Real-world outcomes of Left Atrial Appendage Occlusion with the Amplatzer™ Amulet™: a multicentre observational registry from Southeast Asia

Left Atrial Appendage Occlusion (LAAO) is an alternative therapy for atrial fibrillation (AF) patients at high risk of stroke who have contraindications to long term oral anticoagulation (OAC). However, real-world data specifically regarding the Amplatzer™ Amulet™ device remains limited in Southeast Asian (SEA) populations. This study evaluated the procedural characteristics, safety profiles and 1-year clinical outcomes of the Amulet™ device in the multi-country SEA cohort. This was a multicentre observational study included four centres across three SEA countries (Malaysia, Indonesia and Thailand) from February 2019 to January 2024. The primary outcome was a composite of cardiac mortality and ischemic stroke at 1 year. A total of 104 patients were enrolled. The mean age was 67.2 ± 10.1 years old and 67.3% male. The mean CHA2DS2-VASc was 4.02 ± 1.45 and mean HAS-BLED score was 3.11 ± 1.17. Majority of the patients (64.4%) had ≥ 2 indications for LAAO implantation. Main indications for LAAO implantation were HAS-BLED score ≥ 3 (55.8%), contraindication for OAC because of renal failure (41.3%) and contraindication for OAC because of bleeding (24.0%). Intracardiac echocardiogram was used in 19.3% of the procedure. The periprocedural complications rate was 2.9%. Device implantation was successful in 98.1%, and 77.9% was successful at first deployment. The 1-year all-cause mortality was 10.6%, with 2.9% cardiac related mortality. Risk of recurrent stroke at 1-year was 1.9% with 1 (1%) major bleeding event. At 12-month, 83.5% of the patients were on single or no antiplatelet therapy. Patients from SEA had multiple indications for LAAO. Overall, the dual-seal Amulet™ device demonstrated high procedural success, low complication rates and associated with low rate of AF-related thromboembolic event while using single antiplatelet therapy in most of the patients. (280 words)