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Department of Cardiovascular-Thoracic Surgery, Rush University Medical Center, Chicago, Illinois
Accepted for publication November 13, 2007.
* Address correspondence to Dr Warren, Director of General Thoracic Surgery, Suite 774, 1725 W. Harrison Street, Chicago, IL 60612 (Email: wwarren{at}rush.edu).
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Abstract |
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Methods: We have inserted 231 Pleurx (Cardinal Health Systems, McGaw Park, IL) catheters into 202 patients with symptomatic malignant pleural effusions with the goal of treating the fluid on an outpatient basis. The catheters were drained at home, using vacuum bottles, every other day after an initial week of draining daily. No sclerosing agents were instilled. The catheters were removed when drainage was less than 50 mL/day. Primary tumor sites, irradiation to the hemithorax, and incomplete re-expansion of the lung were studied for their ability to predict prolonged drainage (over 100 days).
Results: In all cases, evacuation of the fluid with a Pleurx catheter palliated the patient’s symptoms. Overall, 134 of 231 (58.0%) catheters were removed after the drainage tapered off. Reaccumulation of the pleural effusion occurred in 5 of 132 (3.8%) patients. The incidence of infection was 5 of 231 (2.2%) and was usually limited to cellulitis at the insertion site. The incidence of blockage was 11 of 231 (4.8%) and was most common in patients with an underlying cancer at sites other than breast and gynecologic primaries. Drainage for more than 100 days was seen most often in patients who had incomplete reexpansion of the underlying lung (p < 0.001). Primary tumor site and irradiation did not have significant predictive value.
Conclusions: Insertion of Pleurx catheters is an effective way to treat patients with a malignant pleural effusion on an outpatient basis with a high degree of patient compliance and few complications. Overall, almost 60% of the catheters can be removed with a very low chance of reaccumulation, and without the need to instill a sclerosing agent. Even patients with a trapped lung can be palliated and released from hospital, although the likelihood of removing the catheter is small.
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Introduction |
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In 1997, the Pleurx catheter (Cardinal Health Systems, McGaw Park, IL) was approved by the Food and Drug Administration for the outpatient management of malignant pleural effusions. This 15.5 Fr silicone elastomer catheter is 66 cm in length onto which is secured a polyester cuff to allow for tissue ingrowth. The catheter insertion length (from cuff to tip) is 24 cm and has many side holes, in addition to an end hole. On the external end of the catheter is a one-way safety valve. After an initial drainage in the operating room, the pleural space is drained (according to a schedule) by the patient at home utilizing vacuum bottles. In this study, we reviewed our clinical experience with this catheter documenting the morbidity and efficacy in draining symptomatic effusions. In addition, we attempted to identify those factors that correlated with drainage over 100 days.
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Material and Methods |
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Inclusion criteria to offer patients this treatment option were the following: (1) pathologically proven diagnosis of malignancy; (2) a symptomatic pleural effusion; (3) patients were expected to be able to go to an outpatient facility or home; (4) patients had a life expectancy of greater than 30 days; and (5) patients did not have an underlying uncorrectable bleeding diathesis. Thoracentesis was suggested in selected cases where the clinical improvement after drainage of the effusion was questionable due to underlying parenchymal involvement. Catheters were offered to all patients, including those known to have an underlying trapped lung and patients who had failed other forms of therapy.
All patients were offered observation only, thoracentesis (repeated as necessary), insertion of a 28 Fr polyvinyl chloride thoracostomy tube (with subsequent pleural sclerosis using doxycycline), or video-assisted thoracoscopy and talc insufflation as alternatives to insertion of a Pleurx catheter. All but two of 212 patients over this period of time elected to undergo insertion of a Pleurx catheter. These two patients refused on the basis of an unwillingness to be responsible for the care and maintenance of the catheter, and the unwillingness to have home health care nursing.
Several factors went into the patients’ decision. Patients expressed an interest in avoiding a general anesthetic and were willing to manage the catheter if it meant they were able to be discharged. Early success with the Pleurx catheter also encouraged referring oncologists to favor this option. In two patients, the attempt to insert the catheter was terminated upon discovering that the pleural fluid was purulent and turbid. In an additional six patients, placement was attempted but unsuccessful, presumably because the pleural debris was loculated, gelatinous, or a rind of solid necrotic tumor. The remaining 202 patients became the basis of this analysis. This was not a randomized trial.
Insertion Technique and Drainage Protocol
The vast majority of catheters were inserted in the midaxillary line in the operating room under local anesthesia. Although the manufacturer recommends tunneling the catheter in the subcutaneous tissue, we found this led to unnecessary handling of the catheter (with increased risk of infection), added potential for kinking, and increased discomfort to the patient. Therefore, a Seldinger technique was used without tunneling the catheter. The only exceptions were the following (as was the case in seven patients): (1) the presence of tumor implants or skin breakdown in the axilla; (2) virtual absence of chest wall subcutaneous tissue; or (3) loculation of a large pleural pocket in the posterior chest wall not tracking along the lateral chest wall. Under these circumstances, the catheter was inserted through the posterior chest wall and tunneled through the subcutaneous tissue to exit at an appropriate site. Patients were instructed to drain up to 600 mL/day using vacuum bottles provided. Patients were instructed to drain every day for the first week and every other day thereafter. No sclerosing agents were instilled through the catheter. When the drainage subsided to 50 mL/day (or 100 mL every other day), the catheters were removed in the office under local anesthesia. This aggressive drainage protocol was proposed in the hopes that keeping the pleural space dry promoted pleural symphysis.
Study Data Points
All hospital records, including pathology, radiology, and operative reports were reviewed. The data collected included age, sex, site of primary malignancy, history of previous radiation therapy, side of insertion, operating room insertion time, amount of fluid drained intraoperatively, cytologic analysis of the fluid, and intraoperative and postoperative complications. Follow-up data were also obtained, including length of time the catheter was in place, complications (including infections, catheter blockage, recurrence of fluid), and survival.
The following factors were analyzed for their ability to predict prolonged drainage (drainage greater than 100 days), catheter blockage, and long-term control on the pleural effusion (symptomatic reaccumulation of pleural effusion over the course of the patient’s life): (1) primary tumor site; (2) incomplete reexpansion of the underlying lung (ie, presence of a "trapped lung"); and (3) previous chest irradiation.
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Results |
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Other Local Problems
One patient developed skin sensitivity to the adhesive on the waterproof dressing requiring a makeshift dressing. No infection developed.
The primary sites of these tumors are presented in Table 1. Other catheter-related problems and the long-term success of the catheters in controlling the pleural fluid are discussed according to the primary tumor site.
Breast Carcinoma
One hundred and one patients with primary breast cancer underwent placement of 115 catheters (unilateral, 87; bilateral, 14). All patients were female, ranging from 24 to 89 years old. The fluid was cytologically positive in 90 of 115 (78.3%) of the pleural spaces. In this population, 64 of 115 (55.6%) of the pleural spaces had received radiation therapy. The chest X-ray taken a week after the catheter was inserted showed that the underlying lung failed to completely reexpand in 11 of 115 (9.6%; Table 2) of the pleural spaces drained.
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Thirty-one of the 101 (30.6%) patients with breast cancer had the Pleurx catheter(s) in place at the time of their death (Table 3). At least seven of 31 patients preferred not to have the catheters removed, even though no drainage was being performed; none of these patients developed a catheter-related infection. The indwelling time for catheters in this cohort of patients ranged from 2 to 319 days. Of patients with breast cancer, 12 of 101 (11.8%) died within 30 days of insertion despite attempts to avoid such patients, according to the inclusion criteria. In 10 of 12 of these patients, the Pleurx catheters were in place. In 9 of 12 patients, the catheters were still functioning well and the patients were palliated of their dyspneic symptoms.
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In follow-up, after the Pleurx catheter was removed, a clinically significant ipsilateral recurrent pleural effusion developed in 3 of 80 (3.8%) pleural spaces (Table 4). The intervals between removal of the catheter and reinsertion were 63, 90, and 104 days. In these three cases, the new effusion was loculated and drained by placement of another Pleurx catheter, all of which were eventually removed.
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Twenty of the 52 (38.5%) catheters were removed after an indwelling period ranging from 5 to 62 days (mean, 30.9 days). Catheter removal was performed within 14 days in 6 of 20 (30.0%) patients.
In three patients, the catheter drained for greater than 100 days. No patient had a catheter reinserted for fluid reaccumulation. There were no catheter-related infections. The catheters became blocked in 8 of 52 (15.4%) pleural spaces drained. All blocked catheters were replaced and the new Pleurx catheters functioned well until removal or until the demise of the patient. Of the 45 patients undergoing placement of one or two Pleurx catheters, 25 died with the catheter(s) in place after an indwelling time ranging from 1 to 251 days.
Gynecologic Carcinoma
In 26 patients, the primary site was in the female reproductive tract (ovary, 20; Fallopian tube, 1; endometrium, 3; cervix, 2). Thirty-one catheters were placed in these 26 patients (unilateral, 21; bilateral, 5). These patients ranged in age from 26 to 75 years. Cytology was positive on the pleural fluid in 25 of 31 (80.6%) of the pleural spaces. None of the pleural spaces drained had received radiation therapy. In 2 of 31 (6.5%) of the pleural spaces, the underlying lung was shown to be trapped.
Of the patients with a gynecologic cancer, 7 of 26 (26.9%) patients died with the catheter(s) in place and functional after an indwelling time ranging from 9 to 61 days. Only one patient died within 30 days of catheter insertion.
Overall, 23 of 31 (74.2%) were removed prior to death after an indwelling period ranging from 9 to 101 days after catheter insertion. The overall mean indwelling time was 66.7 days. Excluding one patient who had drainage of over 100 days, the average length of time the catheter was in place was 42.8 days. None of these 31 catheters became blocked, and only one developed an infection, which was superficial, requiring catheter removal and only local wound care. Only one of the 23 pleural spaces from which a catheter was removed developed a clinically significant recurrent pleural effusion. In each case, this was treated by reinsertion on another Pleurx catheter.
Malignancies Arising From Miscellaneous Other Sites
Thirty patients had primary malignancies arising in miscellaneous other sites (Table 5). Thirty-three catheters were inserted into these 30 patients (unilateral, 27; bilateral, 3). Only one hemithorax received radiation therapy. In 3 of 33 (9.1%) of the pleural spaces drained, the underlying lung failed initially to completely reexpand. Upon analyzing the fluid, only 14 of 33 (42.4%) were found to contain malignant cells. Only one of these pleural spaces were subjected to radiation therapy.
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In this small cohort of patients, only 11 of 33 catheters were removed prior to the patient’s death. The interval between insertion and removal ranged from 16 to 389 (mean, 58.7) days. The overall mean indwelling time was 35.7 days. Excluding one patient whose catheter drained for more than 100 days, the mean time the catheter was in place was 29.7 days.
None of these catheters became blocked and only one developed an infection (cellulitis). One of these 11 (9.1%) pleural spaces developed a clinically significant, loculated recurrent pleural effusion 74 days after catheter removal. The patient elected to undergo reinsertion of a Pleurx catheter.
Statisical Analysis of Data to Predict Drainage Over 100 Days
Primary tumor sites, previous chest irradiation, and incomplete reexpansion of the lung were all assessed for ability to predict those patients left with a catheter functioning for more than 100 days. While patients with primary tumor sites other than breast and miscellaneous sites had a higher incidence of this fluid occurrence (breast, 5.2%; lung, 5.8%; gynecological 3.2%; miscellaneous, 9.1%), this did not reach statistical significance (p = 0.63, Fisher exact test).
Chest irradiation alone did not affect the probability of having drainage for over 100 days (p = 0.117, 
2 = 2.45, df = 1). Adjusting for primary site, we did see elevated risk for breast cancer patients, but the p-value is not reliable because the number of lung cancer patients was too small.
Incomplete reexpansion of the lung was associated with a much higher probability of having the catheter drain for over 100 days (p < 0.001, 2 = 47.77, df = 1).
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Comment |
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Some authors have favored talc as a sclerosing agent administered using either a talc slurry through a chest tube, or insufflating talc into the pleural space at the time of thoracoscopy. A phase III study has demonstrated that both methods of delivery are efficacious, but that the incidence of respiratory failure (talc slurry, 4%; talc insufflation, 8%), and treatment-related mortality (talc slurry, 2.8%; talc insufflation, 3.8%) were much higher than we experienced with Pleurx catheter placement [11]. The insufflation of talc into the pleural space has been shown to precipitate an ARDS-type injury [12–14]. Moreover, in animal studies, talc fibers in the pleural space have been have been disseminated to the brain, lung, heart, spleen and kidneys presumably by hematogenous spread [15]. These concerns have prompted at least one prominent authority to question the use of talc as the sclerosing agent of choice to be instilled into the pleural space [16].
There has been renewed interest in small-bore catheters to drain malignant effusions over an extended period of time on an outpatient basis. Experience with outpatient drainage using 8–14 French pigtail catheters has been reported in the radiologic literature [4, 5, 17, 18]. Many authors instill sclerosing agents in small-bore tubes presumably to effect pleural symphysis [17, 19–21]. However, none of the references provide long-term follow-up to assess recurrence of fluid. In our experience, even after instilling sclerosing agents, these pigtail catheters rarely lead to pleural sclerosis. In addition, these catheters are uncomfortable and patient compliance has been poor. Of those patients who are discharged with the catheter in place, drainage only takes place in a hospital setting.
The evolution of the Pleurx catheter is a reflection of increasing desire on the part of health care providers, patients, and health care insurance carriers to manage malignant pleural effusions entirely outside of the hospital. In the present series, life-long control of the effusion after removal of the catheter was accomplished 96.2% (127 of 132) of the time. However, it must also be stressed that, even in those individuals who died with the catheters in place, the catheters were functional and there was no accumulating effusion at the time of death. The primary goal of placement of this catheter is palliation of dyspnea. The eventual removal of the catheter was of secondary importance.
Compliance and clinical acceptance of these catheters was extremely high among patients. Given the alternative options of intermittent outpatient thoracentesis, or admission for insertion of a chest tube with sclerotherapy (bedside doxycycline or talc insufflation by video-assisted thoracic surgery), all but two chose to have insertion of the Pleurx catheter. Chief among its attractions was the opportunity to be treated as an outpatient and avoiding a general anesthetic. Other advantages cited by patients and referring physicians were patient comfort and long-term control of the effusion. Of the entire group of patients, 40 had previously undergone insertion of a chest tube and doxycycline instillation with reaccumulation of the fluid within 30 days. None of these patients had been given the option of Pleurx catheter previously. These patients were among the most vocal and supportive advocates of this outpatient alternative. All 35 patients who were faced with the development of a recurrent (5 patients) or contralateral effusion (30 patients) chose to have insertion of another Pleurx catheter.
Other indices of patient acceptance was 196 of 202 (97%) compliance with the drainage schedule, and at least 42 patients expressing a preference to leave the catheter in place, even after drainage subsided and the criteria for removal had been met. This acceptance was based on ease of insertion and outpatient management. The low incidence of clinically significant recurrent pleural effusions (3.8%), low incidence of blockage (4.8%), and low incidence of infection (2.2%) were additional positive attributes. Similar results have been reported by others [1, 3, 6, 22].
Given the low incidence of complications and the outpatient setting, this procedure was offered to patients in marginal health. Some oncologists have argued that hospital admission and chest tube insertion is not justified if a patients’ life expectancy is less than 30 days. Although survival at this late stage in life can be very difficult to predict, only 16.3% (33 of 202) catheters were inserted into patients who went on to die within 30 days of the procedure. Even in this population, discharge from the hospital after any other treatment option (except thoracentesis) would have been highly doubtful. Insertion of the Pleurx catheter, in effect, allowed for repeated thoracentesis without the risks of pneumothorax, and avoiding the inconvenience of transporting the patient to and from the doctor’s office.
The incidence of pleurodesis (ie, catheter removal without clinically significant pleural effusion) was highest in breast and gynecologic cancer patients who were found to have complete reexpansion of the lung. On the other hand, patients had the highest probability that the catheter would be functional but remain in place until the time of death (but palliating the patient nevertheless) if they had incomplete reexpansion of the lung. Chest irradiation did not have significant predictive value as a single factor, but may correlate with incomplete reexpansion of the lung.
Even in those cases with a trapped lung, insertion of a Pleurx catheter is justified if the patient has had clinical relief from dyspnea after thoracentesis. This is especially true given the low incidence of complications and proven poor results of conventional chest tube drainage and sclerosis. Predictably, however, these patients are likely to have the catheter in place for their remaining days. However, in at least five cases (breast cancer, 4; lung cancer, 1), a lung that failed to completely reexpand within seven days (and thought to be "trapped"), eventually did reexpand to the point that the pleural space was completely evacuated, drainage subsided, and the catheter was removed (after an indwelling period ranging from 60 to 171 days) without reaccumulation. This phenomenon has also been observed by others [10, 21, 23].
The exact mechanism by which pleural symphysis is accomplished is unclear. However, several clinical observations were made over the course of this experience. After an initial period of amber drainage, many patients noticed the color change to pink or cranberry. Several patients complained of pleuritic pain at the end of their drainage period. We believe that these observations support the conclusion that the catheter incites an inflammatory response in the pleural space. Serial chest X-rays identified the Pleurx catheters in different positions within the pleural space, especially early after insertion. Therefore, as the catheter sweeps around in the pleural space it is in contact with more pleural surface than alternative stiffer catheters. Early in our experience, we had one patient with a history of breast cancer and benign cytology on the initial pleural fluid. Because this was the only site of presumed tumor recurrence, a video-assisted thoracoscopy was performed 11 days after insertion of the Pleurx catheter. Over this period of time, drainage had subsided to 50 mL/day. At the time of thoracoscopy, a subpleural nodule was biopsied, establishing the diagnosis as recurrent carcinoma, but also encountered were widespread thin adhesions, which were also biopsied and found to be inflammatory (Fig 1). It is therefore concluded that, given the right circumstances (which includes, at a minimum, pleural apposition and the ability to mount an inflammatory response), these catheters cause an inflammatory reaction over a broad area of the pleural space, inducing adhesion formation and ultimately sealing the pleural space.
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Acknowledgments |
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