Valvular & structural heart diseaseRandomised controlled trial
Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR)
- Randomised controlled trial
- 1:1 randomisation
- euvolemic control cohort
Authors' conclusion
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.
Study context
- Population
- Patients with severe aortic stenosis (AS) scheduled for transcatheter aortic valve replacement (TAVR), with fluid overload by bioimpedance spectroscopy (BIS) (≥1.0 L and/or ≥7%)111 with fluid overload (FO) randomised
- Participants
- 232 patients
- Comparison
- BIS-guided decongestion vs decongestion by clinical judgment alone after TAVR
- BIS-guidedn = 55
- Clinical judgmentn = 56reference
- Euvolemic controln = 121
- Primary endpoint
- Composite of:
- Hospitalization for HF
- All-cause death
- Follow-up
- 12 months
Primary result
As reported in the abstract
Hazard ratio
0.36
95% CI 0.15–0.87
Events by treatment group
BIS-guided decongestion vs Non-BIS-guided decongestion
HR 0.36 (95% CI 0.15–0.87)
Secondary outcomes
Primary endpoint, BIS-guided vs euvolemic control
- Outcomes identical to euvolemic control (log-rank test)
- P = 0.7
Change in Kansas City Cardiomyopathy Questionnaire score · 12 months
- Higher increase with BIS-guided vs non-BIS-guided decongestion
- P = 0.001
Original publication
Management of Fluid Overload in Patients With Severe Aortic Stenosis (EASE-TAVR). JACC Cardiovasc Interv. Published 9 September 2024. doi:10.1016/j.jcin.2024.06.022
Summarised from the published abstract; every number is checked against it