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      Less major bleeding and higher hemoglobin after left atrial appendage closure in high‐risk patients: Data from a long‐term, longitudinal, two‐center observational study

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          Abstract

          Background

          Left atrial appendage closure (LAAC) is a mechanical alternative for stroke prevention in patients at risk who cannot tolerate oral anticoagulation (OAC).

          Hypothesis

          Our hypothesis was that the reduction of anticoagulation following LAAC results in a decrease of bleeding events and a rise in serum hemoglobin in a high‐risk collective of patients with atrial fibrillation (AF).

          Methods

          Bleeding events, use of erythrocyte concentrates, anticoagulation, embolic events, and serum hemoglobin levels before and following LAAC were compared over more than 4 years.

          Results

          Seventy‐five patients (CHA₂DS₂‐VASc score 4.4 ± 1.7, HAS‐BLED score 4.6 ± 1.1) were analyzed. Before LAAC (observation period 1.8 ± 1.8 years), 67 patients experienced 1.8 ± 1.4 bleeding events (0.9 ± 1.3 major) per year resulting in 0.7 ± 1.3 transfusions per year. After LAAC (2.6 ± 2.0 years), 26 patients ( p < .0001 vs. before) had 0.6 ± 2.1 bleeding events ( p < .0001), 0.2 ± 0.6 major bleedings ( p < .0001) and received 0.6 ± 1.9 transfusions per year ( p = .671). Fourteen patients had stroke before and 3 after LAAC ( p = .008). Serum hemoglobin increased from initially 9.9 ± 3.0 to 11.9 ± 2.3 g/dL until the end of follow‐up ( p = .0005). Adverse embolic events did not differ before and after LAAC in our collective.

          Conclusion

          In this clinical relevant cohort of AF patients with high risk for stroke and intolerance to OAC, we show that LAAC was able to reduce the rate of stroke and bleeding events, which translated into a rising serum hemoglobin concentration.

          Abstract

          In patients with atrial fibrillation (AF) at high risk for stroke and bleeding events, closure of the left atrial appendage (LAAC) led to a relevant reduction of bleeding events and stroke as well as an increase in serum hemoglobin. RRR, relative risk reduction; TIA, transitory ischemic attack.

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          Most cited references27

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          Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation.

          Contemporary clinical risk stratification schemata for predicting stroke and thromboembolism (TE) in patients with atrial fibrillation (AF) are largely derived from risk factors identified from trial cohorts. Thus, many potential risk factors have not been included. We refined the 2006 Birmingham/National Institute for Health and Clinical Excellence (NICE) stroke risk stratification schema into a risk factor-based approach by reclassifying and/or incorporating additional new risk factors where relevant. This schema was then compared with existing stroke risk stratification schema in a real-world cohort of patients with AF (n = 1,084) from the Euro Heart Survey for AF. Risk categorization differed widely between the different schemes compared. Patients classified as high risk ranged from 10.2% with the Framingham schema to 75.7% with the Birmingham 2009 schema. The classic CHADS(2) (Congestive heart failure, Hypertension, Age > 75, Diabetes, prior Stroke/transient ischemic attack) schema categorized the largest proportion (61.9%) into the intermediate-risk strata, whereas the Birmingham 2009 schema classified 15.1% into this category. The Birmingham 2009 schema classified only 9.2% as low risk, whereas the Framingham scheme categorized 48.3% as low risk. Calculated C-statistics suggested modest predictive value of all schema for TE. The Birmingham 2009 schema fared marginally better (C-statistic, 0.606) than CHADS(2). However, those classified as low risk by the Birmingham 2009 and NICE schema were truly low risk with no TE events recorded, whereas TE events occurred in 1.4% of low-risk CHADS(2) subjects. When expressed as a scoring system, the Birmingham 2009 schema (CHA(2)DS(2)-VASc acronym) showed an increase in TE rate with increasing scores (P value for trend = .003). Our novel, simple stroke risk stratification schema, based on a risk factor approach, provides some improvement in predictive value for TE over the CHADS(2) schema, with low event rates in low-risk subjects and the classification of only a small proportion of subjects into the intermediate-risk category. This schema could improve our approach to stroke risk stratification in patients with AF.
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            A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey.

            Despite extensive use of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) and the increased bleeding risk associated with such OAC use, no handy quantification tool for assessing this risk exists. We aimed to develop a practical risk score to estimate the 1-year risk for major bleeding (intracranial, hospitalization, hemoglobin decrease > 2 g/L, and/or transfusion) in a cohort of real-world patients with AF. Based on 3,978 patients in the Euro Heart Survey on AF with complete follow-up, all univariate bleeding risk factors in this cohort were used in a multivariate analysis along with historical bleeding risk factors. A new bleeding risk score termed HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 65 years), Drugs/alcohol concomitantly) was calculated, incorporating risk factors from the derivation cohort. Fifty-three (1.5%) major bleeds occurred during 1-year follow-up. The annual bleeding rate increased with increasing risk factors. The predictive accuracy in the overall population using significant risk factors in the derivation cohort (C statistic 0.72) was consistent when applied in several subgroups. Application of the new bleeding risk score (HAS-BLED) gave similar C statistics except where patients were receiving antiplatelet agents alone or no antithrombotic therapy, with C statistics of 0.91 and 0.85, respectively. This simple, novel bleeding risk score (HAS-BLED) provides a practical tool to assess the individual bleeding risk of real-world patients with AF, potentially supporting clinical decision making regarding antithrombotic therapy in patients with AF.
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              2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)

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                Author and article information

                Contributors
                christian.schach@ukr.de , cschach@hotmail.de
                Journal
                Clin Cardiol
                Clin Cardiol
                10.1002/(ISSN)1932-8737
                CLC
                Clinical Cardiology
                John Wiley and Sons Inc. (Hoboken )
                0160-9289
                1932-8737
                13 August 2023
                November 2023
                : 46
                : 11 ( doiID: 10.1002/clc.v46.11 )
                : 1337-1344
                Affiliations
                [ 1 ] Department for Internal Medicine II University Heart Center Regensburg Regensburg Germany
                [ 2 ] Department for Cardiology Hospital Barmherzige Brüder Regensburg Regensburg Germany
                Author notes
                [*] [* ] Correspondence Christian Schach, MD, Universitäres Herzzentrum Regensburg, Klinik und Poliklinik für Innere Medizin II, Abteilung für Kardiologie, Universitätsklinikum Regensburg, Franz‐Josef‐Strauss‐Allee 11, D‐93051 Regensburg, Germany.

                Email: christian.schach@ 123456ukr.de and cschach@ 123456hotmail.de

                Author information
                http://orcid.org/0000-0001-9560-4015
                Article
                CLC24123
                10.1002/clc.24123
                10642336
                37573576
                0c124339-d165-4f23-bf7f-6d0097868957
                © 2023 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 29 July 2023
                : 22 June 2023
                : 03 August 2023
                Page count
                Figures: 4, Tables: 1, Pages: 8, Words: 4575
                Categories
                Clinical Investigations
                Clinical Investigations
                Custom metadata
                2.0
                November 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.4 mode:remove_FC converted:13.11.2023

                Cardiovascular Medicine
                anticoagulation,atrial fibrillation,bleeding,hemoglobin,left atrial appendage closure,long‐term longitudinal observation

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