The sheath size required for implantation is 9 French. The most widely used devices so far for PFO closure are the CardioSEAL device in the USA (2000 to 2002 the only one available) and the Amplatzer PFO occluder in the rest of the world (available in the USA since 2002).
A PFO closure is only utilized if a patient has experienced a stroke, and other causes of stroke and blood clots have been ruled out.
Among patients younger than 60 years with no other etiology identified after a thorough diagnostic evaluation, transcatheter PFO closure probably reduces the risk of recurrent stroke (summary rate difference −0.67% per year, 95% CI, −0.39% to −0.94%, I2 = 0), with a number needed to treat of 29 to reduce 1 stroke at 5 ...
For small PFOs without associated interatrial septal aneurysm, the 25-mm size Cribriform, PFO occluder, or Helex is preferred. Using devices smaller than 25 mm in adults is not required and may increase the risk for device embolization.
The foramen ovale usually closes 6 months to a year after the baby's birth.
You may be a candidate for minimally invasive PFO closure if you: Have been diagnosed with a PFO and have had a stroke due to an unknown cause (one not attributed to a condition such as atrial fibrillation or carotid artery disease) Can take blood-thinning medication. Ideally are between the ages of 18 and 60.
Possible Complications Some people may have a condition shortness of breath and low arterial blood oxygen levels when sitting or standing. This is called platypnea-orthodeoxia. This is rare. Rarely, people with PFOs may have a higher rate of a certain type of stroke (called paradoxical thromboembolic stroke).
Most PFOs require no treatment. People who have no risk factors for stroke or any history of traveling blood clots usually do not get treatment. Your healthcare provider may want to treat your PFO if you have had problems from these traveling blood clots, like stroke.