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

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.

• Authors: Rajendra K Premchand, Kamal Sharma, Sanjay Mittal, Rufino Monteiro, Satyajit Dixit, Imad Libbus, Lorenzo A DiCarlo, Jeffrey L Ardell, Thomas S Rector, Badri Amurthur, Bruce H KenKnight, Inder S Anand
• Journal: Journal of cardiac failure (J Card Fail) Vol. 20 Issue 11 Pg. 808-16 (Nov 2014) ISSN: 1532-8414 [Electronic] United States
• PMID: 25187002 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Published by Elsevier Inc.

Topics

• Aged
• Autonomic Nervous System (physiopathology)
• Feasibility Studies
• Female
• Follow-Up Studies
• Heart Failure (physiopathology, therapy)
• Humans
• Male
• Middle Aged
• Retrospective Studies
• Stroke Volume (physiology)
• Time Factors
• Treatment Outcome
• Vagus Nerve Stimulation (methods)
• Ventricular Function, Left (physiology)
• Ventricular Remodeling