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Patent foramen ovale—When to close and how?

Offenes Foramen ovale – wann und wie soll es verschlossen werden?

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Abstract

Closure of a patent foramen ovale (PFO) in patients after cryptogenic/cardioembolic stroke is recommended by current guidelines for patients who are 16–60 years of age with a high-risk PFO (class of recommendation A, level of evidence I). The use of double-disk occlusion devices followed by antiplatelet therapy is recommended. The procedure of interventional PFO closure compared with other interventions in cardiology is rather easy to learn. However, it should be performed carefully to avoid postinterventional complications. The number needed to treat (NNT) to avoid one stroke in 5 years in the RESPECT trial was 42, in the CLOSE trial even lower with 20. In the REDUCE trial, the NNT was 28 at 2 years. This can be reduced by longer follow-up, e.g., at 10 years the NNT is 18. While other conditions such as migraine are currently under investigation with respect to the impact of PFO closure, sufficiently powered trials are lacking so that closure in diseases other than stroke should always be individualized.

Zusammenfassung

Der Verschluss eines offenen Foramen ovale (PFO) wird für Patienten nach kryptogenem/kardioembolischem Schlaganfall im Alter zwischen 16 und 60 Jahren in den aktuellen Konsensusleitlinien mehrerer Fachgesellschaften empfohlen (Empfehlungsklasse A, Evidenzlevel I). Die Anwendungen eines sog. Double-Disc-Okklusionssystems wird präferenziell empfohlen. Die interventionelle Technik des PFO-Verschluss ist, verglichen mit anderen interventionellen Eingriffen in der Kardiologie, einfach zur erlernen, sollte aber mit größter Vorsicht zur Vermeidung von periinterventionellen Komplikationen vorgenommen werden. Die „number needed to treat“ (NNT), um ein Schlaganfallrezidiv in 5 Jahren zu verhindern, lag in der RESPECT-Studie bei 42, in der CLOSE-Studie sogar bei nur 20. In der REDUCE-Studie war die NNT 28, um ein Schlaganfallrezidiv in 2 Jahren zu verhindern. Mit längerer Beobachtungszeit reduziert sich die NNT weiter, z. B. nach 10 Jahren auf 18. Viele andere Krankheiten, wie Migräne, sind Gegenstand der Forschung als potenzielle Ziele für den PFO-Verschluss; aktuell fehlen aber ausreichend gepowerte Studien, sodass der Verschluss bei anderen Krankheiten von Fall zu Fall entschieden werden sollte.

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Correspondence to Sven Möbius-Winkler.

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A. Maloku, A. Hamadanchi, M. Franz, G. Dannberg, A. Günther, C. Klingner, P. C. Schulze and S. Möbius-Winkler declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

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Maloku, A., Hamadanchi, A., Franz, M. et al. Patent foramen ovale—When to close and how?. Herz 46, 445–451 (2021). https://doi.org/10.1007/s00059-021-05061-y

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