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      Left Atrial Appendage Transcatheter Occlusion with AMPLATZER™ Amulet™ Device: Real Life Data with Mid-Term Follow-Up Results

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          Abstract

          Background

          Left atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy.

          Objective

          To evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device-related thrombosis.

          Methods

          Sixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15 months (median - 20 months, interquartile range - 9 to 27 months). The postprocedural assessment was done at the 1 st, 6 th, and 12 th month. Patients were clinically evaluated, and transesophageal echocardiography was performed at each visit. We evaluated the condition of normality of variables using the Kolmogorov-Smirnov test. P-values < 0.05 were statistically significant.

          Results

          The most common indication for the procedure was major bleeding with anticoagulants (n: 53, 88.3%). The procedure was completed successfully in 59 (98.3%) patients. Periprocedural mortality was observed in one patient. Postprocedural antiplatelet treatment was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy in 52 (88.1%), 2 (3.4%), and 5 (8.5%) patients, respectively. We found no clinically significant cerebrovascular events, device-related thrombus, or embolization in any patient during the follow-up. Two (3.4 %) patients presented significant peri-device leak (>3 mm) at the 1 st month evaluation, which disappeared at the 12 th month follow-up.

          Conclusion

          We concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes.

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          Most cited references14

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          Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.

          While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions.
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            Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

            The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study.
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              Atrial fibrillation: the most common arrhythmia.

              C Wyndham (1999)
              Atrial fibrillation is the most common sustained arrhythmia, increases with age, and presents with a wide spectrum of symptoms and severity Paroxysmal, persistent, and permanent forms require very individualized approaches to management. New information about electrical and anatomic remodeling emphasizes the importance of time-related thrombogenicity and progressive interference with mechanical function of the atria and ventricles. The most important aspect of diagnosis is risk stratification with respect to risk of thromboembolism. The general goals in treatment are, in order of importance: prevention of thromboemboli, control of ventricular response, restoration of sinus rhythm, and maintenance of sinus rhythm by preventing recurrences. This review focuses on the above issues. The therapeutic choices are discussed under each category Antiarrhythmic drugs, radiofrequency ablation techniques, and device therapy are reviewed with respect to prevention of recurrent atrial fibrillation.
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                Author and article information

                Journal
                Arq Bras Cardiol
                Arq. Bras. Cardiol
                abc
                Arquivos Brasileiros de Cardiologia
                Sociedade Brasileira de Cardiologia - SBC
                0066-782X
                1678-4170
                October 2019
                October 2019
                : 113
                : 4
                : 712-721
                Affiliations
                [1]Hacettepe Universitesi Tip Fakultesi - Department of Cardiogly, Ankara - Turkey
                Author notes
                Mailing Address: Cem Çöteli, Hacettepe Universitesi Tip Fakultesi - Department of Cardiogly, Ankara 06100 - Turkey. E-mail: cemcoteli@ 123456hacettepe.edu.tr
                Author information
                http://orcid.org/0000-0002-0985-3144
                http://orcid.org/0000-0002-4424-3704
                http://orcid.org/0000-0001-5520-7103
                http://orcid.org/0000-0001-9279-8424
                Article
                10.5935/abc.20190138
                7020865
                31365601
                1a700d39-508d-4c22-bb27-315283939fda

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

                History
                : 24 June 2018
                : 12 December 2018
                : 23 January 2019
                Categories
                Original Article

                atrial fibrillation,atrial appendage,mortality,echocardiography/methods,cardiac catheterization,anticoagulants/therapeutic use

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