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

BACKGROUND: 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. OBJECTIVES: This study aimed to investigate outcomes of BIS-guided decongestion in AS patients at 36 months after TAVR. METHODS: 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. RESULTS: 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. CONCLUSIONS: In patients with severe AS and VO, outcome benefits of BIS-targeted decongestive treatment persist up to 3 years after TAVR.