REBALANCE-HF: Encouraging observations for splanchnic nerve ablation in HFpEF

Preliminary data from the REBALANCE-HF single arm roll-in cohort provided supportive safety observations for splanchnic ablation for volume management (SAVM) via greater splanchnic nerve (GSN) ablation for patients with heart failure with preserved ejection fraction (HFpEF). Patients who had the procedure were observed to have pulmonary capillary wedge pressure (PCWP) during exercise and improvements in the health status versus their baseline; however, randomised control assessments are still underway.

The splanchnic bed is the main blood volume reservoir of the body. Since the activation of the sympathetic nervous system recruits blood from this reservoir into the central circulating volume, which leads to elevated filling pressures, ablation of the GSN may redistribute this blood to the periphery and relieve the symptoms of patients with HFpEF.

Prof. Marat Fudim (Duke Cardiology Clinic, NC, USA) presented the preliminary 1-month observations from the single arm roll-in cohort (n=18) [1,2].

One month post-GSN ablation, the mean PCWP was significantly lower relative to baseline during 20W exercise (36.4 mmHg vs 28.9 mmHg; P<0.007) and peak exercise (39.5 vs 31.9; P<0.013). No significant difference was measured 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; see Figure). Notably, New York Heart Association (NYHA) functional class had improved by at least 1 class in 33% of the participants after 1 month, and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score increased by an average 22.1 points (P<0.05). The 6 minute walk test and NT-proBNP levels did not change after the ablation procedure.

Figure: Haemodynamic outcomes in the REBALANCE-HF trial [1]



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 participant 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.

The multicentre, prospective 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 PCWP at 1 month, in rest, with legs up, and during 20W and peak supine exercise intensity.

1. Fudim M, et al. REBALANCE-HF Roll in Cohort. LBT Devices, Heart Failure 2022, 21–24 May, Madrid, Spain.
2. Fudim M, et al. Eur J Heart Fail, May 22, 2022. DOI:10.1002/ejhf.2559.

 

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Posted on 28 July, 2022