EASE-TAVR Study: Guided Decongestion Enhances Quality of Life for Severe Aortic Stenosis Patients
Austria: A recent randomized controlled trial, the EASE-TAVR study, has revealed promising insights into managing fluid overload (FO) in patients with severe aortic stenosis (AS). Conducted to assess the efficacy of quantitatively guided decongestive treatment, the study, published in JACC: Cardiovascular Interventions, highlights the advantages of a structured approach to post-transcatheter aortic valve replacement (TAVR) management.
The researchers revealed that in patients with severe AS and concurrent FO, a quantitatively guided decongestive treatment approach, combined with enhanced management following TAVR, led to better outcomes and improved quality of life than traditional management based solely on clinical judgment.
Fluid overload is a common and serious complication in patients with severe AS, often leading to increased morbidity and decreased quality of life. FO patients with severe AS face a heightened risk of heart failure and mortality following valve replacement, a risk that can be objectively assessed using bioimpedance spectroscopy (BIS). Considering this, Christian Nitsche, Department of Internal Medicine 2, Division of Cardiology, Medical University of Vienna, Vienna, Austria, and colleagues hypothesized that in patients with aortic stenosis and concurrent fluid overload, BIS-guided decongestion could enhance prognosis and quality of life after TAVR.
This randomized controlled trial involved 232 patients with severe aortic stenosis scheduled for TAVR. Following established criteria, fluid overload was evaluated using a portable whole-body BIS device (≥1.0 L and ≥7%). Among the patients identified with FO (n = 111), they were randomly assigned in a 1:1 ratio to receive either BIS-guided decongestion (n = 55) or decongestion based solely on clinical judgment (n = 56) after TAVR. The 121 patients without FO acted as a control group.
The primary outcome measured was a composite of hospitalization for heart failure and all-cause mortality within 12 months, while the secondary outcome focused on changes in the Kansas City Cardiomyopathy Questionnaire from baseline to 12 months.
The study led to the following findings:
- The occurrence of the primary endpoint at 12 months was significantly lower in the BIS-guided versus the non-BIS-guided decongestion group (12.7%, all deaths versus [32.1%, nine hospitalizations for heart failure and nine deaths]; HR: 0.36; absolute risk reduction = −19.4%).
- Outcomes in the BIS-guided decongestion group were identical to the euvolemic control group.
- BIS-guided decongestion was also associated with a higher increase in the Kansas City Cardiomyopathy Questionnaire score from baseline than the non–BIS-guided decongestion.
"EASE-TAVR represents the first randomized controlled trial demonstrating that quantitatively guided decongestive treatment, along with intensified management, can enhance the quality of life and lower the risk of heart failure hospitalization and mortality in patients with severe aortic stenosis and concurrent fluid overload following valve replacement," the researchers concluded.
Reference:
Halavina, K., Koschutnik, M., Donà , C., Autherith, M., Petric, F., Röckel, A., Spinka, G., Danesh, D., Puchinger, J., Wiesholzer, M., Mascherbauer, K., Heitzinger, G., Dannenberg, V., Koschatko, S., Jantsch, C., Winter, M., Goliasch, G., Kammerlander, A. A., Bartko, P. E., . . . Nitsche, C. (2024). Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR): A Randomized Controlled Trial. JACC: Cardiovascular Interventions, 17(17), 2054-2066. https://doi.org/10.1016/j.jcin.2024.06.022
