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{{Patent foramen ovale}}
{{Patent foramen ovale}}


{{CMG}}; '''Associate Editors-In-Chief:''' [[Priyamvada Singh|Priyamvada Singh, M.B.B.S.]] [mailto:psingh@perfuse.org]; '''Assistant Editor-In-Chief:''' [[Kristin Feeney|Kristin Feeney, B.S.]] [mailto:kfeeney@perfuse.org]
{{CMG}}; '''Associate Editors-In-Chief:''' {{IO}}, [[Priyamvada Singh|Priyamvada Singh, M.B.B.S.]] [mailto:psingh13579@gmail.com], [[Kristin Feeney|Kristin Feeney, B.S.]] [mailto:kfeeney@elon.edu]


==Overview==
==Overview==
Surgical closure and [[percutaneous]] closure may be used to treat patent foramen ovale but [[percutaneous]] closure is preferred over [[Surgery|surgical]] closure. [[Asymptomatic]] patients do not require [[surgery]]. [[Percutaneous]] closure is associated with more decrease in recurrent [[stroke]] risk when compared with medical therapy although it is may be associated with [[vascular injury]], [[atrial fibrillation]], and device fracture. CardioSEAL septal occluder and Amplatzer PFO occluder are [[Food and Drug Administration|FDA]] approved devices used in the [[percutaneous]] closure of a patent foramen ovale. [[American Academy of Neurology]] recommend that [[Clinician|clinicians]] must counsel patients by informing them of how common the condition is and the effectiveness of [[percutaneous]] closure. [[American Heart Association]] recommends [[percutaneous]] closure may be considered in patients with patent foramen ovale and [[deep vein thrombosis]], depending on the risk of recurrent of [[deep vein thrombosis]].
==Surgery==
===Surgical Closure===
* Surgical closure is currently uncommon especially after the development of [[percutaneous]] device closure.<ref name="KuttySengupta2012">{{cite journal|last1=Kutty|first1=Shelby|last2=Sengupta|first2=Partho P.|last3=Khandheria|first3=Bijoy K.|title=Patent Foramen Ovale|journal=Journal of the American College of Cardiology|volume=59|issue=19|year=2012|pages=1665–1671|issn=07351097|doi=10.1016/j.jacc.2011.09.085}}</ref>
* There are no recommendations to [[Prophylaxis|prophylactically]] close a patent foramen ovale that was discovered incidentally.<ref name="KuttySengupta2012">{{cite journal|last1=Kutty|first1=Shelby|last2=Sengupta|first2=Partho P.|last3=Khandheria|first3=Bijoy K.|title=Patent Foramen Ovale|journal=Journal of the American College of Cardiology|volume=59|issue=19|year=2012|pages=1665–1671|issn=07351097|doi=10.1016/j.jacc.2011.09.085}}</ref>
*It is less favorable than medical therapy and [[percutaneous]] closure due to it's invasive nature.<ref name="KuttySengupta2012">{{cite journal|last1=Kutty|first1=Shelby|last2=Sengupta|first2=Partho P.|last3=Khandheria|first3=Bijoy K.|title=Patent Foramen Ovale|journal=Journal of the American College of Cardiology|volume=59|issue=19|year=2012|pages=1665–1671|issn=07351097|doi=10.1016/j.jacc.2011.09.085}}</ref>
*It is associated with [[perioperative]] [[Cardiac arrhythmia|arrhythmia]] and [[bleeding]].<ref name="KuttySengupta2012">{{cite journal|last1=Kutty|first1=Shelby|last2=Sengupta|first2=Partho P.|last3=Khandheria|first3=Bijoy K.|title=Patent Foramen Ovale|journal=Journal of the American College of Cardiology|volume=59|issue=19|year=2012|pages=1665–1671|issn=07351097|doi=10.1016/j.jacc.2011.09.085}}</ref>


There is lack of consensus regarding the effectiveness of either surgical or percutaneous closure of [[patent foramen ovale]].  
===Percutaneous Closure===
Insufficient evidence to recommend device closure for a first [[stroke]] exists. [[PFO]] closure may be considered for recurrent [[Paradoxical embolism|cryptogenic stroke]] and high-risk [[patent foramen ovale]] ([[PFO]]) (atrial septal aneurysm)<ref name="pmid18477843">{{cite journal| author=European Stroke Organisation (ESO) Executive Committee. ESO Writing Committee| title=Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. | journal=Cerebrovasc Dis | year= 2008 | volume= 25 | issue= 5 | pages= 457-507 | pmid=18477843 | doi=10.1159/000131083 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18477843 }} </ref>.Some randomized controlled trials to compare the relative effectiveness of medical therapy versus percutaneous closure are on way and in future might be helpful in making therapeutic decisions.
* This is a surgical procedure requiring the use of a [[catheter]].
* A [[meta-analysis]] of some [[Randomized controlled trial|randomized clinical trials]] reported a 3.2% decrease in the absolute recurrent [[stroke]] risk with [[percutaneous]] closure when compared with medical therapy.<ref name="YuanKasner2018">{{cite journal|last1=Yuan|first1=Kristy|last2=Kasner|first2=Scott Eric|title=Patent foramen ovale and cryptogenic stroke: diagnosis and updates in secondary stroke prevention|journal=Stroke and Vascular Neurology|volume=3|issue=2|year=2018|pages=84–91|issn=2059-8688|doi=10.1136/svn-2018-000173}}</ref>
* Studies have found that incidences of major complications such as [[death]], [[Bleeding|major haemorrhage]], need for emergency [[surgery]], [[tamponade]], and fatal [[pulmonary embolism]] are low (1.5–2.3%) after [[percutaneous]] closure. However, other studies found that some complications such as [[Regurgitation (circulation)|valvular regurgitation]], residual [[shunt]], [[atrial fibrillation]]<ref name="pmid19626689">{{cite journal| author=Staubach S, Steinberg DH, Zimmermann W, Wawra N, Wilson N, Wunderlich N et al.| title=New onset atrial fibrillation after patent foramen ovale closure. | journal=Catheter Cardiovasc Interv | year= 2009 | volume= 74 | issue= 6 | pages= 889-95 | pmid=19626689 | doi=10.1002/ccd.22172 | pmc= | url= }} </ref> are increased after [[percutaneous]] closure, especially with larger devices <ref name="pmid16877784">{{cite journal| author=Alaeddini J, Feghali G, Jenkins S, Ramee S, White C, Abi-Samra F| title=Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. | journal=J Invasive Cardiol | year= 2006 | volume= 18 | issue= 8 | pages= 365-8 | pmid=16877784 | doi= | pmc= | url= }} </ref><ref name="pmid14597460">{{cite journal| author=Khairy P, O'Donnell CP, Landzberg MJ| title=Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. | journal=Ann Intern Med | year= 2003 | volume= 139 | issue= 9 | pages= 753-60 | pmid=14597460 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=14597460  }} </ref><ref name="pmid16103257">{{cite journal| author=Homma S, Sacco RL| title=Patent foramen ovale and stroke. | journal=Circulation | year= 2005 | volume= 112 | issue= 7 | pages= 1063-72 | pmid=16103257 | doi=10.1161/CIRCULATIONAHA.104.524371 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16103257  }} </ref><ref name="pmid16876648">{{cite journal| author=Wöhrle J| title=Closure of patent foramen ovale after cryptogenic stroke. | journal=Lancet | year= 2006 | volume= 368 | issue= 9533 | pages= 350-2 | pmid=16876648 | doi=10.1016/S0140-6736(06)69087-9 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16876648  }} </ref><ref name="pmid18070946">{{cite journal| author=Schoen SP, Boscheri A, Lange SA, Braun MU, Fuhrmann J, Kappert U et al.| title=Incidence of aortic valve regurgitation and outcome after percutaneous closure of atrial septal defects and patent foramen ovale. | journal=Heart | year= 2008 | volume= 94 | issue= 7 | pages= 844-7 | pmid=18070946 | doi=10.1136/hrt.2007.132662 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18070946 }} </ref>
*Complications associated with [[percutaneous]] closure include:<ref name="ColladoPoulin2018">{{cite journal|last1=Collado|first1=Fareed Moses S.|last2=Poulin|first2=Marie‐France|last3=Murphy|first3=Joshua J.|last4=Jneid|first4=Hani|last5=Kavinsky|first5=Clifford J.|title=Patent Foramen Ovale Closure for Stroke Prevention and Other Disorders|journal=Journal of the American Heart Association|volume=7|issue=12|year=2018|issn=2047-9980|doi=10.1161/JAHA.117.007146}}</ref>


==International guidelines for prevention of recurrent cerebral embolism in patent foramen ovale==
:*[[Vascular injury]]
:*[[Cardiac]] [[perforation]] or [[Air embolism|air embolization]] during implantation
:*Device [[embolization]]/dislodgement
:*Device fracture
:*Early and late [[thrombosis]]
:*Pericprocedural [[transient ischemic attack]] and transient [[ST elevation|ST elevations]]
:*Large residual [[Shunt (medical)|shunts]] requiring closure
:*[[Atrial arrhythmias|Atrial arrhythmia]]
:*Nickel allergy: Presents with [[chest pain]], [[shortness of breath]], [[fever]], [[rash]], [[migraine headaches]], or [[Palpitation|palpitations]].
*Percutaneous closure with a large-sized device cause impingement of the surrounding structures that may lead to some late complications.
*The annual recurrence rate of stroke/transient ischemic attack is 0 to 5%.


===American Academy of Neurology Guidelines for prevention of recurrent cerebral embolism in patent foramen ovale (DO NOT EDIT)<ref name="pmid15078999">{{cite journal| author=Messé SR, Silverman IE, Kizer JR, Homma S, Zahn C, Gronseth G et al.| title=Practice parameter: recurrent stroke with patent foramen ovale and atrial septal aneurysm: report of the Quality Standards Subcommittee of the American Academy of Neurology. | journal=Neurology | year= 2004 | volume= 62 | issue= 7 | pages= 1042-50 | pmid=15078999 | doi= | pmc= | url= }} </ref>===
===Federal Drug Administration (FDA) Approved Percutaneous Devices for Patent Foramen Ovale Closure===
 
====CardioSEAL Septal Occlusion System====
*Approved in April 2018.
 
====Amplatzer PFO Occluder====
*Approved in 2016 by the [[Food and Drug Administration|FDA]] for patients with [[cryptogenic stroke]] between 18 and 60 years.
*This device is made up of two self-expanding discs with a nickel‐titanium (Nitinol) wire mesh. Each disc stays on either side of the [[atrial septum]] and are connected by a short and thin waist.<ref name="ColladoPoulin2018">{{cite journal|last1=Collado|first1=Fareed Moses S.|last2=Poulin|first2=Marie‐France|last3=Murphy|first3=Joshua J.|last4=Jneid|first4=Hani|last5=Kavinsky|first5=Clifford J.|title=Patent Foramen Ovale Closure for Stroke Prevention and Other Disorders|journal=Journal of the American Heart Association|volume=7|issue=12|year=2018|issn=2047-9980|doi=10.1161/JAHA.117.007146}}</ref>
*Intracardiac mass, [[Vegetation (pathology)|vegetation]] or [[thrombus]] at implantation site, active [[endocarditis]], anatomical challenges, and presence of other [[Right-to-left shunt|right-to-left shunts]] such as an [[atrial septal defect]] are [[Contraindication|contraindications]] to the Amplatzer PFO Occluder.
 
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===International Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale===
 
====American Academy of Neurology Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)<ref name="MesséGronseth2016">{{cite journal|last1=Messé|first1=Steven R.|last2=Gronseth|first2=Gary|last3=Kent|first3=David M.|last4=Kizer|first4=Jorge R.|last5=Homma|first5=Shunichi|last6=Rosterman|first6=Lee|last7=Kasner|first7=Scott E.|title=Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter)|journal=Neurology|volume=87|issue=8|year=2016|pages=815–821|issn=0028-3878|doi=10.1212/WNL.0000000000002961}}</ref>====
{{cquote|
{{cquote|


'''Practice Recommendations'''
'''Practice Recommendations'''


'''(1)''' There is insufficient evidence regarding the effectiveness of either surgical or percutaneous closure of [[PFO]] '''(Level U)'''.
1) Clinicians must counsel patients considering percutaneous PFO closure that having a PFO is common; it occurs in about 1 in 4 people; it is impossible to determine with certainty whether their PFOs caused their strokes or TIAs; the effectiveness of the procedure for reducing stroke risk remains uncertain; and the procedure is associated with relatively uncommon, yet potentially serious, complications (Level A).
 
2) Clinicians should not routinely offer percutaneous PFO closure to patients with cryptogenic ischemic stroke outside of a research setting (Level R). In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available (Level C).
}}
}}
* There is no possible benefit of [[percutaneous]] PFO closure with the STARFlex device in preventing [[stroke]] compared with medical therapy alone (The STARFlex is no longer available in the USA).
*[[Percutaneous]] closure with the AMPLATZER PFO occluder is associated with a possible decrease in the risk of recurrent [[stroke]], possible decrease in the risk of new-onset [[atrial fibrillation]], and a high likelihood of associated procedural complication risk of 3.4%.
'''Rating of Recommendations'''
'''Rating of Recommendations'''
'''A''' = Established as effective, ineffective, or harmful for the given condition in the specified population.
'''B''' = Probably effective, ineffective, or harmful for the given condition in the specified population.
'''C''' = Possibly effective, ineffective, or harmful for the given condition in the specified population.


'''U''' = Data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.
'''U''' = Data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.


===American Heart Association/American Stroke Association guidelines for prevention of recurrent cerebral embolism in patent foramen ovale (DO NOT EDIT)<ref name="pmid20966421">{{cite journal| author=Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC et al.| title=Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. | journal=Stroke | year= 2011 | volume= 42 | issue= 1 | pages= 227-76 | pmid=20966421 | doi=10.1161/STR.0b013e3181f7d043 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20966421  }} </ref>===
====American Heart Association/American Stroke Association Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)<ref name="pmid20966421">{{cite journal| author=Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC et al.| title=Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. |journal=Stroke | year= 2011 | volume= 42 | issue= 1 | pages= 227-76 | pmid=20966421 | doi=10.1161/STR.0b013e3181f7d043 | pmc= |url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20966421  }} </ref><ref name="KernanOvbiagele2014">{{cite journal|last1=Kernan|first1=Walter N.|last2=Ovbiagele|first2=Bruce|last3=Black|first3=Henry R.|last4=Bravata|first4=Dawn M.|last5=Chimowitz|first5=Marc I.|last6=Ezekowitz|first6=Michael D.|last7=Fang|first7=Margaret C.|last8=Fisher|first8=Marc|last9=Furie|first9=Karen L.|last10=Heck|first10=Donald V.|last11=Johnston|first11=S. Claiborne (Clay)|last12=Kasner|first12=Scott E.|last13=Kittner|first13=Steven J.|last14=Mitchell|first14=Pamela H.|last15=Rich|first15=Michael W.|last16=Richardson|first16=DeJuran|last17=Schwamm|first17=Lee H.|last18=Wilson|first18=John A.|title=Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack|journal=Stroke|volume=45|issue=7|year=2014|pages=2160–2236|issn=0039-2499|doi=10.1161/STR.0000000000000024}}</ref>====


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{{cquote|
Insufficient data exist to make a recommendation about [[PFO]] closure in patients with a first [[stroke]] and a [[PFO]]. PFO closure may be considered for patients with recurrent [[cryptogenic stroke]] despite medical therapy. ([[ACC AHA guidelines classification scheme#Level of Evidence|Level of Evidence: C]])
 
1) For patients with a cryptogenic ischaemic stroke or transient ischaemic attack and a PFO without evidence for deep vein thrombosis, available data do not support a benefit for PFO closure (Class III; Level of Evidence A).
 
2) In the setting of PFO and deep vein thrombosis, PFO closure by a transcatheter device might be considered depending on the risk of recurrent deep vein thrombosis (Class IIb; Level of Evidence C).
}}
}}


===European Stroke Organisation guidelines for prevention of recurrent cerebral embolism in patent foramen ovale (DO NOT EDIT)<ref name="pmid18477843">{{cite journal| author=European Stroke Organisation (ESO) Executive Committee. ESO Writing Committee| title=Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. | journal=Cerebrovasc Dis | year= 2008 | volume= 25 | issue= 5 | pages= 457-507 | pmid=18477843 | doi=10.1159/000131083 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18477843  }} </ref>===
'''Class I''' = Conditions for which there is evidence for and/ or general agreement that the procedure or treatment is useful and effective.


{{cquote|
'''Class II''' = Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.
 
'''Class IIa''' = The weight of evidence or opinion is in favor of the procedure or treatment.
 
'''Class IIb''' = Usefulness/efficacy is less well established by evidence or opinion.
 
'''Class III''' = Conditions for which there is evidence and/ or general agreement that the procedure or treatment is not useful/effective and in some cases may be harmful.


'''1''' Device closure should be considered in patients with [[Paradoxical embolism|cryptogenic stroke]] and high-risk [[PFO]]
'''Therapeutic recommendations:'''
}}


'''Level of Evidence A''' = Derived from multiple randomized clinical trials or meta-analyses.


==[[Treatment options in patent foramen ovale with recurrent strokes|Trial supportive data for percutaneous closure in PFO with recurrent stroke]]==
'''Level of Evidence B''' = Data derived from a single randomized trial or nonrandomized studies.


* Surgical closure of [[patent foramen ovale]] is uncommon these days especially after development of percutaneous device closure. Some systematic reviews done to compare medical versus percutaneous closure, found that the rate of recurrent [[strokes]] with medical treatment (5.2%) is greater than that with percutaneous closure (1.3%) <ref name="pmid14597460">{{cite journal| author=Khairy P, O'Donnell CP, Landzberg MJ| title=Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. | journal=Ann Intern Med | year= 2003 | volume= 139 | issue= 9 | pages= 753-60 | pmid=14597460 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=14597460  }} </ref>, <ref name="pmid16103257">{{cite journal| author=Homma S, Sacco RL| title=Patent foramen ovale and stroke. | journal=Circulation | year= 2005 | volume= 112 | issue= 7 | pages= 1063-72 | pmid=16103257 | doi=10.1161/CIRCULATIONAHA.104.524371 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16103257  }} </ref>,<ref name="pmid16876648">{{cite journal| author=Wöhrle J| title=Closure of patent foramen ovale after cryptogenic stroke. | journal=Lancet | year= 2006 | volume= 368 | issue= 9533 | pages= 350-2 | pmid=16876648 | doi=10.1016/S0140-6736(06)69087-9 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16876648  }} </ref> . However, the results of these systematic reviews should be interpreted carefully, because there was lack of uniformity in the selection criteria, duration of follow up and end points in the individual studies that were used for the systematic review. Some randomized controlled trials to compare the relative effectiveness of medical therapy versus percutaneous closure are on way and in future might be helpful in making therapeutic decisions.
'''Level of Evidence C''' = Consensus opinion of experts, case studies, or standard of care.


* Studies have found that incidences of major complications such as death, [[Bleeding|major haemorrhage]], need for emergency surgery, [[tamponade]], and fatal [[pulmonary embolism]] are low (1.5–2.3%) after percutaneous closure <ref name="pmid14597460">{{cite journal| author=Khairy P, O'Donnell CP, Landzberg MJ| title=Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. | journal=Ann Intern Med | year= 2003 | volume= 139 | issue= 9 | pages= 753-60 | pmid=14597460 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=14597460  }} </ref>, <ref name="pmid16103257">{{cite journal| author=Homma S, Sacco RL| title=Patent foramen ovale and stroke. | journal=Circulation | year= 2005 | volume= 112 | issue= 7 | pages= 1063-72 | pmid=16103257 | doi=10.1161/CIRCULATIONAHA.104.524371 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16103257  }} </ref>, <ref name="pmid16876648">{{cite journal| author=Wöhrle J| title=Closure of patent foramen ovale after cryptogenic stroke. | journal=Lancet | year= 2006 | volume= 368 | issue= 9533 | pages= 350-2 | pmid=16876648 | doi=10.1016/S0140-6736(06)69087-9 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16876648  }} </ref>. However, other studies found that some complications like [[valvular regurgitation]] <ref name="pmid18070946">{{cite journal| author=Schoen SP, Boscheri A, Lange SA, Braun MU, Fuhrmann J, Kappert U et al.| title=Incidence of aortic valve regurgitation and outcome after percutaneous closure of atrial septal defects and patent foramen ovale. | journal=Heart | year= 2008 | volume= 94 | issue= 7 | pages= 844-7 | pmid=18070946 | doi=10.1136/hrt.2007.132662 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18070946  }} </ref>, residual shunt, [[atrial fibrillation]]<ref name="pmid19626689">{{cite journal| author=Staubach S, Steinberg DH, Zimmermann W, Wawra N, Wilson N, Wunderlich N et al.| title=New onset atrial fibrillation after patent foramen ovale closure. | journal=Catheter Cardiovasc Interv | year= 2009 | volume= 74 | issue= 6 | pages= 889-95 | pmid=19626689 | doi=10.1002/ccd.22172 | pmc= | url= }} </ref> are increased after percutaneous closure, especially with larger devices <ref name="pmid16877784">{{cite journal| author=Alaeddini J, Feghali G, Jenkins S, Ramee S, White C, Abi-Samra F| title=Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. | journal=J Invasive Cardiol | year= 2006 | volume= 18 | issue= 8 | pages= 365-8 | pmid=16877784 | doi= | pmc= | url= }} </ref>. This is a cause for concern as these post-surgical complications are added risk factors for future [[stroke]] event.
'''Diagnostic recommendations:'''


==Technique==
'''Level of Evidence A''' = Data derived from multiple prospective cohort studies using a reference standard applied by a masked evaluator.  
The Ampltazer septal occluder (ASO) is the most commonly used device as it allows closure of large cavities, is easy to implant, and boasts high success rates. As an instrument, the ASO consists of two self-expandable round discs connected to each other with a 4-mm waist, made up of 0.004–0.005´´ nitinol wire mesh filled with Dacron fabric. Implantation of the device is relatively easy. The prevalence of residual defect is low. The disadvantages are a thick profile of the device and concern related to a large amount of nitinol (a nickel-titanium compound) in the device and consequent potential for [[nickel]] toxicity.


==[[Federal Drug Administration]] (FDA) approved percutaneous devices for patent foramen ovale closure==
'''Level of Evidence B''' = Data derived from a single grade A study or one or more case-control studies, or studies using a reference standard applied by an unmasked evaluator.


* CardioSEAL Septal Occlusion System - Double umbrella-shaped permanent implant.
'''Level of Evidence C''' = Consensus opinion of experts.
* Amplatzer PFO Occluder - Self-expanding wire mesh with double discs. Once the device is in place, tissue grows over it, and it becomes part of the atrial septum.


====European Stroke Organization Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)<ref name="pmid18477843">{{cite journal| author=European Stroke Organisation (ESO) Executive Committee. ESO Writing Committee| title=Guidelines for management of ischaemic stroke and transient ischaemic attack 2008. | journal=Cerebrovasc Dis | year= 2008 | volume= 25 | issue= 5 | pages= 457-507 | pmid=18477843 | doi=10.1159/000131083 | pmc= |url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18477843  }} </ref>====


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{{#ev:youtube|4c3CEgjj2PY}}
1) Device closure should be considered in patients with [[Paradoxical embolism|cryptogenic stroke]] and high-risk [[PFO]].
}}


==References==
==References==
{{Reflist|2}}
{{reflist|2}}
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Latest revision as of 15:55, 27 February 2020

Patent Foramen Ovale Microchapters

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editors-In-Chief: Ifeoma Odukwe, M.D. [2], Priyamvada Singh, M.B.B.S. [3], Kristin Feeney, B.S. [4]

Overview

Surgical closure and percutaneous closure may be used to treat patent foramen ovale but percutaneous closure is preferred over surgical closure. Asymptomatic patients do not require surgery. Percutaneous closure is associated with more decrease in recurrent stroke risk when compared with medical therapy although it is may be associated with vascular injury, atrial fibrillation, and device fracture. CardioSEAL septal occluder and Amplatzer PFO occluder are FDA approved devices used in the percutaneous closure of a patent foramen ovale. American Academy of Neurology recommend that clinicians must counsel patients by informing them of how common the condition is and the effectiveness of percutaneous closure. American Heart Association recommends percutaneous closure may be considered in patients with patent foramen ovale and deep vein thrombosis, depending on the risk of recurrent of deep vein thrombosis.

Surgery

Surgical Closure

Percutaneous Closure

  • Percutaneous closure with a large-sized device cause impingement of the surrounding structures that may lead to some late complications.
  • The annual recurrence rate of stroke/transient ischemic attack is 0 to 5%.

Federal Drug Administration (FDA) Approved Percutaneous Devices for Patent Foramen Ovale Closure

CardioSEAL Septal Occlusion System

  • Approved in April 2018.

Amplatzer PFO Occluder

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International Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale

American Academy of Neurology Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[10]

“

Practice Recommendations

1) Clinicians must counsel patients considering percutaneous PFO closure that having a PFO is common; it occurs in about 1 in 4 people; it is impossible to determine with certainty whether their PFOs caused their strokes or TIAs; the effectiveness of the procedure for reducing stroke risk remains uncertain; and the procedure is associated with relatively uncommon, yet potentially serious, complications (Level A).

2) Clinicians should not routinely offer percutaneous PFO closure to patients with cryptogenic ischemic stroke outside of a research setting (Level R). In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available (Level C).

”
  • There is no possible benefit of percutaneous PFO closure with the STARFlex device in preventing stroke compared with medical therapy alone (The STARFlex is no longer available in the USA).
  • Percutaneous closure with the AMPLATZER PFO occluder is associated with a possible decrease in the risk of recurrent stroke, possible decrease in the risk of new-onset atrial fibrillation, and a high likelihood of associated procedural complication risk of 3.4%.

Rating of Recommendations

A = Established as effective, ineffective, or harmful for the given condition in the specified population.

B = Probably effective, ineffective, or harmful for the given condition in the specified population.

C = Possibly effective, ineffective, or harmful for the given condition in the specified population.

U = Data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.

American Heart Association/American Stroke Association Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[11][12]

“

1) For patients with a cryptogenic ischaemic stroke or transient ischaemic attack and a PFO without evidence for deep vein thrombosis, available data do not support a benefit for PFO closure (Class III; Level of Evidence A).

2) In the setting of PFO and deep vein thrombosis, PFO closure by a transcatheter device might be considered depending on the risk of recurrent deep vein thrombosis (Class IIb; Level of Evidence C).

”

Class I = Conditions for which there is evidence for and/ or general agreement that the procedure or treatment is useful and effective.

Class II = Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

Class IIa = The weight of evidence or opinion is in favor of the procedure or treatment.

Class IIb = Usefulness/efficacy is less well established by evidence or opinion.

Class III = Conditions for which there is evidence and/ or general agreement that the procedure or treatment is not useful/effective and in some cases may be harmful.

Therapeutic recommendations:

Level of Evidence A = Derived from multiple randomized clinical trials or meta-analyses.

Level of Evidence B = Data derived from a single randomized trial or nonrandomized studies.

Level of Evidence C = Consensus opinion of experts, case studies, or standard of care.

Diagnostic recommendations:

Level of Evidence A = Data derived from multiple prospective cohort studies using a reference standard applied by a masked evaluator.

Level of Evidence B = Data derived from a single grade A study or one or more case-control studies, or studies using a reference standard applied by an unmasked evaluator.

Level of Evidence C = Consensus opinion of experts.

European Stroke Organization Guidelines for Prevention of Recurrent Cerebral Embolism in Patent Foramen Ovale (DO NOT EDIT)[13]

“

1) Device closure should be considered in patients with cryptogenic stroke and high-risk PFO.

”

References

  1. ↑ 1.0 1.1 1.2 1.3 Kutty, Shelby; Sengupta, Partho P.; Khandheria, Bijoy K. (2012). "Patent Foramen Ovale". Journal of the American College of Cardiology. 59 (19): 1665–1671. doi:10.1016/j.jacc.2011.09.085. ISSN 0735-1097.
  2. ↑ Yuan, Kristy; Kasner, Scott Eric (2018). "Patent foramen ovale and cryptogenic stroke: diagnosis and updates in secondary stroke prevention". Stroke and Vascular Neurology. 3 (2): 84–91. doi:10.1136/svn-2018-000173. ISSN 2059-8688.
  3. ↑ Staubach S, Steinberg DH, Zimmermann W, Wawra N, Wilson N, Wunderlich N; et al. (2009). "New onset atrial fibrillation after patent foramen ovale closure". Catheter Cardiovasc Interv. 74 (6): 889–95. doi:10.1002/ccd.22172. PMID 19626689.
  4. ↑ Alaeddini J, Feghali G, Jenkins S, Ramee S, White C, Abi-Samra F (2006). "Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale". J Invasive Cardiol. 18 (8): 365–8. PMID 16877784.
  5. ↑ Khairy P, O'Donnell CP, Landzberg MJ (2003). "Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review". Ann Intern Med. 139 (9): 753–60. PMID 14597460.
  6. ↑ Homma S, Sacco RL (2005). "Patent foramen ovale and stroke". Circulation. 112 (7): 1063–72. doi:10.1161/CIRCULATIONAHA.104.524371. PMID 16103257.
  7. ↑ Wöhrle J (2006). "Closure of patent foramen ovale after cryptogenic stroke". Lancet. 368 (9533): 350–2. doi:10.1016/S0140-6736(06)69087-9. PMID 16876648.
  8. ↑ Schoen SP, Boscheri A, Lange SA, Braun MU, Fuhrmann J, Kappert U; et al. (2008). "Incidence of aortic valve regurgitation and outcome after percutaneous closure of atrial septal defects and patent foramen ovale". Heart. 94 (7): 844–7. doi:10.1136/hrt.2007.132662. PMID 18070946.
  9. ↑ 9.0 9.1 Collado, Fareed Moses S.; Poulin, Marie‐France; Murphy, Joshua J.; Jneid, Hani; Kavinsky, Clifford J. (2018). "Patent Foramen Ovale Closure for Stroke Prevention and Other Disorders". Journal of the American Heart Association. 7 (12). doi:10.1161/JAHA.117.007146. ISSN 2047-9980.
  10. ↑ Messé, Steven R.; Gronseth, Gary; Kent, David M.; Kizer, Jorge R.; Homma, Shunichi; Rosterman, Lee; Kasner, Scott E. (2016). "Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter)". Neurology. 87 (8): 815–821. doi:10.1212/WNL.0000000000002961. ISSN 0028-3878.
  11. ↑ Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC; et al. (2011). "Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association". Stroke. 42 (1): 227–76. doi:10.1161/STR.0b013e3181f7d043. PMID 20966421.
  12. ↑ Kernan, Walter N.; Ovbiagele, Bruce; Black, Henry R.; Bravata, Dawn M.; Chimowitz, Marc I.; Ezekowitz, Michael D.; Fang, Margaret C.; Fisher, Marc; Furie, Karen L.; Heck, Donald V.; Johnston, S. Claiborne (Clay); Kasner, Scott E.; Kittner, Steven J.; Mitchell, Pamela H.; Rich, Michael W.; Richardson, DeJuran; Schwamm, Lee H.; Wilson, John A. (2014). "Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack". Stroke. 45 (7): 2160–2236. doi:10.1161/STR.0000000000000024. ISSN 0039-2499.
  13. ↑ European Stroke Organisation (ESO) Executive Committee. ESO Writing Committee (2008). "Guidelines for management of ischaemic stroke and transient ischaemic attack 2008". Cerebrovasc Dis. 25 (5): 457–507. doi:10.1159/000131083. PMID 18477843.


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