Key result
BIS-guided decongestion reduces HF hospitalization or death ~64% versus clinical judgment alone.
Why the study?
Fluid overload increases risk for heart failure and death after valve replacement in severe aortic stenosis, leading investigators to test whether bioimpedance spectroscopy-guided decongestion improves outcomes and quality of life after TAVR.
Does BIS-guided decongestion reduce hospitalization for heart failure and/or all-cause death in patients with severe aortic stenosis and fluid overload following TAVR?
RCT (n=232)
1:1
Does BIS-guided decongestion reduce hospitalization for heart failure and/or all-cause death in patients with severe aortic stenosis and fluid overload following TAVR?
Effect estimate: HR 0.36 (95% CI 0.15-0.87)
Absolute Event Rate: 12.7% vs 32.1%
Quantitatively guided decongestion using bioimpedance spectroscopy significantly improves clinical outcomes and quality of life in patients with severe aortic stenosis and fluid overload post-TAVR.
Supports BIS-guided decongestion post-TAVR in fluid overload; extends quantitative guidance to severe aortic stenosis.
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).
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Halavina et al. (2024) conducted an RCT in Severe aortic stenosis (n=232). BIS-guided decongestion vs. Decongestion by clinical judgment alone was evaluated on Composite of hospitalization for heart failure and/or all-cause death at 12 months (HR 0.36, 95% CI 0.15-0.87). BIS-guided decongestion reduced heart failure hospitalization or all-cause death at 12 months compared to clinical judgment alone (12.7% vs 32.1%; HR 0.36; 95% CI 0.15-0.87).
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