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

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Atrial Fibrillation (n=104). Intervention: Left Atrial Appendage Occlusion with Amplatzer Amulet device. Primary outcome: Composite of cardiac mortality and ischemic stroke at 1 year.

Q: What does this research mean for the field?

The Amplatzer™ Amulet™ device demonstrates high procedural success and low complication rates in Southeast Asian patients undergoing Left Atrial Appendage Occlusion, with a 1-year ischemic stroke rate of 1.9% and cardiac mortality rate of 2.9%. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Keng Tat Koh; Yoga Yuniadi; Y.Y. Oon; Jhi Hui Foo; K Saravanan; Satchana Pumprueg; Teguh Santoso; Alan Yean Yip Fong; Tiong Kiam Ong; Thorsten Lewalter

doi:10.1186/s12872-026-05642-x

February 23, 2026BMC Cardiovascular DisordersOpen Access

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

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Key result

Amulet LAAO demonstrates a 3.9% 1-year composite event rate in Southeast Asian AF patients.

n=104

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Why the study?

Real-world data regarding the Amplatzer Amulet device for LAAO remained limited in Southeast Asian populations.

Does Left Atrial Appendage Occlusion with the Amplatzer Amulet device prevent cardiac mortality and ischemic stroke in Southeast Asian patients with atrial fibrillation and contraindications to oral anticoagulation?

Key Points

To evaluate the procedural safety, characteristics, and 1-year clinical outcomes of left atrial appendage occlusion using the Amplatzer Amulet device in a Southeast Asian population.
Conducted a multicentre observational registry across four centres in three countries (Malaysia, Indonesia, Thailand) enrolling 104 patients between February 2019 and January 2024.
Evaluated patients with atrial fibrillation undergoing implantation, predominantly driven by high bleeding risk (HAS-BLED score ≥ 3 in 55.8%) and renal failure contraindications (41.3%).
Tracked procedural success, periprocedural complications, antithrombotic regimens, and clinical endpoints up to 1-year follow-up (completed in 99.0% of patients).
Successful device implantation was achieved in 98.1% of patients (77.9% on the first deployment), with a periprocedural complication rate of 2.9%.
The 1-year composite primary outcome of cardiac mortality and recurrent ischemic stroke or transient ischemic attack was 3.9%, including 2.9% cardiac mortality, 1.9% recurrent stroke/TIA risk, and 10.6% all-cause mortality.
At 12-month follow-up, 83.5% of patients were maintained on single antiplatelet therapy or no antithrombotic therapy (76.9% on single antiplatelet therapy alone and 6.6% on none).

Study Design

Type

Observational (n=104)

Multicenter

Yes

Structured PICO

Does Left Atrial Appendage Occlusion with the Amplatzer Amulet device prevent cardiac mortality and ischemic stroke in Southeast Asian patients with atrial fibrillation and contraindications to oral anticoagulation?

P

Population

104 patients with atrial fibrillation (AF) at high risk of stroke who have contraindications to long-term oral anticoagulation, mean age 67.2, 67.3% male, from Southeast Asia (Malaysia, Indonesia, Thailand). Mean CHA2DS2-VASc 4.0, mean HAS-BLED 3.1.

I

Intervention

Left Atrial Appendage Occlusion (LAAO) using the Amplatzer Amulet device

O

Outcome

Composite of cardiac mortality and ischemic stroke at 1 yearcomposite

In a real-world Southeast Asian cohort, LAAO with the Amplatzer Amulet device demonstrated high procedural success (98.1%) and a low 1-year rate of the composite of cardiac mortality and ischemic stroke (3.9%).

Limitations

Observational single-arm study without a control group
Limited sample size (n=104)
Follow-up imaging completion rates were moderate (27.5% at 1 year) due to COVID-19 constraints
Potential regional differences limit generalizability beyond Southeast Asia
Multivariable adjustment not performed due to limited sample size
Observational, non-randomized design with 'all-comer' inclusion introduces inherent selection bias
Conducted during the COVID-19 pandemic, which impacted recruitment and severely limited in-person follow-up and imaging surveillance
Small sample size (n=104) is statistically underpowered to detect significant differences in low-frequency adverse events
Inclusion of patients undergoing concomitant AF ablation introduces heterogeneity
Potential misclassification of cardiac vs non-cardiac deaths due to severe concurrent infections (COVID-19)

Implication

Offers real-world Amulet LAAO data in Southeast Asian AF; extends prior evidence but leaves practice change open.

Abstract

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)

Discussion

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Cite This Study

Koh et al. (2026) conducted an observational in Atrial Fibrillation (n=104). Left Atrial Appendage Occlusion with Amplatzer Amulet device was evaluated on Composite of cardiac mortality and ischemic stroke at 1 year. Left Atrial Appendage Occlusion with the Amplatzer Amulet device achieved a 3.9% composite rate of cardiac mortality and ischemic stroke at 1 year in Southeast Asian patients with atrial fibrillation.

synapsesocial.com/papers/699e9143f5123be5ed04e9d9 https://doi.org/10.1186/s12872-026-05642-x

Topics

Left atrial appendage closure

Persistent AF management

Atrial fibrillation

AF ablation outcomes

Anticoagulation in AF

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

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Topics

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

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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