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Randomized Controlled Trial
. 2025 Apr 22;151(16):1150-1161.
doi: 10.1161/CIRCULATIONAHA.124.073521. Epub 2025 Apr 1.

A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

Signe Glargaard  1 , Jakob Hartvig Thomsen  1   2 , Christian Tuxen  1 , Matias Greve Lindholm  3 , Christian Axel Bang  3 , Morten Schou  4   2 , Kasper Iversen  4   5   2 , Rasmus Vedby Rasmussen  4 , Brian Bridal Løgstrup  6   7 , Søren Vraa  8 , Nis Stride  9 , Ekim Seven  10 , Anders Barasa  10   11 , Marlene Tofterup  12 , Dan Eik Høfsten  13 , Kasper Rossing  13   2 , Lars Køber  13   2 , Finn Gustafsson  13   2 , Jens Jakob Thune  1   2
Affiliations
Randomized Controlled Trial

A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

Signe Glargaard et al. Circulation. .

Abstract

Background: TAP-IT (Thoracentesis to Alleviate Cardiac Pleural Effusion-Interventional Trial) investigated the effect of therapeutic thoracentesis in addition to standard medical therapy in patients with acute heart failure and sizeable pleural effusion.

Methods: This multicenter, unblinded, randomized controlled trial, conducted between August 31, 2021, and March 22, 2024, included patients with acute heart failure, left ventricular ejection fraction ≤45%, and non-negligible pleural effusion. Patients with very large effusions (more than two-thirds of the hemithorax) were excluded. Participants were randomly assigned 1:1 to upfront ultrasound-guided pleural pigtail catheter thoracentesis in addition to standard medical therapy or standard medical therapy alone. The primary outcome was days alive out of the hospital over the following 90 days; key secondary outcomes included length of admission and 90-day all-cause mortality. All outcomes were analyzed according to the intention-to-treat principle.

Results: A total of 135 patients (median age, 81 years [25th; 75th percentile, 75; 83]; 33% female; median left ventricular ejection fraction, 25% [25th; 75th percentile, 20%; 35%]) were randomized to either thoracentesis (n=68) or standard medical therapy (n=67). The thoracentesis group had a median of 84 days (77; 86) alive out of the hospital over the following 90 days compared with 82 days (73; 86) in the control group (P=0.42). The mortality rate was 13% in both groups, with no difference in survival probability (P=0.90). There were no differences in the duration of the index admission (control group median, 5 days [3; 8]; thoracentesis group median, 5 days [3; 7], P=0.69). Major complications occurred in 1% of thoracenteses performed during the study period.

Conclusions: For patients with acute heart failure and pleural effusion, a strategy of upfront routine thoracentesis in addition to standard medical therapy did not increase days alive out of the hospital for 90 days, all-cause mortality, or duration of index admission. The current findings lay the groundwork for future research to confirm the results.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05017753.

Keywords: heart failure; pleural effusion; thoracentesis.

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Conflict of interest statement

Dr Bang reports congress travel, speaker, and advisory board funding from Boehringer Ingelheim; speaker and congress travel funding from Novo Nordisk; and congress travel funding from Orion Pharma and Bayer. Dr Schou reports lecture fees from Novo Nordisk, Novartis, AstraZeneca, and Boehringer Ingelheim. Drs Løgstrup and Vraa report speaker funding from Boehringer Ingelheim, Novartis, and AstraZeneca. Dr Stride reports advisory board and congress travel funding from Boehringer Ingelheim and AstraZeneca. Dr Køber reports speaker honoraria from AstraZeneca, Boehringer, Novartis, and Novo Nordisk. Dr Gustafsson reports serving as an advisor for Abbott, Bayer, AstraZeneca, Pfizer, Alnylam, Ionis, Boehringer Ingelheim, AdjuCor, and Corwave, and as a speaker for Novartis, all outside the current work. Dr Thune reports congress travel and honoraria for lectures from AstraZeneca and honoraria for lectures from BMS. Drs Glargaard, Thomsen, Tuxen, Lindholm, Iversen, Rasmussen, Seven, Barasa, Tofterup, Høfsten, and Rossing report no disclosures.

Figures

Figure 1.
Figure 1.
CONSORT diagram of patient flow. CONSORT indicates Consolidated Standards of Reporting Trials; eGFR, estimated glomerular filtration rate; KCCQ, 23-item Kansas City Cardiomyopathy Questionnaire; and LVEF, left ventricular ejection fraction. Created with BioRender.com.
Figure 2.
Figure 2.
Distribution of days alive out of the hospital through 90 days according to randomization group. The histogram shows the distribution of the primary outcome of days alive out of the hospital through 90 days according to allocated treatment group. A, Control group. B, Thoracentesis group. The vertical dashed lines indicate the median values reported with the 25th and 75th percentile. Comparison by the Wilcoxon-Mann-Whitney test is given as the Mann-Whitney parameter with 95% CI. A 95% CI including 0.5 indicates no difference.
Figure 3.
Figure 3.
Ninety-day survival probability and absolute risk of first all-cause hospitalization or all-cause death. Survival probability (A) and absolute risk of first all-cause hospitalization or all-cause death (B) during the 90 days after randomization according to the allocated treatment group. Comparisons are by log-rank test.
Figure 4.
Figure 4.
Patient-reported quality of life assessed by the Kansas City Cardiomyopathy Questionnaire 14 days after discharge and 90 days after randomization. Comparison of clinical summary score (CSS), overall summary score (OSS), and total symptom score (TSS) according to allocated treatment group 14 days after discharge (A) and 90 days after randomization (B). The dark horizontal lines within the boxes indicate the median values. The upper and lower edges of the boxes correspond to the 75th and 25th percentiles, respectively. The whiskers extend from the edges to the largest and smallest value within ±1.5 times the interquartile range, and any data points beyond this range are represented as dots, indicating outliers. P values are from the Wilcoxon–Mann-Whitney test. KCCQ indicates Kansas City Cardiomyopathy Questionnaire.
See this image and copyright information in PMC

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