Patients with an embolic-appearing infarct who are younger than 60 years, have undergone a thorough evaluation to rule out other stroke mechanisms, and have discussed with doctors the potential risks and benefits may be candidates for the procedure.
“For patients with cryptogenic stroke and PFO, percutaneous PFO closure probably reduces the risk of stroke recurrence with [a hazard ratio] of 0.41 and an absolute risk reduction of 3.4% at 5 years; probably is associated with a periprocedural complication rate of 3.9%; and probably is associated with the development of serious nonperiprocedural atrial fibrillation, with a relative risk of 2.72,” according to the advisory authors’ meta-analysis.
Most procedural complications and instances of atrial fibrillation were “self-limited and are of uncertain long-term clinical consequence, given the lower rate of stroke in patients whose PFOs were closed,” the authors said. “Subgroup analysis suggests that the overall benefit seen across trials may not extend to those patients with small shunts and small, deep infarcts.” The authors estimated that the number of patients who need to be treated to prevent one stroke at 5 years is 29.
The advisory updates 2016 guidance that said clinicians should not routinely offer PFO closure outside of a research setting. Since then, three trials published in 2017 the New England Journal of Medicine (RESPECT, CLOSE, and REDUCE) and one trial published in 2018 in the Journal of the American College of Cardiology (DEFENSE-PFO) found that PFO closure reduces the risk of recurrent stroke in patients with a PFO who have had a cryptogenic stroke, compared with medical therapy alone. In addition, the Food and Drug Administration approved the Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. These developments necessitated the practice advisory, the authors said. The advisory was published online April 29 in Neurology. It is endorsed by the American Heart Association/American Stroke Association, the Society for Cardiovascular Angiography and Interventions, and the European Academy of Neurology.
Systematic review
For the update, Steven R. Messé, MD, of the Hospital of the University of Pennsylvania in Philadelphia, and a panel of neurologists, internists, and cardiologists with expertise in stroke and PFO systematically reviewed relevant randomized studies published through August 2019 and conducted meta-analyses to make their recommendations. The literature search identified eight articles that met inclusion criteria, including one article that provided follow-up from a trial that had been included in the previous practice advisory.
“The risk of a second stroke in people with PFO and no other possible causes of stroke is very low, approximately 1% per year while being treated with just medication alone,” Dr. Messé said in a news release. “Also, it is difficult to determine with absolute certainty that the PFO is the cause of a person’s stroke. So it is important that people with PFO are educated about the benefits and risks of PFO closure.” For patients who opt to take medication only, doctors may consider prescribing antiplatelet or anticoagulant drugs, according to the advisory. “All patients with previous stroke should be treated with an antithrombotic medication indefinitely if there is no bleeding contraindication, regardless of whether a PFO is present or if it is closed,” Dr. Messé and colleagues wrote. “However, specific antithrombotic management for patients with stroke thought to be caused by PFO remains uncertain.”