In light of new high-quality evidence, a panel of experts have issued a recommendation for the use of a catheter-based procedure to close a type of 'hole in the heart' followed by antiplatelet drugs (e.g., aspirin) in patients under 60 years old, who have also had a stroke. The expert guideline is published in The BMJ.
The procedure involves slowly moving a catheter (a long, thin, flexible tube) into the heart to close the hole, called patent foramen ovale (PFO). A PFO is a hole in the wall that divides the top two chambers of the heart which has not closed naturally after birth. Most guidelines currently advise against the closure procedure and instead recommend taking lifelong anti-clotting drugs to prevent further strokes.
Up to one in four people have a PFO and for most, it does not cause any problems. This new guideline only recommends having the hole closed if the person has had a stroke, and there is no other obvious cause (known as "cryptogenic" stroke).
PFO closure, antiplatelets and anticoagulants are designed to reduce the risk of a second stroke.
The downside of the procedure is that 3.6 percent of patients will experience an adverse event, but these are usually associated with only short-term effects, so may not be as important to patients as cutting their risk of stroke, suggests the panel, which is composed of doctors, heart and stroke specialists, as well as people with experience of PFO and cryptogenic stroke.
In 2017 three large clinical trials that were published suggested PFO closure might reduce the risk of stroke more than drug treatment alone. The international panel reviewed the latest evidence to see if it might be strong enough to change clinical practice.
However, the panel stresses that doctors should discuss options with the patient, ideally as part of a shared decision making process.
Moreover, PFO closure is associated with higher costs and implementation of this recommendation is likely to have an important cost impact for health funders in the short term, the panel notes. Over the long term, however, they say PFO closure "may reduce costs as a result of reduced stroke rates and reduction in associated costs."
They conclude that further trials are needed to address remaining uncertainties, and that new evidence must be assessed to judge to what extent it may alter the recommendation.
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