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      European Society of Cardiology quality indicators for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death : Developed in collaboration with the European Heart Rhythm Association of the European Society of Cardiology

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          Abstract

          To develop a suite of quality indicators (QIs) for the management of patients with ventricular arrhythmias (VA) and the prevention of sudden cardiac death (SCD). The Working Group comprised experts in heart rhythm management including Task Force members of the 2022 European Society of Cardiology (ESC) Clinical Practice Guidelines for the management of patients with VA and the prevention of SCD, members of the European Heart Rhythm Association, international experts, and a patient representative. We followed the ESC methodology for QI development, which involves (i) the identification of the key domains of care for the management of patients with VA and the prevention of SCD by constructing a conceptual framework of care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. We identified eight domains of care for the management of patients with VA and the prevention of SCD: (i) structural framework, (ii) screening and diagnosis, (iii) risk stratification, (iv) patient education and lifestyle modification, (v) pharmacological treatment, (vi) device therapy, (vii) catheter ablation, and (viii) outcomes, which included 17 main and 4 secondary QIs across these domains. Following a standardized methodology, we developed 21 QIs for the management of patients with VA and the prevention of SCD. The implementation of these QIs will improve the care and outcomes of patients with VA and contribute to the prevention of SCD.

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          The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

          The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
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            Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure.

            Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to improve the prognosis in such patients. We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause. The median LVEF in patients was 25 percent; 70 percent were in NYHA class II, and 30 percent were in class III CHF. The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent. The median follow-up was 45.5 months. There were 244 deaths (29 percent) in the placebo group, 240 (28 percent) in the amiodarone group, and 182 (22 percent) in the ICD group. As compared with placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5 percent confidence interval, 0.86 to 1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23 percent (0.77; 97.5 percent confidence interval, 0.62 to 0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population. Results did not vary according to either ischemic or nonischemic causes of CHF, but they did vary according to the NYHA class. In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent. Copyright 2005 Massachusetts Medical Society.
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              Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction.

              Patients with reduced left ventricular function after myocardial infarction are at risk for life-threatening ventricular arrhythmias. This randomized trial was designed to evaluate the effect of an implantable defibrillator on survival in such patients. Over the course of four years, we enrolled 1232 patients with a prior myocardial infarction and a left ventricular ejection fraction of 0.30 or less. Patients were randomly assigned in a 3:2 ratio to receive an implantable defibrillator (742 patients) or conventional medical therapy (490 patients). Invasive electrophysiological testing for risk stratification was not required. Death from any cause was the end point. The clinical characteristics at base line and the prevalence of medication use at the time of the last follow-up visit were similar in the two treatment groups. During an average follow-up of 20 months, the mortality rates were 19.8 percent in the conventional-therapy group and 14.2 percent in the defibrillator group. The hazard ratio for the risk of death from any cause in the defibrillator group as compared with the conventional-therapy group was 0.69 (95 percent confidence interval, 0.51 to 0.93; P=0.016). The effect of defibrillator therapy on survival was similar in subgroup analyses stratified according to age, sex, ejection fraction, New York Heart Association class, and the QRS interval. In patients with a prior myocardial infarction and advanced left ventricular dysfunction, prophylactic implantation of a defibrillator improves survival and should be considered as a recommended therapy.
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                Author and article information

                Contributors
                Journal
                Europace
                Europace
                europace
                Europace
                Oxford University Press (US )
                1099-5129
                1532-2092
                January 2023
                26 August 2022
                26 August 2022
                : 25
                : 1
                : 199-210
                Affiliations
                Leeds Institute for Data Analytics, University of Leeds , Leeds LS29JT, UK
                Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds , Leeds LS29JT, UK
                Department of Cardiology, Leeds Teaching Hospitals NHS Trust , Leeds LS1 3EX, UK
                Mitera Hospital, Hygeia Group , Athens 15123, Greece
                Leeds Institute for Data Analytics, University of Leeds , Leeds LS29JT, UK
                Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds , Leeds LS29JT, UK
                Department of Cardiology, Leeds Teaching Hospitals NHS Trust , Leeds LS1 3EX, UK
                Departments of Cardiovascular Medicine, Pediatric and Adolescent Medicine, and Molecular Pharmacology & Experimental Therapeutics, Divisions of Heart Rhythm Services and Pediatric Cardiology, Windland Smith Rice Genetic Heart Rhythm Clinic and Windland Smith Rice Sudden Death Genomics Laboratory, Mayo Clinic , Rochester, MN 55905, USA
                Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona , Barcelona 08007, Spain
                IDIBAPS, Institut d’Investigació August Pi i Sunyer (IDIBAPS) , Barcelona 08036, Spain
                Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV) , Madrid 28029, Spain
                Cardiovascular Clinical Academic Group and Cardiology Research Centre, St. George’s, University of London , London SW17 0RE, UK
                St. George’s University Hospitals NHS Foundation Trust , London SW17 0QT, UK
                Department of Cardiology, Istituto Auxologico Italiano, IRCCS , Milan 20149, Italy
                Departments of Medicine and Surgery, University of Milano-Bicocca , Milan 20126, Italy
                Director – Cardiac Arrhythmia Service The Harvard Thorndike EP Institute Beth Israel Deaconess Medical Center Harvard Medical School , Boston, MA 02215, USA
                Department of Cardiology, University Hospital Nancy, Vandœuvre lès Nancy 54500, France
                Heart Center Rhön-Clinic Bad Neustadt, Clinic for Interventional Electrophysiology , Bad Neustadt 97616, Germany
                Cardiology, Electrophysiology Service, University of Campinas (UNICAMP) Hospital , Campinas 13083-888, Brazil
                Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany; and DZHK (German Centre for Cardiovascular Research), partner site Göttingen, Göttingen 10785, Germany
                University of Rennes, CHU Rennes, LTSI-UMR1099 , Rennes 35042, France
                La Paz University Hospital, IdiPaz, Autonoma University , Madrid 28046, Spain
                Agnes Ginges Centre for Molecular Cardiology at Centenary Institute, University of Sydney , Sydney 2050, Australia
                Faculty of Medicine and Health, University of Sydney , Sydney 2050, Australia
                Department of Cardiology, Royal Prince Alfred Hospital , Sydney 2050, Australia
                Patient representative, the ESC Patient Forum , Belgium
                Department of Cardiology, Leiden University Medical Center, Albinusdreef 2 , ZA Leiden 2333, TheNetherlands
                Section of genetics, Department of Forensic Medicine, Faculty of Medical Sciences, University of Copenhagen , Copenhagen 2100, Denmark
                The Department of Cardiology, The Heart Centre, Copenhagen University Hospital , Rigshospitalet 2100, Denmark
                Department of Cardiology, Inselspial Bern, Bern University Hospital, University of Bern , Bern 3010, Switzerland
                Author notes
                Corresponding author. Tel: +306973798970, E-mail address: stzeis@ 123456otenet.gr

                S.A. and S.T. contributed equally to the study.

                Conflict of interest: M.J.A. is a consultant for Abbott, Boston Scientific, Bristol Myers Squibb, Daichii Sankyo, Invitae, LQT Therapeutics, and Medtronic. M.J.A. and/or Mayo Clinic are involved in an equity/intellectual property/royalty relationship with AliveCor, Anumana, ARMGO Pharma, Pfizer, and UpToDate. However, none of these entities were involved in this study. T.D. receives from InHeart—Speaker honoraria, personal (< 5.000€), Siemens—Speaker Honoraria, institutional (< 5.000€), Biotronik—Educational Course Director, personal (< 10.000€), Abbott—Speaker honoraria, personal (< 5.000€) and Boston Scientific—Adverse events committee, personal (< 5.000€). CPG Chair of the Data Science Group of EuroHeart, Deputy Editor of EHJ Quality of Care and Clinical Outcomes. Unrelated to the present work: Research grants from Abbott, BMS, BHF, Horizon 2020, NIHR; speaker’s honoraria from AstraZeneca, Raisio Group, Wondr Medical; Consulting from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Ely-Lilly, Menarini, Vifor outside the submitted work.

                Author information
                https://orcid.org/0000-0002-9854-481X
                https://orcid.org/0000-0002-2007-1928
                https://orcid.org/0000-0003-4732-382X
                https://orcid.org/0000-0002-8011-3333
                https://orcid.org/0000-0003-0424-6393
                https://orcid.org/0000-0002-8731-2853
                https://orcid.org/0000-0002-9025-6821
                https://orcid.org/0000-0003-1379-1684
                https://orcid.org/0000-0002-3477-4667
                https://orcid.org/0000-0001-5347-7441
                https://orcid.org/0000-0002-4399-5568
                https://orcid.org/0000-0002-1737-1903
                https://orcid.org/0000-0001-6441-274X
                https://orcid.org/0000-0001-6645-082X
                https://orcid.org/0000-0003-3895-9316
                https://orcid.org/0000-0002-7197-8415
                Article
                euac114
                10.1093/europace/euac114
                10103575
                36753478
                de33f5ac-16b4-4eae-b57b-9c6ce1b67755
                © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 16 May 2022
                : 27 May 2022
                Page count
                Pages: 12
                Funding
                Funded by: Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program;
                Funded by: National Health and Medical Research Council, doi 10.13039/501100000925;
                Funded by: Practitioner Fellowship;
                Award ID: #1154992
                Categories
                Clinical Research
                AcademicSubjects/MED00200

                Cardiovascular Medicine
                ventricular arrhythmias,sudden cardiac death,quality indicators,treatment,accountability,clinical practice guidelines,outcomes

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