Long-Term Outcomes of Targeted Volume Overload Management in Patients With Severe Aortic Stenosis

Patients with severe aortic stenosis (AS) and volume overload (VO) remain at an increased risk for heart failure and death after transcatheter aortic valve replacement (TAVR). The EASE-TAVR (Bioimpedance guided management of patients scheduled for transcatheter aortic valve replacement) trial demonstrated that decongestive treatment by bioimpedance spectroscopy (BIS) improves 1-year outcomes post-TAVR, whereas long-term effects are unknown.

This study aimed to investigate outcomes of BIS-guided decongestion in AS patients at 36 months after TAVR.

EASE-TAVR randomized patients with severe AS and VO defined by BIS (≥1.0 L and/or ≥7%) 1:1 into: 1) BIS-guided decongestion (n = 55); or 2) decongestion by clinical judgment alone (n = 56) post-TAVR. Patients without VO (n = 121) served as the euvolemic control group. BIS-guided decongestion was performed for 12 months. The primary endpoint was a composite of heart failure hospitalization (HFH) and all-cause death at 36 months. The secondary endpoints included separate analyses of primary endpoint components and frequency of HFH.

Patients in the BIS-guided group had higher diuretic doses compared to the non-BIS-guided group throughout the entire study. At 36 months, the primary endpoint occurred in 21.8% in the BIS-guided and 46.4% in the non-BIS-guided group yielding a hazard reduction of 60% (HR: 0.40; 95% CI: 0.20-0.79). BIS-guided decongestion led to a reduced cumulative incidence of first HFH (3.6%; 95% CI: 0.7-11.2 vs 25.0%; 95% CI: 14.5-37.0), a reduced HFH frequency (28 vs 173 per 1,000 patient years; P < 0.001), and showed a nonsignificant reduced mortality hazard (HR: 0.54; 95% CI: 0.26-1.14) compared to decongestion as per clinical judgment alone.

In patients with severe AS and VO, outcome benefits of BIS-targeted decongestive treatment persist up to 3 years after TAVR.