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* From the Pulmonary and Respiratory Services, Washington Hospital Center, Washington, DC (Drs. Colice and Yusen); Department of Radiology, Yale University School of Medicine (Dr. Curtis); Thoracic Surgery Department, Centre de Pneumo-logie de l’Hôpital Laval (Dr. Deslauriers); Department of Medicine, University of South Carolina (Drs. Heffner and Sahn); Department of Medicine, Vanderbilt University (Dr. Light); Department of Medicine, University of Vermont (Dr. Littenberg); and Department of Medicine, Rush Medical College (Dr. Weinstein).
Correspondence to: Gene L. Colice, MD, FCCP, Pulmonary and Respiratory Services, Washington Hospital Center, 110 Irving St N.W., Washington, DC 20010; e-mail: gxc8{at}mhg.edu
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Abstract |
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 TOP Abstract IntroductionMaterials and MethodsReferences |
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Recommendations: The studies identified through a careful literature review as relevant to the medical and surgical management of PPE have significant methodological limitations. Despite these limitations in the data, there did appear to be consistent and possibly clinically meaningful trends for the pooled data and the results of the randomized, controlled trials and the historically controlled series on the primary management approach to PPE. Based on these trends and consensus opinion, the panel recommends the following approach to managing PPE: • In all patients with acute bacterial pneumonia, the presence of a PPE should be considered. Recommendation based on level C evidence. • In patients with PPE, the estimated risk for poor outcome, using the panel recommended approach based on pleural space anatomy, pleural fluid bacteriology, and pleural fluid chemistry, should be the basis for determining whether the PPE should be drained. Recommendation based on level D evidence. • Patients with category 1 or category 2 risk for poor outcome with PPE may not require drainage. Recommendation based on level D evidence. • Drainage is recommended for management of category 3 or 4 PPE based on pooled data for mortality and the need for second interventions with the no drainage approach. Recommendation based on level C evidence. • Based on the pooled data for mortality and the need for second interventions, therapeutic thoracentesis or tube thoracostomy alone appear to be insufficient treatment for managing most patients with category 3 or 4 PPE. Recommendation based on level C evidence. However, the panel recognizes that in the individual patient, therapeutic thoracentesis or tube thoracostomy, as planned interim steps before a subsequent drainage procedure, may result in complete resolution of the PPE. Careful evaluation of the patient for several hours is essential in these cases. If resolution occurs, no further intervention is necessary. Recommendation based on level D evidence. • Fibrinolytics, VATS, and surgery are acceptable approaches for managing patients with category 3 and category 4 PPE based on cumulative data across all studies that indicate that these interventions are associated with the lowest mortality and need for second interventions. Recommendation based on level C evidence. (CHEST 2000, 18:1158–1171)
Key Words: empyema • fibrinolytics • parapneumonic effusion • thoracentesis
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Introduction |
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TOPAbstractIntroductionMaterials and MethodsReferences |
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Materials and Methods |
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TOPAbstractIntroductionMaterials and MethodsReferences |
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The HSP selected a panel composed of a chair (chosen as a facilitator and organizer), expert representatives from relevant liaison organizations (in addition to the ACCP, these included the American Thoracic Society, American College of Radiology, American Association of Thoracic Surgeons, and the Infectious Disease Society of America), and consultant methodologists. In addition to numerous teleconferences among small groups, the full panel met on two separate occasions. On April 29, 1997, the panel met to agree on the objectives, audience, scope, and general methods for the clinical practice guideline. On March 23, 1998, the panel met to agree on an approach for evaluating the risk categorization for PPE and to review the specific tasks required to make evidence-based recommendations about the medical and surgical treatment of PPE.
The panel’s primary objective was to develop a clinical practice guideline on the evaluation and management of PPE using evidence-based methods.5 6 7 The diagnosis of acute bacterial pneumonia was assumed to be established by appropriate clinical criteria. (The treatment of acute bacterial pneumonia is outside the scope of this guideline.) Specifically excluded from consideration were pleural effusions complicating trauma, postoperative pleural effusions, preexisting pleural effusions, and chylous pleural effusions. Secondary objectives were to enhance communication within the medical community about PPE by standardizing categorization of this problem, to encourage clinical research in this field by defining areas of uncertainty, to improve the quality of clinical research on PPE by pointing out the lack of rigorous controlled trials in this field, and to improve outcome for patients with PPE by providing a rigorous assessment of the clinical research supporting the various available management options. This clinical practice guideline is intended for all physicians caring for adults with pneumonia.
Evaluating PPEs
To evaluate PPE, the panel recommends categorizing patients with
PPE by their risk for a poor outcome. Establishing a method of risk
categorization was critical because management options would be based
on the estimated risk for poor outcome. Estimates of the risk for poor
outcome were based on the clinical judgment that, without adequate
drainage of the pleural space, the patient with PPE would be likely to
have any or all of the following: prolonged hospitalization, prolonged
evidence of systemic toxicity, increased morbidity from any drainage
procedure, increased risk for residual ventilatory impairment,
increased risk for local spread of the inflammatory reaction, and
increased mortality. The panel recognizes that further clinical
research is needed to better quantify the risks for poor outcome by the
categorization scheme proposed.
Based on consensus of clinical opinion, the expert panel developed an annotated table (Table 1 ) for evaluating the risk for poor outcome in patients with PPE based on three variables, pleural space anatomy, pleural fluid bacteriology, and pleural fluid chemistry. The individual features of each of the three variables used to distinguish risk categories were supported by appropriate literature sources.8 9 10 11 12 13 14 15 This annotated table groups patients into four separate categories of risk for poor outcome. Insufficient data were available to reach consensus on how various patient characteristics, eg, age, comorbid disease, and evidence of persistent inflammatory response despite appropriate antibiotic therapy, might affect these risk categories. The panel’s consensus opinion supported drainage for patients with moderate (category 3) or high (category 4) risk for a poor outcome, but not for patients with very low (category 1) or low (category 2) risk for a poor outcome.
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1. Adequate data were provided for 
20 adult patients
with PPE to allow evaluation of at least one relevant outcome (death or
need for a second intervention to manage the
PPE). 2. Reasonable assurance was provided that drainage
was clinically appropriate (patients receiving drainage were in either
categories 3 or 4 based on the risk approach developed by the panel)
and drainage procedure was adequately
described. 3. Original data were presented
(ie, data from patients reported multiple times in the
literature by the same authors were only recorded once, and reviews
were not acceptable).
Analysis of Management Options for PPE
Separate data abstraction forms for case series and historically
controlled series and for randomized, controlled trials were developed,
pilot tested, and refined. Information about study design (including
quality assessments), study setting, patient characteristics,
diagnostic testing, treatments, and outcomes were recorded on these
abstraction forms. Abstraction forms were completed by at least two
panel members for each journal article included for full review. After
completion of the data abstraction forms by each individual reviewer,
inconsistencies in data entry among reviewers were reconciled by the
methodologists, and one final data abstraction form was submitted for
each article. Data from the final forms were used to create the
evidence tables.
The panel grouped PPE management approaches into six categories: no drainage performed, therapeutic thoracentesis, tube thoracostomy, fibrinolytics, video-assisted thoracoscopic surgery (VATS), and surgery (including thoracotomy with or without decortication and rib resection). The fibrinolytic approach required tube thoracostomy for administration of drug, and VATS included postprocedure tube thoracostomy. Surgery may have included concomitant lung resection and always included postoperative tube thoracostomy. All management approaches included appropriate treatment of the underlying pneumonia, including systemic antibiotics. The PPE management approaches were distinguished as either primary or rescue. Primary were those performed as the first approach to managing the PPE and rescue were those performed only after an earlier approach had failed.
Within each article, cohorts were defined, first, by whether drainage was clinically appropriate according to the panel’s risk estimation method (category 3 and 4) and, second, by the PPE management approach. Data on two relevant outcomes, death and the need for a second intervention to manage the PPE, were used in this analysis. In most of the studies reviewed, a causal relationship between the PPE and death could not be determined; consequently, only total deaths, not attributable deaths, were considered. The denominator used to calculate the proportion of patients requiring a second intervention to manage the PPE was not corrected for deaths, because most clinical circumstances should allow a second intervention to manage the PPE before death. The proportion and 95% confidence interval (CI) of patients either dying or requiring a second intervention to manage the PPE were calculated by management approach for each cohort within a study. The proportion and 95% CI of patients suffering each of the two relevant outcomes were then calculated for the pooled data of individual cohorts for each management approach. Formal tests for heterogeneity of the data pooled across all studies within each management approach were not performed because review of the proportions showed wide variability. Data from studies reporting primary and rescue management approaches to PPE are presented separately.
Consensus on recommendations was reached after review of the evidence tables by all panel members. The strength of evidence supporting each drainage approach was graded using the following approach:
A. Randomized, controlled trials with consistent results or individual randomized, controlled trial with narrow CI. B. Controlled cohort and case-control series. C. Historically controlled series and case series. D. Expert opinion without explicit critical appraisal or based on physiology, bench research, or "first principles."
Results
Literature Review
The MEDLINE search yielded 789 citations. After review of
these citations, their bibliographies, and citations from panel
members’ files, 24 articles were identified for full review by the
panel. Included in these 24 articles were 3 randomized, controlled
trials,16
17
18
2 historically controlled
series,19
20
and 19 case series.21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
The 3
randomized, controlled trials, 2 historically controlled series, and 14
of the case series presented results of primary management approaches
to PPE; 5 of the case series26
30
32
34
37
provided data
on rescue approaches. Summaries of the design features and patient
characteristics for the 3 randomized, controlled trials and the 2
historically controlled series and the 14 case series of primary
management are in Tables 2
and 3
, respectively. Altogether, data from 34 separate cohorts (ranging in
size from 4 to 84 patients) in the 19 articles could be categorized
under the six possible primary management approaches.
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Davies and colleagues17 compared the effects of fibrinolytic therapy with tube thoracostomy in managing PPE. Twenty-four patients were randomized to receive either streptokinase (250,000 IU in 20 mL normal saline solution) or saline flush through tube thoracostomy daily for 3 days. The primary end points, prospectively assessed, were pleural fluid drainage and improvement in the chest radiograph. Secondary end points were time to defervescence, time to normalization of the WBC count, length of stay in the hospital, and number of procedures needed for effective pleural space drainage. There was significantly greater pleural fluid drainage and chest radiograph improvement in the group randomized to receive fibrinolytics. Three patients in the tube thoracostomy control group required a second intervention to effectively drain the pleural space vs none in the fibrinolytic group (not significant, p = 0.109). There were no significant differences between the two treatment groups in hospital length of stay, time to defervescence, and time to normalization of WBC count. There were no deaths in either group. Of note, no evidence of systemic fibrinolysis or bleeding complications was found with streptokinase therapy. The authors interpreted the data to indicate that fibrinolytics probably improved management of PPE by improving pleural fluid drainage.
Wait et al18 compared the results after fibrinolytic therapy with VATS in the management of PPE. Twenty patients were randomly allocated to receive either streptokinase (250,000 IU in 100 mL normal saline solution) administered daily for 3 days through tube thoracostomy or immediate VATS. The primary end point was inadequate pleural space drainage assessed by chest radiography. Also prospectively monitored were clinical outcomes, length of hospital stay, and duration of chest tube drainage. The group treated with immediate VATS had a significantly higher treatment success rate (defined as a > 50% reduction in the original pleural fluid) than the fibrinolytic group. One patient in each treatment group died, but more patients receiving fibrinolytics than VATS required a second intervention to manage the PPE. The hospital length of stay and duration of chest tube drainage were significantly shorter in the VATS group than the fibrinolytic group. The authors concluded that VATS as the primary treatment strategy for PPE was more effective than fibrinolytic therapy.
Historically Controlled Series
The two historically controlled series did not include
the same management approaches. Chin and Lim19
analyzed
the treatment responses of PPE to either tube thoracostomy or
fibrinolytics. A historical control group, studied from 1990 to 1992,
of 29 patients was treated with tube thoracostomy. A second group of 23
patients, evaluated from 1992 to 1995, was given streptokinase (250,000
IU in 100 mL normal saline solution) daily through tube thoracostomy.
Outcome measures assessed were time to defervescence, duration of tube
drainage, pleural fluid drainage, length of hospital stay, and clinical
recovery. Baseline characteristics of the two groups were similar.
There were no differences between the two groups in time to
defervescence, days of chest tube drainage, and hospital stay, although
the fibrinolytic group did have a greater amount of total pleural fluid
drainage. The death rate was lower for the group treated with
fibrinolytics but the need for a second intervention to drain the
pleural space was similar for the two treatment groups. The authors
stated that fibrinolytics increased pleural fluid drainage, but did not
markedly improve clinical recovery from PPE compared with tube
thoracostomy.
Mackinlay and colleagues20 compared the outcomes after surgery and VATS for management of PPE. The historically controlled group included 33 patients treated between 1985 and 1991 by thoracotomy with or without rib resection. From 1992 to 1994, 31 patients with PPE underwent VATS. Duration of chest tube drainage, length of hospital stay, and clinical outcomes were evaluated. The groups were generally similar at baseline, except the historically controlled group had a significantly longer preoperative course than the VATS group. Duration of chest tube drainage and length of hospital stay were significantly shorter for the patients treated with VATS. There was one death in each treatment group; four patients in the historically controlled group and none in the VATS group required a second intervention to manage the PPE. The authors concluded that clinical outcomes were comparable for VATS and thoracotomy in managing PPE, but VATS offers advantages in terms of postoperative care.
Rescue Approaches
A summary of design features and patient characteristics for the
five case series26
30
32
34
37
presenting results of
management approaches performed exclusively as a second, or rescue,
intervention after failure of a previous management approach is in
Table 6 . Lawrence et al26
reported the results of VATS performed
in patients resistant to medical management of PPE, either therapeutic
thoracentesis or tube thoracostomy. They found that VATS was successful
in draining PPE in the majority of rescue situations. Performing VATS
did not preclude conversion to other surgical procedures in
unsuccessful cases. Pothula and Krellenstein34
described a
series of cases undergoing thoracotomy after incomplete resolution of
the PPE with tube thoracostomy. Thoracotomy allowed effective drainage;
limited thoracotomy, performed in extremely ill patients, was also
effective. The patients presented by Martella and Santos30
also underwent thoracotomy after inadequate drainage with tube
thoracostomy. Decortication effectively controlled PPE, but 25% of
patients required additional operative procedures to control ongoing
lung infection. Morin et al32
performed thoracotomy after
numerous failed attempts at drainage of the PPE with tube thoracostomy.
Management of PPE was successful in all cases, with prompt recovery.
Temes and colleagues37
described the results of
fibrinolytic therapy in patients who had previously failed to respond
to tube thoracostomy. Most patients (16/26 or 62%) had complete
resolution of PPE with fibrinolytic therapy, but two patients (8%) had
only partial resolution and required long-term empyema tube drainage,
and eight patients (31%) did not improve with fibrinolytics and
underwent surgery.
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Discussion
The studies identified through a careful literature review as
relevant to the medical and surgical management of PPE have significant
methodological limitations. After decades of clinical interest in
PPE, only three randomized, controlled trials have been performed,
including < 100 patients, on the medical and surgical management of
this problem. Most of the published material is derived from case
series in which patient selection and treatment biases could not be
excluded. These methodologic weaknesses resulted in heterogeneous data,
precluded formal hypothesis testing and subgroup analyses, and limited
the strength of any panel recommendations.
Evidence obtained from the literature review indicates that all six PPE management approaches have been effective in some patients. However, the panel was not able to define the patient characteristics that would indicate the likelihood for success with any of the individual management approaches. Furthermore, information about sequential use of PPE management approaches is limited. Despite the limitations in the data available, there did appear to be consistent and possibly clinically meaningful trends for the pooled data and the results of the randomized, controlled trials and the historically controlled series on the primary management approach to PPE. Based on these trends and consensus opinion, the panel recommends the following approach to managing PPE:
• In all patients with acute bacterial pneumonia, the presence of a PPE should be considered. Recommendation based on level C evidence.
• In patients with PPE, the estimated risk for poor outcome, using the panel-recommended approach based on pleural space anatomy, pleural fluid bacteriology, and pleural fluid chemistry, should be the basis for determining whether the PPE should be drained. Recommendation based on level D evidence.
• Patients with very low (category 1) or low (category 2) risk for poor outcome with PPE may not require drainage. Recommendation based on level D evidence.
• Drainage is recommended for management of category 3 or 4 PPE based on the pooled data for mortality and the need for second interventions with the no drainage approach. Recommendation based on level C evidence.
• Based on the pooled data for mortality and the need for second interventions, therapeutic thoracentesis or tube thoracostomy alone appear to be insufficient treatment for managing most patients with category 3 or 4 PPE. Recommendation based on level C evidence. However, the panel recognizes that in the individual patient, therapeutic thoracentesis or tube thoracostomy, as planned interim steps before a subsequent drainage procedure, may result in complete resolution of the PPE. Careful evaluation of the patient for several hours is essential in these cases. If resolution occurs, no further intervention is necessary. Recommendation based on level D evidence.
• Fibrinolytics, VATS, and surgery are acceptable approaches for managing patients with category 3 and category 4 PPE based on cumulative data across all studies that indicate that these interventions are associated with the lowest mortality and need for second interventions. Recommendation based on level C evidence.
The panel urges that these recommendations be viewed cautiously because of the methodological problems described above. Especially important would be to avoid making definitive recommendations on the preferability of individual primary management approaches because of the limited available comparison data. For instance, a randomized, controlled trial showed that VATS is more effective than fibrinolytics,18 and a historically controlled series showed that VATS is as effective as surgery and advantageous in terms of postoperative care.20 However, the total number of patients included in these two studies was too small to support the conclusion that VATS is the preferable primary management approach for PPE. In addition, a randomized, controlled trial suggested that urokinase may be the preferred fibrinolytic because of a better side effect profile and similar efficacy as streptokinase, but the sample size was too small to reach a definitive recommendation.16 (The panel notes that although urokinase is not available at present, personal communication with the manufacturer, Abbott Laboratories (Abbott Park, IL), indicates that this product should be available in the near future.) Only a small amount of data are available for approaches performed as rescue procedures, ie, after a primary management approach had failed to successfully control the PPE. Rescue approaches to PPE had a low mortality, but the need for further interventions after the rescue procedures to effectively control the PPE tended to be high. The most important observation from the panel may be that these findings could be a valuable foundation for designing a large, multicenter, randomized, controlled trial in this area.
The panel recognizes that this analysis was based on the consensus opinion that drainage of PPE should be performed only in patients with moderate (category 3) or high (category 4) risk for poor outcome. This approach differs from the traditional approach to categorizing PPE based on the three classic phases of empyema formation: the exudative stage, the fibropurulent stage, and the organizing stage. However, it had the advantage of ensuring that the panel recommendations were based entirely on data from patients with categories 3 and 4 PPE. Although it is intuitively reasonable that the first step in managing a PPE should be to estimate the risk for poor outcome, the method advised by the panel for risk categorization requires validation. The panel also recognizes that the clinical utility and decision thresholds (cutoff points) for prognostic variables included in this method, such as pleural fluid pH and glucose and size of the pleural effusion on chest radiograph, have not been well-established.
There were several clinically relevant issues that the panel had hoped to evaluate, but could not because of lack of adequate information. Data on the effect of various management options on secondary end points, such as time to defervescence, time to normalization of the WBC count, duration of drainage, length of hospital stay, and time to chest radiograph improvement, were rarely reported. Comparisons between small and large tube thoracostomy and tube thoracostomy insertion under radiographic guidance or percutaneously were not available. The panel had hoped to examine how this clinical practice guideline might be applied in other clinical situations, such as PPE in the lung cancer patient (particularly with an obstructing bronchial lesion), the patient with preexisting parenchymal lung disease (eg, interstitial lung disease), and the patient with lung parenchymal necrosis with or without a bronchopleural fistula. Unfortunately, insufficient data were available to support recommendations in these cases. Similarly, recommendations could not be proposed for special issues regarding antibiotic therapy in PPE (eg, the choice of antibiotic, the duration of antibiotic treatment, the dose of antibiotic, the use of intrapleural antibiotics, and the monitoring of antibiotic treatment). The panel did not explore how individual patient concerns might affect the choice among management options and the cost-effectiveness of the different management approaches.
Several observations from reviewing the methods of these studies are pertinent to designing future trials in this field. There was considerable variability in the surgical approaches to draining PPE. Most studies reported the results for thoracotomy,20 29 30 31 32 but decortication and lung resection may have been performed as well. Results from rib resections were described in several series.21 34 38 The timing of drainage procedures after diagnosis of PPE was not always made clear and probably varied widely among studies. Particularly of concern to the panel was the timing of sequential drainage approaches. A recent extension of a historically controlled series included in this analysis suggested that early surgery provided advantages in patients not responding rapidly to fibrinolytics.40 The radiographic assessments performed before performing drainage procedures were usually not fully described. The panel urges that future studies be directed at better defining the surgical techniques, timing, and radiographic visualization of the pleural space needed for effective PPE drainage.
It should be noted that a recent study, not included in the literature review, support the recommendations of the panel. A small randomized, controlled trial compared fibrinolytics (n = 15) to tube thoracostomy (n = 16) in managing PPE.41 No patients died in this series, but the fibrinolytic group needed a second intervention to manage the PPE significantly less often (2 of 15, or 13.5%) than the group receiving tube thoracostomy (12 of 16, or 75.0%). Of interest, in the group originally receiving tube thoracostomy, delayed use of fibrinolytics avoided surgery in only 6 of the 12 patients.
In summary, methodologic weaknesses in the clinical literature relevant to the medical and surgical management of PPE limit the strength of any recommendations by the panel. Trends in pooled data suggest that fibrinolytics, VATS, and surgery are acceptable approaches for managing PPE, but adequately designed randomized, controlled trials are urgently needed to further define the relative values of each of these procedures.
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Footnotes |
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Support for the development of this clinical practice guideline has been provided solely by the American College of Chest Physicians.
Received for publication May 4, 2000. Accepted for publication June 6, 2000.
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References |
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TOPAbstractIntroductionMaterials and MethodsReferences |
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) and pooled across all studies (
) is shown
for each primary management approach. Horizontal lines extending from
pooled estimates indicate 95% CI.