Evidence map›Paper›PMID 33590355›Full record

Trial reportClinical autonomic research : official journal of the Clinical Autonomic Research Society2021

Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF.

Bruce D Nearing, Imad Libbus, Gerrard M Carlson, Badri Amurthur, Bruce H KenKnight, Richard L Verrier

Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical autonomic research : official journal of the Clinical Autonomic Research Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01823887 (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01823887 phase1 / phase2completednot on this map

Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

TypeinterventionalSponsorCyberonics, Inc.Ran2012 to 2014Enrolled60ConditionsCongestive Heart FailureArmsVagus Nerve Stimulation (VNS)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. [Long-term course of heart disease: How can psychosocial care be improved?]Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2022
    Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Bruce D NearingDepartment of Medicine, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 99 Brookline Avenue, RN-301, Boston, MA, 02215-3908, USA.
Imad LibbusLivaNova USA, Houston, TX, USA.
Gerrard M CarlsonLivaNova USA, Houston, TX, USA.
Badri AmurthurLivaNova USA, Houston, TX, USA.
Bruce H KenKnightLivaNova USA, Houston, TX, USA.
Richard L VerrierDepartment of Medicine, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 99 Brookline Avenue, RN-301, Boston, MA, 02215-3908, USA. rverrier@bidmc.harvard.edu.
LivaNova (United States) · USBeth Israel Deaconess Medical Center · USHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDisturbed autonomic function is implicated in high mortality rates in heart failure patients. High-intensity vagus nerve stimulation therapy was shown to improve intrinsic heart rate recovery and left ventricular ejection fraction over a period of 1 year. Whether these beneficial effects are sustained across multiple years and are related to improved baroreceptor response was unknown.

methodsAll patients (n = 21) enrolled in the ANTHEM-HF clinical trial (NCT01823887, registered 4/3/2013) with 24 h ambulatory electrocardiograms at all time points and 54 normal subjects (PhysioNet database) were included. Intrinsic heart rate recovery, based on ~ 2000 spontaneous daily activity-induced heart rate acceleration/deceleration events per patient, was analyzed at screening and after 12, 24, and 36 months of chronic vagus nerve stimulation therapy (10 or 5 Hz, 250 μs pulse width, 18% duty cycle, maximum tolerable current amplitude).

resultsIn response to chronic high-intensity vagus nerve stimulation (≥ 2.0 mA), intrinsic heart rate recovery (all time points, p < 0.0001), heart rate turbulence slope, an indicator of baroreceptor reflex gain (all, p ≤ 0.02), and left ventricular ejection fraction (all, p ≤ 0.04) were improved over screening at 12, 24, and 36 months. Intrinsic heart rate recovery and heart rate turbulence slope were inversely correlated at both screening (r = 0.67, p < 0.002) and 36 months (r = 0.78, p < 0.005).

conclusionThis non-randomized study provides evidence of an association between improvement in intrinsic heart rate recovery and left ventricular ejection fraction during high-intensity vagus nerve stimulation for a period of ≥ 3 years. Correlated favorable effects on heart rate turbulence slope implicate enhanced baroreceptor function in response to chronic, continuously cyclic vagus nerve stimulation as a physiologic mechanism.

Indexed as

Vagus Nerve StimulationAutonomic Nervous SystemHeart RateHumansStroke VolumeTreatment OutcomeVagus NerveVentricular Function, LeftAutonomic regulation therapyBaroreflex sensitivityHeart failureHeart rate recoveryHeart rate turbulenceVagus nerve stimulation

Identifiers

PMID33590355
PMCPMC8184538
OpenAlexW3129238571

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.