Cited by 377Vagus Nerve Stimulation ResearchCardiac pacing and defibrillation studiesHeart Rate Variability and Autonomic Control

Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: Results of the ANTHEM-HF trial

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Premchand, Rajendra K., Sharma, Kamal, Mittal, Sanjay, Monteiro, Rufino, Dixit, Satyajit, Libbus, Imad, DiCarlo, Lorenzo A., Ardell, Jeffrey L. +4 more·2014·Journal of Cardiac Failure

Abstract

OBJECTIVE: ANTHEM-HF evaluated a novel autonomic regulation therapy (ART) via either left or right vagus nerve stimulation (VNS) in patients with heart failure (HF) and reduced ejection fraction (HFrEF). METHODS AND RESULTS: Sixty subjects (New York Heart Association [NYHA] functional class II-III, left ventricular ejection fraction (LVEF) ≤ 40%, left ventricular end-diastolic diameter ≥ 50 mm to < 80 mm) receiving optimal pharmacologic therapy were randomized at 10 sites. VNS systems were randomly implanted on the left (n = 31) or right (n = 29) side. All patients were successfully implanted and 59 were titrated over 10 weeks to a well tolerated stimulation intensity. One patient died 3 days after an embolic stroke that occurred during implantation. Common device-related adverse events after VNS titration were transient mild dysphonia, cough, and oropharyngeal pain, which were similar for left- and right-side VNS. After 6 months of ART, the adjusted left-right differences in LVEF, left ventricular end-systolic volume (LVESV), and left ventricular end-systolic diameter (LVESD) were 0.2% (95% CI -4.4 to 4.7), 3.7 mL (95% CI -7.0 to 14.4), and 1.3 mm (95% CI -0.9 to 3.6), respectively. In the combined population, absolute LVEF improved by 4.5% (95% CI 2.4-6.6), LVESV improved by -4.1 mL (95% CI -9.0 to 0.8), and LVESD improved by -1.7 mm (95% CI -2.8 to -0.7). Heart rate variability improved by 17 ms (95% CI 6.5-28) with minimal left-right difference. Six-minute walk distance improved an average of 56 m (95% CI 37-75); however, improvement was greater for right-side ART (77 m [95% CI 49-105]). NYHA functional class improved in 77% of patients (baseline to 6 months). CONCLUSIONS: Chronic open-loop ART via left- or right-side VNS is feasible and well tolerated in HFrEF patients. Safety and efficacy measures are encouraging and warrant further study.

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Crossref · 10.1016/j.cardfail.2014.08.009

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Authors
Premchand, R. K., Sharma, K., Mittal, S., Monteiro, R., Dixit, S., Libbus, I., DiCarlo, L. A., Ardell, J. L., Rector, T. S., Amurthur, B., KenKnight, B. H., & Anand, I. S.
Affiliations
  • Krishna Institute of Medical Sciences (IN)
  • Sanjivani Super Speciality Hospitals (IN)
  • Medanta The Medicity (IN)
  • University of California, Los Angeles (US)
  • University of Minnesota (US)
Venue
Journal of Cardiac Failure
Publisher
Elsevier BV
Published
2014-11
Volume
20
Issue
11
Pages
808-816
ISSN
1071-9164 (ISSN-L)
OpenAlex
W2116095873
Cited by
377
References
44
Citations by year
2026: 14 · 2025: 30 · 2024: 40 · 2023: 41 · 2022: 32 · 2021: 34 · 2020: 32 · 2019: 29 · 2018: 24 · 2017: 34 · 2016: 32 · 2015: 31 · 2014: 2 · 2013: 2
FWCI
17.14
Type
journal article
Language
en
Open access
Locations
  • Journal of Cardiac Failure (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
Keywords
vagus nerve stimulation, chronic heart failure, heart failure with reduced ejection fraction, left ventricular ejection fraction, left ventricular end-systolic volume, heart rate variability, 6-minute walk distance, NYHA functional class, device-related adverse events
MeSH terms
Aged, Autonomic Nervous System, Feasibility Studies, Female, Follow-Up Studies, Heart Failure, Humans, Male, Middle Aged, Retrospective Studies, Stroke Volume, Time Factors, Ventricular Function, Left, Treatment Outcome, Ventricular Remodeling, Vagus Nerve Stimulation

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