Chronic Vagal Stimulation for the Treatment of Low Ejection Fraction Heart Failure: Results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) Randomized Controlled Trial

Study Questions:

Does a single dose of vagal nerve stimulation (VNS) attenuate cardiac remodeling, improve cardiac function, and increase exercise capacity in symptomatic heart failure (HF) patients with severe left ventricular (LV) systolic dysfunction despite guideline-recommended medical therapy?

Methods:

Patients in the NECTAR-HF trial were randomized in a 2:1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LV end-systolic diameter (LVESD) at 6 months for control versus therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-hour Holter, and circulating biomarkers.

Results:

Of the 96 implanted patients, 87 had paired data sets for the primary endpoint. Change in LVESD from baseline to 6 months was -0.04 ± 0.25 cm in the therapy group compared with -0.08 ± 0.32 cm in the control group (p = 0.60). Additional echocardiographic parameters of LV end-diastolic dimension, LV end-systolic volume, LV end-diastolic volume, LV ejection fraction, peak V02, and N-terminal pro–B-type natriuretic peptide failed to show superiority compared to sham treatment. However, there were statistically significant improvements in quality of life for the Minnesota Living With Heart Failure Questionnaire (MLHFQ) (p = 0.049), New York Heart Association class (p = 0.032), and the Short Form-36 Physical Component (p = 0.016) in the therapy group.

Conclusions:

VNS in this study failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodeling and functional capacity in symptomatic HF patients, but quality-of-life measures showed significant improvement.

Perspective:

Autonomic imbalance is clearly implicated in the pathophysiology of HF. Whether VNS can become a treatment modality for HF patients remains to be determined.

Clinical Topics: Heart Failure and Cardiomyopathies, Noninvasive Imaging, Acute Heart Failure, Heart Failure and Cardiac Biomarkers, Echocardiography/Ultrasound

Keywords: Biological Markers, Quality of Life, Heart Failure, Stroke Volume, Questionnaires, Ventricular Dysfunction, Left, Systole, Echocardiography, Natriuretic Peptide, Brain, ESC Congress


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