New guidelines detail PFO management, including when to consider closure
Patent foramen ovale (PFO) is a typically benign condition in which the small opening between the left and right atria—which is normally present in all newborns—fails to close shortly after birth and remains present until adulthood. Affecting approximately 25% of the population, there has long been a lack of clarity regarding medical intervention for uncommon but serious PFO-related complications including migraines and stroke.
To address that lack of clarity, the Society for Cardiovascular Angiography and Interventions (SCAI) released new, comprehensive guidelines on May 19 to guide medical practitioners on when to pursue PFO closure or other interventions.
“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, chair of the writing group and chief of the Structural and Interventional Cardiology section at Rush University Medical Center.
Informed by an evidence-based review, the guidelines include treatment recommendations for five different scenarios, including three different scenarios where patients have had a prior PFO-associated stroke, one scenario where a patient has not had a prior PFO-associated stroke, and one scenario where a patient has already undergone PFO closure to advise on post-procedure management.
In addition to exploring the option of percutaneous PFO closure, the document’s recommendations for each scenario also explore treatment options, including antiplatelet therapy and anticoagulation therapy.
“With the publication of multiple positive PFO closure trials, the FDA approval of devices to close PFOs, and the high prevalence of PFOs in adults, SCAI members realized the importance of developing recommendations to aid health care providers, interventional cardiologists, neurologists, and payors in the optimal application of this procedure,” Kavinsky and co-authors wrote.
The panel of experts who developed the guidelines included interventional cardiologists as well as a neurologists from the American Academy of Neurology, with clinical and research expertise on managing PFO as well as expertise in evidence appraisal. The panel also included patient representatives.
The document’s conclusions, which used the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, offer critical insight from an evidence-based perspective to address common criticisms as well as controversy surrounding PFO closure.
“Critics who describe percutaneous PFO procedures as invasive with procedural and device-related complications should remember that PFO closure has an excellent safety profile and that oral anti-platelet and anti-coagulant therapies are associated with significant bleeding events,” the authors wrote.
View the complete version the SCAI Guidelines for the Management of Patent Foramen Ovale here.
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Reference:
1. Clifford J. Kavinsky, Molly Szerlip, Andrew M. Goldsweig, et al. SCAI Guidelines for the Management of Patent Foramen Ovale. May 19, 2022. DOI:https://doi.org/10.1016/j.jscai.2022.100039