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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.”
Calls for thorough work-up
“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”
In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).
Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).
The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”
About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”
The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.
SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.
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.”
Calls for thorough work-up
“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”
In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).
Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).
The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”
About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”
The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.
SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.
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.”
Calls for thorough work-up
“If an alternative plausible higher-risk mechanism of stroke is identified, it is likely that the PFO was an innocent bystander,” the authors said. “Secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. ... The randomized PFO closure trials all mandated thorough evaluations for participants before enrollment ... to rule out other stroke mechanisms; moreover, all studies required TEE [transesophageal echocardiography] to characterize the PFO and ensure that it was the most likely etiology for the initial event.”
In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution (level B); obtain vascular imaging of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B); and perform hypercoagulable studies (level B), according to the advisory. Clinicians must perform a baseline ECG to look for atrial fibrillation (level A), and patients thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B).
Before PFO closure, a clinician with expertise in stroke should assess the patient to ensure that the PFO is the most plausible mechanism of stroke (level B). “If a higher-risk alternative mechanism of stroke is identified, clinicians should not routinely recommend PFO closure (level B),” the authors said. Patients also should be assessed by a clinician with expertise in assessing the anatomic features of a PFO and performing PFO closure (level B).
The randomized trials focused on patients whose PFOs were closed within 6 months of a stroke, and registry studies are needed to assess long-term outcomes, noted Dr. Messé and colleagues. “It remains unclear whether closure provides a similar benefit in these patients who otherwise still fit the studies’ inclusion criteria,” the authors said. “Long-term and large-scale safety registries for patients who have received PFO closure are needed to assess the risk of device erosion, fracture, embolization, and thrombotic and endocarditis risks, and the effect of residual shunts and incidence of atrial fibrillation.”
About 25% of the general adult population has a PFO. “It’s important to note that having a PFO is common, and that most people with PFO will never know they have it because it usually does not cause any problems,” Dr. Messé said. “However, while there is generally a very low risk of stroke in patients with PFO, in younger people who have had a stroke without any other possible causes identified, closing the PFO may reduce the risk of having another stroke better than medication alone.”
The practice advisory was developed with financial support from the AAN. Dr. Messé and most of the authors had no relevant conflicts of interest. Several authors disclosed ties to medical device and pharmaceutical companies.
SOURCE: Messé SR et al. Neurology. 2020 Apr 29. doi: 10.1212/WNL.0000000000009443.
FROM NEUROLOGY