Evidence map›Paper›PMID 30126370›Full record

Observational studyBMC cardiovascular disorders2018

Real-world experience comparing two common left atrial appendage closure devices.

Christian Fastner, Lea Hoffmann, Mohamed Aboukoura, Michael Behnes, Siegfried Lang, Martin Borggrefe, Ibrahim Akin, Christoph A Nienaber

Abstract readComparative StudyMulticenter StudyObservational Study
In one paragraph

Observational study in BMC cardiovascular disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  5. Meta-Analysis Comparing WatchmanFrontiers in cardiovascular medicine · 2020
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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

8 authors.

Christian FastnerFirst Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Centre for AngioScience (ECAS), and DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. christian.fastner@umm.de.ORCID 0000-0001-9367-4386
Lea HoffmannDepartment of Cardiology, University Hospital Rostock, Rostock, Germany.
Mohamed AboukouraDepartment of Cardiology, University Hospital Rostock, Rostock, Germany.
Michael BehnesFirst Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Centre for AngioScience (ECAS), and DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Siegfried LangFirst Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Centre for AngioScience (ECAS), and DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Martin BorggrefeFirst Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Centre for AngioScience (ECAS), and DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Ibrahim AkinFirst Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Centre for AngioScience (ECAS), and DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Christoph A NienaberRoyal Brompton Hospital, London, United Kingdom and National Heart and Lung Institute, Imperial College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe interventional left atrial appendage closure (LAAC) is a guideline-conform alternative to oral anticoagulation (OAC) in non-valvular atrial fibrillation patients with OAC ineligibility. It was aimed to directly compare two contemporary devices in a real-world patient population.

methodsLAAC was conducted in two centres between 2010 and 2014 as well as between 2014 and 2017, respectively, in a standard fashion based on the specific manufacturer's recommendations. Baseline characteristics, procedural data and event rates during intra-hospital and 6 months follow-up were registered in a retrospective approach, and analysed in device-related groups.

resultsA total of 189 patients presented for LAAC device implantation. Baseline characteristics were mostly evenly distributed. In 148 patients, a Watchman™ device (Boston Scientific, Natick, MA, USA) was successfully implanted, an Amplatzer™ Amulet™ (St. Jude Medical, St. Paul, MN, USA) in 34 patients (96.1 and 97.1%, respectively; p = 1.00). Major access site bleedings were more frequent in the Amplatzer™ Amulet™ group (8.9 versus 1.4%; p = 0.046). No intra-hospital thromboembolic event was present. During 6 months follow-up, peri-device leaks > 5 mm and thromboembolic events were uncommon (each p = n.s.).

conclusionsWhile procedural success was equally high with both contemporary devices, complications during follow-up were rare, and evenly distributed.

Indexed as

Atrial AppendageAgedAged, 80 and overAtrial FibrillationCardiac CatheterizationEchocardiography, TransesophagealEquipment DesignEquipment FailureFemaleGermanyHumansMaleRegistriesRetrospective StudiesRisk FactorsTime FactorsAtrial fibrillationComparisonLeft atrial appendageLeft atrial appendage closure deviceOutcome

Identifiers

PMID30126370
PMCPMC6102880

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Registered trials

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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.