Key result
Indwelling pleural catheters with talc require fewer procedures vs therapeutic thoracentesis, but trial feasibility failed.
Why the study?
Does indwelling pleural catheter insertion with daily drainage and talc instillation reduce pleural procedures compared to recurrent therapeutic thoracentesis in adults with refractory heart failure-related pleural effusions?
RCT (n=18)
Open-label
1:1
Yes
Does indwelling pleural catheter insertion with daily drainage and talc instillation reduce pleural procedures compared to recurrent therapeutic thoracentesis in adults with refractory heart failure-related pleural effusions?
A full-scale trial of indwelling pleural catheters for heart failure-related pleural effusions is not feasible due to recruitment challenges and high attrition in a frail population.
Background Heart failure is the most common cause of pleural effusions. For patients with refractory HF-related pleural effusions (HFPE), repeated therapeutic thoracentesis (TT) is standard care. In malignant pleural effusions, indwelling pleural catheters (IPCs) combined with talc instillation improve pleurodesis rates, but their role in HFPE remains uncertain. Aims To evaluate the feasibility of conducting a full-scale multicentre randomised trial comparing recurrent TT with IPC insertion, daily drainage, and talc instillation across 13 UK centres. Feasibility was defined a priori as achieving 80% of the target sample size (40 patients) and enrolling ≥50% of eligible patients. Methods Adults with refractory HFPE were assessed for eligibility and randomised 1:1 to TT or IPC with daily drainage and talc. The trial was non-blinded, and participants were followed for 12 weeks. Results Among 231 patients screened, 43 were eligible; most exclusions reflected insufficient effusion size or symptom severity, or improvement following medical optimisation. Eighteen patients (42% of those eligible) were randomised (median age 79; IQR 70–83; Clinical Frailty Score 6; IQR 5–6). Eight participants completed follow-up; five died, and five withdrew. Pleurodesis occurred in 3/8 (38%) in the IPC/talc arm and in none of the TT arm. The IPC/talc arm required fewer total pleural procedures (1.0 versus 2.0; p<0.001) but experienced a higher complication rate. Conclusions Feasibility targets were not met. Improvements in medical management may have reduced the need for invasive treatment of HFPE, with many screened patients responding to medical therapy alone. Further challenges to recruitment included the elderly, polymorbid and frail nature of the cohort.
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Welch et al. (2026) conducted an RCT in Refractory heart failure-related pleural effusions (n=18). Indwelling pleural catheter with daily drainage and talc instillation vs. Recurrent therapeutic thoracentesis was evaluated on Feasibility (achieving 80% of target sample size and enrolling ≥50% of eligible patients). Indwelling pleural catheters with talc required fewer pleural procedures than therapeutic thoracentesis (1.0 vs 2.0; p<0.001), but trial feasibility targets were not met.
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