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Ann Thorac Surg 2000;69:369-375
© 2000 The Society of Thoracic Surgeons
a Department of Thoracic and Cardiovascular Surgery, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA
b Department of Medical Informatics, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA
Address reprint requests to Dr Putnam, Department of Thoracic and Cardiovascular Surgery, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 109, Houston, TX 77030
e-mail: putnam{at}mdanderson.org
Presented at the Forty-fifth Annual Meeting of the Southern Thoracic Surgical Association, Orlando, FL, Nov 12–14, 1998.
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Abstract |
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Methods. A retrospective review of consecutive PC patients (n = 100; 60 outpatient, 40 inpatient) were treated from July 1, 1994 to September 2, 1998 and compared with 68 consecutive inpatients treated with chest tube and sclerosis between January 1, 1994 and December 31, 1997. Hospital charges were obtained from date of insertion (day 0) through day 7.
Results. Demographics were similar in both groups. Pretreatment cytology was positive in 126 of 168 patients (75%), negative in 21 (12.5%), and unknown in 21 (12.5%). Primary histology included lung (n = 61, 36%), breast (n = 39, 23%), lymphoma (n = 12, 7%), or other (n = 56, 34%). Median survival was 3.4 months and did not differ significantly between treatment groups. Overall median length of stay was 7.0 days for inpatient chest tube and inpatient PC versus 0.0 days for outpatient Pleurx. No mortality occurred related to the PC. Eighty-one percent (81/100) of PC patients had no complications. One or more complications occurred in 19 patients (19%). Patients treated with outpatient PC (n = 60) had early (7-day) mean charges of $3,391 ± $1,753 compared with inpatient PC (n = 40, $11,188 ± $7,964) or inpatient chest tube (n = 68, $7,830 ± $4,497, SD) (p < 0.001).
Conclusions. Outpatient PC may be used effectively and safely to treat malignant pleural effusions. Hospitalization is not required in selected patients. Early (7-day) charges for malignant pleural effusion are reduced in outpatient PC patients compared with inpatient PC patients or chest tube plus sclerosis patients.
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Introduction |
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Once a patient develops MPE, mechanical drainage relieves pulmonary compression and dyspnea. Optimal treatment methods are controversial and may vary in costs and charges [2, 3]. Sclerosis by talc [4], tetracycline, doxycycline [5], bleomycin [6, 7], or instillation of a talc slurry creates sufficient inflammation to achieve pleural symphysis [8, 9]. Each method carries with it certain advantages and disadvantages. They include multiple and repetitive attempts for thoracentesis alone, tube thoracostomy with or without sclerosis, video-assisted thoracic surgery (VATS) for optimal drainage and lung expansion with talc pleurodesis [10–12], outpatient drainage using a variety of small tubes or catheters with or without sclerosis [13], or pleuroperitoneal shunts [14–16] or other drainage devices.
A recent multiinstitutional prospective randomized study examined the efficacy and safety of treating patients with recurrent MPE with a chronic indwelling pleural catheter (PC) (Pleurx; Denver Biomaterials, Golden, CO) versus tube thoracostomy and doxycycline sclerosis [17]. The authors found that patients treated with the PC had equivalent relief of dyspnea, safety, and efficacy as treatment with the tube thoracostomy. Hospitalization was 1 day (median) for patients treated with the PC, in contrast to 7 days (median) for patients treated with tube thoracostomy (chest tube [CT]) and doxycycline sclerosis.
We hypothesized that extending treatment of patients with MPE to the outpatient clinic would: (1) be performed safely, (2) reduce or eliminate the need for hospitalization, and (3) minimize charges compared with those treated as inpatients with tube thoracostomy and drainage.
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Material and methods |
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Pleural catheter patients
Between March 1, 1994 and September 2, 1998, 100 consecutive patients were treated at The University of Texas M.D. Anderson Cancer Center with a chronic indwelling PC (Pleurx) (49 men, 51 women; mean age 58.2 ± 1.1 years). Forty patients, previously admitted by another service for MPE, had placement of the PC as inpatients. Sixty patients underwent placement of the PC and management of their MPE as outpatients. Of the 100 PC patients, 91 had one catheter placed, 8 had two catheters placed, and 1 patient had three catheters placed (bilateral thorax and abdomen).
Chest tube patients
Between January 1, 1994 and December 31, 1997, we identified 68 consecutive patients who were admitted to The University of Texas M.D. Anderson Cancer Center specifically for treatment of MPE with tube thoracostomy and pleurodesis. (24 men, 44 women; mean age 59.7 ± 12.06 years). Histology varied among these patients. Sclerosis was obtained with doxycycline (500 mg in 50 cc normal saline) or talc (5 g in 50 cc normal saline). Chest tubes were removed when drainage was less than 200 cc in a 24-hour period. Patients were excluded who were admitted for primarily other medical problems in addition to their MPE.
Inpatient PC patients (20 men, 20 women) had a mean age of 54.52 ± 10.38 years; output PC patients (31 men, 29 women) had a mean age of 60.66 ± 11.41 years (p = 0.024). Racial characteristics were noted to be equally distributed between treatment groups.
Performance status
A performance status (PS) of 0 refers to a patient that is asymptomatic and fully functional; PS = 1 refers to a patient who is symptomatic and fully ambulatory; and PS = 2 refers to a patient who is symptomatic and in bed less than 50% of the time during the day.
Histology
Primary malignancy of all 168 patients included: lung cancer, 61; breast, 39; lymphoma, 12; ovarian, 11; mesothelioma, 7; unknown primary, 6; stomach, 7; head and neck primary, 4; esophagus, renal cell, and sarcoma, 3 each; cervical, cholangiocarcinoma, endometrial, and gastric, 2 each; and colon, gallbladder, melanoma, pancreas, prostate, and rectal, 1 each. More lung cancer patients were treated by outpatient PC (26 of 60, 43.3%) than by inpatient CT (24 of 68, 35%) or by inpatient PC (11 of 40, 27.5%). More lymphoma patients were treated by inpatient PC (7 of 40, 17.5%) than by outpatient PC (3 of 60, 5%) or inpatient CT (2 of 68, 2.9%). Other histologies were equally distributed between treatment groups.
For all 168 patients, pleural fluid cytology was positive in 126 patients (75%), negative in 21 (12.5%), and not done/unknown in 21 (12.5%).
Radiographs
Pretreatment, posttreatment, and follow-up chest roentgenograms were obtained to assess radiographic improvement in the pleural fluid. Postero-anterior chest radiographs were graded by the following scale: 1 = no effusion seen; 2 = effusion only detected on lateral decubitus films and not on PA/lateral roentgenograms (< 100 mL); 3 = small effusion-blunting of costophrenic angle on PA roentgenogram and/or posterior sulci on lateral roentgenogram (100 to 500 mL); 4 = moderate effusion: fluid accumulation up to between costophrenic angle and hilar level on erect film (> 500 mL); 5 = large effusion: fluid accumulation above hilar level, but hemithorax not completely opacified (> 1,500 mL); and 6 = complete opacification of hemithorax.
Healthcare charges
Charges for care were entered into The University of Texas M.D. Anderson Cancer Center billing system and extracted from the daily transaction report by hospital number and service code date (date the charge was incurred). Charges were linked by patient registration number and analyzed confidentially in a secured facility. Charges included price of the catheter, clinic fees, all professional fees, laboratory, diagnostic imaging for all patients, and room charges for inpatients.
Treatment groups
CT inpatients
After appropriate evaluation, 32F chest tubes were placed in a standard manner at the bedside using local anesthesia. When drainage had dropped to less than 200 cc/24 h, sclerosis with talc (5 g in 50 cc normal saline) or doxycycline (500 mg in 50 cc normal saline) was performed. Chest tubes were discontinued when drainage was less than 200 cc/24 h and the patient was discharged home 4 to 8 hours later.
PC patients
Eligibility for PC required: 1) prior thoracentesis with confirmation of malignancy (or exudate) that relieved dyspnea, and 2) bilateral decubitus chest roentgenograms. In patients not undergoing chemotherapy and in the absence of past history of bleeding problems, prothrombin time (PT), partial thromboplastin time (PTT) and platelets were not routinely performed. Most patients had the PC placed under local anesthesia in a clean procedure room in the outpatient clinic. Most inpatients also had the PC placed in the clinic area. Patients infrequently had the PC placed at the bedside, in the emergency room, or on the general ward.
Technique of PC placement
After examination of the patient, review of the roentgenograms, and informed consent, 1% xylocaine was used as a local anesthesia, and the pleural fluid was located with a needle. A flexible wire was placed into the thorax and directed posteriorly. A counter incision was made inferiorly and medially to the wire, and a tunnel was created for the PC. The catheter was drawn through the tunnel and the Teflon cuff was placed 1 cm away from the skin edge within the tunnel. A peel-away sheath over a dilator was inserted over the wire and placed into the thorax. The PC was threaded through the sheath into the thorax and the peel-away sheath was withdrawn. The wounds were closed and the catheter was secured to the skin. Drainage was undertaken immediately. Then, 1,500 cc or more of the MPE was removed in 38.4% of patients; 40.4% of patients had 1,000 to 1,499 cc of fluid removed, and 21% had less than 1,000 cc removed.
Follow-up of PC patients
After placement of the catheter, patients and caregivers were instructed on self-drainage of their MPE. Typically, patients would drain their effusion at home every other day. When scant or no fluid was obtained on three consecutive attempts, the patient presented to the clinic for removal of the catheter. Patients were routinely evaluated in the clinic at 1-month intervals while the catheter was in place. After removal of the catheter, the patient was discharged to the care of their regular physician.
Statistical analyses
Postoperative survival and disease-free survival were calculated using the product limit method of Kaplan and Meier [18]. Statistical comparisons between groups were made using the long-rank test with survival calculated from the date of treatment. All p values resulted from two-sided tests. Significance was considered to be p less than or qual to 0.05. Mean values are expressed as ±SD. Analysis of variance was calculated using SPSS 7.5 software (SPSS, Inc, Chicago, IL).
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Results |
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Performance status
Initial performance status was different between the two PC groups. For PC inpatients, the mean performance score was 1.9 ± 1.13, compared with PC outpatients’ score of 1.39 ± 0.64 (p = 0.005). The higher performance score in the inpatient PC patients suggests a more symptomatic patient population, with a greater need for inpatient management.
Radiographs
Preprocedure radiographs in PC patients were not significantly different between inpatients and outpatients. Pretreatment radiographs had an effusion rating of 4.60 ± 0.74 compared with posttreatment radiograph rating of 4.03 ± 0.81, (p < 0.001). At last follow-up, effusion rating was not significantly different from the immediate posttreatment radiograph (4.00 ± 1.05 vs 4.03 ± 0.81, p = 0.712).
Drainage
Inpatients had a mean initial drainage of 1,301 ± 452 cc compared with outpatients of 1,090 ± 606 cc (p = 0.064). This observation suggests that a greater initial drainage occurred in PC patients treated as inpatients. Most patients had significant effusions. Seventy-eight of 100 patients had 1,000 cc or greater removed from the ipsilateral hemithorax.
Morbidity and mortality
No mortality occurred related to PC placement or use. Specifically, no emergency operation for bleeding or intrathoracic injury occurred. No morbidity was noted in 81 patients (81%). Nineteen of all PC patients (19 of 100, 19%) had one or more events after catheter placement related to the catheter or the pleural space; eight patients developed fluid recurrence requiring therapy. Most of these patients developed loculations of fluid that progressed. Eight patients had removal of a malfunctioning catheter. Five patients developed infected pleural fluid/empyema requiring additional treatment (percutaneous drainage, antibiotics, or other operation).
During the follow-up period, 2 inpatient PC patients had one event; 1 patient had two events; and 1 patient had three events. Seven outpatient PC patients had one event, 4 had two events, and 4 had three or greater events.
One patient required thoracotomy 3 months after successful placement of the PC as an outpatient. The patient had prior lobectomy for stage IIIa (N2) adenocarcinoma (ACA). Symptomatic pleural fluid with positive cytology developed during postoperative radiation. After approximately 6 weeks, the catheter ceased functioning and the patient experienced increasing dyspnea related to progressive pleural disease. The PC was removed and decortication was performed. The patient subsequently died of progressive pleural carcinomatosis.
A second patient with progressive pleural disease had the PC placed into a loculation of pleural fluid. Dyspnea was relieved slightly. The catheter ceased to function and dyspnea increased related to progressive pleural disease. Decortication was performed with relief of dyspnea.
Pleurodesis
PC patients were followed until death or until catheters were removed. Catheters were removed after pleural symphysis. Pleural symphysis was achieved in 21 patients (21%) and did not differ between treatment groups (inpatient PC 7 of 40 [17.5%] vs outpatient PC 17 of 60 [28.3%], p = 0.436). Three patients in each group were not evaluable and categorized as no pleurodesis.
Length of stay
For all inpatients, there was no difference in hospital stay whether the patient was treated with inpatient CT or inpatient PC. Outpatients treated with the PC had no hospitalization. Length of stay was 8.36 ± 5.52 days (median 7 days) for inpatient CT, 8.85 ± 8.89 days (median 7 days) for inpatient PC (p = 0.728), and 0 days for outpatient PC (p < 0.001).
Hospital charges
Patients treated with CT (n = 68) had early (7-day) mean hospital charges of $7,830 ± $4,497. A charge advantage was noted in the PC group treated as outpatients. Early mean charges for outpatients (n = 60) were only $3,391 ± $1,753 (p < 0.001), in contrast to early mean hospital charges for PC patients treated as inpatients (n = 40, $11,188 ± $7,964) (p < 0.001 for CT, inpatient PC, outpatient PC).
Total hospital charges were examined for each treatment group calculated from insertion date until death or last follow-up evaluation. Patients initially treated with CT as an inpatient had mean charges of $32,252 ± $56,682 compared with inpatient PC charges of $34,626 ± $51,306 and outpatient PC charges of $21,161 ± $32,617 (p = 0.294).
Survival
Overall median survival (n = 168) was 3.48 ± 0.81 months (Fig 1). Survival did not differ significantly between lung, breast, or other histologies (Fig 2, p = 0.13). Median survival for lung cancer patients (n = 61) was 2.07 ± 0.71 months, for breast cancer (n = 39) was 4.50 ± 1.27 months, and for other histology (n = 56) was 4.14 ± 1.73 months. In contrast, lymphoma patients had a significantly long survival (median not reached at 48 months, p = 0.01) compared with the other three histology groups.
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Comment |
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A recent multiinstitutional prospective randomized phase III study examined the results and outcomes of this chronic indwelling silastic PC compared with a chest tube and doxycycline sclerosis (CT-S) in the management of recurrent malignant pleural effusions [17]. One hundred forty-four patients were randomized in a 2:1 distribution to PC (n = 99) or CT-S (n = 45). Median survival was 90 and 109 days, respectively (p = NS). PC patients had significantly fewer hospital days (1.83 days mean) than CT-S patients (6.83 days, p < 0.001). Relief of dyspnea after initial treatment and at 90 days were similar and significant compared with pretreatment values. No catheter patient had symptomatic recurrence of the effusions, whereas approximately 27% of evaluable CT-S patients recurred. The authors noted fewer hospital days in the PC group and equivalent safety and efficacy as CT-S. The authors suggested that PC could be considered as a standard therapy for selected patients with MPE. One particular advantage of this catheter is that it may be placed and managed entirely in the outpatient clinic.
Symptoms, performance status, and survival are comparable with other reported series of patients with MPE [2, 3]. Dyspnea and chest pain predominated and were reflected in appropriate Zubrod scores. Median survival for all patients (3.45 months) reflect the dismal prognosis of recurrent MPE.
Our goal in treating these patients was to relieve symptoms of dyspnea, allow patients to continue to function independently outside of the hospital, or facilitate that goal for inpatients. Treatment as an outpatient and drainage at home may provide a functional and psychological advantage to the patient and family in giving them more "control" over the problems of end-of-life care. The outpatient management of MPE has rapidly evolved into our preferred management for recurrent MPE.
In patients with MPE, pleurodesis was not considered as the end point of treatment; rather, relief of dyspnea and ability to function outside of a hospital environment were emphasized. With this definition, 81% of patients had successful treatment of their MPE by PC. In contrast, CT-S or VATS, drainage, and talc sclerosis are expensive, require inpatient or operating room management, and require pleurodesis for the patient to be discharged. This requirement increases costs as the need for inpatient management increases. The PC provides a consistent and reproducible means for drainage of MPE in an outpatient environment.
Outpatient management of MPE has been performed in small groups of patients with various devices. Usually, small-bore catheters have been placed for drainage before chemical pleurodesis [19–23]. Coordination between interventional radiologist, oncologist, and pulmonologist for placement of small-bore catheters may be time consuming, and the timely management of potential complications may not be obtained. In this population of patients treated by PC, chemical or talc pleurodesis was not attempted. Given the limited experience with PC, we chose to treat a wide variety of patients with recurrent MPE to evaluate the effectiveness, safety, and limitations of this treatment plan before evaluating PC drainage and sclerosis on an outpatient basis. We found that outpatient placement and management of patients with MPE by use of a chronic indwelling catheter to be safe and effective. Dyspnea related to pleural effusion was relieved in all patients; however, dyspnea related to chronic pleural thickening or progressive pleural carcinomatosis was not improved by the catheter.
Outpatient PC patients could be managed with less charges than inpatient CT patients. While outpatient placement of PC was planned for all patients, 40% of PC patients were admitted by another service before requesting thoracic surgery evaluation and treatment recommendations. Inpatient PC patients had a worse performance status as demonstrated by performance scores, suggesting that inpatients were more symptomatic than the corresponding group of outpt PC patients. This improved performance score may indirectly contribute to the survival of 5.85 months in contrast to 2.66 months for inpatient PC patients and 2.24 months for chest tube patients.
Early charges (7 days) for care were examined by comparison of hospital charges by treatment group. Outpatient PC patients had the lowest amount of early charges compared with charges incurred by inpatient PC and inpatient CT patients. Treatment- and histology-specific survival was generally poor (with the exception of lymphoma) and the same between treatment groups. Complications in the PC patients were distributed among treatment groups, and did not increase in outpatient PC patients. Total charges from insertion to death or from insertion to last follow-up evaluation were calculated. Changes ranged widely. Outpatient PC patients had the lowest early charges of any treatment group. Low total charges may reflect a less symptomatic population; although, survival was generally dismal regardless of the treatment provided.
Belani and colleagues [2] presented an analysis of efficient treatment of MPE. Their analysis of costs noted that VATS and talc pleurodesis was about $20,996 (1992 U.S. dollars) [3], compared with CT and sclerosis with doxycycline ($8,061) or bleomycin ($8,657). VATS expenses include operating room expenses, including anesthesiologist and thoracic surgeon fees, as well as hospital convalescence. The authors further suggested that a small-bore catheter for drainage and sclerosis would be well tolerated by the patient and applicable in the ambulatory setting. Twenty-eight patients had been treated, with 16 of 28 (57%) responding to the ambulatory procedure. Belani and colleagues recommended a larger study be considered to examine cost effectiveness, quality of life, and resource utilization.
Patients with loculated effusions may require VATS exploration and release of the loculations and talc pleurodesis. If this fails, then a pleurectomy or pleuroperitoneal shunt may be considered. Catheter drainage under CT direction may also be considered. Patients with trapped lung may never have pleural apposition and, therefore, may never achieve pleural symphysis. In these patients, pleuro-peritoneal shunt or a Pleurx catheter may be considered for palliation of dyspnea. With drainage of the effusion, additional functional lung may be recruited and result in a more functional lung with less residual pleural space. In some patients, the lung may expand and pleural symphysis may occur.
Conclusions
We recommend that PC be considered a standard of care for treatment of patients with MPE. Outpatient PC may be considered a safe, effective, and inexpensive means of treating patients with MPE compared with inpatient PC and inpatient CT. A reduction in healthcare charges for patients with MPE by use of PC during their end-of-life care may be provided with equivalent safety and effectiveness to CT and sclerosis. Outpatient management of patients with MPE (free-flowing effusion or one large loculation, trapped lung, no evidence of infection, etc) with a chronic indwelling PC palliates dyspnea and provides an effective and cost-efficient treatment for these patients with limited life expectancy (Table 1).
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