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September 1, 2014Journal of Cardiac FailureOpen Access

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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Why the study?

Does autonomic regulation therapy via left or right vagus nerve stimulation improve cardiac function and symptoms in patients with HFrEF?

Population

60 subjects with HFrEF receiving optimal pharmacologic therapy.

Comparison

Autonomic regulation therapy via vagus nerve… vs Left-sided VNS compared to right-sided VNS.

Design

RCT, Randomized at 10 sites to left or right side VNS.

Follow-up

6 months

Key result

Autonomic regulation therapy via left or right vagus nerve stimulation in HFrEF patients showed similar improvements in LVEF (adjusted left-right difference 0.2%; 95% CI -4.4 to 4.7) at 6 months.

Authors

RPRajendra Kumar PremchandKSKamal SharmaSMSanjay Mittal

Discussion

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Overview

Supports flexible left or right vagus nerve stimulation in HFrEF; extends evidence confirming side equivalence for autonomic regulation therapy.

Study Design

Type

RCT (n=60)

Randomization

Left or right side

Multicenter

Yes

Structured PICO

Does autonomic regulation therapy via left or right vagus nerve stimulation improve cardiac function and symptoms in patients with HFrEF?

P
Population
60 patients with HFrEF (NYHA class II-III, LVEF ≤ 40%) receiving optimal pharmacologic therapy, randomized to left or right vagus nerve stimulation and followed for 6 months.
I
Intervention
Autonomic regulation therapy (ART) via vagus nerve stimulation (VNS) implanted on the left (n=31) or right (n=29) side, titrated over 10 weeks.
C
Comparator
Left-sided VNS compared to right-sided VNS (no sham/placebo control).
O
Outcome
Changes in left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-systolic diameter (LVESD) at 6 months.surrogate

Main Result

Mean Difference: 0.2 (95% CI -4.4–4.7)

Autonomic regulation therapy via left or right vagus nerve stimulation is feasible, well-tolerated, and associated with improvements in cardiac structure and function in patients with HFrEF.

Cite This Study

Premchand et al. (2014) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) (n=60). Autonomic regulation therapy via vagus nerve stimulation vs. Left vs Right side was evaluated on Adjusted left-right difference in LVEF (MD 0.2%, 95% CI -4.4 to 4.7). Autonomic regulation therapy via left or right vagus nerve stimulation in HFrEF patients showed similar improvements in LVEF (adjusted left-right difference 0.2%; 95% CI -4.4 to 4.7) at 6 months.

synapsesocial.com/papers/6aa1fa07724544dbe03f81adhttps://doi.org/10.1016/j.cardfail.2014.08.009
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