Comparison between flutter valve drainage bag and underwater seal device for the management of non-massive malignant and paramalignant pleural effusions

Introduction The aim of this study is to compare the use of flutter valve drainage bag system as an alternative to conventional underwater seal drainage bottle in the management of non-massive malignant/paramalignant pleural effusion. Methods Forty-one patients with non-massive malignant and paramalignant pleural effusions were randomized into two groups. Group A (21patients) had their chest tubes connected to an underwater seal drainage bottle, while group B (20 patients) had their chest tubes connected to a flutter bag drainage device. Data obtained was analyzed with SPSS statistical package (version 16.0). Results Breast cancer was the malignancy present at diagnosis in 24(58%) patients. Complication rates were similar, 9.5% in the underwater seal group and 10 % in the flutter bag drainage group. The mean duration to full mobilization was 35.0±20.0 hours in the flutter bag group and 52.7±18.5 hours in the underwater seal group, p-value 0.007. The mean length of hospital was 7.9±2.2 days in the flutter bag group and 9.8±2.7 days in the underwater seal group. This was statistically significant, p-value of 0.019. There was no difference in the effectiveness of drainage between both groups, complete lung re-expansion was observed in 16(80%) of the flutter bag group and 18(85.7%) of the underwater seal drainage group, p-value 0.70. Conclusion The flutter valve drainage bag is an effective and safe alternative to the standard underwater seal drainage bottle in the management of non-massive malignant and paramalignant pleural effusion.


Introduction
Thoracic drainage systems are designed to remove air and fluid from the pleural space [1] and the underwater seal drainage system in its present form was first described by Kenyon in 1916 and since then has been the standard form of chest drainage [2]. Placement of underwater seal below the chest wall often causes disconnection of the connectors [3] and it also puts tension on the anchoring stitch, resulting in increased risk of chest tube mishaps. The frequent clamping during transport can cause pulmonary collapse, formation of clots and can result in worsening of an existing pneumothorax [3]. In 1968, Henry Heimlich idealized a device (The Heimlich valve) to replace under water-seal drainage systems [3] and this is the concept of the flutter valve drainage bag as popularized by Portex USA.
Thompson et al. [2,4], showed that bags with integral non-return valves could be used for chest drainage. The flutter valve drainage bag is a 'no water' ambulatory system which incorporates a one-way valve and can be used both in hospital and outpatient drainage of pleural collections [5]. The one-way valve system provides better mobility of patients because clamping is unnecessary during transportation and the valve keeps working regardless of its position/level [3]. Vuorisalo et al. [6] showed that the flutter drainage system is a safe and feasible system when pleural drainage is needed in the treatment of pneumothoraces and pleural effusions.Pleural effusion is an abnormal accumulation of fluid in the pleural space and neoplastic diseases accounts for 13% to 40% of all the pleural effusions worldwide and account for 70% of all massive effusions [7].
Ogunleye et al. [8], also found that neoplastic diseases were the commonest cause of pleural effusions. This was similar to what was found earlier by Thomas et al. [9] in Lagos, Nigeria.
Malignant pleural effusion is confirmed by the presence of malignant cells in pleural fluid or tissue [10]. In patients with established malignancy and pleural effusion, when malignant cells have not or cannot be detected in the pleural fluid or tissue, Sahn et al. [10] labels this group as paramalignant effusions. Malignant Pleural Effusion (MPE) complicates the course of various malignancies, with most cases occurring secondary to pleural metastasis of lung and breast adenocarcinoma [11,12]. Malignant pleural effusion is the commonest indication for insertion of chest tube and drain in Lagos Nigeria and a great number of such individuals are females with breast cancer [8,9]. Massive pleural effusion can be defined on plain radiograph as, complete opacification of an entire hemithorax with or without mediastinal shift [13]. Thus pleural effusions that do not fulfill this definition can be regarded as non-massive pleural effusion.

Results
Of the 41 patients recruited for the study, there were 37 females (90.2%) and 4 males (9.8%) in the study population with a mean age of 50.3±14.3 years (Table 1) (Table 3).
There was no significant difference in the mean duration of drainage between both groups, 6.5±2.6 days in the flutter bag group and 7.9±2.0 days in the underwater seal group, p-value 0.059 (Table 4).
However, there was a significant difference in the length of hospital stay, with the patients in the underwater seal group having a longer hospital stay (P = 0.019) ( Table 4). There was no difference in the effectiveness/completeness of drainage between both groups as seen in the comparison of pre and post extubation chest radiographs. There was also no difference in complication rates between the two groups studied. Overall there were 4 (9.8%) complications in the entire study group. 2 in each group, which translates 10% in flutter valve bag vs 9.5% in the underwater seal group (Table 5).

Discussion
The underwater seal drainage bottle has been the conventional reservoir for drainage of pleural effusion in most patients, however various studies including that of Graham et al. [2] and Vourisalo et al. [6] have demonstrated that, the flutter valve drainage bag may be a useful alternative to the conventional under water seal bottle.
Malignant and paramalignant pleural effusions pose a lot of challenge and constitute a huge burden to patient's physical, social, mental and financial wellbeing. Malignant diseases cause 13% to 40% of all the pleural effusions worldwide and account for 70% of all massive effusions [7]. In this study, the commonest malignancy present at diagnosis of pleural effusion was breast cancer (24 patients (58%)), which was similar to the findings of other authors [7][8][9]. There was a significant decrease in the number of hours from sitting to full mobilization in the flutter valve drainage bag group, when compared to the underwater seal group (P-value 0.007). This supports the findings of Graham et al. [2] and further lends credence to the likelihood of reduction in the incidence of deep vein thrombosis in the flutter bag group, due to early mobilization. There was no difference in the duration of drainage when employing the flutter bag drainage system or the underwater seal drainage device in this study which is confirmed by a previous work [2]. The lack of significance in duration of drainage when using an underwater seal device or a flutter valve drainage bag was also demonstrated in studies by Vourisalo et al. [6] Although one can argue that the underwater seal group in their study, had their chest tubes connected to a suction device, this did not seem to affect the overall significance. Vega et al. [3] in their study showed that, the chest radiographs obtained after removal of flutter bag drainage system were considered normal in 26 patients (72.8%), whereas incomplete lung expansion was seen in 8 patients (22.4%) and small pleural effusion was seen in 1 (5.6%). The main difference between this study and that of Vega et al. [3] is that theirs was not a comparative study. The  This study also shows that the flutter valve drainage bag shortens in-hospital stay. Table 1: distribution of patients with age ranges in decades