Elsevier

International Journal of Cardiology

Volume 323, 15 January 2021, Pages 175-178
International Journal of Cardiology

Short communication
Long-term Follow-Up of Patients with Heart Failure and Reduced Ejection Fraction Receiving Autonomic Regulation Therapy in the ANTHEM-HF Pilot Study

https://doi.org/10.1016/j.ijcard.2020.09.072Get rights and content
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open access

Highlights

  • Chronic VNS is associated with improvement in cardiac function and HF symptoms.

  • The ANTHEM-HF study evaluated VNS in HF patients with 42 months of follow-up.

  • There were no device-related SAEs or malfunctions during extended follow-up.

  • There was significant improvement in cardiac function and HF symptoms at 42 months.

  • This therapy is being further evaluated in a randomized, controlled, pivotal study.

Abstract

Background

The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months.

Methods

Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months.

Results

Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months.

Conclusions

In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.

Keywords

Heart failure
Autonomic regulation therapy
Vagus nerve stimulation
Non-pharmacological therapy

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