Format

Send to

Choose Destination
J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.

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

Author information

1
Department of Cardiology, Krishna Institute of Medical Sciences, Secunderabad, India.
2
Department of Cardiology, Sanjivani Super Specialty Hospitals, Ahmedabad, India.
3
Department of Cardiology, Medanta, Medicity, Haryana, India.
4
Department of Cardiology, Vintage Hospital, Goa, India.
5
Emerging Therapies, Cyberonics, Houston, Texas.
6
Biodev, San Francisco, California.
7
Department of Medicine, University of California, Los Angeles, California.
8
Department of Medicine University of Minnesota, Minneapolis, Minnesota.
9
Department of Medicine University of Minnesota, Minneapolis, Minnesota. Electronic address: anand001@umn.edu.

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.

KEYWORDS:

Heart failure; autonomic regulation therapy; nonpharmacologic therapy; vagus nerve stimulation

PMID:
25187002
DOI:
10.1016/j.cardfail.2014.08.009
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center