S42\u2005Indwelling pleural catheters in refractory transudative pleural effusions: a randomised controlled trial

Abstract

Introduction and Objective Refractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) in the management of recurrent transudative effusions, but no randomised studies. Methods A multi-centre randomised controlled trial, in which patients with pleural effusions secondary to either heart, liver or renal failure were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT) (standard care). The primary outcome was the mean daily breathlessness score over 12 weeks from randomisation, measured using VAS scores, labelled from 0 mm for ’Not breathless at all’ to 100 mm for ‘Worst possible breathlessness’ Results 68 patients were randomised over 4 years at 13 centres, comprising of 46 patients with heart failure; 16 with liver failure; and 6 with renal failure. In total 64 patients received their allocated treatment, 31 with IPCs and 33 with TT. In the primary-outcome analysis the mean breathless score over the 12-week study period was 39.7 mm (SD 29.5) in the intervention arm and 44.8 mm (SD 26.3) in standard care arm (p=0.71). The mean drainage was 2,878 ml (SD 2,505) and 16,215 ml (SD 17,980) in the TT and IPC group, respectively. The standard care group required 1.3 (1.4) additional aspirations during study period. Additionally, in the TT cohort, 3/33 (9%) subsequently required chest drain insertion, 2/33(6%) IPC insertion, 1/33(3%) a medical thoracoscopy, and 1/33(3%) talc slurry pleurodesis. 1 IPC required re-siting in the intervention group. 37/64 (57%) patients were taking anticoagulation. The number of patients with one or more adverse events in the IPC group was 14/31 (45%), compared with 5/35 (14%) in the TT group. There was one case of IPC related infection, which did not necessitate drain removal. The number of bed days and hospital visits was not significantly different (p 0.30 and 0.31 respectively). Conclusion Although IPCs did not offer greater control of breathlessness than repeated TT, they reduced the number of invasive pleural procedures. In this patient cohort with a poor prognosis, poor quality of life and who are typically anticoagulated, IPCs could be used to reduce further invasive procedure.