INcrease Of VAgal TonE in Heart Failure - INOVATE-HF

Apr 04, 2016
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Presenter/Author:
Michael Robert Gold, MD, PhD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
BioControl Medical
Date Presented:
04/04/2016
Date Published:
04/04/2016
Original Posted Date:
04/04/2016
References

Contribution To Literature:

The INOVATE-HF trial failed to show that vagus nerve stimulation improved clinic outcomes versus optimal medical therapy.

Description:

The goal of the trial was to evaluate vagus nerve stimulation versus optimal medical therapy among patients with stable heart failure (HF).



Study Design

  • Randomized
  • Parallel

Eligible patients were randomized to device implant, which provided vagus nerve stimulation (n = 436) versus optimal medical therapy (control group) (n = 271).

  • Total number of enrollees: 707
  • Duration of follow-up: 16 months
  • Mean patient age: 61 years
  • Percentage female: 19%

Other salient features/characteristics:

  • Mean left ventricular ejection fraction (LVEF) = 25%
  • Ischemic etiology for HF in 64%

Inclusion criteria:

  • Age ≥18 years
  • LVEF ≤40% and LV end-diastolic dimension 50-80 mm
  • New York Heart Association (NYHA) class III symptoms on optimal medical therapy
  • Predominately in sinus rhythm

Exclusion criteria:

  • Second- or third-degree atrioventricular (AV) block
  • Permanent atrial fibrillation
  • Uncontrolled diabetes
  • Severe renal or hepatic failure
  • Transient ischemic attack/stroke in the last 3 months

Principal Findings:

The trial was terminated early due to futility for the primary outcome.

The primary outcome, death or HF hospitalization, occurred in 30.3% of the vagus nerve stimulation group versus 25.8% of the control group (p = 0.37). The primary outcome was the same among tested subgroups.

Secondary outcomes:

  • Quality of life, NYHA class, and 6-minute walking distance were favorably affected by vagus nerve stimulation (p < 0.05).
  • LV stroke volume index was similar between groups (p = 0.49).

Interpretation:

Among individuals with stable HF, vagus nerve stimulation did not reduce the rate of death or hospitalization for HF. Reverse remodeling also did not improve with vagus nerve stimulation. However, quality of life, NYHA class, and 6-minute walking distance were favorably affected by vagus nerve stimulation.

References:

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;68:149-58.

Presented by Dr. Michael Robert Gold at the American College of Cardiology Scientific Session, Chicago, IL, April 4, 2016.

Keywords: ACC Annual Scientific Session, Heart Failure, Medical Futility, Quality of Life, Secondary Prevention, Stroke Volume, Vagus Nerve Stimulation, Ventricular Function, Left


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