Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial

Gaetano M. De Ferrari*, Craig Stolen, Anton E. Tuinenburg, D. Jay Wright, Josep Brugada, Christian Butter, Helmut Klein, Petr Neuzil, Cornelis Botman, Maria Angeles Castel, Antonio D'Onofrio, Gert J. de Borst, Scott Solomon, Kenneth M. Stein, Bernd Schubert, Kevin Stalsberg, Nicholas Wold, Stephen Ruble, Faiez Zannad

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

13 Citations (Scopus)

Abstract

Background The NECTAR-HF study evaluated safety and feasibility of vagal nerve stimulation (VNS) for the treatment of heart failure patients. The first six-month randomized phase of the study did not show improvement in left ventricular remodelling in response to VNS. This study reports the 18-month results and provides novel findings aiming to understand the lack of efficacy of VNS, including a new technique assessing the effects of VNS. Methods Ninety-six patients were randomized 2:1 to active or inactive VNS for 6 months, thereafter VNS was activated for all patients. The primary safety endpoint was 18-month all-cause mortality. Results Ninety-one patients continued in the long-term evaluation with active VNS. The on-therapy survival estimate at 18 months was 95% with a 95% one-sided lower confidence limit of 91%, (better than the predefined criterion). Left ventricular systolic volume decreased in the crossover group (VNS OFF → ON; 144 ± 37 to 139 ± 40, p < 0.05) after VNS activation; LVESD (5.02 ± 0.77 to 4.96 ± 0.82, p > 0.05) and LVEF (33.2 ± 4.9 to 33.3 ± 6.5, p > 0.05) did not change. A new technique to detect subtle heart rate changes during Holter recordings, i.e. “heat maps”, revealed that VNS evoked heart rate response in only 13/106 studies (12%) at 6 and 12 months with active VNS. Conclusions Although a favourable long-term safety profile was found, improvements in the efficacy endpoints were not seen with VNS. A new technique for detecting acute heart rate responses to VNS suggests that the recruitment of nerve fibres responsible for heart rate changes were substantially lower in NECTAR-HF than in pre-clinical models.

Original languageEnglish
Pages (from-to)229-234
Number of pages6
JournalInternational Journal of Cardiology
Volume244
DOIs
Publication statusPublished - 1 Oct 2017

Keywords

  • Autonomic modulation
  • Heart failure
  • Neural therapy
  • Parasympathetic nervous system
  • Vagal nerve stimulation
  • Vagus nerve
  • Electrocardiography, Ambulatory/mortality
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Male
  • Treatment Outcome
  • Heart Failure/diagnosis
  • Survival Rate/trends
  • Time Factors
  • Female
  • Vagus Nerve Stimulation/mortality
  • Aged

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