Christian Fastner1, Johannes Brachmann2, Thorsten Lewalter3, Uwe Zeymer4, Horst Sievert5,6, Martin Borggrefe1, Christoph A Nienaber7, Christian Weiß8, Sven T Pleger9, Hüseyin Ince10,11, Jens Maier12, Stephan Achenbach13, Holger H Sigusch14, Matthias Hochadel15, Steffen Schneider15, Jochen Senges15, Ibrahim Akin16. 1. First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Center for AngioScience (ECAS), and DZHK (German Center for Cardiovascular Research) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. 2. Department of Cardiology, Angiology, and Pneumology, Second Medical Clinic, Coburg Hospital, Coburg, Germany. 3. Department of Medicine, Cardiology, and Intensive Care, Hospital Munich-Thalkirchen, Munich, Germany. 4. Klinikum Ludwigshafen, Ludwigshafen am Rhein, Germany. 5. CardioVascular Center (CVC) Frankfurt, Frankfurt, Germany. 6. Anglia Ruskin University, Chelmsford, UK. 7. Cardiology and Aortic Center, Royal Brompton and Harefield NHS Foundation, Trust at Imperial College, London, UK. 8. Department of Cardiology, Klinikum Lüneburg, Lüneburg, Germany. 9. Department of Internal Medicine III, Cardiology, Angiology, and Pneumology, University Hospital Heidelberg, Heidelberg, Germany. 10. Department of Cardiology, Rostock University Medical Center, Rostock, Germany. 11. Department of Cardiology, Vivantes Klinikum Am Urban & im Friedrichshain, Berlin, Germany. 12. Medical Department I, SLK-Kliniken Heilbronn GmbH, Klinikum am Gesundbrunnen, Heilbronn, Germany. 13. Department of Medicine, University of Erlangen, Erlangen, Germany. 14. Clinic for Internal Medicine I, Heinrich-Braun-Klinikum Zwickau gGmbH, Zwickau, Deutschland. 15. Stiftung Institut für Herzinfarktforschung, Ludwigshafen am Rhein, Germany. 16. First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Center for AngioScience (ECAS), and DZHK (German Center for Cardiovascular Research) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. ibrahim.akin@umm.de.
Abstract
OBJECTIVES: Chronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillation patients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure's effectiveness and safety. METHODS: LAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m2, and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m2, respectively). RESULTS: Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA2DS2-VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKD patients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKD patients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m2; p > 0.05 vs. eGFR 30-59 mL/min/1.73 m2). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKD patients (1.4 vs. 0%; p = 0.021). CONCLUSIONS: Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.
OBJECTIVES:Chronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillationpatients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure's effectiveness and safety. METHODS: LAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m2, and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m2, respectively). RESULTS: Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHA2DS2-VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKDpatients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKDpatients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m2; p > 0.05 vs. eGFR 30-59 mL/min/1.73 m2). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKDpatients (1.4 vs. 0%; p = 0.021). CONCLUSIONS: Despite an increased cardiovascular risk profile of CKDpatients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.
Entities:
Keywords:
Atrial fibrillation; Chronic kidney disease; LAARGE; Left atrial appendage; Left atrial appendage closure
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