The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on percutaneous closure of the patent foramen ovale for the prevention of cerebral embolic stroke, in December, 2013.
This document replaces previous guidance on percutaneous closure of patent foramen ovale for the secondary prevention of recurrent paradoxical embolism (NICE interventional procedure guidance 109, October 2003).
A patent foramen ovale (PFO) is the persistence of an opening (the foramen ovale) in the septum between the right atrium and left atrium of the heart. Before birth the fetal heart has a structural opening between the two atria called the foramen ovale. This normal passage allows blood to bypass the lungs and be directed straight to the left side of the circulation, supplying blood to the brain and body before it returns to the placenta. The foramen ovale usually closes spontaneously after birth; however in as many as 1 out of 4 people the foramen ovale remains fully or partially patent into adulthood.
In most people the persistence of this opening does not cause any complications. However, some studies suggest that a PFO can increase the chance of particles (specifically a thrombus or blood clot, for example from deep vein thrombosis in the legs) crossing from the right side into the left side of the heart, and from there into the arterial system where they may block blood vessels and cause serious events such as a stroke or a transient ischaemic attack (TIA).
The optimal treatment for patients with PFO who have had a thromboembolic event remains undefined. Medical management with antiplatelet (e.g. aspirin) or anticoagulation therapy (usually warfarin) is commonly used to reduce the risk of further paradoxical thrombus emboli. Closure of the PFO is sometimes performed for people in whom medical management fails or those in whom anticoagulants are contraindicated (e.g. because of haemorrhagic complications). Surgical closure of a PFO is sometimes performed as an adjunct to open-heart surgery, but is rarely done on its own because of associated morbidity.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.