Management of patent foramen ovale: SCAI issues new official guidelines

ATLANTA: The Society for Cardiovascular Angiography & Interventions (SCAI) today released official guidelines for the management of patent foramen ovale (PFO). A multidisciplinary guideline panel formulated 13 recommendations to address five PFO clinical scenarios. The document was published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).

The foramen ovale is an opening, similar to a small flap, between the two top chambers (atria) of the heart. Everyone is born with this opening, which is essential to the blood flow of the developing fetus. After birth, this opening generally seals itself closed within a few months as the heart begins its normal function of pumping blood on its own, no longer needing to receive oxygen from the mother's blood supply. In some individuals, the opening does not close, which is called a PFO.PFO is present in around 25 percent of the adult population.

In most cases, PFO is benign and requires no treatment. However, it can cause serious complications under certain circumstances. These guidelines address five different scenarios where patients and clinicians may consider additional management of a PFO, including the following:

1. Percutaneous PFO closure versus medical therapy (antiplatelet or anticoagulation or composite)/no therapy in adults without a prior PFO-associated stroke

2. Percutaneous PFO closure versus antiplatelet therapy in adults with a prior PFO-associated stroke

3. Percutaneous PFO closure versus anticoagulation therapy in adults with a prior PFO-associated stroke

4. Percutaneous PFO closure plus lifelong anticoagulation versus anticoagulation alone in adults with a prior PFO-associated stroke

5. Post-procedure management of patients undergoing percutaneous PFO closure with a regimen of one (1) month of aspirin plus clopidogrel followed by five (5) months of aspirin versus another antiplatelet regimen or anticoagulation

"This document represents the first truly rigorous guideline document put forth by the SCAI to lend clarity to a field surrounded by controversy and aid in physician decision making for PFO associated conditions," said Clifford J. Kavinsky, MD, PhD, MSCAI, chair of the writing group and Chief, Section of Structural and Interventional Cardiology at Rush University Medical Center.

The SCAI guideline panel, comprised of experts in the fields of structural heart disease and neurology and patient representatives, employed the GRADE approach to develop a series of clinical questions and patient-important outcomes. Each question was subjected to a systematic evidence review, which informed judgements by the guideline panel to develop each recommendation. SCAI acknowledges the importance of alignment with stroke neurology for any guidance surrounding PFO closure and carried out this effort with representation from the American Academy of Neurology.