Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Severe symptomatic aortic stenosis and atrial fibrillation undergoing transcatheter aortic valve intervention (TAVI) (n=81). Intervention: Left atrial appendage occlusion (LAAO) using the Amplatzer Amulet device combined with TAVI and early cessation of OAC (DAPT for ≥6 months followed by SAPT) vs. Standard medical therapy (SMT) with TAVI (antithrombotic therapy at operator's discretion, predominantly OAC). Primary outcome: Composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year (adjusted OR 0.87, 95% CI 0.32-2.29, p=0.77).

Q: What does this research mean for the field?

Concomitant left atrial appendage occlusion with the Amplatzer Amulet device during TAVI yields similar 1-year composite adverse event rates compared to standard medical therapy in high-risk patients with atrial fibrillation. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Philipp Jakob; Priska Heinz; Yiqi Gong; Chen Mi; Ronald K. Binder; Ulrike Held; Maurizio Taramasso; Francesco Paneni; Philipp Schüetz; Philipp K. Haager; Albert Markus Kasel; Giovanni Pedrazzini; Stephan Windecker; Marco Moccetti; Thomas Pilgrim; Thomas F. Lüscher; Barbara E. Stähli; Fabian Nietlispach

doi:10.1016/j.shj.2025.100735

Key result

Left atrial appendage occlusion with the Amulet device during TAVI yielded similar 1-year composite event rates compared to standard medical therapy (33% vs 37%; adjusted OR 0.87, p=0.77).

Figures

Why the study?

Patients with severe aortic stenosis and AF undergoing TAVI face an increased risk of bleeding and cerebrovascular events.

Does concomitant left atrial appendage occlusion using the Amplatzer Amulet device with early cessation of oral anticoagulation reduce the composite of cerebrovascular events, peripheral embolism, major bleeding, or cardiovascular mortality at 1 year compared to standard medical therapy in high-risk patients with atrial fibrillation undergoing TAVI?

Key Points

Assess the safety and efficacy of combining left atrial appendage occlusion with transcatheter aortic valve intervention compared to standard medical therapy in high-risk patients with atrial fibrillation.
Investigator-initiated, randomized, multicenter, open-label pilot trial of 81 patients with atrial fibrillation undergoing TAVI, assigned to TAVI + LAAO using the Amplatzer Amulet device (n = 40) or TAVI + standard medical therapy (n = 41).
Follow-up was conducted through 1 year to evaluate a primary composite endpoint of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality, alongside a per-protocol sensitivity analysis.
The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and 15 patients (37%) in the TAVI + SMT group (adjusted OR, 0.87; 95% CI: 0.32-2.29, p = 0.77).
Bleeding rates were 13% in TAVI + LAAO versus 17% in TAVI + SMT, while cerebrovascular events occurred in 10% in TAVI + LAAO compared with 2.4% in TAVI + SMT.
In the per-protocol analysis (n = 36 in TAVI + LAAO), the primary endpoint occurred in 25% (9 patients) versus 37% (15 patients) with TAVI + SMT (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27).

Study Design

Type

RCT (n=81)

Blinding

Open-label

Randomization

1:1 ratio using unstratified multi block randomization

Multicenter

Yes

Structured PICO

Does concomitant left atrial appendage occlusion using the Amplatzer Amulet device with early cessation of oral anticoagulation reduce the composite of cerebrovascular events, peripheral embolism, major bleeding, or cardiovascular mortality at 1 year compared to standard medical therapy in high-risk patients with atrial fibrillation undergoing TAVI?

P

Population

81 older high-risk patients (mean age 82.8 years, 46% female, mean STS score 9.0%) with atrial fibrillation and severe aortic stenosis undergoing TAVI across 3 centers in Switzerland, followed for 1 year.

I

Intervention

Transcatheter aortic valve intervention (TAVI) combined with left atrial appendage occlusion (LAAO) using the Amplatzer Amulet device (as a combined procedure or staged before discharge), followed by immediate cessation of oral anticoagulation (OAC) and recommended dual antiplatelet therapy (DAPT) for at least 6 months, then single antiplatelet therapy (SAPT).

C

Comparator

Transcatheter aortic valve intervention (TAVI) plus standard medical therapy (SMT), with antithrombotic therapy left at the operator's discretion (consisting of triple therapy [DAPT + VKA/DOAC], dual therapy [1 antiplatelet agent + VKA/DOAC], DAPT [aspirin + P2Y12 inhibitor], single VKA/DOAC, or SAPT).

O

Outcome

Composite of cerebrovascular events, peripheral embolism, life-threatening/disabling and major bleeding, or cardiovascular mortality at 1 year after randomization, adjudicated by an independent clinical events committee.composite

Main Result

Odds Ratio: 0.87 (95% CI 0.32–2.29)

Absolute Event Rate: 33% vs 37%

p-value: p=0.77

In this randomized pilot study of high-risk patients with AF undergoing TAVI, concomitant LAAO with the Amplatzer Amulet device and early OAC cessation yielded similar 1-year composite outcomes compared to TAVI with standard medical therapy.

Limitations

Pilot trial lacking adequate statistical power and exploratory in nature (no formal sample size calculation).
Open-label design.
The Portico and Lotus transcatheter heart valves used in this study are no longer available, and Portico was used more frequently in the LAAO arm, which may have influenced event rates.
Exploratory pilot study with no formal sample size calculations performed
Open-label design
Results only apply to a high-risk older population (average STS score >8%) with higher procedural complication and mortality rates
Imbalances in procedural characteristics between groups (e.g., higher rate of predilatation and Portico valve use, and numerically more women in the TAVI + LAAO group)

Implication

Concomitant Amulet LAAO during TAVI appears feasible without excess events in high-risk AF; leaves open net benefit in larger confirmatory RCTs.

Abstract

Background Patients with severe aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and cerebrovascular events. This investigator-initiated, randomized, multicenter, open-label pilot study assessed left atrial appendage occlusion (LAAO) in patients with AF undergoing TAVI. Methods Patients were randomly assigned to LAAO (TAVI + LAAO) or standard medical therapy (SMT) (TAVI + SMT). The primary endpoint was a composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population. Results Eighty-one patients (Society of Thoracic Surgeons score: 9.0% ± 5.4%) were enrolled. The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and in 15 patients (37%) in the TAVI + SMT group (adjusted odds ratio [OR], 0.87; 95% CI: 0.32-2.29, p = 0.77). Bleeding rates were comparable between TAVI + LAAO (13%) and TAVI + SMT (17%), with absent nonprocedural bleeding in the TAVI + LAAO group and 5 gastrointestinal bleedings in TAVI + SMT, and cerebrovascular events did not significantly differ between groups (10% in TAVI + LAAO vs. 2.4% in TAVI + SMT). In the per-protocol analysis, occurrence of the primary endpoint was comparable between groups (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27) with cerebrovascular events in 5.6% and 2.4%, and bleeding events in 8.3% and 17% for TAVI + LAAO and TAVI + SMT, respectively. Conclusions This pilot study suggests that among high-risk patients with AF undergoing TAVI, a strategy of a combined procedure with LAAO and early cessation of oral anticoagulation overall showed similar rates of the primary end point as compared to a single TAVI procedure (NCT03088098).

Discussion

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Cite This Study

Jakob et al. (2025) conducted an RCT in Severe symptomatic aortic stenosis and atrial fibrillation undergoing transcatheter aortic valve intervention (TAVI) (n=81). Left atrial appendage occlusion (LAAO) using the Amplatzer Amulet device combined with TAVI and early cessation of OAC (DAPT for ≥6 months followed by SAPT) vs. Standard medical therapy (SMT) with TAVI (antithrombotic therapy at operator's discretion, predominantly OAC) was evaluated on Composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year (adjusted OR 0.87, 95% CI 0.32-2.29, p=0.77). Left atrial appendage occlusion with the Amulet device during TAVI yielded similar 1-year composite event rates compared to standard medical therapy (33% vs 37%; adjusted OR 0.87, p=0.77).

synapsesocial.com/papers/6aa4e7c727d245a4842bca37 https://doi.org/10.1016/j.shj.2025.100735

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Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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