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Review
. 2022 Apr 2;14(4):e23756.
doi: 10.7759/cureus.23756. eCollection 2022 Apr.

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications

Beshoy Iskander  1 , Fatima Anwer  2 , Federico Oliveri  3 , Kakargias Fotios  4 , Priyanka Panday  5 , Ana P Arcia Franchini  5 , Pousette Hamid  2
Affiliations
Review

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications

Beshoy Iskander et al. Cureus. .

Abstract

Patent foramen ovale (PFO) is a standard variant that is present in 25% of the whole adult population. In a certain population, PFO can lead to cerebrovascular accidents. Mechanism of cerebrovascular accidents can be by paradoxical embolization from the right circulation or in situ thrombosis. Diagnosis of a PFO-responsible cerebrovascular accident is based on a thorough work-up to exclude other possible etiologies and detect PFO on trans-thoracic or trans-esophageal echocardiography with bubble study and/or Doppler. Over the last few years, multiple studies have supported that percutaneous PFO closure is superior to medical therapy in the secondary prevention of cerebrovascular accidents. However, numerous adverse events have been linked to PFO closure devices in general compared to medical therapy as new-onset atrial fibrillation, residual shunt, device-related thrombus, bleeding, deep vein thrombosis, pulmonary embolism, and inter-atrial septal erosions. Amplatzer device is one of the PFO occluder devices approved by the FDA. Device-related adverse events have been addressed by comparing the Amplatzer device with other PFO occluder devices. Based on the new data, we expect to see more complications related to PFO closure in the coming few years. We reviewed different studies that looked at the PFO closure-related complications and the trials comparing adverse events in the Amplatzer PFO occluder device compared to other devices. Amplatzer PFO occluder device is either superior or non-statistically different from other PFO occluder devices related to new-onset atrial fibrillation and residual shunt. More studies are needed to address the other less common adverse events. Since many of the device-related complications appear many years after device placement, a long-term follow-up is recommended.

Keywords: amplatzer; amplatzer occluder; amplatzer plug device; atrial fibrillation; percutaneous pfo closure; pfo; pfo closure; pfo closure complications; pfo occluder device; residual shunt.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Amplatzer patent foramen ovale occluder in different sizes
Source: Ref. [16]. Permission to use this figure was obtained from Hindawi (Scientifica).
See this image and copyright information in PMC

References

    1. Incidence of patent ductus arteriosus and patent foramen ovale in normal infants. Connuck D, Sun JP, Super DM, et al. Am J Cardiol. 2002;89:244–247. - PMC - PubMed
    1. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Pristipino C, Sievert H, D'Ascenzo F, et al. https://pubmed.ncbi.nlm.nih.gov/30358849/ Eur Heart J. 2019;40:3182–3195. - PubMed
    1. Prevalence of potential risk factors for stroke assessed by transesophageal echocardiography and carotid ultrasonography: the SPARC study. Stroke Prevention: assessment of risk in a community. Meissner I, Whisnant JP, Khandheria BK, et al. https://pubmed.ncbi.nlm.nih.gov/10488786/ Mayo Clin Proc. 1999;74:862–869. - PubMed
    1. Detection of right to left shunts in decompression sickness in divers. Kerut EK, Truax WD, Borreson TE, Van Meter KW, Given MB, Giles TD. https://pubmed.ncbi.nlm.nih.gov/9036765/ Am J Cardiol. 1997;79:377–378. - PubMed
    1. Prevalence of patent foramen ovale in patients with stroke. Lechat P, Mas JL, Lascault G, et al. https://www.nejm.org/doi/full/10.1056/NEJM198805053181802. N Engl J Med. 1988;318:1148–1152. - PubMed

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