Difference between revisions of "Patent foramen ovale surgery"

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==Surgery==
 
==Surgery==
 
===Surgical Closure===
 
===Surgical Closure===
* Surgical closure is uncommon currently especially after the development of percutaneous device closure.
+
* Surgical closure is uncommon currently especially after the development of [[percutaneous]] device closure.
* There are no recommendations to 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>
+
* 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 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 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>
+
*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>
  
 
===Percutaneous Closure===
 
===Percutaneous Closure===
* A meta-analysis of some randomized clinical trials reported a 3.2% decrease in the absolute recurrent stroke risk with PFO 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>
+
* 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 <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>.
+
* 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>
 
*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>
 
:*Vascular injury
 
:*Vascular injury

Revision as of 21:37, 14 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: Priyamvada Singh, M.B.B.S. [2]; Assistant Editor-In-Chief: Kristin Feeney, B.S. [3]

Overview

There is lack of consensus regarding the effectiveness of either surgical or percutaneous closure of patent foramen ovale. Insufficient evidence to recommend device closure for a first stroke exists. PFO closure may be considered for recurrent cryptogenic stroke and high-risk patent foramen ovale (PFO) (atrial septal aneurysm)[1]. 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.

Surgery

Surgical Closure

Percutaneous Closure

  • Vascular injury
  • Cardiac perforation or air embolization during implantation
  • Device embolization/dislodgement
  • Device fracture
  • Early and late thrombosis
  • Pericprocedural transient ischemic attack and transient ST elevations
  • Large residual shunts requiring closure
  • Atrial arrhythmia
  • Nickel allergy: Presents with chest pain, shortness of breath, fevers, rash, migraine headaches, or 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%.

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 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.[10]
  • Intracardiac mass, vegetation or thrombus at implantation site, active endocarditis, anatomical challenges, and presence of other right-to-left shunts such as an atrial septal defect are contraindications to the Amplatzer PFO Occluder.

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)[11]

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)[12][13]

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)[1]

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

References

  1. 1.0 1.1 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.
  2. 2.0 2.1 2.2 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Homma S, Sacco RL (2005). "Patent foramen ovale and stroke". Circulation. 112 (7): 1063–72. doi:10.1161/CIRCULATIONAHA.104.524371. PMID 16103257.
  8. 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.
  9. 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.
  10. 10.0 10.1 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.
  11. 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.
  12. 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.
  13. 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.



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