Atrial fibrillation after closure of patent foramen ovale in the REDUCE clinical study.
atrial fibrillation
patent foramen ovale
percutaneous closure
stroke
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
revised:
27
10
2021
received:
16
08
2021
accepted:
04
11
2021
pubmed:
14
11
2021
medline:
30
4
2022
entrez:
13
11
2021
Statut:
ppublish
Résumé
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. 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. 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. 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. 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.
Sections du résumé
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.
Types de publication
Clinical Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1551-1557Informations de copyright
© 2021 Wiley Periodicals LLC.
Références
Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013;368:1092-1100.
Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.
Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042.
Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. Antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021.
Lee PH, Song JK, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: the DEFENSE-PFO trial. J Am Coll Cardiol. 2018;71:2335-2342.
Pristipino C, Sievert H, D'Ascenzo F, et al. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Eur Heart J. 2019;40:3182-3195.
Messé SR, Gronseth GS, Kent DM, et al. Practice advisory update summary: patent foramen ovale and secondary stroke prevention: report of the guideline Subcommittee of the American Academy of neurology. Neurology. 2020;94:876-885.
Kasner SE, Rhodes JF, Andersen G, et al. Five-year outcomes with patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2021;384:970-971.
Staubach S, Steinberg DH, Zimmermann W, et al. New onset atrial fibrillation after patent foramen ovale closure. Catheter Cardiovasc Interv. 2009;74:889-895.
Elgendy AY, Elgendy IY, Mojadidi MK, et al. New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials. EuroIntervention. 2019;14:1788-1790.
Oliva L, Huszti E, Barker M, et al. New-onset atrial fibrillation following percutaneous closure of patent foramen ovale: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2021;60:165-174.
Varotto L, Bregolin G, Paccanaro M, De Boni A, Bonanno C, Perini F. Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse? Neurol Sci. 2021;42:101-109.
Chen JZ, Thijs VN. Atrial fibrillation following patent foramen ovale closure: systematic review and meta-analysis of observational studies and clinical trials. Stroke. 2021;52:1653-1661.
Taaffe M, Fischer E, Baranowski A, et al. Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). Am J Cardiol. 2008;101:1353-1358.
Tsivgoulis G, Katsanos AH, Mavridis D, et al. Percutaneous patent foramen ovale closure for secondary stroke prevention: network meta-analysis. Neurology. 2018;91:e8-e18.
Gevorgyan Fleming R, Kumar P, West B, et al. Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale. Catheter Cardiovasc Interv. 2020;95:365-372.
Gaspardone A, Giardina A, Iamele M, et al. Effect of percutaneous closure of patent foramen ovale on post-procedural arrhythmias. J Am Coll Cardiol. 2013;62:2449-2450.
Benjamin EJ, Levy D, Vaziri SM, D'Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort: the Framingham Heart Study. JAMA. 1994;271:840-844.
Alaeddini J, Feghali G, Jenkins S, Ramee S, White C, Abi-Samra F. Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. J Invasive Cardiol. 2006;18:365-368.
Westerman S, Wenger N. Gender differences in atrial fibrillation: a review of epidemiology, management, and outcomes. Curr Cardiol Rev. 2019;15:136-144.