Key result
Vagal nerve stimulation shows no benefit over continued medical therapy for death or worsening HF.
Why the study?
Does vagus nerve stimulation reduce death or worsening heart failure events in patients with chronic heart failure and reduced ejection fraction?
RCT (n=707)
3:2 ratio
Yes
Does vagus nerve stimulation reduce death or worsening heart failure events in patients with chronic heart failure and reduced ejection fraction?
Hazard Ratio: 1.14 (95% CI 0.86–1.53)
Absolute Event Rate: 30.3% vs 25.8%
p-value: p=0.37
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The results are not what we had hoped for, but despite this disappointment, we still feel this approach holds potential. We hope to find new ideas and new refinements in the future, including promising subgroups of patients who may benefit from this treatment.”
“I don't think we should say this is the end of anything. The fact that it was proven to be safe is very reassuring, because it means we have an opportunity to keep moving.”
“I think it's certainly time to go back to the drawing board. Future research will focus on the optimal way to perform stimulation of the vagus nerve and on the search for subgroups of patients who might derive a greater benefit from the treatment.”
Vagus nerve stimulation does not reduce the rate of death or heart failure events in patients with chronic heart failure and reduced ejection fraction compared to continued medical therapy.
BACKGROUND: Heart failure (HF) is increasing in prevalence and is a major cause of morbidity and mortality despite advances in medical and device therapy. Autonomic imbalance, with excess sympathetic activation and decreased vagal tone, is an integral component of the pathophysiology of HF. OBJECTIVES: The INOVATE-HF (Increase of Vagal Tone in Heart Failure) trial assessed the safety and efficacy of vagal nerve stimulation (VNS) among patients with HF and a reduced ejection fraction. METHODS: INOVATE-HF was a multinational, randomized trial involving 85 centers including patients with chronic HF, New York Heart Association functional class III symptoms and ejection fraction ≤40%. Patients were assigned to device implantation to provide VNS (active) or continued medical therapy (control) in a 3:2 ratio. The primary efficacy endpoint was composite of death from any cause or first event for worsening HF. RESULTS: Patients (n = 707) were randomized and followed up for a mean of 16 months. The primary efficacy outcome occurred in 132 of 436 patients in the VNS group, compared to 70 of 271 in the control group (30.3% vs. 25.8%; hazard ratio: 1.14; 95% confidence interval: 0.86 to 1.53; p = 0.37). During the trial, the estimated annual mortality rates were 9.3% and 7.1%, respectively (p = 0.19). Quality of life, New York Heart Association functional class, and 6-min walking distance were favorably affected by VNS (p < 0.05), but left ventricular end-systolic volume index was not different (p = 0.49). CONCLUSIONS: VNS does not reduce the rate of death or HF events in chronic HF patients. (INcrease Of VAgal TonE in CHF [INOVATE-HF]; NCT01303718).
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Gold et al. (2016) conducted an RCT in Heart failure with reduced ejection fraction (n=707). Vagal nerve stimulation vs. Continued medical therapy was evaluated on Composite of death from any cause or first event for worsening HF (HR 1.14, 95% CI 0.86-1.53, p=0.37). Vagal nerve stimulation did not reduce the composite of death or worsening heart failure compared to continued medical therapy (30.3% vs 25.8%; HR 1.14; 95% CI 0.86-1.53; p=0.37).
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