Randomised trial of indwelling pleural catheters for refractory transudative pleural effusions

Abstract

ObjectiveRefractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) for transudative effusions, but no randomised trials. We aimed to investigate the effect of IPCs on breathlessness in patients with transudative pleural effusions when compared with standard care.MethodsA multicentre randomised controlled trial, in which patients with transudative pleural effusions were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT; standard care). The primary outcome was mean daily breathlessness score over 12 weeks from randomisation.Results220 patients were screened from April 2015 to August 2019 across 13 centres, with 33 randomised to intervention (IPC) and 35 to standard care (TT). Underlying aetiology was heart failure in 46 patients, liver failure in 16 and renal failure in six. In primary outcome analysis, the mean±sd breathlessness score over the 12-week study period was 39.7±29.4 mm in the IPC group and 45.0±26.1 mm in the TT group (p=0.67). Secondary outcomes analysis demonstrated that mean±sd drainage was 17 412±17 936 mL and 2901±2416 mL in the IPC and TT groups, respectively. A greater proportion of patients had at least one adverse event in the IPC group (p=0.04).ConclusionWe found no significant difference in breathlessness over 12 weeks between IPCs or TT. TT is associated with fewer complications and IPCs reduced the number of invasive pleural procedures required. Patient preference and circumstances should be considered in selecting the intervention in this cohort.

Nonmalignant Pleural Effusions

“…84 Secondary outcomes, including quality of life and pleurodesis rate within 12 weeks (only 13% in the IPC and 6% in the TT branch) also revealed a relative equivalence between groups. 83 Markedly, a greater proportion of patients had at least one adverse event in the IPC group (59 vs. 37%), though the frequency of serious adverse events was similar. Conversely, TT failed in 17% of patients, thus requiring additional invasive procedures, but IPC succeeded in all.…”

“…To date, the REDUCE study is the only RCT that has evaluated the efficacy of IPCs in refractory NMPE compared with TT. 83 The authors randomized 68 patients (46 HF, 16 HH, and 6 renal failures) to IPC (n ¼ 33) or TT (n ¼ 35). For the primary outcome of mean breathlessness score via visual analog scale (VAS) over 12 weeks, no significant differences were observed between IPC (39.7 mm) and TT (45 mm) approaches.…”

Hepatic Hydrothorax: A Narrative Review

“…Infection rates were between 5 and 35%, with associated mortality (where reported) between 0 and 3.2% [57][58][59][60][61][62]. Notably, Walker et al performed the only randomized controlled trial to date of IPCs in refractory transudative effusions [63]. In this study, 220 patients were screened, leading to the randomization of 33 patients to undergo IPC insertion and 35 patients to undergo serial thoracocenteses.…”

Indwelling pleural catheters: evidence for and management

“…Evaluation of the role of IPCs in those with non-malignant effusions in terms of quality of life, breathlessness and complication rates. There have been some small but significant trials,23 but more multicentre prospective data are urgently required.…”