A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence

Patent foramen ovale (PFO) is a common cardiac anatomic variant that has been increasingly found in young (<60 years) cryptogenic stroke patients. Despite initial neutral randomized-controlled clinical trials (RCTs), there have been four recent RCTs providing consistent data in favor of the e...

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Main Authors: Apostolos Safouris, Odysseas Kargiotis, Klearchos Psychogios, Pericles Kalyvas, Ignatios Ikonomidis, Maria Drakopoulou, Konstantinos Toutouzas, Georgios Tsivgoulis
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-06-01
Series:Frontiers in Neurology
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fneur.2020.00434/full
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author Apostolos Safouris
Odysseas Kargiotis
Klearchos Psychogios
Klearchos Psychogios
Pericles Kalyvas
Ignatios Ikonomidis
Maria Drakopoulou
Konstantinos Toutouzas
Georgios Tsivgoulis
Georgios Tsivgoulis
author_facet Apostolos Safouris
Odysseas Kargiotis
Klearchos Psychogios
Klearchos Psychogios
Pericles Kalyvas
Ignatios Ikonomidis
Maria Drakopoulou
Konstantinos Toutouzas
Georgios Tsivgoulis
Georgios Tsivgoulis
author_sort Apostolos Safouris
collection DOAJ
description Patent foramen ovale (PFO) is a common cardiac anatomic variant that has been increasingly found in young (<60 years) cryptogenic stroke patients. Despite initial neutral randomized-controlled clinical trials (RCTs), there have been four recent RCTs providing consistent data in favor of the efficacy and safety of PFO closure compared to medical therapy for secondary stroke prevention. However, taking into consideration the high prevalence of PFO, the low risk of stroke recurrence under medical treatment and the uncommon yet severe adverse events of the intervention, patient selection is crucial for attaining meaningful clinical benefits. Thorough workup to exclude alternative causes of stroke and identification of high-risk PFOs through clinical, neuroimaging and echocardiographic criteria are essential. Cost effectiveness of the procedure cannot be proven for the time being, since there are no robust data on clinical outcome after PFO-associated stroke but only limited anecdotal data suggesting low risk for long-term disability.
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spelling doaj.art-094511de43a1409699439387692af6902022-12-22T01:54:05ZengFrontiers Media S.A.Frontiers in Neurology1664-22952020-06-011110.3389/fneur.2020.00434543976A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke RecurrenceApostolos Safouris0Odysseas Kargiotis1Klearchos Psychogios2Klearchos Psychogios3Pericles Kalyvas4Ignatios Ikonomidis5Maria Drakopoulou6Konstantinos Toutouzas7Georgios Tsivgoulis8Georgios Tsivgoulis9Stroke Unit, Metropolitan Hospital, Pireus, GreeceStroke Unit, Metropolitan Hospital, Pireus, GreeceStroke Unit, Metropolitan Hospital, Pireus, GreeceSecond Department of Neurology, School of Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, GreeceCardiology Department, Metropolitan Hospital, Pireus, GreeceDepartment of Echocardiography and Laboratory of Preventive Cardiology, Second Cardiology Department, Attikon Hospital, National and Kapodistrian University of Athens, Athens, GreeceFirst Department of Cardiology, Athens School of Medicine, Hippokration Hospital, Athens, GreeceFirst Department of Cardiology, Medical School of Athens University, Hippokration Hospital, Athens, GreeceSecond Department of Neurology, School of Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, GreeceDepartment of Neurology, University of Tennessee Health Science Center, Memphis, TN, United StatesPatent foramen ovale (PFO) is a common cardiac anatomic variant that has been increasingly found in young (<60 years) cryptogenic stroke patients. Despite initial neutral randomized-controlled clinical trials (RCTs), there have been four recent RCTs providing consistent data in favor of the efficacy and safety of PFO closure compared to medical therapy for secondary stroke prevention. However, taking into consideration the high prevalence of PFO, the low risk of stroke recurrence under medical treatment and the uncommon yet severe adverse events of the intervention, patient selection is crucial for attaining meaningful clinical benefits. Thorough workup to exclude alternative causes of stroke and identification of high-risk PFOs through clinical, neuroimaging and echocardiographic criteria are essential. Cost effectiveness of the procedure cannot be proven for the time being, since there are no robust data on clinical outcome after PFO-associated stroke but only limited anecdotal data suggesting low risk for long-term disability.https://www.frontiersin.org/article/10.3389/fneur.2020.00434/fullpatent foramen ovalPFO closurestrokecryptogenicrandomized controlled (clinical) trial
spellingShingle Apostolos Safouris
Odysseas Kargiotis
Klearchos Psychogios
Klearchos Psychogios
Pericles Kalyvas
Ignatios Ikonomidis
Maria Drakopoulou
Konstantinos Toutouzas
Georgios Tsivgoulis
Georgios Tsivgoulis
A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
Frontiers in Neurology
patent foramen oval
PFO closure
stroke
cryptogenic
randomized controlled (clinical) trial
title A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
title_full A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
title_fullStr A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
title_full_unstemmed A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
title_short A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence
title_sort narrative and critical review of randomized controlled clinical trials on patent foramen ovale closure for reducing the risk of stroke recurrence
topic patent foramen oval
PFO closure
stroke
cryptogenic
randomized controlled (clinical) trial
url https://www.frontiersin.org/article/10.3389/fneur.2020.00434/full
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