The results from the three trials have divided medical experts. Some say despite the failure of the studies to meet the primary endpoints, the data still favor PFO closure while others say the evidence to support PFO closure is insufficient at this point. In the intention-to-treat group, there were nine instances of nonfatal ischemic strokes among patients assigned to the device group and 16 in the medical therapy only group. They had their PFOs closed off-label with devices approved for the closure of atrial septal defects.
There were also few stroke events. In the three trials, there were only 56 stroke events among 2, patients over more than 10 years. Sanjay Kaul, MD, MPH, a cardiologist in Los Angeles who was not involved in any of the trials, says the events in each of the individual trials were not frequent enough to yield more definite results. Neurologists are inclined to favor a more cautious approach. They called for a better understanding of who benefits before routine use of devices. Messe says that the evidence is not yet there to support PFO closure as a way to reduce the risk of recurrent strokes.
Unfortunately, it is very challenging to make that determination and we have not yet confirmed that there is a group of patients who will benefit. Some physicians argue that there are subsets of patients who are more likely to benefit from closure. Clay Johnston, MD, PhD, a neurologist at the University of California, San Francisco, agrees that patients who cannot use anticoagulants or antithrombotics or whose stroke was caused by deep vein thrombosis or PFO are likely to benefit from closure.
Other precautions will be discussed with you. You should wait at least 48 hours until you drive a car. You can use stairs as necessary; however, you should not put undue stress on your leg where the procedure was performed. You can walk at a normal pace , or at a comfortable one, soon after going home; however, your doctor will let you know when you can go back to your normal exercise routine. Typically, the physician will ask you to refrain from strenuous exercises for one month following device implantation.
Make sure you ask about when you can go back to work as it may vary depending upon the type of job you do. You should also ask when you can resume normal sexual relations and when you can travel safely. You may be sent home from the hospital with prescription medication ; make sure your doctor knows if you already use any other prescription medication, or if you are taking any vitamins or supplements. In addition, make sure your doctor knows about any plans you may have for dental surgery or other procedures, since you may be required to observe special precautions or take specific prescriptions, such as antibiotics, in advance.
Find an Interventional Cardiologist. A trained physician threads a catheter through the veins of the body into the heart, where a device is used to seal the PFO.
Another method involves more invasive surgery. Large studies of PFO closure in stroke show no benefit to either procedure. Not only was there no benefit after two years, but people who had the procedure done were more likely to have major vascular complications or atrial fibrillation than those who just received medical therapy. Their results were frustrating to people who had observed that in other, weaker studies the device closure had seemed to work.
Critics suggested that perhaps a better device could have reduced the risk of complications, or that the sample size wasn't large enough. The American Academy of Neurology and more have concluded there is no benefit to the procedure in PFO, though percutaneous closure is probably still merited in less common and more severe forms of communication between the left and right sides of the heart.
Such cases include a large atrial septal defect. There are still physicians around who are willing to do this procedure for those who insist on having a patent foramen ovale closed. Some people cannot bear the thought that there is a hole in the heart, even if it is a hole that we have all had, and many people continue to have without problems.
For those who remain interested despite the lack of proven benefit, it is important to get an opinion from a doctor who has no financial stake in doing the procedure. Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Closure or medical therapy for cryptogenic stroke with patent foramen ovale.
N Engl J Med ; Incidence and size of patent foramen ovale in the first 10 decades of life: an autopsy study of normal hearts. Mayo Clin Proc. Chest ; eS. Your Privacy Rights. To change or withdraw your consent choices for VerywellHealth. At any time, you can update your settings through the "EU Privacy" link at the bottom of any page. These choices will be signaled globally to our partners and will not affect browsing data.
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