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

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

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Abstract

Objective Evaluate the effects of a novel autonomic regulation therapy (ART) via vagus nerve stimulation (VNS) in patients with chronic heart failure (HF) and reduced left ventricular ejection fraction during a 12-month follow-up period. Methods The Autonomic Regulation Therapy for the Improvement of Left Ventricular Function and Heart Failure Symptoms (ANTHEM-HF) study enrolled 60 subjects with New York Heart Association class II-III HF and low left ventricular ejection fraction (≤40%), who received open-loop ART using VNS randomized to left or right cervical vagus nerve placement and followed for 6 months after titration to a therapeutic output current (2.0 ± 0.6 mA). Patients received chronic stimulation at a frequency of 10 Hz and pulse duration of 250 µsec. Forty-nine subjects consented to participate in an extended follow-up study for an additional 6 months (12 months total posttitration) to determine whether the effects of therapy were maintained. Results During the 6-month extended follow-up period, there were no device malfunctions or device-related serious adverse effects. There were 7 serious adverse effects unrelated to the device, including 3 deaths (2 sudden cardiac deaths, 1 worsening HF death). There were 5 nonserious adverse events that were adjudicated to be device-related. Safety and tolerability were similar, and there were no significant differences in efficacy between left- and right-sided ART. Overall, mean efficacy measure values at 12 months were not significantly different from mean values at 6 months. Conclusions Chronic open-loop ART via left- or right-sided VNS continued to be feasible and well-tolerated in patients with HF with reduced EF. Improvements in cardiac function and HF symptoms seen after 6 months of ART were maintained at 12 months.

Original languageEnglish (US)
Pages (from-to)639-642
Number of pages4
JournalJournal of cardiac failure
Volume22
Issue number8
DOIs
StatePublished - Aug 1 2016

Keywords

  • Heart failure
  • autonomic regulation therapy
  • nonpharmacological therapy
  • vagus nerve stimulation

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    Premchand, R. K., Sharma, K., Mittal, S., Monteiro, R., Dixit, S., Libbus, I., DiCarlo, L. A., Ardell, J. L., Rector, T. S., Amurthur, B., KenKnight, B. H., & Anand, I. S. (2016). Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study. Journal of cardiac failure, 22(8), 639-642. https://doi.org/10.1016/j.cardfail.2015.11.002