Percutaneous right-sided greater splanchnic nerve (GSN) ablation in patients with heart failure with preserved ejection fraction (HFpEF) improves 12-month outcomes according to study findings published in the Journal of the American College of Cardiology: Heart Failure.
Researchers sought to investigate the first in-human use of splanchnic ablation for volume management for right-sided GSN denervation. They initiated a single-arm, open-label prospective trial (ClinicalTrials.gov Identifier: NCT04287946) of right-sided GSN ablation in patients with HFpEF between January 2020 and March 2020 at the Tbilisi Heart and Vascular Clinic (Tbilisi, Republic of Georgia). They included 11 patients with HFpEF (aged 70±8 years; 8 women), an ejection fraction of 50% or more, elevated pulmonary capillary wedge pressure, and functional class II or III symptoms. Follow-up for splanchnic ablation for volume management included echocardiography, Kansas City Cardiomyopathy Questionnaire, and 6-minute walk test at 1, 3, 6, and 12 months.
Clinical improvements are seen at 1 month and are sustained through 12 months. The 6-minute walk test results improve from baseline (292±82 m) to 1 month (341±88 m) to 12 months (359±75m) (P <.05). The Kansas City Cardiomyopathy Questionnaire scores improve from baseline median (48, IQR 35-52) to 1 month (65, IQR 58-77) to 12 months (80, IQR 77-88) (P <.05), although these are not considered clinically significant gains. The N-terminal pro-brain natriuretic peptide decreases from baseline mean (1292±1186 pg/mL) to 1 month (1202±797 pg/mL; P =.585) to 12 months (379±165 pg/mL; P =.039).
Trial limitations include the lack of a control group and blinding. There is also no minimum time from trial enrollment to procedure, which may have resulted in compliance bias. Additionally, change in splanchnic vascular capacitance is not directly evaluated.
“In this open-label, single-arm feasibility study, right-sided GSN ablation was safe and improved mostly subjective clinical metrics in patients with HFpEF over 12 months,” the study authors wrote.
Disclosure: This research was supported by Axon Therapies. Please see the original reference for a full list of disclosures. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Fudim M, Zirakashvili T, Shaburishvili N, et al. Transvenous right greater splanchnic nerve ablation in heart failure and preserved ejection fraction. JACC Heart Fail. Published online July 6, 2022. doi:10.1016/j.jchf.2022.05.009