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Autonomic regulation therapy for the improvement of left ventricular function and heart failure symptoms: The ANTHEM-HF Study

ESC Congress 2014 - Hot Line report

Heart Failure (HF)


 

Presentation

By Inder Anand, (Minneapolis, United States of America)
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List of Authors:
Rajendra K. Premchand, Kamal Sharma, Sanjay Mittal, Rufino Monteiro, Imad Libbus, Lorenzo DiCarlo, Jeffrey L. Ardell, Thomas S. Rector, Badri Amurthur, Bruce H. KenKnight, Inder S. Anand

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 (NYHA class II-III, LVEF40%, LVEDD50 mm and <80 mm) receiving optimal pharmacological therapy were randomized at 10 sites. VNS systems were randomly implanted on the left (n=31) or right side (n=29). All patients were successfully implanted and 59 were titrated over 10 weeks to a well-tolerated chronic intermittent stimulation (10 Hz, 250 µs, 14 sec on, 66 s off). The current amplitude was titrated to prevent side effects and acute HR changes (average up-titrated output current was 2.0 ± 0.6 mA). One patient died 3 days after an embolic stroke that occurred during implant. Common device-related adverse events after VNS titration were transient mild dysphonia, cough, and oropharyngeal pain, similar for left- and right-sided VNS. After 6 months of ART, in the combined population, absolute LVEF improved by 4.5% [95% CI2.4 to 6.6], LVESV improved by -4.1 mL [-9.0 to 0.8], and LVESD improved by -1.7 mm [-2.8 to -0.7]. The adjusted left-right differences in LVEF, end-systolic volume (LVESV), and end-systolic diameter (LVESD) were 0.2% [-4.4 to 4.7], 3.7 mL [-7.0 to 14.4], and 1.3 mm [-0.9 to 3.6], respectively. Heart rate variability improved by 17 ms [6.5 to 28] with minimal left-right difference. Six-minute walk distance improved an average of 56 m [37 to 75]; however, improvement was greater for right-sided ART (77 m [49 to 105]). NYHA class improved in 77% of patients (baseline to 6 months).
Conclusions
Chronic, low-amplitude ART via left- or right-sided VNS is feasible and well-tolerated in HFrEF patients.  Safety assessment do not raise concerns, efficacy measures are encouraging and warrant further study.

 

Discussion

By Gerhard Hindricks, FESC (Leipzig, Germany)
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References


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SessionTitle:

Hot Line: Heart failure: devices and interventions

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.