Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr 5:18:e10.
doi: 10.15420/icr.2022.27. eCollection 2023.

Patent Foramen Ovale-associated Stroke and COVID-19 Vaccination

Maja Rojko  1 , Natasa Cernic Suligoj  1 , Metka Zorc  1 , Marko Noc  1   2
Affiliations

Patent Foramen Ovale-associated Stroke and COVID-19 Vaccination

Maja Rojko et al. Interv Cardiol. .

Abstract

Background: COVID-19 infection has been associated with paradoxical thromboembolism through a patent foramen ovale (PFO) and ischaemic stroke. Such events have not been reported after COVID-19 vaccination. The aim of the present study was to investigate PFO-associated stroke during the mass COVID-19 vaccination in Slovenia. Methods: This prospective study, conducted between 26 December 2020 and 31 March 2022, enrolled consecutive patients (≥18 years) with PFO-associated stroke referred for a percutaneous closure to a single interventional facility in Slovenia. Results: A total of 953,546 people aged between 18 and 70 years received at least one dose of a COVID-19 vaccine approved by the European Medicines Agency. Of the 28 patients presenting with PFO-associated stroke, 12 patients (42.9%) were vaccinated prior to the event, of whom nine were women and three were men, aged between 21 and 70 years. Stroke occurred within 35 days after vaccination in six patients (50%). Clinical presentation included motor dysphasia, paresis, vertigo, ataxia, paraesthesia, headache, diplopia and hemianopia. At hospital discharge, 11 patients (91.6%) had at least one residual ischaemic lesion. Conclusion: A temporal coincidence of COVID-19 vaccination and PFO-associated stroke has been described. A potential cause-effect relationship may only be hypothesised.

Keywords: COVID-19 vaccination; PFO-associated stroke; patent foramen ovale; stroke.

PubMed Disclaimer

Conflict of interest statement

Disclosure: The authors have no conflicts of interest to declare. Funding: The study was funded by the Center for Cardiovascular Diseases MC Medicor, Izola, Slovenia (EU). Data availability: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. Author contributions: Conceptualisation: MR, NCS, MZ, MN; data curation: MR, NCS, MZ, MN; formal analysis: MR, NCS, MZ, MN; funding acquisition: MR, NCS, MZ, MN; investigation: MR, NCS, MZ, MN; methodology: MR, NCS, MZ, MN; project administration: MR, NCS, MZ, MN; resources: MR, NCS, MZ, MN; software: MR, NCS, MZ, MN; supervision: MR, NCS, MZ, MN; validation: MR, NCS, MZ, MN; visualisation: MR, NCS, MZ, MN; writing – original draft preparation: MR, NCS, MZ, MN; writing – review and editing: MR, NCS, MZ, MN Ethics: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the National Ethics Committee (Number 93/11/12). Consent: All patients have given written informed consent.

Figures

Figure 1:
Figure 1:. Percutaneous Patent Foramen Ovale Closure at MC Medicor, Slovenia (October 2006–October 2022)
See this image and copyright information in PMC

References

    1. Mas JL, Derumeaux G, Guillon B et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011–21. doi: 10.1056/NEJMoa1705915. - DOI - PubMed
    1. 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;377:1022–32. doi: 10.1056/NEJMoa1610057. - DOI - PubMed
    1. Søndergaard L, Kasner SE, Rhodes JF et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033–42. doi: 10.1056/NEJMoa1707404. - DOI - PubMed
    1. 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;71:2335–42. doi: 10.1016/j.jacc.2018.02.046. - DOI - PubMed
    1. Ashraf M, Sajed S. Acute stroke in a young patient with coronavirus disease 2019 in the presence of patent foramen ovale. Cureus. 2020;12:e10233. doi: 10.7759/cureus.10233. - DOI - PMC - PubMed

LinkOut - more resources