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      Risk of Inhospital Stroke or Death Is Associated With Age But Not Sex in Patients Treated With Carotid Endarterectomy for Asymptomatic or Symptomatic Stenosis in Routine Practice: Secondary Data Analysis of the Nationwide German Statutory Quality Assurance Database From 2009 to 2014

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          Abstract

          Background

          Guideline recommendations on carotid endarterectomy are based predominantly on randomized, controlled trials, in which women or elderly patients are often under‐represented. This study analyzed the association of age and sex with the risk of in‐hospital stroke or death following carotid endarterectomy under routine conditions in Germany.

          Methods and Results

          Secondary data analysis using the Statutory German Quality Assurance Database on all carotid endarterectomy procedures (n=142 074) performed between 2009 and 2014. Primary outcome was any stroke or death until discharge; secondary outcomes were any in‐hospital stroke (alone), and death (alone). Descriptive statistics and multilevel multivariable regression analyses were applied. Patients were predominately male (68%), with mean age 71 years. Carotid stenosis was symptomatic in 40%. Primary outcome occurred in 1.8% of women and 1.9% of men. Multivariable regression analysis revealed that more‐advanced age was associated with a higher primary outcome rate (relative risk [RR] per 10‐year increase: 1.19; 95% CI, 1.14–1.24). Risk of death (alone) was associated with age ( RR, 1.68; 95% CI, 1.54–1.84). Age was associated with the risk of stroke (alone; RR, 1.05; 95% CI, 1.00–1.11). Sex was not associated with primary outcome rate (1.01; 95% CI, 0.93–1.10), nor did it significantly modify the age effect.

          Conclusions

          This study shows that increasing age, but not sex, is associated with a higher risk of in‐hospital stroke or death following carotid endarterectomy under everyday conditions in Germany. Whereas the risk of death (alone) is significantly associated with age, the association between age and the risk of stroke (alone) can be considered of minor importance.

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          Most cited references32

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          American Society of Anaesthesiologists physical status classification

          Although the American Society of Anaesthesiologists’ (ASA) classification of Physical Health is a widely used grading system for preoperative health of the surgical patients, multiple variations were observed between individual anaesthetist’s assessments when describing common clinical problems. This article reviews the current knowledge and evaluation regarding ASA Classification of Physical Health as well as trials for possible modification.
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              [Good Practice of Secondary Data Analysis (GPS): guidelines and recommendations].

              In 2005, the Working Group for the Survey and Utilisation of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) first published "Good Practice in Secondary Data Analysis (GPS)" formulating a standard for conducting secondary data analyses. GPS is intended as a guide for planning and conducting analyses and can provide a basis for contracts between data owners. The domain of these guidelines does not only include data routinely gathered by statutory health insurance funds and further statutory social insurance funds, but all forms of secondary data. The 11 guidelines range from ethical principles and study planning through quality assurance measures and data preparation to data privacy, contractual conditions and responsible communication of analytical results. They are complemented by explanations and practical assistance in the form of recommendations. GPS targets all persons directing their attention to secondary data, their analysis and interpretation from a scientific point of view and by employing scientific methods. This includes data owners. Furthermore, GPS is suitable to assess scientific publications regarding their quality by authors, referees and readers. In 2008, the first version of GPS was evaluated and revised by members of AGENS and the Epidemiological Methods Working Group of DGEpi, DGSMP and GMDS including other epidemiological experts and had then been accredited as implementation regulations of Good Epidemiological Practice (GEP). Since 2012, this third version of GPS is on hand and available for downloading from the DGEpi website at no charge. Especially linguistic specifications have been integrated into the current revision; its internal consistency was increased. With regards to contents, further recommendations concerning the guideline on data privacy have been added. On the basis of future developments in science and data privacy, further revisions will follow.
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                Author and article information

                Contributors
                gefaesschirurgie@mri.tum.de
                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                13 March 2017
                March 2017
                : 6
                : 3 ( doiID: 10.1002/jah3.2017.6.issue-3 )
                : e004764
                Affiliations
                [ 1 ] Department of Vascular and Endovascular Surgery Klinikum rechts der Isar Technical University of Munich Germany
                [ 2 ] AQUA‐Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen GmbH Göttingen Germany
                Author notes
                [*] [* ] Correspondence to: Hans‐Henning Eckstein, MD, PhD, Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich, Ismaninger Str 22, Munich 81675, Germany. E‐mail: gefaesschirurgie@ 123456mri.tum.de
                [†]

                Dr Kuehnl and Dr Eckstein contributed equally to this work.

                Article
                JAH32002
                10.1161/JAHA.116.004764
                5524011
                28288976
                81f012c8-e834-4324-875b-e7f10333518b
                © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 21 November 2016
                : 20 December 2016
                Page count
                Figures: 4, Tables: 4, Pages: 12, Words: 7692
                Funding
                Funded by: School of Medicine of the Technical University of Munich
                Award ID: 8700000162
                Categories
                Original Research
                Original Research
                Cardiovascular Surgery
                Custom metadata
                2.0
                jah32002
                March 2017
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.1.3 mode:remove_FC converted:11.07.2017

                Cardiovascular Medicine
                aging,carotid artery,sex,stenosis,surgery,cerebrovascular disease/stroke,cardiovascular surgery,quality and outcomes,women

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