TY - JOUR
T1 - Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR)
T2 - A Randomized Controlled Trial
AU - Halavina, Kseniya
AU - Koschutnik, Matthias
AU - Donà, Carolina
AU - Autherith, Maximilian
AU - Petric, Fabian
AU - Röckel, Anna
AU - Spinka, Georg
AU - Danesh, Daryush
AU - Puchinger, Jürgen
AU - Wiesholzer, Martin
AU - Mascherbauer, Katharina
AU - Heitzinger, Gregor
AU - Dannenberg, Varius
AU - Koschatko, Sophia
AU - Jantsch, Charlotte
AU - Winter, Max-Paul
AU - Goliasch, Georg
AU - Kammerlander, Andreas A
AU - Bartko, Philipp E
AU - Hengstenberg, Christian
AU - Mascherbauer, Julia
AU - Nitsche, Christian
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/9/9
Y1 - 2024/9/9
N2 - 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.
AB - 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.
KW - Humans
KW - Aortic Valve Stenosis/physiopathology
KW - Female
KW - Male
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Quality of Life
KW - Treatment Outcome
KW - Aged
KW - Aged, 80 and over
KW - Severity of Illness Index
KW - Risk Factors
KW - Time Factors
KW - Heart Failure/physiopathology
KW - Dielectric Spectroscopy
KW - Water-Electrolyte Imbalance/physiopathology
KW - Aortic Valve/surgery
KW - Predictive Value of Tests
KW - Recovery of Function
KW - Prospective Studies
KW - cardiac decompensation
KW - TAVR
KW - congestion
KW - outcome
KW - volume status
UR - http://www.scopus.com/inward/record.url?scp=85202522070&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2024.06.022
DO - 10.1016/j.jcin.2024.06.022
M3 - Journal article
C2 - 39260962
SN - 1936-8798
VL - 17
SP - 2054
EP - 2066
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 17
ER -