In heart failure with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention.
Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial.
The open-label (roll-in) arm of REBALANCE-HF will enroll up to 30 patients, followed by the randomized, sham-controlled portion of the trial (up to 80 additional patients). Patients with HF, LVEF ≥50%, and invasive peak exercise PCWP ≥25 mmHg underwent SAVM. Baseline and follow-up assessments included resting and exercise PCWP, NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test, and NTproBNP. Efficacy and safety were assessed at 1 and 3 months.
Here we report on the first 18 patients with HFpEF have been enrolled into the roll-in, open-label arm of the study across 9 centers; 14 (78%) female; 16 (89%) NYHA class III; and median (IQR) age 75.2 (68.4-81) years, LVEF 61.0 (56.0-63.2)%, and average (SD) 20W exercise PCWP 36.4 (±8.6) mmHg. All 18 patients were successfully treated. Three non-serious moderate device/procedure-related adverse events were reported. At 1-month, the mean PCWP at 20W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p<0.01), NYHA class improved by at least 1 class in 33% of patients (p=0.02) and KCCQ score improved by 22.1 points (95% CI 9.4-34.2) (p<0.01).
The preliminary open-label results from the multi-center REBALANCE-HF roll-in cohort support the safety and efficacy of SAVM in HFpEF. The findings require confirmation in the ongoing randomized, sham-controlled portion of the trial. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.