The Silent And Apparent Neurological Injury In Transcatheter Aortic Valve Implantation (Sanity) Study

Abstract

Background and aim(s):Breathlessness is the most common symptom of pleural effusion and the commonest reason for effusion drainage. However, mechanisms underpinning breathlessness in patients with pleural effusion are poorly understood and symptom response following effusion drainage is variable. The PLEASE Study aims to prospectively identify i) factors associated with breathlessness in pleural effusion and ii) factors that predict symptomatic benefits after fluid drainage.Method: 150 subjects with symptomatic pleural effusions undergoing therapeutic pleural drainage will be recruited. The following tests will be performed pre-and 24 hours post-drainage: 1) Patient and effusion-related characteristics; 2) Degree of breathlessness using Visual Analogue Score (VAS) and Dyspnea-12 (D-12) Questionnaire; 3) Functional capacity with six-minute walk test; 4) Lung function testing; and 5) Diaphragm mechanics using ultrasound. Results:The median age of the 50 recruited subjects was 70 (IQR 59-76) and 58% were male. Most (90%) completed the study. The majority of effusions were malignant (60%) and of moderate size, grade 3 of 5 (48%). Median drainage volume was 1450 mL (847-2303 mL). Breathlessness scores significantly improved (p < 0.01) after pleural fluid drainage in the overall cohort; median improvement of 28 mm for VAS (MCID 14 mm) and −9 points for D-12 scores. However a sizable portion of patients had no symptom relief; VAS score was unchanged or worsened in 26% (n = 12) and D-12 unchanged or worsened in 13% (n = 6). Improvement in breathlessness strongly correlated with severity of breathlessness before drainage; pre-drainage VAS (r = −0.670) and D12 (r = −0.617). Functional capacity (six-minute walk distance) and lung function improved post-drainage. Diaphragm mechanics were often abnormal before drainage, but normalized afterwards. Conclusions:Pleural effusion drainage improves breathlessness in~80% of cases as well as functional capacity, lung function and diaphragm shape and function. Symptom benefits correlate strongly with severity of breathlessness at baseline.