Key result
Vagal nerve stimulation shows no clinical benefit in large controlled trials for HFrEF.
Why the study?
Despite strong pathophysiological rationale and promising early studies, two large controlled trials of vagal nerve stimulation in heart failure failed to demonstrate expected benefit, likely due to an incomplete understanding of autonomic electrical modulation and dosing.
Does vagal nerve stimulation improve clinical outcomes in patients with heart failure with reduced ejection fraction?
Does vagal nerve stimulation improve clinical outcomes in patients with heart failure with reduced ejection fraction?
While vagal nerve stimulation has a strong pathophysiological rationale for HFrEF, large clinical trials have so far failed to show significant clinical benefit, highlighting the need for better understanding of dosing and patient selection.
Large trials advise against vagal nerve stimulation for HFrEF; leaves open optimal dosing and patient selection for future studies.
Vagal nerve stimulation (VNS) has a strong pathophysiological rationale as a potentially beneficial treatment for heart failure with reduced ejection fraction. Despite several promising preclinical studies and pilot clinical studies, the two large, controlled trials-NECTAR-HF and INOVATE-HF-failed to demonstrate the expected benefit. It is likely that clinical application of VNS in phase III studies was performed before a sufficient degree of understanding of the complex pathophysiology of autonomic electrical modulation had been achieved, therefore leading to an underestimation of its potential benefit. More knowledge on the complex dose-response issue of VNS (i.e., pulse amplitude, frequency, duration and duty cycle) has been gathered since these trials and a new randomized study is currently underway with an adaptive design and a refined approach in an attempt to deliver the proper dose to a more selected group of patients.
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Dusi et al. (2021) conducted a review in Heart failure with reduced ejection fraction (HFrEF). Vagal nerve stimulation (VNS) was evaluated. Vagal nerve stimulation failed to demonstrate the expected clinical benefit in large controlled trials for heart failure with reduced ejection fraction, despite promising preclinical and pilot studies.
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