Evidence map›Paper›PMID 25736061›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2015

Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation.

Steffen Gloekler, Samera Shakir, Janosch Doblies, Ahmed A Khattab, Fabien Praz, Ênio Guerios, Dezsoe Koermendy, Stefan Stortecky, Thomas Pilgrim, Lutz Buellesfeld and 7 more

Abstract readComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Risk factors, clinical implications, and management of peridevice leak following left atrial appendage closure: A systematic review.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
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  4. Article
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  8. Left atrial appendage occlusion with the Amplatzer Amulet: update on device sizing.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2020
    Review
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  10. Article
  11. Article
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  13. Pericardial tamponade as a complication of invasive cardiac procedures: a review of the literature.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2019
    Review
  14. Observational
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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

17 authors.

Steffen GloeklerCardiology, Cardiovascular Department, Bern University Hospital, Bern, Switzerland.
Samera Shakir
Janosch Doblies
Ahmed A Khattab
Fabien Praz
Ênio Guerios
Dezsoe Koermendy
Stefan Stortecky
Thomas Pilgrim
Lutz Buellesfeld
Peter Wenaweser
Stephan Windecker
Aris Moschovitis
Milosz Jaguszewski
Ulf Landmesser
Fabian Nietlispach
Bernhard Meier

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications.

aimTo investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion.

methodsRetrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success.

resultsThere were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78% with ACP vs. 70% with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94%, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8%, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14%, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2%, 0 vs. 0%, or 6 vs. 6%, p = ns).

conclusionTranscatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure.

Indexed as

Septal Occluder DeviceAgedAged, 80 and overAtrial AppendageAtrial FibrillationCardiac CatheterizationFemaleHumansMaleMiddle AgedProsthesis DesignRegistriesRetrospective StudiesRisk AssessmentRisk FactorsStroke

Identifiers

PMID25736061

What OpenQuestion holds

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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.