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Randomized Controlled Trial
. 2015 Feb 14;36(7):425-33.
doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.

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

Faiez Zannad  1 , Gaetano M De Ferrari  2 , Anton E Tuinenburg  3 , David Wright  4 , Josep Brugada  5 , Christian Butter  6 , Helmut Klein  7 , Craig Stolen  8 , Scott Meyer  8 , Kenneth M Stein  8 , Agnes Ramuzat  9 , Bernd Schubert  9 , Doug Daum  8 , Petr Neuzil  10 , Cornelis Botman  11 , Maria Angeles Castel  5 , Antonio D'Onofrio  12 , Scott D Solomon  13 , Nicholas Wold  8 , Stephen B Ruble  8
Affiliations
Randomized Controlled Trial

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

Faiez Zannad et al. Eur Heart J. .

Abstract

Aim: The neural cardiac therapy for heart failure (NECTAR-HF) was a randomized sham-controlled trial designed to evaluate whether a single dose of vagal nerve stimulation (VNS) would attenuate cardiac remodelling, improve cardiac function and increase exercise capacity in symptomatic heart failure patients with severe left ventricular (LV) systolic dysfunction despite guideline recommended medical therapy.

Methods: Patients 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 vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.

Results: Of the 96 implanted patients, 87 had paired datasets 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, left ventricular end diastolic volume, LV ejection fraction, peak V02, and N-terminal pro-hormone brain natriuretic peptide failed to show superiority compared to the control group. However, there were statistically significant improvements in quality of life for the Minnesota Living with Heart Failure Questionnaire (P = 0.049), New York Heart Association class (P = 0.032), and the SF-36 Physical Component (P = 0.016) in the therapy group.

Conclusion: Vagal nerve stimulation as delivered in the NECTAR-HF trial failed to demonstrate a significant effect on primary and secondary endpoint measures of cardiac remodelling and functional capacity in symptomatic heart failure patients, but quality-of-life measures showed significant improvement.

Keywords: Autonomic nervous system; Heart failure; Vagal stimulation.

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Figures

Figure 1
Figure 1
Consort diagram for neural cardiac therapy for heart failure.
Figure 2
Figure 2
(A) Investigational bipolar helical vagal cuff. (B) Precision(TM) Pulse Generator and implanted lead.
Figure 3
Figure 3
New York Heart Association class change from baseline to Month 6 (P = 0.032).
See this image and copyright information in PMC

Comment in

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