REBALANCE-HF: Encouraging results of GSN ablation in HFpEF

Preliminary data from the REBALANCE-HF roll-in cohort demonstrated positive safety and efficacy results of splanchnic ablation for volume management (SAVM) via greater splanchnic nerve (GSN) ablation for patients with heart failure and preserved ejection fraction (HFpEF). The procedure was associated with reductions in pulmonary capillary wedge pressure (PCWP) during exercise and improvements in the health status of patients.

“The splanchnic bed is the main blood volume reservoir of the body,” outlined Dr Marat Fudim (Duke Cardiology Clinic, NC, USA) [1]. “Since the activation of the sympathetic nervous system (SNS) recruits blood from this reservoir into the central circulating volume, which leads to elevation of filling pressures, ablation of the GSN may redistribute this blood to the periphery and relieve the symptoms of patients with HFpEF.”

The REBALANCE-HF study (NCT04592445) is currently randomising patients with HFpEF to right-sided GSN ablation or a sham procedure to analyse to efficacy and safety of this procedure. The primary endpoint is the change in pulmonary capillary wedge pressure (PCWP) at 1 month, in rest, with legs up, and during 20 W and peak exercise intensity. Additionally, 1-2 open-label roll-in patients were included at each site. Dr Fudim presented a first analysis and preliminary data of this roll-in cohort (n=18) [1,2].

One month post-GSN ablation, the mean PCWP was significantly improved during 20 W exercise (36.4 mmHg vs 28.9 mmHG; P<0.007) and peak exercise (39.5 vs 31.9; P<0.013). There was no significant difference between the mean resting state PCWP at baseline and 1 month (17.5 vs 26.7; P=0.417) or with legs up (23.2 vs 20.5; P=0.066). Notably, New York Heart Association (NYHA) functional class had improved by at least one class in 33% of the patients after 1 month, and KCCQ overall score was increased by an average 22.1 points (P<0.05). The 6-minute walk test and NT-proBNP levels had not improved after the ablation procedure. Concerning safety, 3 non-serious device-related adverse events were reported, with 1 case of acute HF decompensation, 1 case of transient hypertension during the procedure, and 1 patient experiencing back pain after ablation.

Although these preliminary results are promising, more data is needed before this approach can be applied in the real world. The randomised part of REBALANCE-HF will provide more information on the efficacy and safety of this ablation procedure in patients with HFpEF.

1. 
   
   1. Fudim M, et al. 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. LBT – Devices, Heart Failure 2022, 21–24 May, Madrid, Spain.
   2. Fudim M, et al. Eur J Heart Fail. 2022; May 22. Doi: 10.1002/ejhf.2559.

 

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Posted on 24 May, 202213 June, 2022