Vagal nerve stimulation (VNS) does not reduce the rate of heart failure events or death in patients with chronic heart failure, according to research published in the Journal of the American College of Cardiology.
Michael R Gold, MD, PhD, Cardiology Division, Medical University of South Carolina, Charleston, SC, and colleagues conducted a multinational, randomized trial (Increase of Vagal Tone in Heart Failure, INOVATE-HF) of 707 patients across 85 centers who had chronic heart failure, New York Heart Association functional class III symptoms, and ejection fraction ≤40%. Patients were randomized in a 3:2 ratio to receive either a device implementation to provide VNS, or to continue medical therapy as usual.
Patients were followed for a mean of 16 months. In that time, 132 of 436 patients in the VNS group experienced the primary efficacy outcome: composite of death from any cause or first event for worsening heart failure. In the control group, 70 of 271 patients reached that outcome (30.3% versus 25.8%). Estimated annual mortality rates were 9.3% and 7.1% in the VNS and control groups, respectively.
“Heart failure … is a major cause of morbidity and mortality despite advances in medical and device therapy,” noted Dr Gold. “[D]ecreased vagal tone is an integral component of the pathophysiology of heart failure. VNS does not reduce the rate of death or heart failure events in chronic heart failure patients.”
- Gold MR, Van Veldhuisen DJ, Hauptman PJ, et al. Vagus nerve stimulation for the treatment of heart failure. The INOVATE-HF trial. J Am Coll Cardiol. 2016;68(2):149-185; doi: 10.1016/j.jacc.2016.03.525