Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study

Asger Andersen, Kristina Laut Matzen, Grethe Andersen, Magnus Settergren, Christina Sjostrand, Helle K. Iversen, Risto O. Roine, David Hildick-Smith, J. David Spence, John F. Rhodes, Scott E. Kasner, Lars Sondergaard, Jens Erik Nielsen-Kudsk*

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

14 Citationer (Scopus)

Abstract

Objectives: To describe the occurrence of postprocedural atrial fibrillation (AF) among patients with cryptogenic stroke undergoing patent foramen ovale (PFO) closure in the REDUCE clinical study and analyze for potential risk factors for the development of postprocedural AF. Background: AF is an adverse event that might potentially counterbalance the stroke prevention benefit from PFO closure. Data on AF after transcatheter PFO closure are sparse. Methods: We evaluated data from patients having PFO closure (Gore HELEX or Gore Cardioform Septal Occluder) in the REDUCE clinical trial (n = 408) in at post hoc explorative analysis. Median follow-up was 5.0 years. Results: AF occurred in 30 patients (7.4%) after PFO closure with a total of 34 AF events. Most were reported as non-serious (68%), detected within 45 days post-procedure (79%), and resolved within 2 weeks of onset (63%). One subject with AF had recurrent stroke. Postprocedural AF occurred more frequently among subjects with higher age and large device sizes. Male sex was the only independent predictor of postprocedural AF. We found no association between the type of occluder (HELEX or Gore Cardioform Septal Occluder) or PFO anatomical characteristics and post-procedural AF. Conclusion: In the REDUCE clinical study, postprocedural atrial fibrillation was mostly early onset, transient and with no later recurrence. Postprocedural AF occurred more frequently among patients with higher age and larger devices. Male sex was the only independent predictor of postprocedural AF.

OriginalsprogEngelsk
TidsskriftCatheterization and Cardiovascular Interventions
Vol/bind99
Udgave nummer5
Sider (fra-til)1551-1557
Antal sider7
ISSN1522-1946
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
The REDUCE clinical study was sponsored by W.L. Gore & Associates. This analysis on postprocedural AF was not funded by the company and W. L. Gore had no influence on the manuscript.

Publisher Copyright:
© 2021 Wiley Periodicals LLC.

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