A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

Signe Glargaard; Jakob Hartvig Thomsen; Christian Tuxen; Matias Greve Lindholm; Christian Axel Bang; Morten Schou; Kasper Iversen; Rasmus Vedby Rasmussen; Brian Bridal Løgstrup; Søren Vraa; Nis Stride; Ekim Seven; Anders Barasa; Marlene Tofterup; Dan Eik Høfsten; Kasper Rossing; Lars Køber; Finn Gustafsson; Jens Jakob Thune

doi:10.1161/CIRCULATIONAHA.124.073521

A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

Signe Glargaard^*
, Jakob Hartvig Thomsen
, Christian Tuxen
, Matias Greve Lindholm
, Christian Axel Bang
, Morten Schou
, Kasper Iversen
, Rasmus Vedby Rasmussen
, Brian Bridal Løgstrup
, Søren Vraa
, Nis Stride
, Ekim Seven
, Anders Barasa
, Marlene Tofterup
, Dan Eik Høfsten
, Kasper Rossing
, Lars Køber
, Finn Gustafsson
, Jens Jakob Thune

^*Corresponding author for this work

Cardiology

Research output: Contribution to journal › Article › Research › peer-review

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.

Original language	English
Pages (from-to)	1150-1161
Number of pages	12
Journal	Circulation
Volume	151
Issue number	16
Early online date	1 Apr 2025
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.124.073521
Publication status	Published - 22 Apr 2025

Funding

This study was funded by the Independent Research Fund Denmark (grant 1030-00131B), Hartmann Foundation (grant A36846), Per Henriksen Fund, and Research Foundation at Copenhagen University Hospital-Bispebjerg and Frederiksberg, Denmark. No funding agency was involved in developing the methodology or conducting, analyzing, or reporting on the trial.

Funders	Funder number
Independent Research Fund Denmark	1030-00131B
Simon Fougner Hartmann Family Fund	A36846
Per Henriksen's Fund
Copenhagen University Hospital

Keywords

Acute Disease
Aged
Aged, 80 and over
Female
Heart Failure/therapy
Humans
Male
Pleural Effusion/therapy
Stroke Volume
Thoracentesis/methods
Treatment Outcome
Heart failure
Pleural effusion
Thoracentesis

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10.1161/CIRCULATIONAHA.124.073521Licence: CC BY-NC-ND

Cite this

Glargaard, S., Hartvig Thomsen, J., Tuxen, C., Lindholm, M. G., Bang, C. A., Schou, M., Iversen, K., Rasmussen, R. V., Løgstrup, B. B., Vraa, S., Stride, N., Seven, E., Barasa, A., Tofterup, M., Høfsten, D. E., Rossing, K., Køber, L., Gustafsson, F., & Thune, J. J. (2025). A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure. Circulation, 151(16), 1150-1161. https://doi.org/10.1161/CIRCULATIONAHA.124.073521

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title = "A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure",

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 = "Acute Disease, Aged, Aged, 80 and over, Female, Heart Failure/therapy, Humans, Male, Pleural Effusion/therapy, Stroke Volume, Thoracentesis/methods, Treatment Outcome, Heart failure, Pleural effusion, Thoracentesis",

author = "Signe Glargaard and \{Hartvig Thomsen\}, Jakob and Christian Tuxen and Lindholm, \{Matias Greve\} and Bang, \{Christian Axel\} and Morten Schou and Kasper Iversen and Rasmussen, \{Rasmus Vedby\} and L{\o}gstrup, \{Brian Bridal\} and S{\o}ren Vraa and Nis Stride and Ekim Seven and Anders Barasa and Marlene Tofterup and H{\o}fsten, \{Dan Eik\} and Kasper Rossing and Lars K{\o}ber and Finn Gustafsson and Thune, \{Jens Jakob\}",

year = "2025",

month = apr,

day = "22",

doi = "10.1161/CIRCULATIONAHA.124.073521",

language = "English",

volume = "151",

pages = "1150--1161",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "16",

}

Glargaard, S, Hartvig Thomsen, J, Tuxen, C, Lindholm, MG , Bang, CA, Schou, M, Iversen, K, Rasmussen, RV, Løgstrup, BB, Vraa, S, Stride, N, Seven, E, Barasa, A, Tofterup, M, Høfsten, DE, Rossing, K, Køber, L, Gustafsson, F & Thune, JJ 2025, 'A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure', Circulation, vol. 151, no. 16, pp. 1150-1161. https://doi.org/10.1161/CIRCULATIONAHA.124.073521

TY - JOUR

T1 - A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

AU - Glargaard, Signe

AU - Hartvig Thomsen, Jakob

AU - Tuxen, Christian

AU - Lindholm, Matias Greve

AU - Bang, Christian Axel

AU - Schou, Morten

AU - Iversen, Kasper

AU - Rasmussen, Rasmus Vedby

AU - Løgstrup, Brian Bridal

AU - Vraa, Søren

AU - Stride, Nis

AU - Seven, Ekim

AU - Barasa, Anders

AU - Tofterup, Marlene

AU - Høfsten, Dan Eik

AU - Rossing, Kasper

AU - Køber, Lars

AU - Gustafsson, Finn

AU - Thune, Jens Jakob

PY - 2025/4/22

Y1 - 2025/4/22

N2 - 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.

AB - 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.

KW - Acute Disease

KW - Aged

KW - Aged, 80 and over

KW - Female

KW - Heart Failure/therapy

KW - Humans

KW - Male

KW - Pleural Effusion/therapy

KW - Stroke Volume

KW - Thoracentesis/methods

KW - Treatment Outcome

KW - Heart failure

KW - Pleural effusion

KW - Thoracentesis

U2 - 10.1161/CIRCULATIONAHA.124.073521

DO - 10.1161/CIRCULATIONAHA.124.073521

M3 - Article

C2 - 40166829

SN - 0009-7322

VL - 151

SP - 1150

EP - 1161

JO - Circulation

JF - Circulation

IS - 16

ER -

A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure

Abstract

Funding

Keywords

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