Complications

Complication
Timeframe
Likelihood
short term
low

Patients who suffer from an acute illness resulting in temporary elevation of right heart pressures (e.g., acute PE, pneumonia, and mechanical ventilation) may experience right-to-left shunting of blood across the PFO, resulting in persistent hypoxemia.

Patients on mechanical ventilation may have difficulty weaning from oxygen supply as they often remain hypoxemic.

short term
low

Incomplete closure may be treated with observation.

Published reports show use of an additional device to close residual defects.[42]

short term
low

There are case reports of thrombus forming on the closure device, which can be complicated by embolic phenomenon.[43][44]

short term
low

An extremely rare complication of device deployment that requires surgical intervention.

short term
low

An extremely rare complication of device deployment that requires surgical intervention.

short term
low

PFO closure with antiplatelet therapy increases the absolute risk of persistent atrial fibrillation or flutter by 1.8% and transient atrial fibrillation or flutter by 1.2% at 1 year.[25]

short term
low

An extremely rare complication of device deployment.

short term
low

An extremely rare complication of device deployment.[44]

long term
low

Evidence suggests migraines are more frequent in patients with PFO and anecdotal evidence suggests improvement in headache symptoms after closure.[2][14]

In a patient with frequent, disabling migraines despite medications, closure of a PFO may be considered.

Although percutaneous closure is relatively safe, the evidence is not strong enough to recommend closure due to migraines.

Further evidence is likely to emerge with ongoing studies.

PFO closure in one UK study failed to achieve its primary end point of eliminating migraine headaches in 40% of subjects. However, significant reduction in migraine headache burden did occur.[41]

Migraine headache

long term
low

There is a low but not negligible rate of recurrent stroke despite percutaneous closure.

This may be due to mechanisms independent of a PFO or device, incomplete closure or thrombus formation on the device.[38][39]

long term
low

An extremely rare complication of device deployment.[44]

variable
low

Paradoxical embolism occurs through a PFO.

An evaluation by the multidisciplinary team is recommended to determine management options for the patient, including PFO closure with medical therapy or medical therapy alone.

Certain prothrombotic mutations such as factor V Leiden (FV[G1691A] mutation) and the prothrombin mutation (PT[G20210A] mutation) have been suggested as increasing risk of cerebral ischemia in patients with PFO.[40]

variable
low

Paradoxical embolism occurs through a PFO.

The majority of clinical trials for PFO closure did not include TIA in the inclusion criteria. Careful multidisciplinary evaluation is recommended to determine the management plan for the patients.[22][23]​​​ Initiation of antiplatelet or anticoagulation therapy is recommended, depending on the patient’s specific factors. 

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