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Neurology society opposes routine use of closure devices for patients with PFO, stroke
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The American Academy of Neurology issued an update to a guideline on patent foramen ovale closure devices, recommending that the devices not be routinely used for prevention of recurrent ischemic stroke.
The practice advisory published in Neurology was based on a systematic review of current literature on people with PFO who also had an ischemic stroke or a transient ischemic attack. The research addressed whether PFO closure is superior to medical therapy alone and whether anticoagulation is superior to antiplatelet therapy for the prevention of recurrent stroke.
Limited evidence
“Compared with other ways to prevent a second stroke, such as medications to reduce blood clots, the devices used to close a [PFO] have limited evidence to support their use,” Steven R. Messé, MD, FAAN, associate professor of neurology at the Hospital of the University of Pennsylvania and an author of the practice advisory, said in a press release. “It’s still uncertain how effective these devices are in reducing stroke risk, and the procedure is associated with uncommon but potentially serious complications.”
Steven R. Messé
No device is currently approved by the FDA for PFO closure for stroke prevention, and all such uses in the United States are off-label. An FDA advisory panel narrowly recommended in May that a device (Amplatzer PFO Occluder, St. Jude Medical) receive such an indication.
The advisory mainly focused on the findings of three trials: CLOSURE 1, PC and RESPECT; as well as the differences between the STARFlex device (NMT Medical) and the Amplatzer. From these trials, the writing group determined that because of limitations of the efficacy evidence and the risk for serious adverse events, the risk–benefit tradeoff for these devices is still uncertain.
There is insufficient evidence that PFO closure with the STARFlex device provides better stroke prevention vs. medical therapy alone (risk difference, 0.13%; 95% CI, –2.2 to 2), and although PFO closure with the Amplatzer device may decrease risk for recurrent stroke (risk difference, –1.68%; 95% CI, –3.18 to –0.19), it may increase risk for new-onset atrial fibrillation (risk difference, 1.64%; 95% CI, 0.07-3.2) and for procedural complications (risk difference, 3.4%; 95% CI, 2.3-5), according to the authors.
Clinical guidance
The update includes four key recommendations:
- Clinicians should counsel patients considering PFO closure that PFO is common, is difficult to determine with certainty that their PFO is the cause of the stroke, and should educate them on the potential for serious complications after the procedure.
- PFO closure to treat cryptogenic stroke is not routinely recommended outside of a research setting, but if a patient continues to have recurrent stroke, even after best medical therapy and no other causes are indicated, then a clinician may offer the Amplatzer device, if available.
- Clinicians should routinely offer antiplatelets, not anticoagulants, to patients with cryptogenic stroke and PFO when no other indication is given for anticoagulation because the evidence for anticoagulants in this population is insufficient (risk difference, 2%; 95% CI, –21 to 25).
- However, if recurrent stroke occurs in a patient already on antiplatelet therapy, then the clinician may offer anticoagulation instead.
According to the advisory, more randomized controlled trials are needed on carefully selected patients who have limited vascular risk factors and for whom other stroke etiologies have been excluded.
“It can be very challenging to determine the specific mechanism of a stroke. Unfortunately, unlike [MI], stroke pathogenesis is very heterogeneous, ranging from disease of the small perforating intracranial vessels, extracranial or intracranial large vessel atherothromboembolism or dissection, cardioembolism, and then less likely causes such as sympathomimetic drugs, vasospasm, vascular inflammation or infection, and hypercoagulability,” Messé told Cardiology Today’s Intervention. “Even after a thorough evaluation, 25% to 40% of patients will not have a clear etiology determined and many have multiple etiologies identified.”
He said, “If we really wanted to have the best answer, we would stop off-label PFO closures, and randomize more patients to confirm that there is a benefit and determine who is most likely to receive that benefit, as well as have a better sense of procedural and long-term safety. However, I do not think that is likely.”
Messé said the writing group is awaiting the results from another randomized PFO closure trial that utilized the Helex Septal Occluder (W.L. Gore) and a few other randomized trials being performed outside the U.S.
He also said that if the FDA approves the Amplatzer device for PFO closure, a prospective registry should be established.
Messé told Cardiology Today’s Intervention that this is a contentious issue. “It is worth noting that I know neurologists who are true believers in PFO closure for select patients, and cardiologists who do not believe that closure has been proven effective yet,” he said. “Even among the author panel, which included neurologists, cardiologists, and an internist, there was not unanimity in the final recommendations. The American Academy of Neurology process did allow for recommendations if 80% of the authors agreed.” – by Tracey Romero
Disclosure: Messé reports receiving funding from GlaxoSmithKline and W.L. Gore & Associates as an investigator for the REDUCE trial sponsored by Gore, and serving as subinvestigator for the CLOSURE I trial funded by NMT Medical. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
Back to TopJohn D. Carroll, MD
The practice advisory is already out of date since it does not have the latest results from the RESPECT trial, which is the largest randomized trial in the field. They waited 12 years to update this practice advisory, and waiting a few more months would have been prudent.
A partnership between cardiology and neurology is needed locally for optimal care of these patients, and nationally for clinical trial leadership and professional society alignment and collaboration. It is unfortunate and a missed opportunity that this practice advisory does not have the input and approval of the American College of Cardiology, the American Heart Association or the Society for Cardiovascular Angiography and Interventions. The American Academy of Neurology’s failure to have a consensus-driven approach in a practice guideline will only confuse clinicians and patients.
Furthermore, it is very odd to do a practice advisory about a procedure with no one on the committee who performs the procedure. I hope it is not the American Academy of Neurology’s policy to normally exclude interventionalists and surgeons when the topic is a procedure or an operation.
Many neurologists clearly differ with this practice advisory, because they refer patients for closure and this advisory has a conclusion that is extremely restrictive. Clinicians and patients want and need access to an approved PFO closure technology.
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