Evidence map›Paper›PMID 35710343›Full record

ArticleBMC cardiovascular disorders2022

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure).

Lucie Kretzler, Christoph Mues, Carsten Wunderlich, Anke Langbein, S G Spitzer, Ulrich Gerk, Sebastian Schellong, Thomas Ketteler, Hans Neuser, Marcus Schwefer and 4 more

Open access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cardiovascular disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 15% of its field
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
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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

14 authors at 5 institutions in 1 country.

Lucie KretzlerClinical Study Center (CSC), Berlin Institute of Health (BIH), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany. Lucie.Kretzler@charite.de.
Christoph MuesDresden University of Technology, Dresden, Germany.
Carsten WunderlichDresden University of Technology, Dresden, Germany.
Anke LangbeinDresden University of Technology, Dresden, Germany.
S G SpitzerDresden University of Technology, Dresden, Germany.
Ulrich GerkDresden University of Technology, Dresden, Germany.
Sebastian SchellongDresden University of Technology, Dresden, Germany.
Thomas KettelerDresden University of Technology, Dresden, Germany.
Hans NeuserDresden University of Technology, Dresden, Germany.
Marcus SchweferDresden University of Technology, Dresden, Germany.
Ruth StrasserDresden University of Technology, Dresden, Germany.
Karim IbrahimTechnische Universität Dresden, Campus Chemnitz , Klinikum Chemnitz, Flemmingstrasse 2, 09116, Chemnitz, Germany.
Steffen Schoen *Dresden University of Technology, Dresden, Germany.
Marian Christoph *Technische Universität Dresden, Campus Chemnitz , Klinikum Chemnitz, Flemmingstrasse 2, 09116, Chemnitz, Germany.
TU Dresden · DEHelios Vogtland Klinikum Plauen · DEStädtisches Klinikum Dresden · DEFreie Universität Berlin · DESt.-Johannes-Hospital Dortmund · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVarious randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.

aimsThe prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety. METHODS AND

resultsThe total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.

conclusionsThe ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers. Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803 .

Indexed as

Atrial AppendageAtrial FibrillationStrokeAnticoagulantsCardiac CatheterizationFibrinolytic AgentsHumansProspective StudiesRegistriesTreatment OutcomeAnticoagulantsFibrinolytic AgentsAtrial fibrillationLeft atrial appendagePatient registryStroke prevention

Identifiers

PMID35710343
PMCPMC9205092
OpenAlexW4282967068

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.