Malignant Pleural Effusion
FINAL REPORT
Introduction
Pleural effusions in patients with malignancies are frequent complication of a variety of advanced cancers. These are often difficult to treat and result in recurrent dyspnea as well as frequent hospital visits for multiple treatments.
The usual approach to patients with symptomatic malignant pleural effusion (MPE) is to perform repeated pleural taps (thoracentesis), or to place an intercostal catheter and attempt pleurodesis with a sclerosing agent such as talc or a tetracycline. The first approach is resource intensive (requires multiple visits to physician or ultrasound department), painful and only partially and temporarily effective in relieving symptoms. The second requires a 10-14 day hospitalization, can only be performed in a portion of patient who undergo chest tube placement, can be significantly painful and has been associated with severe pulmonary complications.
A new procedure has been developed; using a long-term tunneled catheter inserted into the pleural space. This catheter can permit self-drainage by the patient or home care nurses on a regular basis at home. It is thought that the use of this catheter will assist in avoiding emergency visits, acute care hospitalizations and repeated procedures for these patients, enhancing quality of life for patients and reducing health care costs. The
catheter can be safely inserted as an outpatient procedure under local anesthesia.
In order to better understand the current management of malignant pleural effusions in the Calgary Health Region, and to evaluate the potential impact of a new treatment approach for this disease, the Malignant Pleural Effusion project was initiated and completed as part of the Calgary Health Region (CHR) Quality Improvement and Health Information (QIHI) program via the Medicine Quality Council.
Participants
Team leader:
· Dr. Alain Tremblay, Department of Medicine, Division of Respiratory Medicine
Team Members:
· Lori Forand, QI measurement and evaluation specialist in QIHI
· Linda Perkins, Concurrent Review Coordinator QIHI
· Sheila Cloutier, Home care, CHR
· Lee Johnson, TBCC outpatient clinic manager
· Patricia Barclay, TBCC Dyspnea clinic nurse
· Trish Clark, Palliative Clinical Nurse Specialist TBCC
· Dr. Neil Hagen, Senior Leader Medical Services Palliative care medicine TBCC
· Brent Wylie, FMC Respiratory Services
Sponsors:
· Marlene Mysack, Senior Leader Patient Care Services TBCC
· Dr. Sid Viner, Medical Director, PLC site
· Medicine Quality Council / Quality Improvement and Health Information (QIHI) program
Data collection team
· Dianne Burnand, Janet James Whalen, Bev Campbell
Methods
In order to gain the most out of this evaluation, simultaneous sub-studies were conducted, each addressing various issues related to Malignant Pleural Effusions.
A retrospective analysis on hospitalized patients treated for malignant pleural effusion was conducted for CHR adult hospitals during a calendar year. This was followed by a prospective data collection on a cohort of inpatients treated for MPE and a comparable group of outpatients treated with the Pleurx catheter. Thirdly, a prospective database of all patients undergoing Pleurx placement was maintained and analyzed. Finally a literature review was completed to review published experience with the Pleurx approach to the treatment of MPE.
The remainder of this report details the findings of these studies.
Retrospective analysis
A retrospective analysis of the CHR health record database was performed to assess the scope of this clinical problem. The records were queried for the period of fiscal 2000/2001. Full datasets can be found in appendix 1.
A total of 561 inpatients were detected with malignancy and pleural effusion or MPE, accounting for a total of over 10,000 hospital days. A total of 160 intercostal catheters and 153 thoracentesis were performed in this inpatient population. Thirty three attempts at pleurodesis were documented, suggesting that the majority (80%) of patients undergoing chest tube placement do not qualify for this procedure. In fact, only 6 % of the total group of patients received pleurodesis.
Table 1: Patients hospitalized with malignancy and pleural effusion or malignant pleural effusionCHR Site: / Total / % of Total Cases / Deaths** / % Deaths / Total Days / ALOS (days) / Male / Female / CHR Resident / % CHR Resident
FMC / 285 / 51% / 65 / 23% / 5,079 / 17.8 / 119 / 166 / 198 / 69%
PLC / 161 / 29% / 40 / 25% / 2,855 / 17.7 / 61 / 100 / 131 / 81%
RGH / 115 / 20% / 30 / 26% / 2,126 / 18.5 / 52 / 63 / 102 / 89%
CHR IP Total / 561 / 100% / 135 / 24% / 10,060 / 17.9 / 232 / 329 / 431 / 77%
* Includes all IP discharges with one or more malignancies with pleural effusion and Malignant Pleural Effusion alone (ICD code 197.2)
** This represents a death during the reported hospital stay.
ALOS - average length of stay (total days divided by total discharges)
Data from patients with malignancy, pleural effusion and chest tube placement was analyzed separately in table 2 to identify patients in which the MPE clearly represented an important clinical problem for the patient. We found 160 patients accounting for over 2600 hospital days meeting these criteria.
Table 2: Inpatients with MPE with an Insertion of Intercostal Catheter for DrainageSite Identifier: / Total / Total Days Stay / ALOS (days)
FMC / 108 / 1,819 / 16.8
PLC / 33 / 596 / 18.1
RGH / 19 / 204 / 10.7
CHR Adult Sites / 160 / 2,619 / 16.4
It was also found that patients treated under the care of Respirologists had the shortest LOS of all specialties who had admitted at least 10 patients across all sites (Table 3).
Table 3: Average LOS according to admitting physician specialtyMost Responsible Physician Service / FMC / PLC / RGH / Total
Total / ALOS / Total / ALOS / Total / ALOS / Average LOS
01 Family Practitioner / 44 / 21.2 / 60 / 24.1 / 74 / 22.3 / 22.6
10 Internist / 12 / 13.2 / 31 / 11 / 17 / 12.5 / 11.9
16 Nephrologist / 10 / 43.2 / - / - / - / - / 43.2
18 Respirologist / 12 / 10.0 / 16 / 9.1 / 14 / 8.9 / 9.3
30 General Surgeon / 18 / 17.4 / 20 / 20.6 / 5 / 19.2 / 19.1
31 Cardiovascular Surgeon/Cardioth / 63 / 12.3 / 4 / 14.3 / - / - / 12.4
50 Obstetrician & Gynaecologist / 30 / 17.4 / 3 / 8 / - / - / 16.5
55 Intensivist / 10 / 23.2 / 3 / 12.7 / 2 / 8.0 / 19.1
66 Haematologist / 11 / 28.5 / 12 / 13.7 / - / - / 20.8
74 Oncologist / 63 / 18.8 / - / - / - / - / 18.8
The conclusion from these data is that patients with MPE are commonly seen as inpatients in the CHR, that their LOS are prolonged, and that only a small minority (6%) receive pleurodesis, the only treatment know to result in long term control of this problem, short of the new approach being evaluated currently.
Prospective analysis
A) Hospital cohort
Three data coordinators within the Region’s three adult acute care sites collected daily data over a five-week period from March 4th through April 8th 2002. Data coordinators visited all inpatient acute care units, except for peri-partum, pediatric and psychiatry units, on a daily basis to locate any suitable patients. Data was gathered using daily chart reviews and patients were followed until their discharge from acute care.
Three elements were required for a patient to be included in the study. The patient was required to be diagnosed with a malignancy, to have documentation of a pleural effusion for which they were being actively treated, either with chest tube or a therapeutic thoracentesis (draining > 200ml of fluid).
Full details of this cohort can be found in appendix 2.
B) Pleurx cohort
A convenience sample of 18 patients undergoing Pleurx catheter placement was selected from the larger Pleurx database (see below). The selection criteria for these 18 consecutive patients was residence within the Calgary City Limits and procedure before April 17th, 2002, in order to avoid inaccuracies in re-admission data from patient outside the CHR and so that a 3 month follow-up be ensured within the timeline of this project.
Data Collection
Descriptive data was collected on the Hospital cohort regarding specific interventions performed in hospital to compare with the retrospective data. Data were collected on patients in both groups regarding hospital admissions and LOS for the period 3 months pre and post procedure or admission for comparison.
Results
In the 5 week data collection period, 13 inpatients were identified with actively treated malignant pleural effusions. This is consistent with the previous finding of 160 patients receiving intercostal catheters over one year (13.3 / month) in the retrospective analysis.
11 chest tubes were placed with 3 patients enduring more than one chest tube. Repeated thoracentesis occurred in 2 patients both of whom were at PLC. It should be noted that only 2/13 hospitalized patients (15%) actually underwent pleurodesis, including only one of three patients with 2 chest tubes. This number which concurs with the retrospective data is extremely low given that pleurodesis is the only way to achieve long term symptom control short or using the Pleurx catheter.
Mean and median LOS for these patients are seen in table 4. The main indications for remaining in hospital other than
MPE were diagnostic workups or palliative pain management.
Site / Mean / MedianFMC / 20.4* / 25.0
PLC / 27.3 / 30.5
RGH / 20.7 / 19.0
The Pleurx cohort consisted of 18 patients with symptomatic pleural effusions referred for treatment. 5 patients had the procedure while admitted in hospital, but none were admitted specifically for the procedure. Discharge home was facilitated by the procedure in 4 patients, while the 5th was transferred to hospice. All 13 other procedures were performed as outpatient procedures in the FMC bronchoscopy suite or TBCC Dyspnea clinic.
The CHR health record database was searched to identify all inpatient admissions in the CHR for the period of 3 months pre and post catheter placement or hospital discharge for each group. This data is summarized in tables 5 & 6.
The Pleurx patients and Hospital patients had similar numbers of hospital admissions per patient in the 3 months prior to intervention (0.59 vs. 0.4), but the Pleurx group had higher number of inpatient days than the Hospital group (6.05 vs. 2.6 days / patient) suggesting that the Pleurx group were not necessarily in better health to start off.
Table 5: Hospital Admissions 3 months Pre and Post interventionHospital Cohort / Pleurx Cohort
Admissions Pre/patient / 0.4 / 0.59
Admissions Post/patient / 1 / 0.24
The situation changed dramatically in the 3 months post intervention with the Pleurx patients experiencing much lower readmissions (0.24 vs. 1/patient) and hospital days (1.41 vs. 8 / patient) than the hospitalized cohort. This is strong evidence that the Pleural catheter approach avoids hospitalization.
In addition, the actual admission days
Table 6: Hospital Days 3 months Pre and Post interventionHospital Cohort / Pleurx Cohort
Hospital Days Pre/patient / 2.6 / 6.05
Hospital Days Post/patient / 8 / 1.41
(see table 4) associated with the intervention for the Hospital group are not represented in this analysis, suggesting that an even larger number of hospital days could potentially be avoided.
This analysis demonstrates that in patients with malignant pleural effusions and similar pre-procedure hospitalizations rates, treatment with a tunneled pleural catheter (Pleurx) leads to fewer hospital readmissions and hospital days than the standard treatment. This also confirms that the minority of patients treated as inpatients for MPE receive pleurodesis, which is in fact the only other way to obtain long term symptom relief.
Pleurx Database
The placement of indwelling long term tunneled pleural catheter for home drainage of malignant pleural effusions first became available in the CHR in October 2001 at the Foothills Medical Center site, based out of the Bronchoscopy Suite and operated by the Respiratory Medicine division as well as the Respiratory Services department. Procedures are performed on outpatients and FMC inpatients by a member of the Respiratory Medicine division (Alain Tremblay), and assisted by a respiratory therapist.
The procedure was expanded to a specialized clinic at the Tom Baker Cancer Center (Dyspnea Clinic) in January of 2002. This clinic is operated by Dr. Tremblay and Pat Barclay, RN. Strong support from the palliative care team is provided Patricia Clark.
All patients in whom a Pleurx catheter insertion was attempted were entered in a database. The main purpose of the data base was to monitor patient demographic, primary tumor sites, complication rates, spontaneous pleurodesis rates, and survival. A summary of the first 53 insertions follows.
A total of 48 patients underwent 53 procedures. (3 patients received bilateral drains, 2 patients had a second successful insertion after the first failed). Mean age was 62.8 years, with a range of 35 to 87.
Lung cancer and breast cancer comprised over 50% of cases, which was expected as these are common tumors, and both are associated with MPE as a frequent complication of disease. It should also be noted that lung cancer is the number one cancer killer for both men and women (more than breast, prostate and colon combined) and that breast cancer is the most common non skin tumour in women. This emphasizes the importance of effective palliative treatments for patients with these tumours.
Of note, 3 patients with mesothelioma were treated with 4 catheters (one patient received sequential bilateral drains) with good success in relieving dyspnea. This is a significant achievement for a disease in which no therapy has ever been shown to modify its course.
Complications have been minimal. Five attempted insertions were unsuccessful (9.4%). Two patients had loculated fluid confirmed on subsequent ultrasound, one had tumour involvement of the skin making catheter placement impossible, one had insufficient remaining pleural fluid because of recent tube drainage, and one had a clot blocking the catheter immediately after insertion. The last 3 have had successful reinsertion attempts. In all, 96% of all effusions treated had an eventually successful Pleurx tube placement.