Evidence map›Paper›PMID 41321777›Full record

ArticleStructural heart : the journal of the Heart Team2025

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.

Philipp Jakob, Priska Heinz, Yiqi Gong, Mi Chen, Ronald K Binder, Ulrike Held, Maurizio Taramasso, Francesco Paneni, Philipp Schuetz, Philipp K Haager and 9 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Structural heart : the journal of the Heart Team, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03088098 (Randomized Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03088098 nacompletednot on this map

Randomized Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation: The TAVI LAAO Trial

TypeinterventionalSponsorUniversity of ZurichRan2016 to 2025Enrolled81ConditionsAtrial Fibrillation, Aortic StenosisArmsLAAO
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Philipp JakobDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Priska HeinzDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Yiqi GongDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Mi ChenDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Ronald K BinderDepartment of Cardiology and Intensive Care, Klinikum Wels, Wels, Austria.
Ulrike HeldDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Maurizio TaramassoClinic of Cardiac Surgery, HerzZentrum Hirslanden Zurich, Zurich, Switzerland.
Francesco PaneniDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Philipp SchuetzDivision of General Internal and Emergency Medicine, Medical University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland.
Philipp K HaagerHOCH Cantonal Hospital St. Gallen, Department of Cardiology, St. Gallen, Switzerland.
Markus KaselDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Giovanni PedrazziniCardiology Department, Cardiocentro Ticino, Lugano, Switzerland.
Stephan WindeckerDepartment of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
Marco MoccettiCardiology Department, Cardiocentro Ticino, Lugano, Switzerland.
Thomas PilgrimDepartment of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
Thomas F LüscherCenter for Molecular Cardiology, University of Zurich, Schlieren, Switzerland.
Barbara E StähliDepartment of Cardiology, University Heart Center, University Hospital Zurich and the Center for Translational and Experimental Cardiology (CTEC), University of Zurich, Zurich, Switzerland.
Fabian NietlispachCardiovascular Center Zurich, Heart Center im Park, Zürich, Switzerland.
TAVI-LAAO Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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, 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).

Indexed as

Antithrombotic therapyAortic valve stenosisAtrial fibrillationLeft atrial appendage occlusionTranscatheter aortic valve intervention

Identifiers

PMID41321777
PMCPMC12664515

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.