Pediatric Patent Foramen Ovale Atrial Septal Defects Treatment & Management

Updated: Sep 16, 2019
  • Author: Barry A Love, MD; Chief Editor: Syamasundar Rao Patnana, MD  more...
  • Print

Approach Considerations

Zier et al conducted a comprehensive literature review of contemporary studies, focusing on randomized trials and meta-analyses that compare medical therapy and device closure of patent foramen ovale (PFO) for the treatment of PFO-associated clinical syndromes. It can be difficult to determine the extent to which the PFO is a causative factor in the disease process in many PFO-associated conditions. As a result, the investigators recommend that before implicating the PFO and proceeding with closure, healthcare providers perform a comprehensive diagnostic evaluation to exclude other obvious etiologies of PFO-associated conditions. [13]


Medical Care

Inpatient observation in the neonate with cyanosis due to atrial right-to-left shunting may be required until the underlying cause is defined.

A small left-to-right shunt associated with a patent foramen ovale (PFO) does not require treatment.

In patients who have experienced a stroke or transient ischemic attack, treatment with aspirin or warfarin appears to decrease the risk of a subsequent event; however, no evidence in adults suggests that warfarin is superior to aspirin. [14]

Outpatient follow-up is indicated for patients with cyanosis due to right-to-left shunting at the patent foramen ovale (PFO) to check for evidence of resolution of shunting as changes in pulmonary vascular resistance occur. 


Consultation with a pediatric cardiologist for evaluation of associated congenital heart defects and assessment of degree of left-to-right or right-to-left shunting may be indicated.

Consultation with a neurologist in patients with suspected stroke is indicated.


Transfer of patients with patent foramen ovale is likely to be indicated only for surgical closure or transcatheter device closure of the patent foramen ovale in patients with problematic right-to-left shunting.


Activity is not restricted. However, scuba diving at depths greater than 35 ft increases the risk of decompression illness. Patent foramen ovale closure is therefore recommended for divers who descend to depths greater than 35 ft. [15]


Surgical Care

In most instances, no therapy is needed for a patent foramen ovale. The simple presence of a patent foramen ovale in an infant, child, or adult is a normal finding. Asymptomatic patients do not require medication and should not be considered for patent foramen ovale closure.

Residual atrial septal defects or patent foramen ovale following prior cardiac surgery for complex congenital heart disease, including Fontan fenestrations, should be closed to treat systemic hypoxemia and to prevent potential paradoxical embolism. [16]

Closure of a patent foramen ovale is indicated if right-to-left shunting is identified as a previous or potential source of paradoxical embolism. Closure should be performed in patients with a patent foramen ovale and history of stroke only after an extensive evaluation excludes other causes of the stroke or sources of emboli. Closure may also be indicated in patients who have recurrent symptoms of stroke while receiving warfarin. Patent foramen ovale closure may be indicated in preparation for neurosurgical procedures in the sitting position, which carry a high risk of paradoxical air embolism. [17] Closure may also be indicated in divers, for whom a patent foramen ovale represents an increased risk for decompression illness. [15]

Transcatheter closure of a patent foramen ovale is controversial. In the setting of cryptogenic stroke and a patent foramen ovale, nonrandomized data show that transcatheter closure is effective in preventing recurrent strokes. [18]

In the United States, two closure devices, the Amplatzer PFO Occluder (Abbott Cardiac Arrhythmias and Heart Failure, Plymouth, MN)

and the CardioSEAL device (NMT Medical; Boston, MA), were available under a special humanitarian device exemption (HDE) for patent foramen ovale closure; however, the HDE was withdrawn in 2006 because the number of device uses exceeded the 4000/year allowed by the US Food and Drug Administration under the HDE rules. Currently, Amplatzer PFO Occluder (Abbott Cardiac Arrhythmias and Heart Failure, Plymouth, MN) is approved for patent foramen ovale closure in the United States. Outside the United States, several closure devices are available including the Amplatzer PFO Occluder, the StarFlex PFO Occluder (NMT Medical; Boston, MA), the CardioSEAL device, and the Gore Helex Occluders (Gore Medical, Flagstaff, AZ). Transcatheter suture closure [19] and radiofrequency closure [20] are investigational; to date, the results have been disappointing.

Ongoing randomized controlled trials are comparing medical therapy (warfarin or aspirin) with transcatheter device closure of patent foramen ovale in the prevention of stroke. Patients who have had one stroke with a patent foramen ovale may qualify for these trials. One of the difficulties in comparing therapies for secondary prevention of stroke in patients with a patent foramen ovale is the relatively low recurrence rate. In patients with stroke and a patent foramen ovale, the recurrence risk appears to be 1-3% per year. [10] In patients with atrial septal aneurysm, the risk is somewhat higher at about 5% per year. [10] Even so, this relatively low recurrence risk means that randomized trials need to enroll large numbers of patients and observe them for many years to establish a benefit (or at least noninferiority) to medical therapy.

In the United States, off-label use of transcatheter closure devices is common in situations in which patients have a patent foramen ovale and have had a single stroke and do not wish to enter a randomized trial. Although the American Academy of Neurology has discouraged this type of an approach and encourages participation in randomized controlled trials, [21] evidence of nonrandomized trials is sufficient for many to proceed with this approach. The Amplatzer Septal Occluder (AGA Medical Company; Golden Valley, MN), approved for closure of atrial septal defects (see video below), and the CardioSEAL device, approved for closure of muscular ventricular septal defects, are both used off-label for transcatheter patent foramen ovale closure in the United States.

Transesophageal echocardiogram showing a 10-mm Amplatzer Septal Occluder in place across a patent foramen ovale.

In patients with orthodeoxia-platypnea secondary to a patent foramen ovale, patent foramen ovale closure is curative and normalizes the arterial oxygen saturation. [9]  

Surgical closure of a foramen ovale has largely been supplanted by the availability of safe and effective transcatheter closure methods. The safety and effectiveness of surgical foramen ovale closure has not been systematically compared with medical therapy or transcatheter device closure.

Follow-up echocardiography is recommended after surgical closure or placement of a transcatheter device to confirm persistent closure.