Recommendation for NHSScotland

Percutaneous patent foramen ovale (PFO) closure plus antiplatelet therapy should be considered in carefully selected patients with a diagnosis of cryptogenic ischaemic stroke.

The evidence for PFO closure comes from randomised controlled trials (RCTs) in patients aged 60 or younger, patients considered for this intervention should fall within this age limit. Patients should also have their diagnosis of cryptogenic ischaemic stroke supported by imaging and have a confirmed PFO.

Prior to PFO closure, patients must have had a full investigation to rule out other explanations for ischaemic stroke, and based on these investigations a multi-disciplinary team should agree that paradoxical embolism is the most likely explanation for the stroke.

In exploring patient preferences, the potential benefits and risks of the PFO closure procedure compared with medical therapies alone should be highlighted, including the risk of developing persistent atrial fibrillation or flutter.

PFO closure plus antiplatelet therapy is unlikely to be cost-effective in the short-term (up to 10 years) but becomes cost effective over the lifetime of the patient, with an incremental cost effectiveness ratio (ICER) under £10,000.

PFO closure procedures should be consolidated within a small number of centres with a unified referral pathway to ensure equity of access for eligible patients. Centres offering PFO closure must have on-site access to appropriate facilities and expertise for percutaneous cardiac procedures and transoesophageal echocardiography.

NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.

What were we asked to look at?

We were asked to look at the evidence surrounding percutaneous patent foramen ovale (PFO) closure compared with medical therapy alone in patients with cryptogenic ischaemic stroke.

Why is this important?

In 2018, there were 8,388 admissions to hospital for ischaemic stroke in Scotland, and up to one third of ischaemic strokes are classed as cryptogenic (‘of unknown origin’). Currently, the most common treatment for patients who have a cryptogenic ischaemic stroke is long-term medical therapy. Patients who have a cryptogenic ischaemic stroke are typically younger (60 or under) and have fewer comorbidities compared with patients diagnosed with other stroke sub-types. Long-term
medical therapy and risk of ischaemic stroke recurrence can place a significant burden on patients and the health service.

Studies suggest there is a potential association between cryptogenic ischaemic stroke and the presence of a PFO. Closing this PFO may provide a way of reducing lifetime risk of ischaemic stroke recurrence in patients with cryptogenic ischaemic stroke. Therefore, percutaneous closure of the PFO using an implantable medical device, alongside medical therapy, is an option in this patient group. Although this procedure has been available for a number of years, three trials published in 2017 and 2018 may help to establish the relative effects of PFO closure.

Referred by

The West of Scotland Regional Planning Team