Early discharge for patients with benign pleural effusions using a Wayne catheter (pigtail) chest drain - analysis of safety, complications, and quality of life

ABSTRACT Objective: to assess safety, efficacy and quality of life in patients with benign pleural effusions undergong pleural drainage with Wayne pleural catheter (DW) in an outpatient setting. Method: this is a prospective study, in which 47 patients were evaluated between July 2017 and October 2018. Patients with non-malignant pleural effusions underwent pleural drainage with clinical evolution compatible with outpatient care were included. Patients who underwent drainage due to other conditions and patients were excluded. Results: after catheter placement, the mean length of hospital stay was 3.14 (± 3.85) days, and 21 patients (44.68%) were discharged within 24 hours. The mean time with the catheter was 12.63 (± 7.37) days. The analysis of the pleural fluid was transudate in 87.3% of cases and exudate in 12.3%. The causes of pleural effusion were heart failure (72.3%), renal failure (19.1%), liver failure (6.3%) and pneumonia (8.5%). The quality of life, analyzed according to the parameters of the questionnaire SF 36, showed low average values when compared to other studies. Analyzing each descriptor, the average was greater only in the limitation related to physical aspects. In the other descriptors, the results were similar, but smaller. Conclusion: the outpatient use of pleural catheters of the Wayne type (pigtail) proved to be feasible, safe and with a low associated infection rate. This is a viable option for selected patients.

As a result, most of the evidence found for the care of malignant pleural effusions is applied to patients with benign ones, also due to the lack of specific guidelines 2 .
Among the most common procedures in patients with pleural effusion, thoracentesis and pleural drainage stand out 1 . Tubular pleural drainage has been used for a long time. Although Hippocrates was the first to report and treat a pleural empyema in 400 BC, there is evidence for the treatment of this condition as far back as 3000 BC, in Egypt. Pleural drains are also used to drain pneumothorax and pleural effusions, with proven efficacy [1][2][3] . The study and advancement of technology has allowed us to reach increasingly effective and safer treatments. A modernization of the classic tubular drain is the Wayne catheter (WC), popularly known as pigtail catheter, due to the curled tip shape. Using smaller gauges than those normally used in tubular drains, the WC, when adapted to the Heimlich valve, allows patients undergoing pleural drainage to be treated well outside the hospital setting, according to the British Thoracic Society Pneumothorax Management Guide 4 . It was initially developed for pneumothorax drainage, but it is widely used for the drainage of pleural effusions, because of its easy handling and since it causes less pain compared with the tubular drain 4,5 .
An adaptation of the WC was developed about 10 years ago for prolonged use, with characteristics similar to long-term vascular catheters. These catheters are implanted with the Seldinger technique, followed by subcutaneous tunneling. They are cited in the literature as indwelling pleural catheters (IPC). IPC are an important therapeutic option to treat neoplastic pleural effusions, especially in patients with pulmonary entrapment. They have been evaluated in large, randomized studies and systematic reviews, and have been considered costeffective in recent works. The main feature is the possibility of home use [6][7][8][9] .
The use of IPC in pleural effusions caused by advanced heart disease, liver disease, and renal failure has also been the subject of a recent systematic review, which suggests their use as a viable and effective measure 10,11 .
Such evidence leads us to believe that patients can remain with pleural drains outside the hospital environment.
There is also evidence that pleural drainage in patients with chronic diseases is safe and brings respiratory comfort more quickly [12][13][14] . There remains the question about the safety and effectiveness of the WC's outpatient use.
Evidence on this subject is scarce, and it involves other diseases besides benign pleural effusions 15 . The aim of this study is to evaluate the safety, efficacy, and quality of life in patients with benign pleural effusions undergoing pleural drainage with WC in an outpatient setting.

METHOD
We conducted a prospective, observational study, evaluating 47 consecutive patients between July lidocaine. Catheters were connected to a sterile, closedsystem collection bag for better quantification and care.
After clinical and baseline improvement, and only after adequate lung expansion seen on chest X-ray, individuals were discharged from the hospital, with an outpatient return scheduled within 10 days. Upon discharge, we oriented all about care with the drain, quantification of drain output, and daily dressings. The guidelines were reinforced by a printed form and delivered to the companion at the time of discharge. Drain output was not a limiting factor for hospital discharge.
At outpatient return, we evaluated patients and removed the catheter when the output was less than 150mL in 24 hours. In cases of high output, patients were reassessed weekly. After removal, individuals answered a questionnaire on quality of life. After this consultation,

Miotto
Early discharge for patients with benign pleural effusions using a Wayne catheter (pigtail) chest drain -analysis of safety, complications, and quality of life patients were followed up via electronic medical records to assess drainage related complications within 180 days.
We consolidated the obtained data and submitted it to statistical analysis, with calculation of the percentage of events in analytical variables and means and standard deviation in numerical ones. We performed sample calculation based on the population covered by the health care provider, but as this is a pragmatic study, we evaluated all individuals who met the inclusion criteria in the chosen period 18 . In addition to the analysis of epidemiological data, we assessed clinical data that included the cause and nature of the pleural effusion, volume of drained fluid, and complications such as pain, infection, and need for readmission after drain removal.
We compared patients by sex and assessed the influence of smoking on the analyzed variables. To compare the results, we adopted the chi-square test, with a significance level of 5%. The chi-square was statistically significant with p<0.001, indicating an association between these categories. To verify whether smoking influences length of stay, drainage time, and complications, we applied the non-parametric Kruskal-Wallis test.
We chose to assess pain through the use of analgesics during the period with the catheter, as this represents a longer follow-up period than the assessment only at the time of medical consultation.
Thus, we divided patients into 3 groups as for the use of analgesics: frequent use (according to the prescribed time), occasional use (only when in pain) and those who did not use analgesics. All were equally instructed to take analgesics in case of pain.
We performed quality of life analysis using the SF 36 questionnaire, widely used in research on quality of life and previously used in patients with pleural effusion 16,17 . Patients answered the questionnaire between three and 34 days after WC placement, in the outpatient reassessment after discharge.
All patients were being treated for some non-neoplastic comorbidity.
After drainage, the mean length of hospital stay was 3.14 (±3.85) days, with 21 patients (44.68%) being discharged within 24 hours after drainage. Ten patients (21.27%) required readmission within 180 days after drainage, eight of these (80%) due to causes unrelated to pleural effusion.  Table 1 shows the demographic data, as well as complications. There was no significant difference between men and women, except for the frequent use of analgesics, more common in women. Table 2 shows complications, length of stay, characteristics, and drainage volume according to smoking. There was no significant difference between groups in all variables analyzed. led us to believe in good results with the outpatient use. In this prospective analysis, we observed patients with advanced ages, up to 95 years. This is because our service is specialized in the care of elderly patients.
A limitation of the study was the sample of patients, which was initially calculated according to the healthcare provider's population. The number of patients evaluated was imprecise in relation to the calculated sample, portraying the pragmatic nature of the study.
Studies with more accurate sample size calculation and a larger number of patients will provide evidence of greater certainty.
We chose to use the WC and not the IPC for this study for two reasons. The first is that the patients underwent drainage mainly to relieve symptoms, on an urgent basis. This routine does not fit the use of IPC. The second is that the cost of the IPC is higher, rendering it unfeasible on a large scale in group medicine.
The short hospital stay time after drainage and the small percentage of readmissions due to pleural effusion show the effectiveness of the treatment.
Patients feel more comfortable after drainage, which leads to faster compensation of comorbidities and shorter hospital stay. In addition to the cost reduction due to the shorter hospital stay, we also emphasize the lower probability of developing delirium and infection by multi-resistant microorganisms 21 . The 4.25% infection rate is comparable to that found in other studies, both for WC and for IPC 15,20,22 .
Another variable analyzed was smoking, since 34.04% of the patients were active or former smokers.
According to INCA data from 2013, the prevalence of smoking in the adult population is 14.7% 23 . Our data showed a much higher percentage of smokers, perhaps because it is a selected population, with chronic diseases, in which smoking plays an important role. Despite this, there was no statistically significant difference between smokers and non-smokers regarding complications, length of stay, and drainage time (Tables 1 and 2).
As for pain, we chose to evaluate the use of analgesics as this is a continuous parameter. The assessment using the visual analogue scale, as some studies describe 15,16 is performed at the time of return and, until then, the pain may have been significantly reduced. Thus, we observed that 65.95% of patients  15,16 . In the analysis of each descriptor, the mean was higher only in the limitation by physical aspects.
In the other descriptors, the results were similar, but smaller 16  Spontaneous pleurodesis is described in cases of prolonged use of pleural drains 9,16 . We did not objectively evaluate this in the present study, but the low rehospitalization rate related to pleural effusion (4.25%) suggests that it can occur with the use of WC as well.
The cost of using WC for benign effusions can also be assessed. With an average hospital stay of 3.14 days after the initial drainage and an average drainage time of 12.63 days, there is a reduction of 9.49 days of hospitalization, on average. Other studies have already shown better cost-effectiveness with the use of IPC for malignant effusions when compared with the usual care for the inpatient 8,22 . Thus, we believe that for the use of WC in benign effusions (simpler and cheaper than IPC) the analysis applies in a similar way.
Despite the small number of patients included, we believe that the results presented reflect the routine in the management of pleural effusions in elderly patients.
A possible bias in the study is the lack of a control group, which could be obtained from hospitalized patients, but the assessment of quality of life in such individuals would possibly be altered by hospitalization.

CONCLUSION
Early discharge and the use of outpatient Wayne pleural catheters (pigtail) proved to be feasible, safe, and with a low rate of associated infections. The quality-of-life analysis showed lower results than those of similar studies, but the populations studied were different. It is a viable option for selected patients.