Louis Saffran, MD; David E. Ost, MD, FCCP; Alan M. Fein, MD, FCCP; and Mark J. Schiff, MD

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1 Outpatient Pleurodesis of Malignant Pleural Effusions Using a Small-Bore Pigtail Catheter* Louis Saffran, MD; David E. Ost, MD, FCCP; Alan M. Fein, MD, FCCP; and Mark J. Schiff, MD Study objective: Patients with symptomatic malignant pleural effusion are usually treated with large-bore chest tube placement and pleurodesis requiring > 3 days of hospitalization. We sought to demonstrate the feasibility of ambulatory drainage and sclerosis using a small-bore pigtail catheter in patients with malignant pleural effusions. We reasoned that this approach would improve symptoms and quality of life at a reduced cost. Methods: A 14F pigtail catheter was percutaneously inserted into the pleural space and connected to a closed gravity-drainage bag system. The patients were instructed in the use of the drainage system and discharged to return for sclerosis with 4 g of talc after the drainage was < 100 ml/24 h. Patients were graded for dyspnea and performances status using the Eastern Cooperative Oncology Group score (ECOG) and baseline and transitional dyspnea index score (BDI-TDI) before tube placement and again at 30 days. Radiographic response was graded as total response, partial response, or failure. Telephone follow-up was initiated when the patient could not return for evaluation. Results: Ten ambulatory women, ages 41 to 79 years, were enrolled. The chest tube was left in place from 1 to 10 days, draining a mean of 2,956 ml (1,685 to 6,050 ml). Only two patients were unable to undergo sclerosis owing to catheter dislodgment and minimal drainage. Six reported symptomatic improvement at 30 days confirmed by TDI and ECOG scores in four of six. One with a prior history of a lobectomy was found to have a chylous pleural effusion and experienced a hydropneumothorax, for which sclerosis was unsuccessful. One died in hospital on day 26 after sclerosis despite radiographic resolution. Of the four patients who had improved dyspnea and functional status by TDI and EGOG scores, radiographic response was complete in three and partial in one. Two of the six were not able to return for follow-up because of weakness but reported improvement by telephone inquiry. Conclusion: Ambulatory sclerosis of malignant effusion using a small-bore catheter is a feasible alternative to inpatient sclerosis with a large-bore chest tube, especially in patients with strong preferences for outpatient care. (CHEST 2000; 118: ) Key words: ambulatory sclerotherapy; malignant pleural effusions; pigtail catheter; sclerosis; talc slurry Abbreviations: ECOG Eastern Cooperative Oncology Group; TDI transitional dyspnea index Cancer accounts for 40% of all pleural effusions, especially in those 50 years old. 1 In the United States, approximately 100,000 cases of pleural effusions are caused by malignancy. Bronchogenic and breast cancers account for 75% of malignant pleural effusions, with the remaining 25% *From the Department of Medicine (Drs. Saffran, Ost, Fein, and Schiff), Center for Pulmonary and Critical Care Medicine, North Shore University Hospital, Manhasset/New York University, and the Department of Medicine (Dr. Fein), SUNY at Stony Brook, Stony Brook, NY. Manuscript received May 25, 1999; revision accepted March 7, Correspondence to: Louis Saffran, MD, 297 Mineola Blvd, Mineola, NY represented by a cross-section of other neoplastic diseases. 2 Approximately two thirds of malignant pleural effusions occur in women because of the strong association of malignant effusions with breast and ovarian cancer. Most patients with malignant pleural effusion are symptomatic. The most common presenting complaints are shortness of breath, cough, chest pain, and a sense of fullness within the chest. Treatment is directed toward relief of these symptoms. If the malignancy is sensitive to chemotherapy (eg, lymphoma, small cell lung cancer), systemic treatment alone may control the effusion. When the tumor does not respond to chemotherapy, management of CHEST / 118 / 2/ AUGUST,

2 the effusion includes thoracentesis. If the fluid reaccumulates after repeated thoracentesis, options are chemical pleurodesis via chest tube, thoracoscopy with pleurodesis, open thoracotomy with pleurectomy, or pleuroperitoneal shunting. Most reported series have studied chemical pleurodesis using a chest tube in hospitalized patients. Once the drainage decreased to 100 ml/24 h, a sclerosing agent was instilled, with 3 days of hospitalization commonly required. Intrapleural chemical agents include tetracycline, doxycycline, bleomycin, talc insufflation, or talc slurry. The purpose of this study was to evaluate the efficacy, safety, and effect on quality of life of outpatient sclerosis using small-bore pigtail catheters. The pigtail catheter was used to prevent accidental dislodgment. We chose to use talc as a sclerosant because it has a much higher success rate compared with tetracycline (90% vs 20 to 80%), 3 7 is less painful, and is less expensive than bleomycin. 8,9 We reasoned that if efficacy could be demonstrated to be comparable, patients with malignant effusions might prefer outpatient small-bore catheter scleroses to inpatient large-bore or surgical pleurodesis. We report a feasibility study conducted entirely in the outpatient setting of pleurodesis for malignant pleural effusions. Materials and Methods Ten consecutive ambulatory patients with symptomatic malignant pleural effusions, with an Eastern Cooperative Oncology Group (ECOG) score of 3 were enrolled. Informed consent was obtained in all cases. A predrainage ECOG, baseline dyspnea index, and chest radiograph were obtained. All patients had recurrent symptomatic pleural effusions after initial thoracentesis. Ultrasound guidance was used in two patients with loculated fluid by chest radiograph. Lidocaine was used for local anesthesia, and a small incision was made with a scalpel before inserting a 14F pigtail catheter (van Sonnenberg Chest drain set; Boston Scientific; Watertown, MA; Fig 1). The trocar method for insertion was used, and the catheter was locked to prevent it from dislodging, then connected by tubing (Boston Scientific) to a Dover urine leg bag (Sherwood Medical; St. Louis, MO) for gravity drainage. All tubes were secured to the skin with a catheter cuff set (Percufix Catheter Cuff Kit; Boston Scientific). Not 1 L was drained before discharging the patient. The patient and their family were provided with a graduated measuring cylinder, home-care instructions, and emergency contact information. Intermittent closure of the catheter using the shutoff valve was permitted. The patient recorded the amount of drainage, and this was reported during the daily telephone interviews. Once the drainage decreased to 100 ml/d, the patients were instructed to return for sclerotherapy. Sclerotherapy was accomplished by instillation of 50 ml of 1% lidocaine followed by 4 g of talc slurry and 20 ml of saline solution flush. The patient was observed for 1 h before discharge. The tube was clamped for 2 h, after which a shutoff valve was opened to permit gravity drainage. The catheter was removed the following day. Figure 1. 14F pigtail catheter with connecting tube and leg bag. Thirty-day follow-up consisted of a chest radiograph, ECOG score, and transitional dyspnea index (TDI). Radiographic response was categorized as complete (no reaccumulation of fluid), partial (reaccumulation of fluid below the predrainage level), or failure (reaccumulation of fluid to the predrainage level or greater). Patients who could not return for follow-up were questioned by telephone as to their symptoms. Results Ten women were enrolled, ages 41 to 79 years (mean, 55 years). Primary malignancies were breast carcinoma (n 6), breast and ovarian carcinoma (n 1), non-small cell lung carcinoma (n 2), and leiomyosarcoma (n 1). Patients 3 and 10 underwent drainage despite the effusions appearing loculated because they appeared to be free-flowing single loculations. The chest tubes remained in place for an average of 5.7 days (range, 1 to 10 days), draining a mean of 2,956 ml (range, 450 to 6,050 ml). Figure 2 shows an example of a chest radiograph with a pigtail catheter in place and a 5-month follow-up chest radiograph. Ultrasound localization was used in 2 of 10 patients. Baseline fluid characteristics and chest tube drainage quantities are listed in Table 1. Of the 10 patients who entered the study, 8 underwent sclerosis. In one patient, the pigtail was dislodged after 24 h with no subsequent reaccumulation of fluid after 5 months. In another patient, drainage was only 450 ml at 2 days. A large-bore chest tube failed to increase drainage, and no sclerosis was performed. CT of the chest revealed a large mass. Six of the eight patients who underwent sclerosis had subjective symptomatic improvement; four of the six also had improvement as measured by the TDI and ECOG scores; three of these four had complete radiologic improvement, and one had partial improvement. Two of the six who had symptomatic improvement were not able to return for later 418 Clinical Investigations

3 Figure 2. Chest radiograph of a patient with the pigtail catheter in place (left), and 5-month follow-up chest radiograph (right). follow-up because they were not ambulatory. By telephone inquiry, they reported significant improvement of their dyspnea (Table 2). Two patients who underwent sclerosis did not have symptomatic improvement, although one had resolution by chest radiograph. The first patient was hospitalized for dysphagia a few days after sclerosis. An effusion on the opposite side was discovered, so she underwent sclerosis in the hospital. After sclerosis, she experienced increasing dyspnea and finally was intubated in the ICU. The patient died 26 days later of respiratory failure. At the time of death, the patient did not have reaccumulation of fluid. The other patient without symptomatic improvement after sclerosis had a history of a lobectomy and was found to have a chylous effusion. She experienced a hydropneumothorax after drainage but underwent sclerosis anyway. Sclerosis proved unsuccessful in this case. Neither wound infections nor occluded catheters were reported. After sclerosis with talc, pain was not significant. Discussion The development of malignant pleural effusion frequently heralds a poor prognosis. In addition, recurrent malignant pleural effusions can cause severe debilitating symptoms and impair the quality of life. Current options for palliation of symptomatic effusions include repeated thoracenteses, large-bore (28F to 36F) or small-bore (7F to 16F) chest tube drainage, chemical sclerotherapy, or video-assisted thorascopic drainage and sclerosis. Although repeated thoracentesis can give symptomatic relief, the recurrence rate is reported to be high. 10 Inpatient drainage with large-bore chest tubes connected to Table 1 Patient Characteristics and Pleural Data* Patient No. Sex Age, yr Cancer Cytology ph Pleural Glucose, mg/dl Duration Chest Tube Placement, d Total Chest Tube Drainage, ml 1 F 41 Breast ,685 2 F 57 Breast NA 7.47 NA 6 6,050 3 F 49 Leiomyosarcoma 7.57 NA F 41 Breast ,615 5 F 56 Lung NA ,035 6 F 71 Breast ,770 7 F 64 Breast ,135 8 F 59 Breast ,150 9 F 46 Breast , F 69 Lung 7.14 NA 8 3,755 Mean ,956 *NA not available. CHEST / 118 / 2/ AUGUST,

4 Table 2 Baseline and Follow-up Performance, Dyspnea, and Radiographic Data* Patient No. ECOG Baseline BDI Baseline Chest Radiograph ECOG Follow-up TDI Follow-up Chest Radiograph Telephone Follow-up Fluid to hilum NF NF NF Improvement Anterior loculation 1 8 Full response Anterior loculation NA NA CT revealed a lung mass Fluid to hilum 0 1 6Z Partial response Fluid to hilum NF NF NF Improvement Fluid to hilum 1 3 Full response Fluid above hilum NA NA Dead, d Fluid below hilum 3 3 Partial response Fluid to hilum 3 3Z Full response Anterior loculation NA NA Hydropneumothorax mean 2 5 *BDI baseline dyspnea index; NF not able to follow-up in the office; NA not applicable; Z impairment for reasons other than shortness of breath. Telephone follow-up for patient who could not have follow-up in the office because of pain. Any positive number indicates improvement. Patient had a partial response without sclerosis, only with drainage. Decreased ambulation secondary to a new brain lesion. wall suction followed by sclerosis is the most commonly used palliative intervention However, inpatient chest tube drainage has several drawbacks, including the cost of hospitalization, severely limited mobility, and discomfort. Video-assisted thoracoscopy offers the advantage of visualization of the pleural surface and allows small adhesions to be broken up, thereby allowing apposition of the pleural surfaces. This technique has the highest success rate but also requires hospitalization with local anesthesia supplemented by IV narcotic and neuroleptic agents in most cases. 14 Multicenter studies are underway currently comparing video-assisted thoracoscopy with standard chest tubes for sclerosis of malignant pleural effusions. 2 Small-bore drainage of malignant effusions was first found to be feasible by Talamonti et al. 15 Satisfactory drainage was obtained in 8 of 12 patients with, no demonstrable recurrence of the effusion after a mean follow-up of 8.5 weeks. 15 Since then, a number of articles have reported successful palliation using small-bore chest tube for pleurodesis Small-bore chest tubes have somewhat lower success rates when compared with conventional chest tubes. The most common complications reported are infection and pneumothorax. The pneumothorax rate is higher when the Seldinger technique is used, as opposed to the trocar method of insertion. 16,18 The success rate with small-bore chest tubes used on an inpatient basis ranges from 62 to 95% Difficulties with tube occlusion have been described when using chest tubes smaller than 12F. 18,20 The length of time the chest tubes have remained in place is similar for both the large-bore chest tubes and the small-bore chest tubes, usually 5 to 6 days. All but one study, by Walsh et al, 17 used ultrasound 18,19 or fluoroscopic guidance 16,19,20 for placement of the chest tubes. We used ultrasound guidance in the two patients with anterior loculations. There may have been a benefit to fluoroscopy in the patient with the large lung mass; however, it is likely that fluoroscopic evaluation would not have differentiated a mass from an effusion. Patz et al, 21 in 1996, published the first and only other series of 19 patients with malignant effusions who underwent ambulatory sclerotherapy using small-bore (10.3F) catheter drainage with fluoroscopic guidance. Tubes were in place 2 to 11 days (mean, 5.1 days), and bleomycin was used for sclerosis. Overall, there was a 53% complete and 26% partial success rate, and two tubes became clogged; both tubes easily cleared with a guidewire. One patient had a wound infection and empyema that necessitated hospitalization for 6 days. All patients experienced marked improvement in respiratory symptoms after drainage and sclerosis. 21 In our study, we demonstrated for only the second time that pleural drainage and sclerotherapy with small-bore tubes can be successfully performed on an outpatient basis. Our study is unique in that radiologic guidance was not used unless the effusion appeared to be loculated, making it more easily performed in an outpatient setting. We also used talc slurry as opposed to tetracycline, doxycycline, 20 or bleomycin 19,21 as was used in the prior studies. Talc slurry has demonstrated superior results compared with bleomycin and is much less expensive ($50 vs $1,000/dose). In addition, patients do not experience any nausea or vomiting with talc as has been reported previously with bleomycin. 21 Doxycy- 420 Clinical Investigations

5 Table 3 Charges Excluding Physician Fee Supplies cline instillation is associated with more pain than talc and requires repeated installations. Talc slurry, however, produces a significant pleural reaction, making follow-up chest radiographs less easily interpretable. However, the radiographs usually clear approximately 1 to 2 weeks after sclerosis. Our 30-day response rate was similar to that reported for inpatient drainage therapy with smallbore tubes. No prior study has used objective measurements for dyspnea. Dyspnea improved after sclerotherapy as measured by baseline dyspnea index TDI in all patients in whom it was measured. Functional studies also improved in 50% of patients as demonstrated by the ECOG scores, and 75% if the two patients who could not return for follow-up are included. In addition, clogging of the catheters was not observed in our study as had been previously reported with 10F and 12F catheters. 18,20,21 In one patient, the chest tube fell out because the catheter was inadequately secured. In all other patients, the pigtail successfully avoided accidental dislodgment of the catheter. The diagnosis-related group fee for chest tube insertion and drainage of a malignant pleural effusion is $9,100, with a projected length of stay of 7.4 days. The cost of thorascopic pleurodesis has been estimated to be $4,000. Outpatient pigtail catheter with sclerosis resulted in charges of $500 (Table 3). Summary Outpatient Pigtail Charges Excluding Physician Fee, $ van Sonnenberg 14F pigtail catheter 87 Connecting tube 10 Percufix catheter cuff kit 12 Urine leg bag 2 Sterile gloves 3 Scalpel 9 Sterile towels 2 3 Sterile gown 2.50 Talc 50 Miscellaneous 50 Lidocaine, 1% 2 4 Chest radiograph 91 Total We demonstrated that outpatient catheter sclerosis is feasible in patients with malignant pleural effusions. Patients reported improved functional status without any significant complications or mortality. Although efficacy was lower than with conventional inpatient chest tube sclerosis, the cost was also significantly lower. In addition, the patient s desire to remain at home could be accommodated. This quality-of-life issue is important in patients who may have significant near and intermediate mortality. References 1 Hausheer FH, Yarbro JW. Diagnosis and treatment of malignant pleural effusion. Semin Oncol 1985; 12: Lynch TJ. Management of malignant pleural effusions. Chest 1993; 103(suppl):385S 389S 3 Kennedy L, Sahn SA. Talc pleurodesis for treatment of pneumothorax and pleural effusion. Chest 1994; 106: Kennedy L, Rusch VW, Strange C, et al. Pleurodesis using talc slurry. Chest 1994; 106: Gravelyn T, Michelson M, Gross B, et al. Tetracycline pleurodesis for malignant pleural effusion: a 10 year retrospective study. Cancer 1987; 59: Oszko M. Pleural effusions: pathophysiology and management with intrapleural tetracycline. Drug Intell Clin Pharm 1988; 22: Zaloznik A, Oswald S, Langin M. Intrapleural tetracycline in the management in malignant pleural effusion: a randomized study. Cancer 1983; 51: Paladine W, Cunningham TJ, Sponzo R, et al. Intracavitary bleomycin in the management of malignant effusions. Cancer 1976; 38: Gupta N, Opfell RW, Padova J, et al. Intrapleural bleomycin vs tetracycline for control of malignant effusions: a randomized study [abstract]. Proc Am Assoc Cancer Res 1980; C-189: Anderson CB, Philpott GW, Ferguson TB. The treatment of malignant pleural effusions. Cancer 1974; 33: Ruckdeschel JC. Management of malignant pleural effusions. Semin Oncol 1995; 22: Hausheer RH, Yarbro JW. Diagnosis and treatment of malignant pleural effusion. Semin Oncol 1985; 12: Austin EH, Flye MW. The treatment of recurrent malignant effusion. Ann Thorac Surg 1979; 28: Colt HG, Mathur PN. Thoracoscopy. In: Colt HG, Mathur PN, eds. Manual of pleural procedures. Baltimore, MD: Williams & Wilkins, 1999; Talamonti WJ, Victor LD, Signori EE, et al. Small bore catheter pleurodesis in the treatment of malignant effusions [abstract]. Chest 1986; 89(suppl):482S 16 Parker AL, Charnock GC, Delany DJ. Small bore catheter drainage and sclerotherapy for malignant pleural effusion. Cancer 1989; 64: Walsh FW, Albert MW, Solomon DA, et al. Malignant pleural effusion: pleurodesis using a small-bore percutaneous catheter. South Med J 1989; 82: Morrison MC, Mueller PR, Lee MJ, et al. Sclerotherapy of malignant pleural effusion through sonographically placed small bore catheter. AJR Am J Roentgenol 1992; 158: Van Le L, Parker LA, Demars LR, et al. Pleural effusion: outpatient management with pigtail catheter chest tubes. Gynecol Oncol 1994; 54: Seaton KG, Patz EF, Goodman PC. Palliative treatment of malignant pleural effusions: value of small-bore cathter thoracostomy and doxycycline sclerotherapy. AJR Am J Roentgenol 1995; 164: Patz EF, McAdams HP, Goodman PC, et al. Ambulatory sclerotherapy for malignant pleural effusions. Radiology 1996; 199: CHEST / 118 / 2/ AUGUST,