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...
Main Authors: | , , , , , , , |
---|---|
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 |
_version_ | 1818477518326333440 |
---|---|
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. |
first_indexed | 2024-12-10T09:38:42Z |
format | Article |
id | doaj.art-094511de43a1409699439387692af690 |
institution | Directory Open Access Journal |
issn | 1664-2295 |
language | English |
last_indexed | 2024-12-10T09:38:42Z |
publishDate | 2020-06-01 |
publisher | Frontiers Media S.A. |
record_format | Article |
series | Frontiers in Neurology |
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 |
work_keys_str_mv | AT apostolossafouris anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT odysseaskargiotis anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT klearchospsychogios anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT klearchospsychogios anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT pericleskalyvas anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT ignatiosikonomidis anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT mariadrakopoulou anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT konstantinostoutouzas anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT georgiostsivgoulis anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT georgiostsivgoulis anarrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT apostolossafouris narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT odysseaskargiotis narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT klearchospsychogios narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT klearchospsychogios narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT pericleskalyvas narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT ignatiosikonomidis narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT mariadrakopoulou narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT konstantinostoutouzas narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT georgiostsivgoulis narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence AT georgiostsivgoulis narrativeandcriticalreviewofrandomizedcontrolledclinicaltrialsonpatentforamenovaleclosureforreducingtheriskofstrokerecurrence |