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      Autonomic regulation therapy to enhance myocardial function in heart failure patients: the ANTHEM‐HFpEF study

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          Abstract

          Background

          Approximately half of the patients presenting with new‐onset heart failure (HF) have HF with preserved left ventricular ejection fraction (HFpEF) and HF with mid‐range left ventricular ejection fraction (HFmrEF). These patients have neurohormonal activation like that of HF with reduced ejection fraction; however, beta‐blockers and angiotensin‐converting enzyme inhibitors have not been shown to improve their outcomes, and current treatment for these patients is symptom based and empiric. Sympathoinhibition using parasympathetic stimulation has been shown to improve central and peripheral aspects of the cardiac nervous system, reflex control, induce myocyte cardioprotection, and can lead to regression of left ventricular hypertrophy. Beneficial effects of autonomic regulation therapy (ART) using vagus nerve stimulation (VNS) have also been observed in several animal models of HFpEF, suggesting a potential role for ART in patients with this disease.

          Methods

          The Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Patients with Heart Failure and Preserved Ejection Fraction (ANTHEM‐HFpEF) study is designed to evaluate the feasibility, tolerability, and safety of ART using right cervical VNS in patients with chronic, stable HFpEF and HFmrEF. Patients with symptomatic HF and HFpEF or HFmrEF fulfilling the enrolment criteria will receive chronic ART with a subcutaneous VNS system attached to the right cervical vagus nerve. Safety parameters will be continuously monitored, and cardiac function and HF symptoms will be assessed every 3 months during a post‐titration follow‐up period of at least 12 months.

          Conclusions

          The ANTHEM‐HFpEF study is likely to provide valuable information intended to expand our understanding of the potential role of ART in patients with chronic symptomatic HFpEF and HFmrEF.

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          Most cited references19

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          Outcome of heart failure with preserved ejection fraction in a population-based study.

          The importance of heart failure with preserved ejection fraction is increasingly recognized. We conducted a study to evaluate the epidemiologic features and outcomes of patients with heart failure with preserved ejection fraction and to compare the findings with those from patients who had heart failure with reduced ejection fraction. From April 1, 1999, through March 31, 2001, we studied 2802 patients admitted to 103 hospitals in the province of Ontario, Canada, with a discharge diagnosis of heart failure whose ejection fraction had also been assessed. The patients were categorized in three groups: those with an ejection fraction of less than 40 percent (heart failure with reduced ejection fraction), those with an ejection fraction of 40 to 50 percent (heart failure with borderline ejection fraction), and those with an ejection fraction of more than 50 percent (heart failure with preserved ejection fraction). Two groups were studied in detail: those with an ejection fraction of less than 40 percent and those with an ejection fraction of more than 50 percent. The main outcome measures were death within one year and readmission to the hospital for heart failure. Thirty-one percent of the patients had an ejection fraction of more than 50 percent. Patients with heart failure with preserved ejection fraction were more likely to be older and female and to have a history of hypertension and atrial fibrillation. The presenting history and clinical examination findings were similar for the two groups. The unadjusted mortality rates for patients with an ejection fraction of more than 50 percent were not significantly different from those for patients with an ejection fraction of less than 40 percent at 30 days (5 percent vs. 7 percent, P=0.08) and at 1 year (22 percent vs. 26 percent, P=0.07); the adjusted one-year mortality rates were also not significantly different in the two groups (hazard ratio, 1.13; 95 percent confidence interval, 0.94 to 1.36; P=0.18). The rates of readmission for heart failure and of in-hospital complications did not differ between the two groups. Among patients presenting with new-onset heart failure, a substantial proportion had an ejection fraction of more than 50 percent. The survival of patients with heart failure with preserved ejection fraction was similar to that of patients with reduced ejection fraction. Copyright 2006 Massachusetts Medical Society.
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            HFSA 2010 Comprehensive Heart Failure Practice Guideline.

            Heart failure (HF) is a syndrome characterized by high mortality, frequent hospitalization, reduced quality of life, and a complex therapeutic regimen. Knowledge about HF is accumulating so rapidly that individual clinicians may be unable to readily and adequately synthesize new information into effective strategies of care for patients with this syndrome. Trial data, though valuable, often do not give direction for individual patient management. These characteristics make HF an ideal candidate for practice guidelines. The 2010 Heart Failure Society of America comprehensive practice guideline addresses the full range of evaluation, care, and management of patients with HF. Copyright 2010. Published by Elsevier Inc.
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              Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial.

              Heart failure (HF) is increasing in prevalence and is a major cause of morbidity and mortality despite advances in medical and device therapy. Autonomic imbalance, with excess sympathetic activation and decreased vagal tone, is an integral component of the pathophysiology of HF.
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                Author and article information

                Contributors
                anand001@umn.edu
                Journal
                ESC Heart Fail
                ESC Heart Fail
                10.1002/(ISSN)2055-5822
                EHF2
                ESC Heart Failure
                John Wiley and Sons Inc. (Hoboken )
                2055-5822
                28 December 2017
                February 2018
                : 5
                : 1 ( doiID: 10.1002/ehf2.v5.1 )
                : 95-100
                Affiliations
                [ 1 ] LivaNova PLC London UK
                [ 2 ] Yashoda Hospital Secunderabad India
                [ 3 ] Medanta—The Medicity New Delhi India
                [ 4 ] Krishna Institute of Medical Science Secunderabad India
                [ 5 ] University of California—Los Angeles Los Angeles CA USA
                [ 6 ] Minneapolis VA Health Care System, University of Minnesota Cardiology 111 C, One Veterans Drive Minneapolis MN 55417 USA
                Author notes
                [*] [* ] Correspondence to: Inder S. Anand, Professor of Medicine, Minneapolis VA Health Care System, University of Minnesota Medical School, Cardiology 111 C, One Veterans Drive, Minneapolis, MN 55417, USA.

                Email: anand001@ 123456umn.edu

                Article
                EHF212241 ESCHF-17-00123
                10.1002/ehf2.12241
                5793957
                29283224
                b3c0df32-6b2e-4203-8f2b-c164114a3982
                © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

                This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                Page count
                Figures: 1, Tables: 0, Pages: 6, Words: 2957
                Product
                Categories
                Study Design
                Study Design
                Custom metadata
                2.0
                ehf212241
                February 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.3.2 mode:remove_FC converted:31.01.2018

                autonomic balance,heart failure,preserved ejection fraction,neuromodulation,autonomic regulation therapy,vagus nerve stimulation

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