PFO: Should Anyone be Closed and With What?

12th Biennial Meeting of the International Andreas Gruentzig Society:  Rio de Janeiro - February 2-6, 201

From SESSION 6 — Structural

Moderator:  Steve Bailey
Panelists: Kirk Garratt, Gyula Gal, Adam Greenbaum, Nickolas Kipshidze, Brian O’Murchu

Framing the question at hand, what is the state of the current knowledge?

The current state of the art is uncertain. Non-randomized and registry studies have indicated that PFO closure when compared to “standard medical therapy” may improve outcomes. Individual trials using differing criteria have demonstrated trends in short-term outcomes in favor of closure of PFO in cryptogenic stroke but only meta-analyses using the larger numbers of patients have shown benefit. Concerns remain about the prevalence of atrial fibrillation at its association with stroke in this population.

What are the Gaps in the current knowledge?
Current trials have many limitations including enrollment bias, participation of other subspecialties such as neurology and questions regarding endpoint assessment. These trials were limited in that many of the higher risk patients were closed for clinical indications and not enrolled in trials. As cryptogenic stroke includes multiple entities patients may have been included that had other underlying risks for stroke. Whether the devices tested were optimized for treatment of PFO is also a consideration.

Our Summary and Recommendations:
Before recommending PFO closure in all patients, we still need studies in which patients at high risk for embolic events are enrolled who have been extensively screened for other etiologies including paroxysmal afib. The studies need to be conducted over a longer time period to allow discrimination of outcomes. Endpoints should be discrete as well as composite endpoints.

Further studies into the role of PFO in migraines are still warranted.