Patent foramen ovale surgery


 * Associate Editors-In-Chief: Priyamvada Singh, M.B.B.S. [mailto:psingh@perfuse.org]; Assistant Editor-In-Chief: Kristin Feeney, B.S. [mailto:kfeeney@perfuse.org]

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) .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.

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) === Practice Recommendations

(1) There is insufficient evidence regarding the effectiveness of either surgical or percutaneous closure of PFO (Level U). Rating of Recommendations

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) ===

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. (Level of Evidence: C)

===European Stroke Organisation guidelines for prevention of recurrent cerebral embolism in patent foramen ovale (DO NOT EDIT) ===

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

Trial supportive data for percutaneous closure in PFO with recurrent stroke

 * 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%), , . 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.


 * 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, , . However, other studies found that some complications like valvular regurgitation , residual shunt, atrial fibrillation are increased after percutaneous closure, especially with larger devices . This is a cause for concern as these post-surgical complications are added risk factors for future stroke event.

Technique
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

 * CardioSEAL Septal Occlusion System - Double umbrella-shaped permanent implant.
 * 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.



