What question did this study set out to answer?

Evaluate the 12-month safety, feasibility, and sustained efficacy of autonomic regulation therapy delivered via vagus nerve stimulation in patients with chronic heart failure and reduced left ventricular ejection fraction.

November 11, 2015Journal of Cardiac FailureOpen Access

Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study

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Why the study?

Does autonomic regulation therapy via vagus nerve stimulation maintain safety and efficacy at 12 months in patients with HFrEF?

Population

49 patients with chronic heart failure and reduced left ventricular ejection fraction, NYHA class II-III…

Comparison

Autonomic regulation therapy via vagus nerve… vs Left versus right cervical vagus nerve placement.

Design

Cohort, Randomized to left or right cervical vagus nerve placement

Follow-up

12 months total posttitration

Authors

RPRajendra Kumar PremchandUniversity of Copenhagen KSKamal SharmaAmerican College of Cardiology SMSanjay MittalMedanta The Medicity

Discussion

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Implication

Supports sustained safety and efficacy of vagus nerve stimulation to 12 months in HFrEF; hypothesis-generating pending randomized trials.

Key Points

Evaluate the 12-month safety, feasibility, and sustained efficacy of autonomic regulation therapy delivered via vagus nerve stimulation in patients with chronic heart failure and reduced left ventricular ejection fraction.
Follow-up phase of the randomized ANTHEM-HF study involving 60 patients with NYHA class II–III heart failure and left ventricular ejection fraction ≤40%, initially randomized to left or right cervical vagus nerve stimulation (10 Hz, 250 µsec, therapeutic current 2.0 ± 0.6 mA).
Assessed an extended 6-month period (12 months total post-titration) in 49 consenting participants to examine whether improvements in cardiac function were preserved.
Zero device malfunctions or device-related serious adverse events occurred during the 6-month extension, with 7 unrelated serious adverse events reported (including 3 deaths: 2 sudden cardiac, 1 worsening heart failure) and 5 device-related nonserious adverse events.
Safety, tolerability, and efficacy profiles were not significantly different between left- and right-sided stimulation groups.
Mean efficacy measure values at 12 months showed no significant difference compared to values at 6 months, demonstrating durability of therapeutic improvements.

Structured PICO

Does autonomic regulation therapy via vagus nerve stimulation maintain safety and efficacy at 12 months in patients with HFrEF?

Population

49 patients with chronic heart failure (HF) and reduced left ventricular ejection fraction (≤40%), NYHA class II-III, who consented to participate in an extended follow-up study (from an original cohort of 60 enrolled subjects).

Intervention

Autonomic regulation therapy (ART) via vagus nerve stimulation (VNS) with chronic stimulation at a frequency of 10 Hz and pulse duration of 250 µsec (therapeutic output current 2.0 ± 0.6 mA) for 12 months total posttitration.

Comparator

Left versus right cervical vagus nerve placement.

Outcome

Safety, tolerability, and maintenance of efficacy (cardiac function and HF symptoms) at 12 months.safety

Chronic open-loop autonomic regulation therapy via vagus nerve stimulation appears feasible, safe, and maintains improvements in cardiac function and symptoms up to 12 months in patients with HFrEF.

Cite This Study

Premchand et al. (2015) studied this question.

synapsesocial.com/papers/6a9533ed2fdd6c151ff22a4e https://doi.org/10.1016/j.cardfail.2015.11.002

Topics

HFrEF treatment Heart failure

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Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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