The REBALANCE-HF trial at HFSA 2023 reveals that right greater splanchnic nerve ablation was well-tolerated and safe in patients with HFpEF, with additional analysis shedding light on the proportion of responders to the procedure.
The REBALANCE-HF trail are offering clinicians with new insight into the safety, tolerability, and potential benefits of right greater splanchnic nerve ablation in patients with heart failure with preserved ejection fraction (HFpEF).
Presented at the Heart Failure Society of America (HFSA) 2023 Annual Scientific Meeting, results of the trial suggest 55% of patients were considered responders to the endovascular ablation procedure, with these patients experiencing clinical and statistical improvements in quality of life, NTproBNP, and 6-minute walk test at 6 months and trending towards significance at 1 year.
“[Splanchnic Ablation for Volume Management] utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients,” said principal investigator Sanjiv Shah, MD, advanced heart failure specialist and director of research at the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine.2 "These results show that HFpEF patients who are able to augment cardiac output during exertion and those without advanced structural heart disease may benefit most from [Splanchnic Ablation for Volume Management].”
Billed as the largest randomized controlled, blinded, feasibility device trial in patients with HFpEF to date, REBALANCE-HF was launched with the intent of exploring the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve in patients with HFpEF. The primary outcome of interest for the trial was the reduction in mean pulmonary capillary wedge pressure (PWCP) at 1-month relative to baseline, which investigators noted evaluated as a repeated measure at legs-up and exercise. Secondary endpoints of interest included change in KCCQ score from baseline, change in 6-minute walk test from baseline, incidence of heart failure hospitalizations through 12 months, and reduction in PWCP for each stage of exercise.1,2
A total of 116 patients were enrolled across 18 sites. These patients were randomized to greater right splanchnic nerve ablation with the Satera™ Ablation System or a sham procedure. Investigators noted the mean procedure time among the ablation group was 53 minutes and there was a 98% procedural success rate.1
Relative to their counterparts in the sham group, results suggested those randomized to greater splanchnic nerve ablation experienced a 13-point improvement in KCCQ-OSS at 6 months in treatment (P =.02), a 36-meter improvement in 6-minute walk test at 6 months (P=.08), and a 39% relative improvement in NT-proBNP at 6 months sham (P=.10). Further analysis suggested those randomized to greater splanchnic nerve ablation experienced a -4.5 mmHg reduction in PCWP at 1 month compared to a peak PCWP of -1.6 mmHg for sham (P=.10).1
Investigators noted the identification of a responder group, which they purport makes up 55% of the study population. According to investigators, responders can be identified using standard echocardiography and orthostasis measurements.1
"The favorable hemodynamics and improvements in clinical symptoms in this responder population versus the sham group is promising. Although we need additional data to confirm the results, the easy-to-perform SAVM procedure has the potential to become a front-line interventional procedure and change how we treat HFpEF patients, a notoriously complex population that makes up at least 50% of heart failure patients," said study investigator Marat Fudim, MD, MHS, advanced heart failure specialist at Duke University Medical Center, who presented the data at HFSA 2023.2