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Pediatric Patent Foramen Ovale Atrial Septal Defects Treatment & Management

  • Author: Barry A Love, MD; Chief Editor: P Syamasundar Rao, MD  more...
Updated: Jan 30, 2015

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) should 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.[19]


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.[20]


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 consider patent foramen ovale closure.

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.[21] Closure may also be indicated in divers, for whom a patent foramen ovale represents an increased risk for decompression illness.[20]

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.[22]

In the United States, 2 closure devices, the Amplatzer PFO Occluder (AGA Medical Company; Golden Valley, 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, no device is specifically 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[23] and radiofrequency closure[24] 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.[17] In patients with atrial septal aneurysm, the risk is somewhat higher at about 5% per year.[17] 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,[25] 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.

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.

Contributor Information and Disclosures

Barry A Love, MD Assistant Professor , Department of Medicine, Division of Cardiology, Assistant Professor, Division Pediatric Cardiology, Director, Pediatric Electrophysiology Service, Department of Pediatrics, Division of Pediatric Cardiology, Mount Sinai School of Medicine

Disclosure: Nothing to disclose.


Michael A Portman, MD, MD Professor, Department of Pediatrics, University of Washington School of Medicine; Director of Research, Division of Cardiology, Seattle Children's Hospital; Attending Physician, Seattle Children's Heart Center; Attending Physician, Cardiology Clinic, Providence Everett Medical Center

Michael A Portman, MD, MD is a member of the following medical societies: American Academy of Pediatrics, American College of Cardiology, American Heart Association, American Physiological Society, Society for Pediatric Research

Disclosure: Nothing to disclose.

Specialty Editor Board

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Alvin J Chin, MD Emeritus Professor of Pediatrics, University of Pennsylvania School of Medicine

Alvin J Chin, MD is a member of the following medical societies: American Association for the Advancement of Science, Society for Developmental Biology, American Heart Association

Disclosure: Nothing to disclose.

Chief Editor

P Syamasundar Rao, MD Professor of Pediatrics and Medicine, Division of Cardiology, Emeritus Chief of Pediatric Cardiology, University of Texas Medical School at Houston and Children's Memorial Hermann Hospital

P Syamasundar Rao, MD is a member of the following medical societies: American Academy of Pediatrics, American Pediatric Society, American College of Cardiology, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society for Pediatric Research

Disclosure: Nothing to disclose.

Additional Contributors

Paul M Seib, MD Associate Professor of Pediatrics, University of Arkansas for Medical Sciences; Medical Director, Cardiac Catheterization Laboratory, Co-Medical Director, Cardiovascular Intensive Care Unit, Arkansas Children's Hospital

Paul M Seib, MD is a member of the following medical societies: American Academy of Pediatrics, American College of Cardiology, American Heart Association, Arkansas Medical Society, International Society for Heart and Lung Transplantation, Society for Cardiovascular Angiography and Interventions

Disclosure: Nothing to disclose.

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This 2-dimensional echocardiogram in an infant (subcostal long-axis view) shows a patent foramen ovale. Right atrium (RA) and left atrium (LA).
Color Doppler of the patent foramen ovale (PFO) seen in the previous image. A small amount of left-to-right flow is present. This left-to-right flow pattern is typical for PFO seen in newborn infants.
Transesophageal echocardiogram showing the atrial septum. The "flap" of the septum primum is seen. The diagnosis of patent foramen ovale (PFO) cannot be made until right-to-left bubble contrast is demonstrated. LA = Left atrium; RA = Right atrium.
Bubble-contrast injection during Valsalva maneuver. The "flap" of the foramen ovale is opened and bubbles are seen crossing from the right atrium to the left atrium (arrow).
Transesophageal echocardiogram revealing a 25-mm Amplatzer patent foramen ovale (PFO) occluder in place across the PFO shown in the previous 2 images.
Transesophageal echocardiogram of a patent foramen ovale (PFO) closed with 25-mm Amplatzer PFO occluder. Bubble-contrast study with Valsalva post-device placement shows no residual right-to-left bubble passage.
Transcranial Doppler (TCD) study with bubble-contrast study. A Doppler probe is used to interrogate the right middle cerebral artery. Frame 1 shows normal findings. Note the absence of bubble artifact of Doppler signal in the middle cerebral artery. Frame 2 shows strongly positive (5/5) bubble transit seen in a patient with a patent foramen ovale (PFO) during Valsalva maneuver. TCD is a useful screening tool for PFO because of its ease-of-use and ability to easily quantify the amount of potential right-to-left shunt. One of the pitfalls is the inability to differentiate between other sources of right-to-left shunt, such as pulmonary arteriovenous malformation and a PFO.
Transesophageal echocardiogram of bubble contrast study showing right-to-left passage of bubble-contrast with a Valsalva maneuver. RA = Right atrium. LA = Left atrium. Arrow shows bubble passage to LA.
Transesophageal echocardiogram showing a 10-mm Amplatzer Septal Occluder in place across a patent foramen ovale.
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