title: Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study.
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.
authors.affiliation: Krishna Institute of Medical Sciences, Secunderabad, India.
authors.forename: Rajendra K
authors.initials: RK
authors.lastname: Premchand
authors.affiliation: Sanjivani Super Specialty Hospitals, Ahmedabad, India.
authors.forename: Kamal
authors.initials: K
authors.lastname: Sharma
authors.affiliation: Medanta, The Medicity, Haryana, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Vintage Hospital, Goa, India.
authors.forename: Rufino
authors.initials: R
authors.lastname: Monteiro
authors.affiliation: Sanjivani Super Specialty Hospitals, Ahmedabad, India.
authors.forename: Satyajit
authors.initials: S
authors.lastname: Dixit
authors.affiliation: Cyberonics, Inc., Houston, Texas.
authors.forename: Imad
authors.initials: I
authors.lastname: Libbus
authors.affiliation: BioDev LLC, San Francisco, California.
authors.forename: Lorenzo A
authors.initials: LA
authors.lastname: DiCarlo
authors.affiliation: University of California at Los Angeles, Los Angeles, California.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Ardell
authors.affiliation: University of Minnesota, Minneapolis, Minnesota.
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Rector
authors.affiliation: Cyberonics, Inc., Houston, Texas.
authors.forename: Badri
authors.initials: B
authors.lastname: Amurthur
authors.affiliation: Cyberonics, Inc., Houston, Texas.
authors.forename: Bruce H
authors.initials: BH
authors.lastname: KenKnight
authors.affiliation: University of Minnesota, Minneapolis, Minnesota. Electronic address: anand001@umn.edu.
authors.forename: Inder S
authors.initials: IS
authors.lastname: Anand
mesh_terms: D001341:Autonomic Nervous System / Q000503:physiopathology*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013318:Stroke Volume / Q000502:physiology*; D013997:Time Factors; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*; D016277:Ventricular Function, Left / Q000502:physiology*; D020257:Ventricular Remodeling
keywords: Heart failure; autonomic regulation therapy; nonpharmacological therapy; vagus nerve stimulation