Information for the public
Benefits and risks
Benefits and risks
When NICE looked at the evidence, it decided that there was enough evidence on how well it worked and how safe it was to be used in the NHS. The 12 studies that NICE looked at involved a total of 18,560 patients.
Generally, they showed that, compared with patients who had drug therapy, patients who had percutaneous closure of the patent foramen ovale had fewer strokes, transient ischaemic attacks and other related problems, during the 4 years after the procedure.
The hole in the heart was still successfully closed in at least three-quarters of patients 1–2 years after the procedure.
The studies showed that the risks of percutaneous patent foramen ovale closure included:
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fluid around the heart, which can sometimes be life threatening
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damage to the heart during the procedure
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the device being positioned wrongly
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bleeding
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air getting into the bloodstream
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an infection in the heart
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blood clots elsewhere in the body (heart, legs and lungs)
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an abnormal hole forming between an artery and one of the upper chambers of the heart
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development of an abnormal heart rhythm (although this was temporary in most patients).
In general, the risk of having a serious reaction or complication with the procedure was similar as with having medical treatment.
A small number of people died as a result of the procedure (8 in around 8000 people).
NICE was also told about some other possible risks: the device wearing away the tissue around it, and temporary worsening of migraines.
If you want to know more about the studies see the guidance. Ask your health professional to explain anything you don't understand.