Health Policy Advisory Committee on
Technology
Technology Brief Update
PleurX® catheter system for the treatment of malignant
pleural effusion
July 2015
© State of Queensland (Queensland Department of Health) 2015
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DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
The State of Queensland acting through Queensland Health (“Queensland Health”) does not
guarantee the accuracy, currency or completeness of the information in this Brief. Information may
contain or summarise the views of others, and not necessarily reflect the views of Queensland
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This Brief is not intended to be used as medical advice and it is not intended to be used to diagnose,
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This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this Brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
Territories, the Australian and New Zealand governments and Medical Services Advisory Committee
(MSAC). It is a sub-committee of the Australian Health Ministers’ Advisory Council (AHMAC),
reporting to AHMAC’s Hospitals Principal Committee (HPC). AHMAC supports HealthPACT through
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This brief was prepared by Jonathan Henry Jacobsen from ASERNIP-S.
2015 Summary of findings
The PleurX® Catheter system is designed to treat malignant pleural effusions (MPE) and
malignant ascites. As a new and, as yet, not fully established technology, the included
studies reported contrasting findings regarding the efficacy of the device. A health
technology assessment of limited evidence indicated that the PleurX® catheter system
resulted in higher rates of technical success and longer effusion-free periods than largevolume paracentesis. A single non-randomised comparative study reported an increase in
overall survival in patients with PleurX®, compared with those undergoing chemical
pleurodesis. However, this observation requires further research as it is unclear whether the
increase in survival is directly attributable to the PleurX® catheter or due to differences in
the baseline characteristics of the patient groups. In contrast, a meta-analysis of
randomised controlled trials (RCTs) found that talc pleurodesis was more successful at
managing the symptoms of MPE than the PleurX® catheter. However, all of the included
studies demonstrated a consistently strong safety profile, with few adverse events being
reported with the PleurX® catheter. The economic analysis performed by the UK’s National
Institute for Health and Care Excellence demonstrates a cost benefit of the PleurX® catheter
compared to inpatient large-volume paracentesis. However, this benefit is lost when the
compared to outpatient large-volume paracentesis. Two RCTs are due to be completed
within 48 months.
2015 HealthPACT Advice
HealthPACT noted that this technology is this technology is appropriate to use for malignant
pleural effusions and malignant ascites. In addition, the technology is relatively inexpensive,
convenient and safe to use and is likely to gradually diffuse into Australian clinical practice.
HealthPACT notes that no further assessment of the evidence is required at this time and
supports the introduction of this technology into the public sector.
PleurX® catheter system for malignant pleural effusions: Update July 2015
1
TECHNOLOGY BRIEF UPDATE 2015
Technology, Company and Licensing
Register ID
WP038
Technology name
PleurX® catheter system
Patient indication
Patients with recurrent, malignant pleural effusions with or
without trapped lung syndrome
Reason for assessment
In 2012, a Technology Brief was completed to investigate the use of the PleurX® tunnelled
pleural catheter system in patients with symptomatic, recurrent malignant pleural effusions
(MPE) and trapped lung syndrome. In light of the continually developing evidence on the
subject, the Brief recommended that this technology be monitored for further evidence in
48 months. In line with this recommendation, the purpose of the current Update is to
consider the evidence that has emerged since 2012, and to determine whether this new
evidence may provide additional information to inform policy decisions.
Description of the technology
The PleurX® (CareFusion Corporation, California, USA) tunnelled pleural catheter system
was developed to control symptomatic, recurrent MPE and trapped lung syndrome. The
PleurX® device and similar catheters are referred to as in-dwelling pleural catheters, and act
to facilitate the drainage and re-expansion of the lung. The catheter is positioned using
ultrasound or X-ray guidance while the patient is under conscious sedation. The procedure is
minimally invasive and may be performed in a hospital or outpatient setting using local
anaesthetic. The standard treatment for MPE is pleurodesis (removal of the pleural space)
using chemical agents such as talc poudrage. The limited peer-reviewed literature indicated
that the PleurX® catheter is relatively safe and improves symptoms for patients with MPE.
Placement of an in-dwelling pleural catheter may offer patients with poor quality of life and
limited life expectancy shorter hospital stays and fewer major complications.
PleurX® catheter system for malignant pleural effusions: Update July 2015
1
2015 Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
2015 Licensing, reimbursement and other approval
The PleurX® catheter received the CE mark and United States Food and Drug Administration
510(k)1 approval in 2012.
2015 Australian Therapeutic Goods Administration approval
Yes
ARTG number (s) 150008, 142784, 143553
No
Not applicable
2015 Diffusion of technology in Australia
Within Australia, the use of tunnelled pleural catheters for MPE is widespread. However, the
extent to which the PleurX® catheter system has diffused is unclear.
2015 International utilisation
Country
Level of Use
Trials underway or
completed
Limited use
Widely diffused
Canada

Egypt


Germany


Italy


Netherlands


Spain

UK


USA


2015 Cost infrastructure and economic consequences
CareFusion Corporation has indicated that the insertion kit (vacuum bottle and catheter)
and the 500 mL and 1000 mL drainage bottles cost $425, $56.65 and $64.38 respectively.2
Additional costs associated with the PleurX® Catheter system include the training of, and
PleurX® catheter system for malignant pleural effusions: Update July 2015
2
visits from, community nurses. CareFusion Corporation contends that the cost of the
catheter system and nurse visits are offset by the reduction in hospital visits; however, this
contention could not be confirmed.
2015 Evidence and Policy
Safety and effectiveness
One systematic review (level I interventional evidence), one health technology assessment
(HTA) (level III-2 interventional evidence) and one non-randomised comparative study (level
III-3 Interventional evidence) were included in the Technology Brief Update (Table 1). The
included studies evaluated the safety and efficacy of the PleurX® catheter system for MPE.
The comparator to the PleurX® catheter system was large-volume paracentesis in the HTA
and chemical pleurodesis in the systematic review and non-randomised comparative study.
All three studies evaluated adverse events attributable to the PleurX®.
Table 1
Characteristics of included studies
Study / Design
Inclusion criteria
Exclusion
criteria
Number of
patients or
studies/Length
of follow-up
Conflicts of interest
Systematic
review (level I)
Published RCTs
comparing
tunnelled pleural
catheters
(PleurX®) to
chemical
pleurodesis for
MPE.
Non-randomised
comparative
studies, case
series,
conference
abstracts or
letters.
Level II studies
(n=3)
There were no conflicts of
interest from either the
author or included studies.
Not reported.
Not reported.
Level III-3 study
(n=1)
Level IV studies
(n=9)
Kheir et al.
3
2015
USA
HTA (level III-2)
White &
Carolan-Rees
4
2012
Srour et al.
5
2013
The authors report no
conflict of interest.
Follow-up =
3 months – 3
years
United Kingdom
Nonrandomised
comparative
study (level III3)
Follow-up =
1 – 12 months
Biopsy proven
MPE or MPE
secondary to
malignancy.
Easter
Cooperative
Oncology Group
performance
status of 4
(completely
disabled),
previous
pleurodesis.
PleurX® (n=167)
Not reported.
Chemical
pleurodesis
(n=156)
Follow-up = 6
months
Canada
HTA, health technology assessment; MPE, malignant pleural effusion; N/A, not applicable; RCT, randomised controlled trial
Kheir et al. 20153
The systematic review evaluated all available RCTs comparing tunnelled pleural catheters
(PleurX® catheter system) with chemical pleurodesis for the management of MPE. The
PleurX® catheter system for malignant pleural effusions: Update July 2015
3
authors searched four literature databases (The Cochrane Library, EMBASE, Medline and
PubMed) for relevant studies published up to May 2014. The search terms were not
reported. Data was meta-analysed where possible.
Three RCTs involving a total of 370 patients with MPE were included in the systematic
review (Table 2). The length of follow-up ranged from 1 to 12 months. PleurX® was
compared with talc chemical pleurodesis in two studies and with doxycycline in one study.
Table 2
Included RCTs by Kheir et al. 2015
3
Study
Country
Cancer types
Patient numbers
Comparison
Follow-up
Davies et al.
6
2012
United
Kingdom
All types
No. for PleurX®=
49
No. for talc= 46
PleurX®
Talc pleurodesis
12 months
Demmy et al.
7
2012
USA
All types
No. for PleurX®=
28
No. for talc= 29
PleurX®
Talc pleurodesis
1 month
Putnam et al.
8
1999
USA
All types
No. for PleurX®=
91
No. for Dox = 28
PleurX®
Doxycycline
3 months
Effectiveness
Overall, the success rate (no significant pleural effusion identified on radiography until the
study end or death) of tunnelled pleural catheter was similar to chemical pleurodesis
(p=0.27; 3 studies). However, there was significant heterogeneity within and between the
included studies (I2 statistic=87%). A subsequent sensitivity analysis of studies that
compared tunnelled pleural catheters to talc pleurodesis, determined that tunnelled pleural
catheters were less likely to achieve success than talc pleurodesis (p<0.001).
Two RCTs reported that the PleurX® system reduced hospital stay (range 0 to 1 day)
compared with chemical pleurodesis (range 4 to 6.5 days) (p-value not reported).
Safety
No deaths were reported. There was no difference in the number of adverse events
between tunnelled pleural catheter and chemical pleurodesis (p<0.05).
White & Carolan-Rees 20124
The aim of the HTA conducted by the National Institute of Health and Care Excellence (NICE)
was to compare the safety and effectiveness of the PleurX® catheter system with largevolume paracentesis for patients with treatment-resistant, malignant ascites and to
determine whether the technology should be adopted by the National Health Service in the
United Kingdom.
Published literature, information provided by the sponsor (CareFusion Corporation) and
input from a Medical Technology Advisory Committee informed the evidence base for the
PleurX® catheter system for malignant pleural effusions: Update July 2015
4
HTA. The HTA included 10 studies submitted by the sponsor: one non-randomised
comparative study, eight case series (one of which was a conference abstract) and one case
report (Table 3). The HTA reported on six clinical outcomes: the technical success of the
catheter insertion and drainage procedure; resolution of symptoms; quality of life
outcomes; adverse events; drainage frequency; and resource consumption. These outcomes
were infrequently reported by the included studies. The most commonly reported findings
are presented below.
Table 3
Studies evaluated by White & Carolan-Rees 2012
4
Study
Level of
evidence
Patient numbers
Control therapy
Follow-up
Rosenburg et al.
9
2004
III-2 (nonrandomised
comparative
study)
N=107
Inpatient largevolume
paracentesis
41 months
Mullan et al.
10
2011a
IV (retrospective)
N=50
N/A
1,036 days
Courtney et al.
11
2008
IV (prospective)
N=34
N/A
12 weeks
Tapping et al.
12
2011
IV (retrospective)
N=28
N/A
1 year
Richard et al.
13
2001
IV (retrospective)
N=10
N/A
100 days
Saiz-Mendiguren
14
et al. 2010
IV (prospective)
N=10
N/A
124 days
Mullan et al.
15
2011b
IV (retrospective)
Subset of
patients from
Mullan et al.
2011a
N=4
N/A
NR
Iyengar et al.
16
2002
IV (retrospective)
N=3
N/A
12 weeks
Brooks et al.
17
2006
Case report
(retrospective)
N=1
N/A
18 months
IV (abstract only)
NR
N/A
NR
18
Day et al. 2011
N/A, Not applicable; NR, Not reported
Effectiveness
Five studies reported technical success. Overall, all five studies reported a high success rate
(100 per cent). Only one study reported a minor intraoperative adverse event; however,
detail regarding the event was not reported. Catheter patency at the end of the study or at
death was 67 per cent in the non-randomised comparative study and ranged between 85
and 100 per cent in the case series.
The Medical Technology Advisory Committee noted any potential improvements in quality
of life were due to the reduction in hospital visits and alleviation of symptoms due to
smaller, more frequent drainage. However, the Committee was uncertain of when the
PleurX® catheter system for malignant pleural effusions: Update July 2015
5
PleurX® catheter should be offered in the clinical pathway of a patient. It was suggested that
this be left to the discretion of the physician and patient.
Safety
A single case series study reported a mortality rate of 90 per cent at the end of the study.14
The deaths were attributable to the natural disease progression and not the PleurX®
catheter system. No other study reported the number of deaths. The non-randomised
comparative study reported complication rates of 7.5 per cent for both patients in the
PleurX® catheter system and those in the large-volume paracentesis groups. The rate of
adverse events ranged from 0 to 59 per cent in the case series studies. Loculations (pockets
of fluid) and fluid leakage were the most commonly reported adverse events.
The HTA concluded that the PleurX® catheter system was safe and effective when compared
with large-volume paracentesis.
Srour et al. 20135
The outcomes of 360 Canadian adults with MPE who were treated with either the PleurX®
catheter system (n=193) or chemical pleurodesis (n=167) between March 2003 and April
2009 were retrospectively analysed. One study author conducted all of the pleural catheter
placements either as an inpatient or outpatient procedure between May 2006 and April
2009. A community nurse visited the patient at home three times a week to drain the
catheter. The catheters were removed when the volume of pleural effusion was less than 50
mL on three consecutive visits. Chemical pleurodesis, which involved placing five grams of
talc within the pleural cavity, was performed between March 2003 and February 2006.
There were no statistically significant differences between the tunnelled pleural catheter
and the chemical pleurodesis group with respect to baseline characteristics such as age,
previous chest irradiation and side of intervention. However, there were significantly more
patients in the tunnelled pleural catheter cohort with lymphoma (p=0.005) and
mesothelioma (p=0.008). By contrast, gynaecological tumours were more common in the
chemical pleurodesis group.
Effectiveness
Throughout the analysis period, 167 of the 193 patients (87%) in the tunnelled pleural
catheter group and 156 of the 167 patients (93%) in the chemical pleurodesis groups had
died (
PleurX® catheter system for malignant pleural effusions: Update July 2015
6
Table 4).
PleurX® catheter system for malignant pleural effusions: Update July 2015
7
Table 4 Efficacy outcome reported by Srour et al. 2013
Clinical outcome
5
Tunnelled pleural
catheter
Chemical
pleurodesis
p-value
Patient death by the
end of the study (%)
167/193 (87)
156/167 (93)
NR
Median survival from
time of catheter
insertion (days)
148
133
p=0.011
Freedom from
catheter and pleural
effusion (%)
50/193 (26)
57/167 (34)
p=0.28
Effusion-free survival
(days)
101
58
p=0.021
14/193 (7.3)
26/167 (15.6)
p=0.01
2/193 (1)
1/167 (0.05)
p=1.0
Reintervention
required (%)
Thoracostomy
Video-assisted
thorascopic surgery
or pleurscopy
N/A, not applicable; NR, not reported
Pleural effusion was controlled more effectively with the tunnelled pleural catheter than
with chemical pleurodesis (p<0.005). Further, the effusion-free and overall survival time was
longer for patients with a PleurX® catheter than for those who received chemical
pleurodesis. The authors attributed the greater survival time to better effusion control
observed in the in-dwelling pleural catheter cohort. Patients who received tunnelled pleural
catheters required significantly fewer reinterventions (thoracostomy) compared with those
who received chemical pleurodesis group (p<0.01).
The PleurX® catheter was removed in 96 patients before they died. Of these, 26 patients
(27%) experienced recurrent pleural effusion.
Safety
Transient respiratory deterioration occurred less frequently in the tunnelled pleural
catheter group (0% versus 4%; p<0.004). There were no statistical differences with respect
to other adverse events such as catheter blockage, fever, fluid leak, development of
pneumothorax, pain, bleeding, catheter dislodgement or cellulitis.
2015 Economic evaluation
White & Carolan-Rees 20124
The sponsor (CareFusion Corporation) submitted a decision tree with an embedded Markov
model to determine the cost-effectiveness of the PleurX® catheter system. The model
examined patients with malignant, treatment-resistant ascites who received either the
PleurX® catheter system or large-volume paracentesis as an inpatient or outpatient
PleurX® catheter system for malignant pleural effusions: Update July 2015
8
procedure. The model duration was 26 weeks owing to the high associated mortality rate of
the condition.
The model assumptions were: no change in survival rates; a similar level of treatment
monitoring for all treatment options; the need for two nurse visits to train the patient to
self-manage drainage; an at home nurse visit (15 minutes); a drainage volume of 9.2 litres
per procedure for large-volume ascites; an average drainage volume of 3.5 litres per week
for the PleurX® catheter; and the cost of reintervention similar to a first-time catheter
insertion procedure.
The cost per patient treated with PleurX® was GBP £2,466 ($3,319), compared with GBP
£3,146 ($4,235) and GBP £1,457 ($1,961) for inpatient and outpatient paracentesis. Basecase analysis demonstrated a saving of GBP £679 ($914) per patient when the PleurX®
catheter system was used compared with inpatient large-volume paracentesis. However,
the PleurX® catheter cost an additional GBP £1,010 ($1,359) per patient, compared with
outpatient large-volume paracentesis. The cost saving for PleurX® was heavily dependent on
the reduced number of bed days, which were valued at GBP £312 ($420) per day.
An economic evaluation19 of the TIME2 trial6, a RCT comparing an in-dwelling pleural
catheter (Rocket Medical Pty) to talc pleurodesis for MPE, concluded the total mean cost for
the catheter and talc pleurodesis was USD $4,993 ($5,176) and USD $4,581 ($4,749)
respectively. The total mean difference was USD 401 ($416) (95% CI, $-1,438 to $2,344)
however, this was not statistically significant. A sensitivity analysis demonstrated a cost
saving of USD $1,719 ($1,782) per patient when an in-dwelling pleural catheter was used in
patients who survive for 14 weeks or fewer. The cost saving was lost for patients who
survive for more than 14 weeks.
2015 Ongoing research
Searches of ClinicalTrials.gov and the Australian and New Zealand Clinical Trials Register
identified one clinical trial investigating the impact of doxycycline on the PleurX® catheter
system for pleural effusion in Canada. An additional trial was found investigating a tunnelled
pleural catheter for pleural effusion in Singapore. However, the manufacturer of the
catheter was not reported (
PleurX® catheter system for malignant pleural effusions: Update July 2015
9
Table 5)
PleurX® catheter system for malignant pleural effusions: Update July 2015
10
Table 5 Registered clinical trial characteristics
Trial Identifier/
Location
Design
Number of
patients
Intervention
Outcomes
Trial status
(Estimated
completion
date)
NCT01411202
Canada
RCT
Blinded,
parallel
assignment
40
PleurX® with
injection of 500
mg doxycycline
in 50 mL of
normal saline
Primary:
Time to
pleurodesis up to
90 days
Secondary:
Rate of
pleurodesis,
number of
adverse events
and pulmonary
function at 90
days
Recruiting
December 2016
Primary:
Number of
hospital days for
all causes up to 1
year
Secondary:
Number of
hospital days
attributable to
pleural effusion,
number of
adverse events,
breathlessness
score, selfreported quality of
life score, health
costs up to 1 year
Recruiting
May 2015
PleurX® with
placebo
injection of 50
mL of normal
saline
NCT02045121
Singapore
RCT
Open label,
parallel
assignment
160
Tunnelled
pleural catheter
Talc pleurodesis
RCT, randomised controlled trial
2015 Other Issues
There are many manufacturers of tunnelled pleural catheters. The Rocket in-dwelling
Pleural Catheter (Rocket Medical plc, Tyne and Wear, United Kingdom) is also used in
Australia. The cost of the Rocket insertion kit is $250 and the 600 mL vacuum drainage
bottle is $275.
2015 Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies 3
Total number of Level I studies: 1
Total number of Level III-2 studies: 1 (HTA)
Total number of Level III-3 studies: 1
PleurX® catheter system for malignant pleural effusions: Update July 2015
11
Literature Search Date
16/02/2015
2015 References
1.
Food and Drug Administration (2012). 510(k) Summary, Food and Drug
Administration, Maryland
http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112831.pdf.
2.
Marc Russell. PleurX costing data. In: ASERNIP-s, editor.2014.
3.
Kheir, F., Shawwa, K. et al (2015). 'Tunneled Pleural Catheter for the Treatment of
Malignant Pleural Effusion: A Systematic Review and Meta-analysis'. American
Journal of Therapeutics.
4.
White, J.& Carolan-Rees, G. (2012). 'PleurX peritoneal catheter drainage system for
vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites: a NICE
Medical Technology Guidance'. Appl Health Econ Health Policy, 10 (5), 299-308.
5.
Srour, N., Amjadi, K. et al (2013). 'Management of malignant pleural effusions with
indwelling pleural catheters or talc pleurodesis'. Canadian Respiratory Journal, 20
(2), 106-10.
6.
Davies, H. E., Mishra, E. K. et al (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, 307 (22), 2383-9.
7.
Demmy, T. L., Gu, L. et al (2012). 'Optimal management of malignant pleural
effusions (results of CALGB 30102)'. J Natl Compr Canc Netw, 10 (8), 975-82.
8.
Putnam, J. B., Jr., Light, R. W. et al (1999). 'A randomized comparison of indwelling
pleural catheter and doxycycline pleurodesis in the management of malignant
pleural effusions'. Cancer, 86 (10), 1992-9.
9.
Rosenberg, S., Courtney, A. et al (2004). 'Comparison of percutaneous management
techniques for recurrent malignant ascites'. J Vasc Interv Radiol, 15 (10), 1129-31.
10.
Mullan, D., Laasch, H.-U.& Jacob, A. Tunneled intraperitoneal catheters in the
management of malignant ascites: complications and cost implications. 2012.
11.
Courtney, A., Nemcek, A. A., Jr. et al (2008). 'Prospective evaluation of the PleurX
catheter when used to treat recurrent ascites associated with malignancy'. J Vasc
Interv Radiol, 19 (12), 1723-31.
12.
Tapping, C. R., Ling, L.& Razack, A. (2012). 'PleurX drain use in the management of
malignant ascites: safety, complications, long-term patency and factors predictive of
success'. Br J Radiol, 85 (1013), 623-8.
13.
Richard, H. M., 3rd, Coldwell, D. M. et al (2001). 'Pleurx tunneled catheter in the
management of malignant ascites'. J Vasc Interv Radiol, 12 (3), 373-5.
14.
Saiz-Mendiguren, R., Gomez-Ayechu, M. et al (2010). '[Permanent tunneled drainage
for malignant ascites: initial experience with the PleurX(R) catheter]'. Radiologia, 52
(6), 541-5.
15.
Mullan, D., Laasch, H.-U.& Hussan, H. Fibrinolysis in the management of malignant
ascites and non-functioning intra-peritoneal tunnelled catheters. 2011.
PleurX® catheter system for malignant pleural effusions: Update July 2015
12
16.
Iyengar, T. D.& Herzog, T. J. (2002). 'Management of symptomatic ascites in
recurrent ovarian cancer patients using an intra-abdominal semi-permanent
catheter'. Am J Hosp Palliat Care, 19 (1), 35-8.
17.
Brooks, R. A.& Herzog, T. J. (2006). 'Long-term semi-permanent catheter use for the
palliation of malignant ascites'. Gynecol Oncol, 101 (2), 360-2.
18.
Day, R., Keen, A.& Perkins, P. (2011). What are the experiences of patients with
malignant abdominal ascites? [poster], Lisbon
19.
Penz, E. D., Mishra, E. K. et al (2014). 'Comparing cost of indwelling pleural catheter
vs talc pleurodesis for malignant pleural effusion'. Chest, 146 (4), 991-1000.
PleurX® catheter system for malignant pleural effusions: Update July 2015
13
Technology Brief 2012
Register ID
WP038
Name of technology
Pleurx® catheter system
Purpose and target group
Patients with recurrent, malignant, pleural
effusions with or without trapped lung syndrome
Stage of development in Australia

Yet to emerge

Established

Experimental

Established but changed indication
or modification of technique

Investigational

Should be taken out of use

Nearly established
Australian Therapeutic Goods Administration approval

Yes

No

Not applicable
ARTG number 142784, 143553
International utilisation
Country
Level of use
Trials underway or
completed
Limited use
Widely diffused

Australia
Egypt


Germany


Italy


Netherlands


UK

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2012 Impact summary
The Pleurx® (CareFusion Corporation, San Diego, CA, USA) tunnelled pleural catheter system
was developed to control symptomatic, recurrent malignant pleural effusions (MPE) and
trapped lung syndrome. The Pleurx® device and similar catheters are referred to as indwelling pleural catheters. The catheter is placed using ultrasound or X-ray guidance by
appropriately trained personnel under conscious sedation with local anaesthetic. The
procedure is minimally invasive and may be performed in a hospital or outpatient setting.
The traditional standard of care for MPE is pleurodesis using chemical agents such as talc
Title: Month Year
1
poudrage or slurry. The limited peer-reviewed literature indicated that the Pleurx® catheter
is relatively safe and improves symptoms for patients with MPE. Placement of an in-dwelling
pleural catheter may offer patients with limited quality of life and duration of survival
shorter hospital stays and fewer major complications. In-dwelling pleural catheters are a
well-established technology; however, their role in the broader context of a multidisciplinary team dedicated to pleural services is an area undergoing development.
Background
Pleural effusion refers to the build-up of abnormal amounts of fluid in the pleural space due
to excess production or decreased absorption of fluid. Effusions result in a flattening of the
diaphragm, dissociation of the pleura, and reduced ventilation. Malignant cells in the pleural
fluid and/or parietal pleura indicate the presence of MPE and advanced disease. MPE is
most commonly symptomatic and patients experience dyspnoea (shortness of breath),
coughing, and pain on breathing. An MPE is considered recurrent when a patient who has
undergone a pleural drainage procedure presents with another pleural effusion on the same
side.1
Median patient survival following diagnosis of MPE ranges from three to 12 months. Life
expectancy depends on the stage and type of the underlying malignancy. Primary tumours
of the lung and breast account for a 50-65 per cent of all MPE diagnoses and the rest are
associated with lymphomas or tumours of the genitourinary or gastrointestinal tracts, or
other locations.2 Discovery of an MPE indicates disseminated and/or advanced disease and
MPE management options are focused on drainage of fluid and relief of symptoms.
Patients presenting with MPE are a heterogeneous patient population with variable life
expectancy and quality of life; the management of MPE must therefore be highly
individualised. The complex nature of managing MPE precludes the adoption of a single
treatment pathway for the condition.3 Factors which may influence treatment strategy for
MPE include the severity of symptoms and life expectancy of the patient, histology of the
primary tumour, and the tumour’s response to therapy. The degree of lung re-expansion
following fluid removal is also a determinant of therapeutic strategy.
The provision of pleural services requires a multi-disciplinary team approach to the
management of MPE. This includes the need for a team of staff trained in both the diagnosis
and management of pleural disease, access to clinic facilities with dedicated areas for
pleural procedures, and appropriate resources and technology to offer a range of timely
interventions.4 For the treatment of MPE the aim of pleural services is to provide rapid
symptomatic relief with a minimal number of invasive procedures, a focus on ambulatory
care, and limited hospital stays. Pleural services also facilitate ongoing access to care in the
community setting and appropriate patient follow-up. In the absence of appropriate followup, patients may present to emergency departments with complications or recurrence of
PleurX® catheter system for malignant pleural effusions: Update July 2015
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symptoms and subsequently undergo invasive or unnecessary procedures.4 The role of
pleural services in the management of patients with pleural disease and MPE in the
Australian context is an area currently undergoing development.
Treatment options for MPE include:
observation (if the patient is asymptomatic);
therapeutic pleural aspiration (in patients with life expectancy shorter than one
month);
thoracoscopy with intercostal tube drainage and instillation of a sclerosant
(pleurodesis)- provided the underlying lung expands fully. This is performed by a
specialised proceduralist in a theatre setting;
Tube thoracostomy with pleurodesis using talc slurry. This procedure may be
performed as a bedside procedure in an inpatient setting; and
placement of an in-dwelling pleural catheter under ultrasound or X-ray guidance.
For recurrent MPE, the treatment standard is pleurodesis using chemical agents provided
the underlying lung expands fully.5
Thoracoscopy is a percutaneous procedure in which an endoscopic instrument is placed
within the pleural space to visualise and sample the pleura. The procedure can be used as a
diagnostic tool or for therapeutic drainage or pleurodesis. Thoracoscopy alone can facilitate
lung re-expansion and positioning of the pleura for pleurodesis. The procedure has a low
peri-operative mortality rate. Major complications (uncommon) include empyema and
acute respiratory failure secondary to infection or re-expansion pulmonary oedema.2
Therapeutic thoracoscopy involves installation of a drainage tube to relieve the effusion,
known as thoracostomy. Pleurodesis may be performed in conjunction with therapeutic
thorascopy in a theatre setting using talc poudrage/insufflation; or, at bedside using talc
slurry via tube thoracostomy. Instillation of the sclerosant causes irritation of the pleura and
subsequent closure of the pleural space. This prevents the build-up of fluid and is
considered the definitive treatment for MPE.
A survey of 859 pulmonologists in the United States, United Kingdom, Canada, Australia,
and New Zealand found significant variation in how pleurodesis is performed. The study also
determined that pleurodesis agents currently available are perceived as suboptimal with
talc poudrage or insufflation and talc slurry perceived to be the most effective. 6
In-dwelling pleural catheters (IPCs) are soft, flexible catheters placed in the pleural space
and tunnelled through the subcutaneous tissue. IPCs are inserted under local anaesthetic
and light sedation, most often in the outpatient setting. Attachment of a vacuum drainage
bottle facilitates drainage and re-expansion of the lung and the catheter may remain in situ
PleurX® catheter system for malignant pleural effusions: Update July 2015
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until death. Fluid may be drained as required, by patients, and in the home setting. The
catheter may be removed if the patient experiences spontaneous pleurodesis.7 A
disadvantage associated with the device is the duration of treatment; the catheter may
remain in the patient’s body for extended periods of time, causing unease or exposing the
patient to the risk of infection. For patients receiving an IPC, accessibility to appropriately
trained staff from a number of specialties for follow-up and removal of the catheter (if
necessary) should form a part of their management strategy.4, 8
For patients presenting with trapped lung syndrome (where the lung cannot achieve full
expansion) associated with MPE, tube thoracostomy and pleurodesis are not indicated and
more invasive therapies are problematic as they require long recovery periods. As a result,
the Pleurx® catheter may be an attractive therapeutic approach for these patients.2, 9
2012 Clinical need and burden of disease
MPE is common, affecting 660 patients per million each year.10 In Australia and New
Zealand this equates to over 13,000 patients per annum.10 The incidence of MPE can be
expected to rise with increased population and life expectancy and the increase in
mesothelioma cases over the coming decades.
Australia has a high incidence of mesothelioma, a cancer associated with exposure to
asbestos. The age standardised incidence of mesothelioma was 2.8 per 100,000 people in
2005 and as many as 700 cases are diagnosed each year.11
In 2010-2011, Medicare processed 1,162 claims for Medicare Benefits Schedule item
number 38436 for thoracoscopy, with or without division of pleural adhesions, including
insertion of intercostal catheter where necessary, with or without biopsy.12, 13 It should be
noted that this item number is not exclusive to the treatment of MPE.
2012 Diffusion of technology in Australia
There are several pleural drainage systems available including the Pleurx® catheter15 which
was approved in 2007 and is marketed within Australia.
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Table 6 gives the ARTG approval numbers and approved indication for the Pleurx® catheter.
PleurX® catheter system for malignant pleural effusions: Update July 2015
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Table 6
Australian Register of Therapeutic Goods (ARTG) approval number and indication
for the Pleurx® catheter
ARTG approved catheter and
manufacturer, ARTG number
Approval
date
Approved indication
CareFusion Australia 316 Pty Ltd
- Drainage system - Bottle kits Drainage system, pleural
2/08/2007
Plastic bottles, suction line tubing, valve caps that will be
connected to a pleural drain and used to eliminate blood,
air or purulent secretions from the pleural cavity
21/08/2007
Pleural drainage kits/packs used to eliminate blood, air or
purulent secretions from the pleural cavity. Contains
vacuum bottles, lines and valve caps that may be
connected together, along with consumables.
142784
CareFusion Australia 316 Pty Ltd
- Drainage system, pleural
143553
2012 Comparators
Existing comparators to the Pleurx® catheter which have TGA approval are summarised in
Table 7 below.
Pleurodesis is the conventional management strategy for MPE. Common sclerosants used
for pleurodesis include talc poudrage or slurry, and bleomycin. Sclerosants are introduced
via an intercostal tube and may require significant surgical resources and lengthy hospital
stays. Pleurodesis is not suitable for patients with trapped lung syndrome. 2, 14
Table 7
Additional approved pleural drainage systems
Manufacturer
Name of device
ARTG number
Admac industries Pty Ltd
Drainage system, pleural
135724
Atrium Australia – Pacific Rim Pty Limited
Drainage system, pleural
119726
®
B Braun Australia
Celsite Access Ports
137318
Baldwin Medical & Veterinary Devices
(Australia) Pty Ltd
Drainage system fluid collector,
pleural
162220
Control Medics Pty Ltd
Pleura-safe
162038, 157981, 120316
Coviden Pty Ltd
Drainage system, pleural
187240, 187241, 144075,
145734
Rocket Medical Pty Ltd
Pleural & Peritoneal Catheter
System
145658, 14379, 166369
William A Cook Australia Pty Ltd
Drainage system, pleural
142280
ARTG: the Australian Register of Therapeutic Goods
2012 Safety and effectiveness
One systematic review and one randomised controlled trial (RCT) were selected for inclusion
in this technical brief. The recent systematic review (2010) assessed the safety and efficacy
of tunnelled pleural catheters, including the Pleurx® in 1,361 patients, and, the Tenkhoff
catheter in nine. No recent, high-level evidence was identified subsequent to the publication
of this systematic review. The systematic review also reported on an RCT comparing Pleurx®
PleurX® catheter system for malignant pleural effusions: Update July 2015
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to pleurodesis (Putnam et al 1999) with only the patients receiving the Pleurx® catheter
(n=91) included in the systematic review. Table 8 summarises the evidence included in this
technical brief.
Table 8
Included evidence and patient overlap
Study
Patients
Efficacy and safety of tunnelled pleural
catheters in adults with malignant pleural
effusions: a systematic review
Total number of included
studies: 19
Van Meter et al 2010
94 patients from Putnam et
al (1999) were included in
the systematic review
Treated with other catheter: 9
Randomized Comparison of Indwelling
Pleural Catheter and Doxycycline
Pleurodesis in the Management of
Malignant Pleural Effusions
Level II evidence
1,370 patients
Treated with Pleurx®: 1,369
Level I evidence
Putnam et al 1999
Patient overlap
Total number of included
patients: 144
Treated with Pleurx®: 99
(evaluated 94)
Treated with pleurodesis: 45
(evaluated 43)
Table 9 summarises RCTs implanting the Pleurx® catheter that are currently recruiting.
Table 9
Pleurx® catheter RCTs that are currently recruiting
Study
Study population, methods, study
purpose
Status and primary
endpoint
Impact of Aggressive
Versus Standard
Drainage Regimen
Using a Long Term
Indwelling Pleural
Catheter (ASAP)
Estimated enrolment: 131 (USA)
Currently recruiting –
estimated study
completion November
2012
NCT00978939
A Prospective,
Randomized
Controlled Trial for a
Rapid Pleurodesis
Protocol for the
Management of Pleural
Effusions
NCT00758316
Patients will be randomised to the
aggressive drainage arm or the
standard drainage arm.
Study purpose is to determine if the
rate of spontaneous pleurodesis can
be increased by increasing the
frequency of pleural drainage to
spare patients the need for long term
management of the Pleurx® catheter.
Estimated enrolment: 240
(Singapore)
Patients will be randomised to
thoracoscopy with pleurodesis or
combined thoracoscopy with
pleurodesis and Pleurx® catheter.
Incidence of successful
pleurodesis utilising an
aggressive drainage
protocol (daily drainage)
versus that of a standard
drainage protocol
(drainage every other
day).
Currently recruiting –
estimated study
completion June 2013
Pleurodesis/pleural
catheter success
Study purpose is to compare
thoracoscopic poudrage alone
(standard care) versus combined
thoracoscopic poudrage and Pleurx®
catheters.
Source: Clinical Trials Database (US) accessed May 2012.
16, 17
PleurX® catheter system for malignant pleural effusions: Update July 2015
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Van Meter et al (2010)5
This systematic review included one RCT (level II evidence) and 18 case series (level IV)
assessing the safety and effectiveness of the Pleurx® catheter in 1,370 patients. The RCT
compared placement of the Pleurx® catheter to pleurodesis.17 The methods, including
search strategy (to October 2009), databases searched, study selection criteria and data
analysis, were clearly detailed. Of the 1,370 included patients, nine were treated with a
Tenckhoff catheter (a small-bore flexible tube tunnelled into the pleural space). All other
patients were treated with the Pleurx® catheter. Per protocol analysis was conducted where
studies did not report outcomes the patients were removed from both the numerator and
denominator.
All included studies aside from the single RCT were uncontrolled, retrospective, case series
with variable reporting of key outcomes. When reported, outcomes were generally not
graded for severity. The patients treated with IPCs in the included literature were adult
patients with an effusion in the setting of malignancy. This limits the transferability of
findings to more defined patient populations and introduces several confounding factors
such as the size of effusion, patient comorbidities and patient life expectancy.
Effectiveness
Mean time to pleurodesis was 52 days (reported by 12 studies). Catheter removal was
attributed to spontaneous pleurodesis in 381 of 808 patients (47%). Amongst the 12 studies
reporting spontaneous pleurodesis, the incidence ranged from 12 per cent to 76 per cent
and symptomatic improvement from 86 per cent to 100 per cent. Symptomatic
improvement was variably defined across the included studies and consisted of the
following descriptive terms: “symptomatic improvement”; “relief of dyspnoea”;
“improvement in respiratory performance status”; “increased exercise tolerance”;
“improvement of pain”; and, “catheter was useful”. One study rated improvement of
dyspnoea using a three-point scale. Table 10 summarises the effectiveness outcomes
presented in the systematic review.
Table 10
Effectiveness outcomes
Outcome
Number of
studies
n/N
Per
cent
Symptomatic improvement
12
628/657
95.6
Spontaneous pleurodesis
12
430/943
45.6
Recurrence of MPE
NR
50/651
7.7
Repeat placement of a
catheter
NR
33/652
5.1
Catheter removed due to
complication
8
54/633
1.6
NR: not reported
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Safety
One procedure-related death due to respiratory arrest following intravenous sedation was
reported (the patient had previously requested no resuscitation). Ten of the 19 included
studies reported that the catheter was used without any complications in 517 of 591
patients (87.5%). Table 11 summarises the reported complications.
Table 11
Complications of catheter placement
Outcome
Number of studies
reporting outcome
n/N
Per cent
Malfunction of the catheter
2
11/121
9.1
Catheter clogging
10
33/895
3.7
Dislocation of catheter
7
14/648
2.2
Unspecified pain
2
8/142
5.6
Pain, beyond immediate
post-procedure
5
18/558
3.2
Requiring chest tube
1
3/51
5.9
Asymptomatic
3
9/168
5.4
Unspecified
5
17/439
3.9
Empyema
13
33/1168
2.8
Cellulitis
10
32/935
3.4
Unspecified
3
7/346
2.0
Tumour metastases
10
9/1093
0.8
Bleeding
6
4/903
0.4
Pneumothorax
Infectious complications
Putnam et al (1999)18
The RCT (level II) which was included in the systematic review by Van Meter et al 2010, was
a multi-institutional study from 1994 to 1997 in which 144 patients received either a Pleurx®
catheter or pleurodesis with doxycycline. Inclusion criteria were malignancy with at least a
moderate sized pleural effusion and dyspnoea relieved after therapeutic thoracentesis. As
the comparison between the Pleurx® catheter and pleurodesis was not included in the
systematic review, the results of this trial are included here. Forty five patients were
randomised to treatment with pleurodesis and 99 to Pleurx®. Four patients from the
pleurodesis group and two patients from the Pleurx® group did not receive the intended
treatment, or were withdrawn from the study due to protocol violations (incorrect
sclerosant or incorrect treatment timing). Patient disability was assessed using the validated
PleurX® catheter system for malignant pleural effusions: Update July 2015
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assessment tools, the scale for dyspnoea (Borg score) and a quality of life questionnaire
(Guyatt CRQ).
Safety
Early in-hospital morbidity (e.g., fever, pneumothorax) occurred in six of 43 (14%) patients
treated by pleurodesis and 10 of 94 (11%) patients treated by Pleurx®. One patient in the
Pleurx® group experienced hypercapnic respiratory failure secondary to over-sedation and
no procedure-related deaths occurred. The degree of pain experienced by patients in the
two groups was similar and there was no significant difference between groups in the
amount of analgesic received. Table 12 summarises the safety outcomes, including the fact
that patients in the Pleurx® group experienced more late complications.
Table 12
Early and late morbidity
Pleurx® (n=94)
Pleurodesis (n=43)
Early morbidity (in hospital)
Fever
3
Fever
2
Pneumothorax
3
Severe pain
2
Misplacement of the catheter
2
Hydropneumothorax
1
Re-expansion pulmonary oedema
1
Chest tube
replacement
1
Late morbidity (in the 90-day follow-up period)
Local cellulitis around the catheter tract
6
Pleural infection
1
Catheter obstruction
2
Pain during fluid drainage
7
Tumour seeding of catheter tract
3
Pain at chest tube
site
1
Effectiveness
Effectiveness outcomes are summarised in Table 13. The median hospitalisation time (the
time from randomisation to discharge), for patients in the Pleurx® arm was significantly
shorter than for patients in the pleurodesis arm (1 day versus 6.5 days; p<0.0001).
Treatment failure was defined as recurrence of effusion after initial control and occurred in
12 patients (13%) in the Pleurx® group and six (21%) in the pleurodesis group (p values not
reported). All six patients in the pleurodesis group experienced failure within 30 days. In the
Pleurx® group, recurrence was due to loculations in seven patients (58.3%). In two patients,
recurrence occurred after initial spontaneous pleurodesis and in a further two, after
catheter occlusion. Replacement of the catheter after occlusion resulted in spontaneous
pleurodesis in one patient. One patient did not have a determined cause of recurrence.
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Table 13
Effectiveness outcomes
Effectiveness outcome
Pleurx®,
N=91
Pleurodesis,
N=43
Hospitalisation days (median)
1.0
6.5*
Fluid drained in the first 24 hours
(mL)
1905 ± 916
1500 ± 916
Recurrence of effusion post
discharge, n (%)
12 (13)
6 (21)
Spontaneous pleurodesis, n (%)
42 (46%)
NA
Median time to pleurodesis
(range)
29 days (8223)
NA
*p<0.0001 compared with the Pleurx® group; NA: not applicable
Improvements in the quality of life measures were similar between both groups at 30, 60
and 90 days post treatment (Table 14). Both groups experienced improvements in quality of
life measures.
Table 14
Quality of life outcomes
Follow-up time
point
Borg score at rest
Pleurx®
Pleurodesis
Borg score exercise
Pleurx®
Pleurodesis
Guyatt CRQ
Pleurx®
14.5 ± 4.8
(96)
Pleurodesis
Initial
2.4 ±1.7
(99)
2.5 ± 2.0
(44)
4.9 ± 1.9
(99)
4.9 ± 2.1
(45)
Change after
treatment
1.1 ± 1.9
(93)
1.1 ± 1.8
(30)
2.5 ± 2.0
(90)
2.5 ± 1.7
(28)
Change at 30 days
0.9 ± 1.8
(62)
0.5 ± 2.1
(28)
2.2 ± 2.4
(60)*
1.0 ± 2.4
(26)
5.2 ± 7.5
(59)
5.5 ± 8.7 (27)
Change at 60 days
1.3 ± 1.2
(49)
1.3 ± 1.4
(20)
2.3 ± 2.5
(46)
1.6 ± 2.3
(20)
6.5 ± 8.5
(44)
7.8 ± 7.1 (20)
Change at 90 days
0.4 ± 2.1
(35)
0.4 ± 1.9
(21)
2.2 ± 2.3
(34)
1.3 ± 2.3
(20)
7.2 ± 7.1
(33)
6.3 ± 8.2 (21)
-
15.8 ± 5.7
(44)
-
All numbers are the mean ± standard deviation of differences from initial values; *p=0.050; (n) indicates the number of patients
evaluated at the specified time point; Borg score: modified scale score for dysponea at rest and after walking 100 feet; Guyatt
CRQ: the dysponea component of the Guyatt Chronic Respiratory Questionnaire.
2012 Cost impact
Information from the manufacturer indicates the following pricing in United States (US)
dollars for variations on the Pleurx® catheter system:7
Pleurx® patient starter kit, 1000 mL or 500 mL $265
Pleurx® pleural catheter kit $550
PleurX® catheter system for malignant pleural effusions: Update July 2015
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The Pleurx® catheter kit contains all of the components necessary for the preparation,
placement, closing, drainage, and dressing of the site. The patient starter kit contains four
drainage bottles and maintenance materials.
Two studies incorporating cost data specific to Pleurx® were identified in the literature. A
retrospective review identified 100 patients treated with Pleurx® and compared those
patients to 68 treated with pleurodesis.19 As a component of the analysis, hospital charges
for each patient were obtained from the time of admission to seven days post-procedure
and treatment strategies were compared. The analysis determined that outpatient
treatment with Pleurx® was less costly than inpatient treatment with Pleurx®. The study also
indicated that outpatient Pleurx® treatment was associated with significantly lower mean
hospital charges as compared to inpatient pleurodesis. Table 15 below summarises the
results.
Table 15
Costs associated with treatments for MPE
Mean hospital charges
(US dollars)
Pleurx® inpatient,
N=40
Pleurx®
outpatient, N=60
Pleurodesis,
N=68
11,188 ± 7,964
3,391 ± 1,753
7,830 ± 4,497*
Data is reported as a mean and standard deviation. p<0.001 as compared to inpatient Pleurx®. MPE: malignant pleural
effusions
A second study using Medicare data from the US assessed the incremental cost
effectiveness of treating MPE with talc pleurodesis versus placement of the Pleurx® catheter
(outpatient procedure).20 The study did not explicitly discriminate between bedside
pleurodesis and thoracoscopic pleurodesis. The study determined that treatment with the
catheter was marginally more costly and less effective than treatment with talc. Cost data
were estimated using Medicare Diagnosis-Related Group (DRG) reimbursement data from
2008 and integrated into a base-case scenario. The analysis was conducted from the
perspective of an insurer and considered only direct health care costs to patients and direct
insurance-covered costs. The time horizon for the model was six months and effectiveness
was evaluated using the outcome of “effusion resolved” with patients assumed to be alive
after six months. The base-case estimate of probability of success (resolved effusion) was
0.80 with talc pleurodesis and 0.45 for catheter placement.
The study found that treatment with talc was slightly less costly than placement of the
Pleurx® device (talc, US$8,170.80; Pleurx®, US$9,011.60) although Pleurx® became more
cost effective when life expectancy was six weeks or less. Table 16 summarises the cost
estimates for procedure-related admissions and equipment presented in the study.
Table 16
Costs associated with talc pleurodesis and Pleurx® device placement
Item
Cost in US dollars (2008 )
Admission for talc
5,279
PleurX® catheter system for malignant pleural effusions: Update July 2015
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Admission for infection
7,877
Visit with physician
100
Placement of Pleurx®
1,956
Case of Pleurx® supplies (10 boxes)
750
The differences in reported costs between the two studies may be attributable to the type
of analysis performed. One study considered mean hospital charges from a third party
insurer’s perspective with efficacy considered independently. The other modelled the
incremental cost effectiveness of the treatments relative to each other using decision
analysis.
An important cost consideration for the placement of an in-dwelling pleural catheter is
whether a patient has ongoing access to trained staff in a day procedure setting. Insufficient
follow-up may result in patients presenting to emergency departments and undergoing
further interventions for complications or recurrence of symptoms, thereby increasing the
costs associated with catheter placement.8 Appropriate clinical end-points for a cost analysis
of the technology may include: the rate of spontaneous pleurodesis; rate of re-intervention;
duration of hospital stay; and the rate of adverse events. However, an analysis of these endpoints will also be affected by the confounding factors of patient co-morbidity, underlying
malignancy and life-expectancy. Areas of future research include the costs associated with
the provision of pleural services, in which, IPCs are considered as part of a patient’s
individual management plan.
Ethical, cultural or religious considerations
No ethical, cultural or religious considerations were identified.
2012 Other issues
There is limited comparative data in trials using the Pleurx® device; and, where available,
the comparator pleurodesis arm involves an out-dated form of pleurodesis (doxycycline).
There are two recently published studies which use another in-dwelling pleural catheter
(Rocket Medical, Washington, US) in a comparison with pleurodesis.14, 22
A trial conducted in Western Australia compared treatment with an in-dwelling pleural
catheter (IPC; Rocket Medical, Washington, UK) to pleurodesis in a prospective, multicentre
study; in which, treatment strategy was based on patient choice. The investigators
concluded that patients treated with the catheter required significantly fewer days in
hospital compared to those who received pleurodesis. The study reported fewer additional
pleural procedures amongst patients treated with an IPC and noted that safety profiles and
symptom control were comparable. 14
PleurX® catheter system for malignant pleural effusions: Update July 2015
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A randomised controlled trial in the UK (conducted in 7 centres) compared treatment with
an IPC (Rocket Medical, Washington, UK) to pleurodesis by chest tube insertion and talc
slurry. The investigators found no statistically significant difference between IPCs and
pleurodesis at relieving patient-reported dyspnoea. The length of initial hospitalisation was
significantly shorter in the IPC group as compared to the pleurodesis group (p<0.001);
however, differences in the quality of life scores as measured by the QLQ-30 were not
statistically significant.22
A Hospital in Perth has recently opened a clinic staffed by pleural specialists dedicated to
diagnosis, treatment and management of patients with pleural disease. The clinic may offer
patients faster access to services when symptoms reoccur as well as facilitate the follow-up
and home care of individuals with MPE.8
Whilst IPCs may offer the benefit of shorter hospital stays, in some patients this benefit may
not be realised, as due to underlying conditions or co-morbidities patients may have to
remain in hospital. As a result, the benefits of IPCs should be assessed in the context of the
overall management of the patient by a multidisciplinary team or order to provide the best
care possible.
One study has been completed investigating the use of the Pleurx® catheter in patients with
pleural effusions who have a primary diagnosis of advanced congestive heart failure (CHF).23
2012 Summary of findings
The peer-reviewed literature indicates that the Pleurx® catheter is relatively safe, improves
symptoms for patients with MPE and may be associated with shorter hospital stays as
compared to pleurodesis. When offered by a coordinated multi-disciplinary team dedicated
to pleural services, in conjunction with appropriate follow-up and after care, in-dwelling
pleural catheters may be integral to treatments strategies aiming to provide sustained
symptomatic relief, with a focus on ambulatory care and minimal hospital stays. However
there may be some situations in which shorter hospital stay may not be realised due to
other underlying conditions or co-morbidities, and so the choice to use IPCs should be
assessed in this context.
2012 HealthPACT assessment:
Based on one RCT and a systematic review consisting of poor quality level IV evidence it is
recommended that the Pleurx® catheter be monitored for 48 months. However, recently
published evidence is available for the comparable Rocket Medical™ IPC, including the data
from the trial in Western Australia, which may warrant further investigation.
PleurX® catheter system for malignant pleural effusions: Update July 2015
14
2012 Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the following link on the HealthPACT web site.
Total number of studies
Total number of Level II studies
Total number of Level IV studies
2
1
1
2012 References
1. Rubins, J., (2011). Pleural Effusion [Internet]. Medscape. Available from:
http://emedicine.medscape.com/article/299959-overview [Accessed 16 May 2012].
2. Roberts, M. E., Neville E., Berrisford, R.G., et al (2010). ‘Management of a malignant
pleural effusion: British Thoracic Society pleural disease guideline 2010’,Thorax, 65,
ii32-ii40.
3. Maskell, N. A., (2012). ‘Treatment options for malignant pleural effusions: patient
preference does matter’. JAMA, 307 (22), 2432-2433.
4. Hooper, C. E., Lee, G., Maskell, N. A., (2010). ‘Setting up a specialist pleural disease
service’, Respirology, 15(7), 1028-1036.
5. Van Meter, M. E. M., McKee, K. Y., Kohlwes, J., (2010). ‘Efficacy and safety of
tunnelled pleural catheters in adults with malignant pleural effusions: A systematic
review’, J Gen Intern Med, 26 (1), 70-76.
6. Lee, G. Y. C, Baumann, M. H., Maskell, N. A., Grant, W., et al (2003). ‘Pleurodesis
practice for malignant pleural effusions in five English speaking countries: survey of
pulmonologists’, Chest, 124, 2229–2238.
7. CareFusion (2012). PleurX® catheter system [Internet]. CareFusion. Available
from:http://www.carefusion.com/pdf/Interventional_Specialties/PleurX%20_Brochu
re.pdf [Accessed 21 May 2012].
8. Madden, C., (2012). “One-stop shop” for pleural disease an Australasian first
[Internet]. The Australian Asbestos Network. Available from:
http://www.australianasbestosnetwork.org.au/Project+News/936.aspx [Accessed 15
August 2012].
9. Grannis, F. W., Lai, L., Kim, J. Y., (2011). ‘Fluid Complications’, In: Chapter 41, Cancer
Management: A Multidisciplinary Approach, Medical, Surgical and Radiation
Oncology [Internet]. Available from:http://www.cancernetwork.com/cancermanagement/fluid-complications/article/10165/1802878 [Accessed 16 May 2012]
PleurX® catheter system for malignant pleural effusions: Update July 2015
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10. Lee, G. Y. C., & Light, R. W., (2004). ‘Management of malignant pleural effusions’,
Respirology, 9, 148-156.
11. The Mesothelioma Center, (2012). Mesothelioma incidence and trends in Australia
[Internet]. The Mesothelioma Center. Available from:
http://www.asbestos.com/mesothelioma/australia/ [Accessed 22 May 2012]
12. The Department of Health and Ageing (2012). MBS online [Internet]. The
Department of Health and Aging. Available from: http://www.mbsonline.gov.au/
[Accessed 16 May 2012].
13. Medicare Australia (2012). Statistics-Item reports [Internet]. Medicare Australia.
Available from: https://www.medicareaustralia.gov.au/statistics/mbs_item .shtml
[Accessed 16 May 2012].
14. Fysh, E. T. H, Waterer, G. W., Kendall, P., Bremner, P., et al (2012). ‘Indwelling pleural
catheters Reduce Inpatient Days over Pleurodesis for Malignant Pleural Effusion’.
Chest, 142(2), 394-400.
15. Australian Register of Therapeutic Goods (ARTG, 2012). Australian Register of
Therapeutic Goods [Internet]. The Department of Health and Ageing. Available from:
https://www.ebs.tga.gov.au/ [Accessed 2 May 2012].
16. ClinicalTrials.gov (2012). Impact of Aggressive Versus Standard Drainage Regimen
Using a Long Term Indwelling Pleural Catheter (ASAP) -Identifier NCT00978939
[Internet]. Available from: http://clinicaltrials.gov/ct2/
show/NCT00978939?term=00978939&rank=1[Accessed 22 May 2012].
17. ClinicalTrials.gov (2012). A Prospective, Randomized Controlled Trial for a Rapid
Pleurodesis Protocol for the Management of Pleural Effusions; Identifier
NCT00758316 [Internet]. Available from: http://clinicaltrials.gov/ct2/show/
NCT00758316?term=00758316&rank=1 [Accessed 22 May 2012].
18. Putnam, J. B., Light, R. W., Rodriguez, M. R., Ponn, R., Olak, J., et al (1999). ‘A
randomized comparison of indwelling pleural catheter and doxycycline pleurodesis
in the management of malignant pleural effusions’, Cancer, 86, 1992-1999.
19. Putnam, J. B., Walsh, G. L., Swisher, S.G., et al (2000). ‘Outpatient management of
malignant pleural effusion by a chronic indwelling pleural catheter’, Ann Thorac Surg,
69, 369-375.
20. Olden, A. M., Holloway, R., (2010). ‘Treatment of malignant pleural effusion: Pleurx®
catheter or talc pleurodesis?’, J Palliat Med, 13(1), 59-65.
21. Dresler, C. M., Olak, J., Herndon, J. E., Richards, W. G., et al (2005). ‘Phase III
intergroup study of talc poudrage versus talc slurry sclerosis for malignant pleural
effusion’, Chest, 127 (3), 909-915.
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22. Davies, H. E., Mishra, E. K., Kahan, B. C., et al (2012). ‘Effect of an indwelling pleural
catheter vs chest tube and pleurodesis for relieving dyspnea in patients with
malignant pleural effusion: the TIME2 randomized controlled trial’, JAMA, 307 (22),
2383-2389.
23. Herlihy, J. P., Loyalka, P., Gnananandh, J., Gregoric, I. D., et al (2009). ‘PleurX
catheter for the management of refractory pleural effusions in congestive heart
failure’, Texas Heart Inst J, 36(1), 38-43.
Search criteria to be used (MeSH Terms)
Pleural Effusion, Malignant; pleural effusion; malignant; neoplasms; catheters, Indwelling.
PleurX® catheter system for malignant pleural effusions: Update July 2015
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Appendix A
Expert clinical opinion
Clinical review was sought from two expert clinicians in the field, namely, a cardiac surgeon
and a respiratory physician. Firstly, the clinicians highlighted that the Pleurx® catheter is
indicated for patients presenting with MPE with or without trapped lung syndrome.
However, patients who subsequently develop trapped lung syndrome requiring reintervention are not indicated for receiving the Pleurx® catheter.
Secondly, it should be noted that insertion of an IPC such as the Pleurx® catheter should be
done under ultrasound or X-ray guidance, in order to prevent complications associated with
the incorrect insertion of the catheter. Situations can occur in which interventional
radiologists and other qualified clinicians insert the Pleurx® catheter according to the
product information leaflet, which specifies that the catheter should be inserted fully before
the sheath is introduced. However, should a clinician fully insert the catheter ‘blindly’
without using ultrasound or X-ray guidance (according to the product information leaflet)
inadvertent penetration of the heart and chest wall can occur resulting in significant
complications and the need for corrective intervention by a cardiac surgeon.
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