Valvular & structural heart diseaseRandomised controlled trial
Long-Term Outcomes of Targeted Volume Overload Management in Patients With Severe Aortic Stenosis
- randomized trial
- 1:1 randomization
- euvolemic control group
- 36-month follow-up
Authors' conclusion
In patients with severe AS and VO, outcome benefits of BIS-targeted decongestive treatment persist up to 3 years after TAVR.
Study context
- Population
- Patients with severe aortic stenosis (AS) scheduled for transcatheter aortic valve replacement (TAVR), with or without volume overload (VO) defined by bioimpedance spectroscopy (BIS) (≥1.0 L and/or ≥7%)BIS-guided decongestion 55 · decongestion by clinical judgment alone 56 · euvolemic control group (without VO) 121
- Participants
- 55 / 56 / 121
- Comparison
- BIS-guided decongestion vs decongestion as per clinical judgment alone
- BIS-guidedn = 55
- non-BIS-guidedn = 56reference
- euvolemic control groupn = 121
- Primary endpoint
- Composite of:
- Heart failure hospitalization (HFH)
- All-cause death
- Follow-up
- 36 months
Primary result
As reported in the abstract
Hazard ratio
0.40
95% CI 0.20–0.79
By group
BIS-guided vs non-BIS-guided
HR 0.40 (95% CI 0.20–0.79)
Secondary outcomes
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Mortality · nonsignificant | 0.54 (0.26–1.14) | ||
| 0.20.5125Hazard ratio (log scale) |
| Outcome | BIS-guided | non-BIS-guided | euvolemic control group | Estimate | P value |
|---|---|---|---|---|---|
| Cumulative incidence of first HFH | 3.6% (95% CI 0.7–11.2) | 25.0% (95% CI 14.5–37.0) | Not reported in the abstract | ||
| HFH frequency · reduced HFH frequency with BIS-guided | 28 per 1,000 patient years | 173 per 1,000 patient years | Not reported in the abstract | P < 0.001 |
Diuretic doses · throughout the entire study
- Higher diuretic doses in the BIS-guided group compared to the non-BIS-guided group
Original publication
Long-Term Outcomes of Targeted Volume Overload Management in Patients With Severe Aortic Stenosis. JACC Adv. Published 1 April 2026. doi:10.1016/j.jacadv.2026.102705
Summarised from the published abstract; every number is checked against it