دورية أكاديمية
Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study.
العنوان: | Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. |
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المؤلفون: | Piayda K; Department of Cardiology, Pneumology and Vascular Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Nordrhein-Westfalen, Germany., Hellhammer K; Department of Cardiology, Pneumology and Vascular Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Nordrhein-Westfalen, Germany., Nielsen-Kudsk JE; Department of Cardiology, Aarhus University, Aarhus, Denmark., Schmidt B; Department of Cardiology, Bethanien-Krankenhaus, Frankfurt am Main, Hessen, Germany., Mazzone P; Department of Cardiology, Ospedale San Raffaele, Milano, Italy., Berti S; Department of Cardiology, Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica, Pisa, Toscana, Italy., Fischer S; Department of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Sachsen-Anhalt, Germany., Lund J; Department of Cardiology, Turku University Hospital, Turku, Finland., Montorfano M; Department of Interventional Cardiology, Istituto Scientifico Universitario San Raffaele, Milano, Lombardia, Italy., Della Bella P; Department of Arrhythmology, San Raffaele Hospital, Milano, Lombardia, Italy., Gage R; Structural Heart, Abbott Cardiovascular-St Paul, Saint Paul, Minnesota, USA., Zeus T; Department of Cardiology, Pneumology and Vascular Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Nordrhein-Westfalen, Germany Zeus@med.uni-duesseldorf.de. |
المصدر: | BMJ open [BMJ Open] 2021 Mar 24; Vol. 11 (3), pp. e040455. Date of Electronic Publication: 2021 Mar 24. |
نوع المنشور: | Journal Article; Multicenter Study; Observational Study |
اللغة: | English |
بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
مواضيع طبية MeSH: | Atrial Appendage*/diagnostic imaging , Atrial Appendage*/surgery , Atrial Fibrillation*/therapy , Stroke*, Aged ; Anesthesia, General ; Cardiac Catheterization/adverse effects ; Conscious Sedation ; Humans ; Prospective Studies ; Treatment Outcome |
مستخلص: | Objective: To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). Background: Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. Methods: Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. Results: Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1-3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000). Conclusions: In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. Trial Registration Number: NCT02447081; Results. Competing Interests: Competing interests: Dr Nielsen-Kudsk has served as a proctor for Abbott and is a consultant for Abbott and Boston Scientific. Dr Schmidt has served as a consultant for Boston Scientific and Medtronic. Dr Mazzone has served as a consultant for Abbott, Boston Scientific, and Medtronic. Dr Berti has served as a proctor for Abbott. Dr Fischer has served as a proctor for Biotronik and Boston Scientific and is a consultant for Abbott. Dr Lund has served as a proctor for Abbott. Dr Montorfano has served as a proctor for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Della Bella has served as a proctor and consultant for Abbott. Mr Gage is an employee of Abbott and was involved in data review and analysis. Dr Zeus has received consulting fees, travel expenses or study honorariums from Medtronic and Edwards Lifesciences outside of this work. All other authors have nothing to disclose with regard to this project. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
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فهرسة مساهمة: | Keywords: cardiology; stroke medicine; thromboembolism |
سلسلة جزيئية: | ClinicalTrials.gov NCT02447081 |
تواريخ الأحداث: | Date Created: 20210325 Date Completed: 20210519 Latest Revision: 20210519 |
رمز التحديث: | 20231215 |
مُعرف محوري في PubMed: | PMC7993182 |
DOI: | 10.1136/bmjopen-2020-040455 |
PMID: | 33762228 |
قاعدة البيانات: | MEDLINE |
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