Ablation of right greater splanchnic nerve may benefit in HFpEF
Endovascular ablation of the right greater splanchnic nerve improved quality of life and exercise capacity in patients with HF with preserved ejection fraction, according to findings from a first-in-human study.
Sanjiv J. Shah, MD, the Neil J. Stone, MD, Professor of Cardiology and director of the Institute for Augmented Intelligence in Medicine – Center for Deep Phenotyping and Precision Therapeutics at Northwestern University Feinberg School of Medicine, presented results from the trial of the greater splanchnic nerve ablation system (Satera, Axon Therapies) at the virtual Heart Failure Society of American Scientific Meeting.
He said patients with HFpEF often have elevated pulmonary capillary wedge pressure on exercise, and the excess blood volume that causes it may come from the splanchnic vascular bed.
The system “seeks to restore volume balance, stop disease progression and improve heart failure symptoms by selectively ablating the neural pathway carrying information from the chronically hyperactive sympathetic nervous system to the splanchnic vascular bed,” he said.
The procedure does not require an implant and can be done on an outpatient basis, he said, noting absence of the right greater splanchnic nerve has not been an issue in treatments for patients with abdominal pain.
For the first-in-human safety study, the researchers performed ablation of the right greater splanchnic nerve on 11 patients (mean age, 70 years; 73% women) with chronic HFpEF and elevated pulmonary capillary wedge pressure. All procedures were successful.
The cohort had improved NYHA class and Kansas City Cardiomyopathy Questionnaire overall score at 1 month and 3 months (P < .05 for all), Shah said.
Mean 6-minute walk distance improved from 273 m at baseline to 342 m at 1 month and 347 m at 3 months (P < .05 for both), while N-terminal pro-B-type natriuretic peptide levels declined from 1,292 pg/mL at baseline to 627 pg/mL at 3 months (P < .05), he said.
No patients had orthostatic hypotension or worsening HF, and four had procedure-related adverse events, all of which were resolved without sequelae, he said.
The study and a previous study of surgical ablation of the right greater splanchnic nerve “demonstrate that permanent right greater splanchnic nerve ablation in HFpEF is well tolerated and results in clinically meaningful improvements in quality of life and exercise capacity,” Shah said.
The next step, he said, is the REBALANCE-HF phase 2 trial, which is scheduled to begin enrolling in January.
“These strategies such as splanchnic denervation have the potential to improve hemodynamics, even though they don’t really modify the myocardium,” Margaret M. Redfield, MD, professor of medicine and chair of the division of circulatory failure in the department of cardiology at Mayo Clinic in Rochester, Minnesota, said in a discussant presentation. “They are certainly worthy of continued study.”
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Shah SJ, et al. Late-breaking clinical trials II. Presented at: Heart Failure Society of America Scientific Meeting; Sept. 30-Oct. 6, 2020 (virtual meeting).