PFO Closure for Migraine? Decompression Sickness? Experts Mull the Evidence

A new European position paper seeks to standardize the approach for treating patients with patent foramen ovale (PFO) and decompression sickness, desaturation syndromes, migraine, and other complex clinical presentations beyond stroke/TIA management.

The paper is the second in a series on PFO management, following part I, published in 2019, which focused on PFO and thromboembolism. Part II, published online today in EuroIntervention, outlines the current literature linking PFO and these other conditions, making recommendations based on a rigorous review of the available evidence.

“We wanted to address the issue of PFO, because people usually approach this anatomical entity as something problematic when they see it,” lead author Christian Pristipino, MD (S. Filippo Neri Hospital, Rome, Italy), told TCTMD. “So we thought it was important to approach it from the clinical point of view, addressing all the syndromes that it is associated with.”

PFO closure for ischemic-stroke prevention in the absence of other triggers is now supported by a range of guidelines and policy papers; its use in other settings, however, has been more controversial and less evidence-based.

“The most important take-home message is that we need more research to give answers to these patients that are suffering from these syndromes,” Pristipino said. “The strong feeling that comes out from this extensive review of all the available evidence of the syndromes is that we have very heterogeneous population in decompression syndrome, for example, and in migraine, and we need really to have research to be able to differentiate these subgroups of patients in a way to be able to target them with the right therapy at the right moment.”

It’s likely that PFOs play a role in all of the syndromes included in the position paper, but to what extent and how much an intervention could change outcomes remains to be known. Closing a PFO in one patient—for example, a professional diver at higher risk for decompression sickness—might have a greater impact than doing so on others, Pristipino explained. For these specific patients, closure should be considered, the paper states.

We need more research to give answers to these patients that are suffering from these syndromes. Christian Pristipino

For migraine, however, the indications are more limited, given the heterogeneity of the patients in currently available randomized studies and the results to date. “They are encouraging because they show that of course PFO closure can be useful in some subgroups, but we still have to learn which [those are],” he said. “Therefore we indicated that closing of a PFO could be done in migraine only for research reasons or for compassionate use in patients that did not respond to all the existing therapies and [have] migraine with aura.”

Trials are ongoing looking at the effect of PFO closure in migraine patients, and Pristipino is hopeful these will provide more definitive answers. “The most important thing is to try to target the right population and to really make explicit inclusion criteria in a way that it can be understood which are the patients that we are studying,” he said. “We need really strict inclusion criteria and also standardized follow-up outcomes for these migraine studies, because one of the biggest problems in these studies is that they chose different endpoints and so they are hardly comparable.”

For desaturation, “it's even more instrumental to close the PFO, because often we can demonstrate a cause/effect relationship between the PFO and the clinical syndrome,” Pristipino explained. “In this case, it is suggested to close the PFO, because this would be really the mechanism by which the syndrome is manifested.”

The position paper also reviews the potential for PFO-related stroke in other high-risk conditions like pregnancy and neurosurgery in the sitting position, where they advise against and for performing routine PFO screening, respectively.

Pristipino views this paper as “the first step of bringing attention to these syndromes and to these patients that are usually treated in such a different way throughout the world. We hope this can be a contribution to start giving rational answers to these patients that are shared in a multidisciplinary way—in a way that patients who come to physicians to seek medical advice around the world would not find two different approaches and answers to their problem.”