Evidence map›Paper›PMID 34381870›Full record

ArticleInternational journal of cardiology. Heart & vasculature2021

Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer™ Amulet™ Observational Study.

Alberto Ranieri De Caterina, Jens Erik Nielsen-Kudsk, Boris Schmidt, Patrizio Mazzone, Sven Fischer, Juha Lund, Matteo Montorfano, Ryan Gage, Simon Cheung Chi Lam, Sergio Berti

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of cardiology. Heart & vasculature, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02447081 (Amplatzer™Amulet™ Observational Post-Market Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

NCT02447081 completednot on this map

Amplatzer™Amulet™ Observational Post-Market Study

Typeobservational_patient_registrySponsorAbbott Medical DevicesRan2015 to 2018Enrolled1,088ConditionsAtrial Fibrillation, Thromboembolism, StrokeArmsSubjects implanted with Amulet Device
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
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

10 authors at 7 institutions in 6 countries.

Alberto Ranieri De CaterinaDepartment of Interventional and Diagnostic CardiologyOspedale del Cuore, Fondazione Toscana "G. Monasterio", Massa, Italy.
Jens Erik Nielsen-KudskDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Boris SchmidtCardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik 3 - Kardiologie, Frankfurt, Germany.
Patrizio MazzoneArrhythmology and Cardiac Pacing Unit, Ospedale San Raffaele, Milan, Italy.
Sven FischerDepartment of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Germany.
Juha LundHeart Center, Turku University Hospital, Turku, Finland.
Matteo MontorfanoInterventional Cardiology Unit, Ospedale San Raffaele, Milan, Italy.
Ryan GageStructural Heart Clinical Affairs, Abbott Medical, St. Paul, USA.
Simon Cheung Chi LamDepartment of Medicine, Queen Mary Hospital, Hong Kong.
Sergio BertiDepartment of Interventional and Diagnostic CardiologyOspedale del Cuore, Fondazione Toscana "G. Monasterio", Massa, Italy.
Fondazione Toscana Gabriele Monasterio · ITIRCCS Ospedale San Raffaele · ITAarhus University Hospital · DKAbbott (United States) · USAgaplesion Bethanien Krankenhaus · DEQueen Mary Hospital · CNTurku University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPercutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO).

methods1088 AF patients were enrolled in the prospective, multicenter, Amplatzer™ Amulet™ Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders.

results702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHA

conclusionsIn this large group of patients undergoing LAAO using the Amplatzer™ Amulet™ device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men. CLINICAL

trial registrationClinicaltrials.gov Identifier: NCT02447081.https://clinicaltrials.gov/ct2/show/NCT02447081.

Indexed as

AF, atrial fibrillationCV, cardiovascularDAPT, dual antiplatelet therapyDRT, device-related thrombusGender differenceLAAO, left atrial appendage occlusionLeft atrial appendage occlusionMortalityPCI, percutaneous coronary interventionSAPT, single antiplatelet therapyStrokeTAVI, transcatheter aortic valve implantationTEE, transesophageal echocardiographyTIA, transient ischemic attack

Identifiers

PMID34381870
PMCPMC8333339
OpenAlexW3185038152

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.