Malignant pleural effusions: treatment with tunneled long-term drainage catheters Jeffrey S. Pollak, MD

Malignant pleural effusions: treatment with tunneled
long-term drainage catheters
Jeffrey S. Pollak, MD
Malignant pleural effusion is a significant cause of morbidity
and a poor prognostic indicator. Traditional treatments have
variable success and significant drawbacks, including a length
of stay in the hospital. Alternatively, a tunneled pleural catheter
permits long-term drainage as an outpatient, cost-effectively
controlling the effusion and related symptoms in over 80 to
90% of patients. Other advantages are the ability to treat
trapped lungs and large locules. Spontaneous pleurodesis
may occur in over 40% of patients, and the catheter can be
used to administer sclerosant or antineoplastic agents.
Complications tend to be minor and easily managed. A
tunneled pleural catheter should be considered for all patients
with MPE having a reasonable expectancy of being an
outpatient. Curr Opin Pulm Med 2002, 8:302–307 © 2002 Lippincott
Williams & Wilkins, Inc.
Section of Vascular and Interventional Radiology, Department of Radiology, Yale
University School of Medicine, New Haven, Connecticut, USA.
Correspondence to Jeffrey S. Pollak, MD, Section of Vascular and Interventional
Radiology, Department of Radiology, Yale University School of Medicine, P.O. Box
208042, New Haven, CT 06520-8042, USA; e-mail: [email protected]
Current Opinion in Pulmonary Medicine 2002, 8:302–307
Abbreviations
MPE
malignant pleural effusion
ISSN 1070–5287 © 2002 Lippincott Williams & Wilkins, Inc.
Malignant pleural effusion (MPE) is a common clinical
problem, with an estimated annual incidence in the
United States of over 150,000 [1]. Almost half of patients
with disseminated cancer will develop this problem
sometime during their course [2,3]. The etiology is lung
or breast cancer in over 50%, lymphoma, ovarian cancer,
or gastrointestinal cancer in 25%, and mesothelioma or
cancers with no identifiable primary accounting for most
of the rest.
Thoracic symptoms are present in three-quarters of patients with MPE, with dyspnea on exertion being most
common, followed by cough and chest discomfort [1,2,4].
The 30-day mortality is 29 to 50% and the median survival is 3 to 12 months, with lymphoma and breast cancer
patients tending toward the longer survival times [2,3].
Given these considerations, the management of MPE is
generally palliative, with the goals of prompt relief of
symptoms, minimal discomfort, minimal disruption of
the patient’s everyday life, and cost-effectiveness. Minimizing time in the hospital is often an important factor in
achieving these goals. Unfortunately, current regimens
for managing MPE have variable success, can be uncomfortable, and may result in a relatively significant number
of the patient’s remaining days being spent in the
hospital.
Treatment options for malignant
pleural effusion
Systemic therapy may be effective in controlling effusions in some patients with lymphoma, small-cell lung
cancer, and germ-cell tumors, but locally directed
therapy is usually needed in the symptomatic patient.
The simplest option of thoracentesis is a valuable diagnostic maneuver, both in determining the etiology and
assessing symptomatic improvement. Unfortunately,
fluid will reaccumulate in almost all patients [2]. Repeated thoracentesis carries increased risks of pneumothorax, infection, and loculation; therefore, this treatment is typically limited to patients who are expected to
respond to systemic therapy or those with a very short
life expectancy.
The most common treatment is tube thoracostomy and
instillation of a sclerosing agent after the lung has reexpanded to induce chemical pleurodesis. Frequently
used agents are tetracycline class compounds, bleomycin, and talc slurry. Several randomized trials have found
no difference between these three, although talc is often
302
Tunneled pleural catheter for malignant effusions Pollak 303
still recommended based on its lower cost [5–7]. While
one randomized study showed thoracoscopic insufflation
of aerosolized talc to be superior to bleomycin instillation, another randomized study comparing talc poudrage
to talc slurry showed no difference between these two
[8,9]. Interestingly, two studies reported pleurodesis
rates of up to 43 to 77% with just tube thoracostomy and
short-term continuous drainage [10,11].
Side effects of chemical sclerotherapy are primarily pain
and fever. Additional major complications reported with
talc are respiratory distress, including adult respiratory
distress syndrome, and hypotension, with incidences as
high as 21 to 33% [12,13]. This includes doses below 10
g, which had been suggested as a threshold value for the
occurrence of these more serious complications. Other
limitations of chemical sclerotherapy are the discomfort
related to traditional large surgical chest tubes, the need
for a hospital stay averaging nearly one week, ineffective
management of pleural effusions where the lung is
trapped and does not completely expand, and the ineffective management of patients with high daily outputs
contraindicating sclerotherapy or who fail attempts at
sclerotherapy (including large symptomatic residual locules). In order to address the first two concerns, reports
have appeared on the use of smaller chest tubes and
ambulatory, outpatient management with such tubes for
short durations prior to sclerotherapy [14–19].
Pleuroperitoneal shunts and pleurectomy are generally
reserved for persistent or recurrent MPEs. The former is
limited by the need for frequent pumping of the shunt
and occlusion in as many as 25% [20]. Pleurectomy is
a major surgical procedure with a complication rate of
23% [21].
Another alternative for managing MPE is a long-term
drain in the pleural space. This permits outpatient management of the effusion, relieving associated symptoms
regardless of whether pleurodesis occurs.
Early experience with long-term
pleural drainage
Early reports using long-term pleural drains for MPE
were encouraging, even after other treatment failures. In
1986, Leff et al. [22] reported the use of a Tenckhoff
catheter connected to a subcutaneously implanted access
port in a single patient. This was accessed for drainage
twice a week to relieve dyspnea. A year later, Hewitt and
Janssen [23] described the use of a standard chest tube or
Foley catheter connected to a collection system such as
a urinary drainage bag, generally with an intervening
Heimlich valve to permit only egress from the pleural
space. Significant cost savings were proposed when compared to repeated thoracenteses or short-term standard
thoracostomy. One drawback of this nontunneled catheter system is the risk of catheter dislodgment. Two
subsequent reports noted the value of tunneled Tenckhoff catheters with externalized proximal ends that could
be drained by patients or visiting nurses at home whenever needed to relieve symptoms [24,25]. All 13 patients
in these two series had effective palliation of their symptoms, and two of the four in Zeldin’s series achieved
pleurodesis. None of the 9 patients in Robinson’s paper
had significant changes in their serum protein or albumin
levels. Three developed local infections and all were
controlled with oral antibiotics. No catheter displacements occurred. More recent experience with long-term
pleural drainage is with the Pleurx (Denver Biomaterials,
Inc., Golden, CO), a catheter specifically designed for
this purpose.
Denver Pleurx system
The Denver Pleurx is currently the only tunneled catheter specifically designed for managing pleural effusions
and was approved by the United States Food and Drug
Administration in 1997 (Fig. 1). It is a 15.5 French silicone catheter that is soft and relatively comfortable for
long-term use. It has side holes along its distal 24 cm to
permit easy entry of fluid and a proximal polyester cuff
to induce fibrosis along the subcutaneous tunnel. This
decreases the risk of dislodgment and pericatheter leakage and probably decreases the risk of infection in the
pleural space. The proximal end has a valved hub that is
closed except when a dilator enters it. This prevents
inadvertent leakage of pleural fluid or entry of air. A cap
is placed over the hub when the tube is not being used
and the exposed proximal end covered by a dressing
supplied in the kit.
Patients benefiting from this tube should have a freeflowing effusion or large locule and improvement in
symptoms after prior thoracentesis. After sterilely prepping the skin and giving local anesthesia, an 18-gauge
needle is advanced into the pleural space through an
intercostal space slightly above the diaphragm. A lateral
approach with the needle directed slightly posterior aids
in eventually positioning the tube in the posterior costophrenic sulcus for free flowing effusions. The puncture
site can be determined most precisely using ultrasound
guidance, especially for a loculated collection. The catheter is then subcutaneously tunneled to this entry site
from a location 5 to 8 cm anteroinferiorly. The needle is
exchanged over a wire for a 16-gauge French peel-away
sheath, through which the catheter is placed. The pleural
entry incision is stitched closed and the catheter secured
at the exit site with a suture. A chest x-ray is obtained to
assess catheter position, residual fluid, possible pneumothorax, and the status of the underlying lung. A small
pneumothorax is occasionally seen due to entry of air
through the peel-away sheath.
When first placed, the effusion can be drained using a
tube that connects to wall suction. It is recommended
304 Diseases of the pleura
Figure 1. The Denver Pleurx catheter
that no more than 1500 ml of fluid be removed. Subsequent drainages are performed using a special vacuum
bottle system. The bottle has a preconnected tube containing a dilator at its free end and a clamp along its shaft
(Fig. 2). Drainage should be performed at least every
other day, but can be done more frequently. A typical
drainage takes no more than 15 minutes and is readily
accomplished by a visiting nurse, family members, or the
patient. As the bottle’s capacity is only 600 ml (and may
lose adequate suction after 500 ml), patients with large
effusions will occasionally require more than one. No
more than 1000 ml of fluid should be drained every 8
hours. Chest pain is common during the first several
times complete drainage occurs, as the pleural layers reappose against the catheter, but this then generally
abates. If the patient has three drainages that are scant
and imaging shows no fluid reaccumulation, the Pleurx is
removed as spontaneous pleurodesis has occurred. If
necessary, a tube exists permitting connection of the
Pleurx to a water-seal suction system.
Experience with the Pleurx
The results of the randomized investigational trial leading to approval of the Pleurx by the FDA were reported
in 1999 [26]. Two-thirds of 144 patients received the
Pleurx and one-third were treated with conventional
doxycycline sclerotherapy through a chest tube. Equivalent safety and efficacy were shown and there was no
difference in median survival. The Pleurx group had a
trend toward greater improvement in dyspnea after ex-
ercise at 1 to 3 months but similar improvements were
seen in quality of life. The median hospitalization time
was 1 day for Pleurx patients, the minimum mandated by
the study design. The sclerotherapy group had a significantly longer median hospitalization time of 6.5 days.
Spontaneous pleurodesis developed in 46% of Pleurx patients (median 29 days, range 8 to 223 days), while
pleurodesis occurred in 54% of sclerotherapy patients. A
lower amount of fluid drained in the first week correlated
with a greater chance for spontaneous pleurodesis. Late
recurrence of an uncontrolled effusion occurred in 13%
of Pleurx patients. Causes included separate undrained
locules developing in seven, catheter occlusion in two,
recurrent effusion after pleurodesis in two, and unknown
in one. Some of these were managed with catheter replacement or repositioning. Late recurrence occurred in
21% of sclerotherapy patients, which was not significantly different. The severity of pain was similar between the two groups, as was the 10 to 14% rate of early,
in-hospital complications. Late complications occurring
with the Pleurx were mostly minor and either easily
treated or of little consequence to the patient’s overall
condition. Local cellulitis responding to antibiotics occurred in 6, tumor seeding of the catheter track in 3,
catheter obstruction in 2 (replaced in 1), and pleural infection in 1: the only incident requiring hospitalization.
In 2000, Putnam et al. [27] looked more closely at the
ability of the Pleurx to cost-effectively manage patients
with MPE outside the hospital. Of 100 patients treated
Tunneled pleural catheter for malignant effusions Pollak 305
Figure 2. Pleurx vacuum bottle drainage system
The preconnected tube has a firm dilator at its e nd to enter the hub of
the Pleurx catheter.
with the Pleurx, 60 outpatients and 40 previously admitted inpatients, 81% had relief of dyspnea and were able
to function outside of the hospital environment. This
was despite the fact that pleurodesis occurred in only
21%, with no difference between inpatients and outpatients. Significantly lower early, first-week hospital
charges were found for patients receiving a Pleurx as an
outpatient as compared to either those receiving it as an
inpatient or a cohort of 68 patients treated with chest
tube and sclerotherapy. The initial outpatient group also
showed a trend toward lower long-term charges over the
remainder of the patient’s life or medical follow-up. Survival was similar in all three groups, although the outpatient Pleurx group tended to live the longest – perhaps
due to a higher initial performance status. One or more
adverse events occurred in 19% of Pleurx patients: recurrent fluid accumulation in 8–generally due to growing
loculations, catheter malfunction in 8, and pleural infection in 5.
A small series was also reported by Smart and Tung in
2000 [28]. All three patients experienced improvement
in dyspnea and no complications occurred. Pleurodesis
appeared to occur in at least one patient and probably a
second.
In early 2001, Pollak et al. [29] reported on their experience in 28 patients, treating 31 hemithoraces. This in-
cluded 9 patients that were also part of the initial Pleurx
trial summarized above. Dyspnea improved in 94% and
remained improved in 91% at 30 days. The MPE was
controlled in 90% of pleural spaces, including 42%
achieving pleurodesis. Of note, pleurodesis occurred in
both spaces that were failures of prior chemical sclerotherapy, one of which was one of two patients with symptomatic locules (control of the effusion was achieved in
the other locule). Reasons for not controlling the effusion
were an initially unrealized multiloculated effusion, the
development of a multiloculated effusion, and a growing
residual locule in one patient in whom a second catheter
could not be placed due to restrictions of the investigative trial. Only 1 patient developed a recurrent effusion
10 months after successful pleurodesis.
While only 33% were actually treated as outpatients, in
only 7% was hospital time deemed necessary due to care
for the catheter. Catheter-related discomfort was not uncommon, especially with complete drainage, but this
persisted beyond the first week in only four patients.
Adverse events occurred in 21%, which were all minor
and readily managed. Four patients had catheters removed and new ones placed for poor drainage, one had
external catheter migration necessitating exchange and
also developed tumor tracking along the catheter route,
and the last patient had a positive pleural fluid culture
306 Diseases of the pleura
that probably represented colonization. She was already
on antibiotics for other reasons and, as she had coincidentally achieved pleurodesis, her catheter was removed.
The most recent report on the Pleurx concerns its use in
11 patients (12 hemithoraces) with trapped lung, which
is generally considered a contraindication to chemical
sclerotherapy [30]. Ten patients (91%) had symptomatic
benefit, although none developed pleurodesis. Nine
were treated as outpatients. Six complications occurred
in 5 patients but these were generally minor and easily
treated. The catheter occluded in one patient who also
developed loculation. A second catheter was placed in a
large locule and the first one removed, but it ruptured
and a fragment remained in the pleura. Two other patients developed localized skin breakdown and cellulitis
that responded to wound care and antibiotics, and two
had positive pleural fluid cultures, at least one of which
was felt to represent colonization.
Conclusion
The experience with drainage of MPE using a tunneled
pleural catheter is still not large but appears to be quite
promising. Advantages include cost-effective outpatient
control of the effusion and its symptoms in over 80 to
90%, a soft silicone catheter that is well tolerated by
patients for even months, a fibrotic barrier induced by
the cuff that retards dislodgment, intermittent rather
than continuous drainage, and treatment of large locules
and trapped lungs, which are difficult to otherwise manage. Pleurodesis may occur in over 40%, usually within 1
month, and chemical sclerotherapy can be administered
through the catheter, as an outpatient, to potentially increase pleurodesis rates and speed removal of the catheter. Alternatively, the catheter can be used to administer intrapleural anticancer agents.
Complications tend to be minor and generally do not
significantly affect the patient’s overall state. While inadequate drainage by the catheter may eventually occur
in as many as 16% of patients (due to occlusion or fibrotic
separation from remaining fluid), this is usually easily
managed by a new catheter placed in the outpatient setting. In fact, the major limitation is a complex multiloculated effusion, which is a problem for any treatment modality. When considering all these factors, a tunneled
pleural catheter becomes an attractive first line treatment for most patients with MPE who have a reasonable
expectancy of being an outpatient.
References and recommended readings
Papers of particular interest, published within the annual period of review,
have been highlighted as:
•
Of special interest
••
Of outstanding interest
1
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2
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5
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in 90%. Talc was recommended as the agent of choice due to its cost advantage.
6
•
Patz EF Jr, McAdams HP, Erasmus JJ, et al.: Sclerotherapy for malignant
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7
•
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8
•
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9
•
Yim AP, Chan AT, Lee TW, et al.: Thoracoscopic talc insufflation versus talc
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10
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11
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•
A retrospective review of 29 patients having 33 talc pleurodeses showed complications in 52%. Major complications occurred in 24%, consisting of hypoxemia
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14
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20
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21
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22
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27
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23
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28
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24
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29
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26
•
Putnam JB Jr, Light RW, Rodriguez RM, et al.: A randomized comparison of
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This reviews a randomized trial comparing tunneled long-term pleural catheter
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30
•
Pien GW, Gant MJ, Washam CL, et al.: Use of an implantable pleural catheter
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This study looked at the use of tunneled pleural drains in 11 patients with symptomatic, refractory malignant pleural effusions and underlying trapped lungs. This is
important since trapped lung syndrome is difficult to manage. Symptomatic benefit
occurred in 91% of patients.