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Randomized Controlled Trial
. 2024 Sep 9;17(17):2054-2066.
doi: 10.1016/j.jcin.2024.06.022.

Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial

Kseniya Halavina  1 , Matthias Koschutnik  1 , Carolina Donà  1 , Maximilian Autherith  1 , Fabian Petric  1 , Anna Röckel  1 , Georg Spinka  1 , Daryush Danesh  2 , Jürgen Puchinger  2 , Martin Wiesholzer  3 , Katharina Mascherbauer  1 , Gregor Heitzinger  1 , Varius Dannenberg  1 , Sophia Koschatko  1 , Charlotte Jantsch  1 , Max-Paul Winter  1 , Georg Goliasch  1 , Andreas A Kammerlander  1 , Philipp E Bartko  1 , Christian Hengstenberg  1 , Julia Mascherbauer  2 , Christian Nitsche  4
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Free article
Randomized Controlled Trial

Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial

Kseniya Halavina et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Fluid overload (FO) subjects patients with severe aortic stenosis (AS) to increased risk for heart failure and death after valve replacement and can be objectively quantified using bioimpedance spectroscopy (BIS).

Objectives: The authors hypothesized that in AS patients with concomitant FO, BIS-guided decongestion could improve prognosis and quality of life following transcatheter aortic valve replacement (TAVR).

Methods: This randomized, controlled trial enrolled 232 patients with severe AS scheduled for TAVR. FO was defined using a portable whole-body BIS device according to previously established cutoffs (≥1.0 L and/or ≥7%). Patients with FO (n = 111) were randomly assigned 1:1 to receive BIS-guided decongestion (n = 55) or decongestion by clinical judgment alone (n = 56) following TAVR. Patients without FO (n = 121) served as a control cohort. The primary endpoint was the composite of hospitalization for heart failure and/or all-cause death at 12 months. The secondary endpoint was the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire.

Results: The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided vs the non-BIS-guided decongestion group (7/55 [12.7%, all deaths] vs 18/56 [32.1%, 9 hospitalizations for heart failure and 9 deaths]; HR: 0.36; 95% CI: 0.15-0.87; absolute risk reduction = -19.4%). Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group (log-rank test, P = 0.7). BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline compared to non-BIS-guided decongestion (P = 0.001).

Conclusions: In patients with severe AS and concomitant FO, quantitatively guided decongestive treatment and associated intensified management post-TAVR was associated with improved outcomes and quality of life compared to decongestion by clinical judgment alone. (Management of Fluid Overload in Patients Scheduled for Transcatheter Aortic Valve Replacement [EASE-TAVR]; NCT04556123).

Keywords: TAVR; cardiac decompensation; congestion; outcome; volume status.

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Conflict of interest statement

Funding Support and Author Disclosures This study was supported by the Austrian Society of Cardiology. Dr Dannenberg has received consulting fees from Abbott; and has received educational grants from Edwards Lifesciences. Dr Kammerlander has received speaker fees from Bayer and Boehringer Ingelheim; has received advisory board honoraria from Boehringer Ingelheim; and has received research grants from Pfizer. Dr Hengstenberg has received proctoring/speaker fees from Boston Scientific and Edwards Lifesciences; and has received institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic). Dr Mascherbauer has received proctor fees from Abbott and Edwards Lifesciences; has received consulting fees from Boston Scientific, Edwards Lifesciences, and Shockwave Medical; and has received educational grants from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Nitsche has received speaker fees/institutional research grants from Pfizer; and has received advisory board honoraria from Prothena). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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