Johannes Brachmann1, Thorsten Lewalter2, Ibrahim Akin3, Horst Sievert4, Volker Geist5, Uwe Zeymer6,7, Damir Erkapic8, Harald Mudra9, Sven Pleger10, Matthias Hochadel7, Jochen Senges7. 1. Department of Cardiology, Klinikum Coburg, Coburg, Germany. 2. Department of Cardiology and Intensive Care, Peter Osypka Heart Center Munich, Hospital for Internal Medicine Munich South, Am Isarkanal 36, 81379, Munich, Germany. thorsten.lewalter@ikms.de. 3. Department of Cardiology, University Hospital Mannheim, Mannheim, Germany. 4. Department of Cardiology, Katharinenhospital Frankfurt, Frankfurt, Germany. 5. Department of Cardiology, Klinkum Bad Segeberg, Bad Segeberg, Germany. 6. Department of Cardiology, Klinikum Ludwigshafen, Ludwigshafen, Germany. 7. Institut für Herzinfarktforschung, Ludwigshafen, Germany. 8. Department of Cardiology, University Hospital Giessen, Giessen, Germany. 9. Department of Cardiology, Klinikum Neuperlach, Munich, Germany. 10. Department of Cardiology, University Hospital Heidelberg, Heidelberg, Germany.
Abstract
BACKGROUND: Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS: LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively. RESULTS: A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%). CONCLUSIONS: LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.
BACKGROUND: Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS: LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively. RESULTS: A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%). CONCLUSIONS: LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.
Entities:
Keywords:
Atrial fibrillation; Left atrial appendage occluder; Stroke
Authors: Agnieszka Kotalczyk; Michał Mazurek; Zbigniew Kalarus; Tatjana S Potpara; Gregory Y H Lip Journal: Nat Rev Cardiol Date: 2020-10-27 Impact factor: 32.419