-9%).
  • High rate of palliation (91%) was evidenced by no need for additional interventions for relief of symptomatic pleural effusions.
  • The spontaneous pleurodesis rate of 26% is lower than other tunneled catheter studies.

Limitations:

The study was limited by
  •  No appropriate control group
  •  Lack of a definitive symptom assessment scale
  •  Lack of control for insertion operator, location, indication, or phase of disease.
     

Nursing Implications:

Tunneled pleural catheters offer an alternative method of pleural drainage and may even induce spontaneous pleurodesis in patients with symptomatic malignant pleural effusions. The process of placing the catheter is minimally invasive, is associated with a low complication rate, and allows for rapid recovery of patients with limited life expectancy. More than 90% of patients receiving this therapy experienced symptomatic relief that did not require additional interventions for treatment of pleural effusions. This therapy option for management of symptomatic pleural effusions may be suggested by nurses familiar with the management of malignant pleural effusions. Studies addressing specific symptom relief would be valuable to validate the effectiveness of this intervention.

Thornton, R.H., Miller, Z., Covey, A.M., Brody, L., Sofocleous, C.T., Solomon, S.B., & Getrajdman, G.I. (2010). Tunneled pleural catheters for treatment of recurrent malignant pleural effusion following failed pleurodesis. Journal of Vascular and Interventional Radiology: JVIR, 21(5), 696-700.

doi: 10.1016/j.jvir.2010.01.021
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Study Purpose:

The objective of the study was to review the effectiveness of the use of single tunneled, valved pleural catheters in the treatment of symptomatic recurrent malignant pleural effusion following failed chemical pleurodesis.

Intervention Characteristics/Basic Study Process:

Two hundred seventy patients who underwent placement of a tunneled pleural catheter between January 2002 and December 2006 were identified after reviewing interventional radiology billing records. After subsequent review of inpatient and outpatient medical reports for each case, 63 were reportedly treated for dyspnea associated with recurrent malignant pleural effusion following failed pleurodesis. In the incidence of suboptimal drainage post-procedure, fibrinolytic therapy with tissue-type plasminogen activator (tPA) dissolved in saline was administered into the catheter to dwell for two hours in the pleural space prior to drainage and was repeated at one- or two-day intervals, if clinically required for optimal drainage and symptom relief. Catheters were drained every other day until the volume decreased to 50 mL, in which case it was drained every three days. Catheters were subsequently removed from patients who achieved durable symptom relief on three consecutive drainages during the three-day intervals with less than 50 mL of drainage and who had no radiographic evidence of re-accumulation. For those with larger drainage volumes, however, catheters were left in place for continued use.

Sample Characteristics:

  • Sixty-three of the 270 identified patients underwent pleural catheter placement for treatment of dyspnea associated with recurrent malignant pleural effusion (68 were documented hemithoraces).
  • The mean age was 61 years, with a range of 30-85 years.
  • Of the sample, 30.2% were males, and 69.8% were females.
  • Of the 63 patients identified, malignancy was as followed: breast (22), lung (14), ovarian (7), pancreatic (4), primary peritoneal (4), mesothelioma (2), esophagus (2), carcinoid (2), chronic lymphocytic leukemia (1), colorectal (1), melanoma (1), cervical (1), squamous cell (1), and adenocarcinoma of unknown primary (1).
  • Nine patients had pre-existing pigtail drainage catheters prior to placement of the tunneled catheter.
     

Setting:

This single-site study was conducted in both inpatient and outpatient settings in Interventional Radiology.

 

Phase of Care and Clinical Applications:

  • Patients were undergoing long-term follow-up care.
  • The study has clinical applicability for end-of-life and palliative care.
     

Study Design:

The study was a retrospective review.

Measurement Instruments/Methods:

Dyspnea was measured, but the scale or instrument used was not defined.

Results:

  • Sixty of 63 patients experienced “immediate clinical improvement in dyspnea” following catheter placement. No clear symptomatic improvement was noted in the remaining three.
  • Fifty-seven of 63 patients (90%) were discharged from the hospital with a tunneled pleural drain after a median of three days (range 0-29 days).
  • Twenty-one of the 68 hemithoraces (31%) required subsequent fibrinolytic therapy to promote drainage of complex pleural effusions.
  • One patient had the pleural catheter removed prior to discharge, while five patients died before discharge.
  • Twenty-seven patients (43%) were discharged in two days or less.
  • Those with longer hospital stays were due to treatment of other disease-related medical conditions.
  • Symptomatic recurrence of pleural effusion occurred in one patient 19 days after tunneled pleural catheter removal requiring catheter drainage.
  • Median survival following catheter placement was 64 days (range 34-164 days).
  • Mean follow-up for survivors was 746 days.

Conclusions:

The large majority of patients (95%) experienced prompt symptom relief and clinical improvement following tunneled pleural catheter insertion. Parynchymal lung disease or rapid progression of disease was reported among the patients who did not improve from catheter placement.

Limitations:

  • The study had a small sample size of less than 100.
  • Authors did not describe how dyspnea was measured and evaluated pre- and post-catheter placement, making it hard to quantify/gauge the extent to which patients experienced symptomatic relief of dyspnea.
  • Authors were unable to analyze the durability of symptom relief due to lack of “uniformity” of clinical follow-up and documentation (i.e., regarding patients' drainage schedule, drainage volumes, symptoms, imaging).
     

Nursing Implications:

Use of tunneled pleural catheters for the treatment of recurrent malignant pleural effusion appears to be an appropriate and beneficial intervention for patients suffering from dyspnea following failed pleurodesis. The majority experienced immediate symptomatic relief of their dyspnea following catheter placement, although one-third of cases may necessitate transcatheter fibrinolytic therapy for adequate drainage. As noted by the authors, it is less invasive and more cost-effective than more successful, though high-risk interventions such as decortication (which is 100% effective but associated with high morbidity and mortality and not recommended for this population), thoracentesis (which offers immediate symptomatic relief but is associated with 98%-100% recurrence within 30 days), or thoracoscopy with talc poudrage (which has a high success rate but is more invasive and requires general anesthesia). It is also worth noting the short hospitalization period reported for 43% of the patient population, who were discharged within two days of catheter placement and symptom relief. However, effectiveness for patients with progressive disease remains questionable.

Systematic Review/Meta-Analysis

Van Meter, M.E., McKee, K.Y., & Kohlwes, R.J. (2011). Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: A systematic review. Journal of General Internal Medicine, 26(1), 70-76.

doi: 10.1007/s11606-010-1472-0
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Purpose:

The objective of this systematic review was to review published data on the efficacy and safety of tunneled indwelling pleural catheters (TIPCs).

Search Strategy:

Databases searched were MEDLINE, EMBASE, and ISI Web of Science through 2009. A manual search was conducted of reference lists for relevant additional studies.

Search keywords were malignant pleural effusion (MPE), tunneled indwelling pleural catheter (TIPC), and palliative care.

Studies were included if they reported on

  • Adult patients
  • Patients with MPE
  • Patients treated with TIPCs.

Studies with and without control were included.

Studies were excluded if they reported on non-malignant effusions, empyema, chylothoras, long-bore chest tubes, or non-tunneled catheters. Studies in which all patients underwent thorascopy, video-assisted thorascopic surgery (VATS), or pleurodesis were excluded. Studies were excluded if they weren't published in English. Studies without primary data also were excluded.

Literature Evaluated:

  • A total of 1,011 references were retrieved, which generated 25 eligible reports.
  • Data were abstracted independently by two authors, and discrepancies were resolved by discussion and consultation with a third author.
  • Abstractors were not blinded to any study details.
  • The GRADES system was used for evaluation of quality.
  • Case studies and one randomized controlled trial had low-level evidence.

This systematic review pertains to the dyspnea Putting Evidence Into Practice topic in that one outcome of the review evaluated “symptomatic improvement” with emphasis, although not exclusive focus, on dyspnea.
 

Sample Characteristics:

  • The final number of studies included was 19.
  • The total sample size was 1,370 patients.
  • The sample range across studies was 8–263.
  • The average age was 63 years.
  • Of the sample, 50.5% were women.
  • Most patients had recurrent MPE with failed thoracentesis or other treatment.
  • The majority of the patients had a lung cancer diagnosis, but some also had breast cancer, mesothelioma, and a few other cancers.

Phase of Care and Clinical Applications:

  • Patients were undergoing end-of-life care.
  • The study has clinical applicability for palliative care.

Results:

Symptom relief was variably defined in the studies. Three studies reported symptom improvement without further delineation. One study rated dyspnea improvement on a three-point scale. The remaining studies reported symptomatic relief as “relief of dyspnea” or “improvement in respiratory performance,” “increased exercise tolerance,” “ improvement of pain,” and “catheter was useful.” When combined, 628 of the 657 patients (95.6%) experienced some degree of improvement in their symptoms, although the magnitude of improvement cannot be determined. Serious complications were rare. The most common complications were cellulitis (32 of 935, 3.4%) and obstruction or clogging (33 of 895, 3.7%) or unspecified malfunction of the catheter (11 of 121, 9.1%). The quality of the studies was low, as evaluated by the GRADES system.

Authors suggest that TIPC may improve symptoms for patients with MPE.

Conclusions:

Based on the low-quality evidence in the form of the case studies, evidence is insufficient to demonstrate the effectiveness of TIPCs. 

Nursing Implications:

More rigorous studies need to be conducted to establish evidence with respect to dyspnea.


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