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      Therapy optimization in patients with heart failure: the role of the wearable cardioverter-defibrillator in a real-world setting

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          Abstract

          Background

          The wearable cardioverter-defibrillator (WCD) has emerged as a valuable tool to temporarily protect patients at risk for sudden cardiac death (SCD). The aim of this study was to determine the value of the WCD for therapy optimization of heart failure patients.

          Methods

          One hundred five consecutive patients that received WCD between 4/2012 and 9/2016 were included in the study. All patients were followed for clinical outcome and echocardiographic parameters during WCD therapy and had continued follow-up after WCD therapy, irrespective of subsequent implantable cardioverter-defibrillator (ICD) implantation.

          Results

          The most common indication for WCD were newly diagnosed ischemic (ICM) or non-ischemic cardiomyopathy (NICM) with left ventricular ejection fraction (LVEF) ≤35%. Mean WCD wear time was 68.8 ± 50.4 days with a mean daily use of 21.5 ± 3.5 h. Five patients (4.8%) received a total of five appropriate WCD shocks.

          During WCD wear, patients with ICM and NICM showed significant improvement in LVEF, reducing the proportion of patients with a need for primary preventive ICD implantation to 54.8% (ICM) and 48.8% (NICM). An ICD was finally implanted in 51.4% of the study patients (24 trans-venous ICDs, 30 subcutaneous ICDs).

          After discontinuation of WCD therapy, all patients were followed for a mean of 18.6 ± 12.3 months. 5.6% of patients with implanted ICDs received appropriate therapies. No patient with subcutaneous ICD needed change to a trans-venous device. None of the patients without an implanted ICD suffered from ventricular tachyarrhythmias and no patient died suddenly.

          In patients with NICM a significant LVEF improvement was observed during long-term follow-up (from 34.8 ± 11.1% to 41.0 ± 10.2%).

          Conclusions

          WCD therapy successfully bridged all patients to either LVEF recovery or ICD implantation. Following WCD, ICD implantation could be avoided in almost half of the patients. In selected patients, prolongation of WCD therapy beyond 3 months might further prevent unnecessary ICD implantation. The WCD as an external monitoring system contributed important information to optimize device selection in patients that needed ICD implantation.

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          Most cited references20

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          Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both.

          The risk of sudden death from cardiac causes is increased among survivors of acute myocardial infarction with reduced left ventricular systolic function. We assessed the risk and time course of sudden death in high-risk patients after myocardial infarction. We studied 14,609 patients with left ventricular dysfunction, heart failure, or both after myocardial infarction to assess the incidence and timing of sudden unexpected death or cardiac arrest with resuscitation in relation to the left ventricular ejection fraction. Of 14,609 patients, 1067 (7 percent) had an event a median of 180 days after myocardial infarction: 903 died suddenly, and 164 were resuscitated after cardiac arrest. The risk was highest in the first 30 days after myocardial infarction--1.4 percent per month (95 percent confidence interval, 1.2 to 1.6 percent)--and decreased to 0.14 percent per month (95 percent confidence interval, 0.11 to 0.18 percent) after 2 years. Patients with a left ventricular ejection fraction of 30 percent or less were at highest risk in this early period (rate, 2.3 percent per month; 95 percent confidence interval, 1.8 to 2.8 percent). Nineteen percent of all sudden deaths or episodes of cardiac arrest with resuscitation occurred within the first 30 days after myocardial infarction, and 83 percent of all patients who died suddenly did so in the first 30 days after hospital discharge. Each decrease of 5 percentage points in the left ventricular ejection fraction was associated with a 21 percent adjusted increase in the risk of sudden death or cardiac arrest with resuscitation in the first 30 days. The risk of sudden death is highest in the first 30 days after myocardial infarction among patients with left ventricular dysfunction, heart failure, or both. Thus, earlier implementation of strategies for preventing sudden death may be warranted in selected patients. Copyright 2005 Massachusetts Medical Society.
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            Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients.

            The angiotensin-receptor-neprilysin inhibitor (ARNI) LCZ696 reduced cardiovascular deaths and all-cause mortality compared with enalapril in patients with chronic heart failure in the prospective comparison of ARNI with an Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. To more completely understand the components of this mortality benefit, we examined the effect of LCZ696 on mode of death.
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              Defibrillator implantation early after myocardial infarction.

              The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction ( or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.) 2009 Massachusetts Medical Society
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                Author and article information

                Contributors
                +49(0)621-383-4231 , susanroeger@hotmail.com
                stefanie.rosenkaimer@umm.de
                anna.hohneck@umm.de
                siegfried.lang@umm.de
                ibrahim.el-battrawy@umm.de
                boris.rudic@umm.de
                erol.tueluemen@umm.de
                ksenija.stach@umm.de
                jurgen.kuschyk@umm.de
                ibrahim.akin@umm.de
                martin.borggrefe@umm.de
                Journal
                BMC Cardiovasc Disord
                BMC Cardiovasc Disord
                BMC Cardiovascular Disorders
                BioMed Central (London )
                1471-2261
                15 March 2018
                15 March 2018
                2018
                : 18
                : 52
                Affiliations
                [1 ]ISNI 0000 0001 2162 1728, GRID grid.411778.c, First Department of Medicine, , University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, ; Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
                [2 ]ISNI 0000 0004 5937 5237, GRID grid.452396.f, German Centre for Cardiovascular Research (DZHK), Partner Site Heidelberg/Mannheim, ; Mannheim, Germany
                Author information
                http://orcid.org/0000-0002-7585-0224
                Article
                790
                10.1186/s12872-018-0790-8
                5856002
                29544442
                310bc1c0-d597-4299-9a73-c44b554fcabb
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 28 December 2017
                : 8 March 2018
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2018

                Cardiovascular Medicine
                heart failure,ischemic cardiomyopathy,non-ischemic cardiomyopathy,subcutaneous icd,sudden cardiac death,wearable cardioverter-defibrillator

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