SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke

• Published in: Catheterization and cardiovascular interventions 2019-04, Vol.93 (5), p.859-874
• Main Authors: Horlick, Eric, Kavinsky, Clifford J., Amin, Zahid, Dean Boudoulas, Konstantinos, Carroll, John D., Hijazi, Ziyad M., Leifer, Dana, Lutsep, Helmi L., Rhodes, John F., Tobis, Jonathan M.
• Format: Article
• Language: English
• Subjects: Angiography; ASD/PDA/PFO; Clinical trials; closure; comparative effectiveness/patient centered outcomes research; Decision making; evidence‐based medicine; FDA approval; Neurology; Regulatory agencies; Stroke; structural heart disease intervention
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.28111

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high‐quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi‐disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient‐centered care.