Efficacy and safety of left atrial appendage closure procedure in patients with non-valvular atrial fibrillation with contraindication and/or failure for oral anticoagulants: A systematic review and meta-analysis.

Ricardo Dos Santos Simões, Julia Simões Corrêa Galendi, Wanderley Marques Bernardo, Aline Frossard Ribeiro Bortoluzzi, Janaina Cardoso Nunes Marinho

Journal: Clinics (Sao Paulo, Brazil) 2024;79():100465

PMID: 39216123

Abstract

BACKGROUND

With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants.

OBJECTIVE

To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants.

METHOD

The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses.

RESULTS

Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified.

CONCLUSIONS

For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce.

Copyright © 2024. Published by Elsevier España, S.L.U.

Address: Núcleo de Avaliação de Tecnologias em Saúde da Unimed do Brasil, Unimed do Brasil, São Paulo, SP, Brazil.; Núcleo de Avaliação de Tecnologias em Saúde da Unimed do Brasil, Unimed do Brasil, São Paulo, SP, Brazil. Electronic address: [email protected].
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