Accepted Manuscript Autonomic Regulation Therapy via Left or Right Cervical Vagus Nerve Stimulation in Patients with Chronic Heart Failure: Results of the ANTHEM-HF Trial 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 PII:
S1071-9164(14)01189-0
DOI:
10.1016/j.cardfail.2014.08.009
Reference:
YJCAF 3399
To appear in:
Journal of Cardiac Failure
Received Date: 16 July 2014 Revised Date:
18 August 2014
Accepted Date: 18 August 2014
Please cite this article as: Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS, Autonomic Regulation Therapy via Left or Right Cervical Vagus Nerve Stimulation in Patients with Chronic Heart Failure: Results of the ANTHEMHF Trial, Journal of Cardiac Failure (2014), doi: 10.1016/j.cardfail.2014.08.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
A new autonomic regulation therapy was assessed in an uncontrolled open-label study
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Chronic ART via left or right vagus nerve stimulation was safe in HFrEF patients
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Some echo parameters (LVEF, LVESD) improved significantly over 6 months
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Heart rate variability, exercise tolerance, and NYHA class significantly improved
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Left and right ART had similar safety and efficacy profiles
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ACCEPTED MANUSCRIPT
Autonomic Regulation Therapy via Left or Right Cervical Vagus Nerve Stimulation in Patients with Chronic Heart Failure: Results of the ANTHEM-HF Trial
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Rajendra K Premchand,1 Kamal Sharma,2 Sanjay Mittal,3 Rufino Monteiro,4 Satyajit Dixit,2 Imad Libbus,5 Lorenzo A DiCarlo,6 Jeffrey L Ardell,7 Thomas S Rector,8 Badri Amurthur,5 Bruce H KenKnight,5 Inder S Anand8
Krishna Institute of Medical Sciences, Secunderabad, India; 2Sanjivani Super Specialty Hospitals, Ahmedabad, India; 3Medanta, The Medicity, Haryana, India; 4Vintage Hospital, Goa, India; 5Cyberonics, Inc., Houston, United States of America; 6Managing Director, BioDev LLC, San Francisco CA; 7 University of California at Los Angeles, Los Angeles, United States of America; 8University of Minnesota, Minneapolis, United States of America
Correspondence to: Inder S. Anand, MD, FRCP, D Phil (Oxon.) VA Medical Center, Cardiology 111-C One Veterans Drive, Minneapolis, MN 55417
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Email:
[email protected]
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Phone: +1 (612) 467-3663; Fax: +1 (612) 970-5899
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Short title: Autonomic Regulation Therapy for Heart Failure
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This work was supported by Cyberonics, Inc., Houston, USA [ClinicalTrials.gov registration #NCT01823887, CTRI registration #CTRI/2012/05/002681].
Word Count: Abstract 260; Manuscript 6,293
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ACCEPTED MANUSCRIPT
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).
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Methods and Results: Sixty subjects (NYHA class II-III, LVEF≤40%, LVEDD≥50 mm and
