Patent foramen ovale surgery

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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

  • 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.[2]

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.[3]
  • Studies have found that incidences of major complications such as death, major haemorrhage, need for emergency surgery, tamponade, and fatal pulmonary embolism are low (1.5–2.3%) after percutaneous closure [4][5][6]. However, other studies found that some complications like valvular regurgitation [7], residual shunt, atrial fibrillation[8] are increased after percutaneous closure, especially with larger devices [9]. This is a cause for concern as these post-surgical complications are added risk factors for future stroke event.

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. 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.

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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.

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.

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. 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. 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.
  5. Homma S, Sacco RL (2005). "Patent foramen ovale and stroke". Circulation. 112 (7): 1063–72. doi:10.1161/CIRCULATIONAHA.104.524371. PMID 16103257.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  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.


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