SCAI PFO Closure Guideline Addresses Real-world Patient Scenarios

While not everyone is happy, the guideline-writers say it provides guidance about important patient subsets not included in RCTs.

SCAI PFO Closure Guideline Addresses Real-world Patient Scenarios

ATLANTA, GA—An expert consensus guideline created in collaboration with cardiologists, neurologists, and patients addresses decision-making about patent foramen ovale (PFO) closure in a wide variety of clinical scenarios where data are murky.

“These guidelines represent an effort to clarify the treatment of patient subsets who were not included in the published randomized clinical trials,” writing group chair Clifford J. Kavinsky, MD, PhD (Rush University Medical Center, Chicago, IL), told TCTMD.

Among those subsets are patients with nonstroke indications such as refractory migraine, platypnea-orthodeoxia syndrome, diving decompression illness, thrombophilia, systemic embolism, and venous thromboembolism (VTE). The only option for some is oral antiplatelet or anticoagulant therapies that increase the risk of bleeding events.

In 2019, the Society for Cardiovascular Angiography and Interventions (SCAI) and the American Academy of Neurology (AAN) published the first US expert consensus document on PFO closure for cryptogenic stroke, which had a primary goal of addressing and ending the long-held contention between cardiologists and neurologists around this topic and establishing partnerships to improve patient care.

To TCTMD, Kavinsky said the new guideline continues that partnership even though it has been, and continues to be, fraught with some level of disagreement, which he referred to in his presentation by observing: “They say a good guideline document is one where everyone on the panel is not completely happy or unhappy.”

In a session here at the SCAI 2022 Scientific Sessions introducing the new recommendations, panelist and writing committee member Jonathan M. Tobis, MD (University of California, Los Angeles), acknowledged being “an irritant” on the guideline panel.

“There are some, I would say, subjective or decision-making processes that are very variable,” Tobis noted as reason for some of his objections to recommendations. One example he gave was PFO closure for migraine where the data do or do not support closure depending on which studies you include in your analysis.

The guideline committee ultimately agreed that while it cannot support routine closure of PFO for refractory migraines, “observational and retrospective studies suggest an association between PFO and certain subsets of patients with migraine headaches, while acknowledging that all RCTs of PFO closure for refractory migraine headaches did not meet their primary efficacy endpoint.” The recommendation effectively allows for physician/patient choice, noting that it may be a reasonably decision in those who “have failed to benefit from conventional medical therapy, and who place a high value on the uncertain benefits of having their PFO closed and a lower value on the uncertain harms.”

“We had to make the best recommendations that we could, given the evidence that we have,” said panelist and writing committee member Megan Coylewright, MD, MPH (Erlanger Health System, Chattanooga, TN). “The good thing about this is it also directs us to where there are holes in evidence [and] helps sort of streamline what we need the next research trials to do to help come up with updated guidelines.”

The guideline was simultaneously published in the Journal of the Society for Cardiovascular Angiography & Interventions.

No Hornet’s Nest Here

In addition to experts in the fields of structural heart disease and neurology, the guideline committee also incorporated patient representatives, who Kavinsky told TCTMD were “very vocal” and largely liberal about wanting PFO closure as an option.

Coylewright recalled that one colleague had worried that allowing patient representatives into the discussions would be like opening a hornet’s nest. “It wasn’t a hornet’s nest. It was actually really helpful,” she said, adding that while physicians tend to think they know what patients want, involving patient voices improves the process for everyone.

The committee used the GRADE approach to develop a series of clinical questions and patient-specific outcomes that were then analyzed by a technical review panel before the guideline committee made recommendations. Moderator and vice chair of the guideline committee, Molly Szerlip, MD (Baylor Scott & White The Heart Hospital, Plano, TX), noted that while the American College of Cardiology does not use the GRADE approach in their guideline process, SCAI felt it provided the committee with “the best possible data to be able to make decisions on the clinical level.”

The guideline focuses on five PFO closure scenarios that were left unresolved by RCTs: following PFO-associated ischemic stroke, in patients without prior stroke for other indications, in patients with other stroke risk factors, in patients requiring long term anticoagulation for other reasons, and in post-PFO closure medical management.

Regarding key patient subsets, the committee decided on conditional recommendations:

  • in favor of closure in platypnea-orthodeoxia
  • in favor of closure in systemic embolism
  • against closure in thrombophilia
  • in favor of closure in deep vein thrombosis, but only in those with a PFO-related stroke
  • against closure in TIA
  • against closure in decompression illness

Some Worries Still

Coylewright clarified that a conditional recommendation in favor of closure “does not mean that if patients have a preference to have their PFO closed, they can just have it closed.” Likewise, a conditional recommendation against closure leaves room for patient discussion. She presented a clinical case example in which a middle-aged patient with a long history of debilitating migraines was offered PFO closure but ultimately chose Botox instead.

In an editorial accompanying the study in JSCAI, Robert J. Sommer, MD (Columbia University Irving Medical Center, New York, NY), and Jamil A. Aboulhosn, MD (Ronald Reagan UCLA Medical Center, Los Angeles, CA), say that while most of the guideline recommendations are reasonable, they worry that some could be used “to justify blanket denials of insurance coverage to patients who, in the judgment of their physician, would benefit from the intervention.”

Sommer and Aboulhosn say a perfect example of this is TIA patients, since some may have an indication for closure based on clear focal neurologic findings or prolonged symptoms.

“Similarly with decompression illness, while a typical patient could be instructed to stop diving to avoid the risk of recurrent episodes as a satisfactory alternative to PFO closure, professional divers would lose their livelihood if the PFO could not be closed,” they write.

  • Kavinsky reports no relevant conflicts of interest.
  • Sommer reports institutional support from W. L. Gore & Associates.
  • Aboulhosn reports consulting for Abbott Medical.