Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE‐HF trial roll‐in cohort

Abstract

Aims In heart failure (HF) 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. Methods and results The open‐label (roll‐in) arm of REBALANCE‐HF will enrol up to 30 patients, followed by the randomized, sham‐controlled portion of the trial (up to 80 additional patients). Patients with HF, left ventricular ejection fraction (LVEF) ≥50%, and invasive peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg underwent SAVM. Baseline and follow‐up assessments included resting and exercise PCWP, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6‐min walk test, and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP). Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 18 patients with HFpEF that have been enrolled into the roll‐in, open‐label arm of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; and median (interquartile range) age 75.2 (68.4–81) years, LVEF 61.0 (56.0–63.2)%, and average (standard deviation) 20 W 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 20 W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p < 0.01), NYHA class improved by at least one class in 33% of patients (p = 0.02) and KCCQ score improved by 22.1 points (95% confidence interval 9.4–34.2) (p < 0.01). Conclusion The preliminary open‐label results from the multicentre 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.

August 2022 at a glance: focus on heart failure with preserved ejection fraction and cardiac amyloidosis

“…The open‐label (roll‐in) arm will enrol up to 30 patients, followed by a randomized, sham‐controlled phase. The preliminary open‐label results from the REBALANCE‐HF roll‐in cohort are reported in this issue 25 …”

“…The preliminary open-label results from the REBALANCE-HF roll-in cohort are reported in this issue. 25 Intramyocardial injection of mesenchymal stromal cells has shown benefits in ischaemic heart disease and HF. 26 The effects of CD34+ transendocardial cell therapy have been assessed in a prospective non-randomized pilot study enrolling 30 HFpEF patients who underwent cell transplantation and were followed for 6 months.…”

Novel Therapeutic Devices in Heart Failure

“…The visceral vascular bed is a natural reservoir of blood volume that can be quickly relocated for an urgent need (like hypovolemia, hemorrhage, or exercise). Redistribution of blood volume from the extra-thoracic compartments into the central circulation is believed to be a significant contributor to elevated filling pressures in HF patients, including HF with preserved ejection fraction (HFpEF) [ 8 ]. Modulation (blockage or partial blockage) of the splanchnic nerves (SNM) decreases sympathetic tone.…”

“…At least one NYHA class improvement was experienced by 39% of patients at 1 month and 50% at 3 months after the SNM procedure. This study reported three non-serious device-related adverse events (AE): HF decompensation due to periprocedural fluid overload, transient hypertension and back pain following ablation [ 8 ].…”

Restoring balance in heart failure with preserved ejection fraction

“…In this issue of the Journal, Fudim and colleagues report short‐term safety and efficacy outcomes from the open‐label roll‐in cohort of the REBALANCE‐HF trial which is evaluating SAVM for HFpEF 11 . The REBALANCE‐HF trial is a randomized study comparing SAVM with sham control, with planned enrollment of 60–90 patients with HFpEF.…”