Materiały źródłowe

• #1 Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence – PubMed

  https://pubmed.ncbi.nlm.nih.gov/38134261/

  Patent foramen ovale (PFO) is frequently identified in young patients with ischemic stroke. Randomized controlled trials provide robust evidence supporting PFO closure in selected patients with cryptogenic ischemic stroke; however, several questions remain unanswered. This report summarizes current knowledge on the epidemiology of PFO-associated stroke, the role of PFO as a cause of stroke, and anatomic high-risk features. […] We further highlight areas for future research in PFO-associated stroke including the efficacy and safety of PFO closure in the elderly population, incidence, and long-term consequences of atrial fibrillation post-PFO closure, generalizability of the results of clinical trials in the real world, and the need for assessing the effect of neurocardiology teams on adherence to international recommendations. Other important knowledge gaps such as sex, race/ethnicity, and regional disparities in access to diagnostic technologies, PFO closure devices, and clinical outcomes in the real world are also discussed as priority research topics.

• #2 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention

  https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism

  Interdisciplinary involvement in decision making regarding PFO management is axiomatic and should include an interventional cardiologist and other specialists dictated by the patients clinical manifestations. […] The diagnosis of PFO is required only for deciding on a treatment. […] A PFO is seen in ~25% of the general population and may therefore coexist by chance in a patient with an unexplained left circulation embolism. […] A meta-analysis of observational studies showed a stronger relative association of PFO with cryptogenic stroke in patients. […] The risk of paradoxical embolism (RoPE) score represents an attempt to assign a causal relationship probability to individual PFOs in the setting of stroke of unknown cause and may be useful in helping to guide management decisions.

• #3 Patent foramen ovale: indications for closure and techniques | EuroIntervention

  https://eurointervention.pcronline.com/article/patent-foramen-ovale-indications-for-closure-and-techniques

  Non-surgical closure of the patent foramen ovale (PFO) has been possible for 40 years and proved safe in probably a million cases performed worldwide. […] The most compelling respective randomised data have been gathered so far in the realm of secondary prevention of cerebral attacks and migraine. […] PFO closure may not convey the projected amount of benefit. This even opens the door for primary prevention in some PFOs with high-risk characteristics. […] Considering that PFO closure is a safe, technically simple, and effective procedure that can be carried out by a single operator in less than 15 minutes, it is our opinion that this intervention is underutilised, especially in a high-risk subgroup of patients who could even benefit from PFO closure for primary prevention. […] PFO closure should also be considered for primary prevention in patients at high risk of paradoxical embolism due to the tendency for venous thrombosis, vocational or recreational activities fostering right to left shunts, in the presence of high-risk PFO, or those who can expect a collateral benefit (e.g., patients suffering from migraine, sleep apnoea, etc.). […] In our opinion a more proactive role in PFO closure for secondary prevention (and even for primary prevention in a specific subset of patients) is mandated.

• #4 Patent Foramen Ovale Closure for Stroke Prevention: Key Principles for Clinical Practice – Neurology Advisor

  https://www.neurologyadvisor.com/features/patent-foramen-ovale-closure-for-stroke-prevention-key-principles-for-clinical-practice/

  Even with thorough testing, declaring a patent foramen ovale as the most likely culprit responsible for a cryptogenic stroke remains a challenge. […] Now, after 30 years of intense scrutiny, we have consistent evidence from multiple clinical trials that PFO closure is effective at preventing recurrence. […] To optimize this strategy, careful patient selection is essential. […] In practice, opinions were sharply divided, often with cardiologists favoring closure and neurologists favoring noninvasive medical therapy, although all wanted more data. […] The US Food and Drug Administration has approved 2 devices with highly favorable efficacy and safety profiles. […] Overall, the clinical trial evidence in favor of PFO closure is clear and compelling. […] Finally, in 2018, the DEFENSE-PFO trial further confirmed that PFO closure reduced the risk for recurrent stroke, and meta-analyses of the trials have shown consistent benefits.

• #5 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention

  https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism

  The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.

• #6 PFO Closure Strategies to Prevent Cryptogenic Stroke Recurrence – Cardiac Interventions Today

  https://citoday.com/articles/2017-may-june/pfo-closure-strategies-to-prevent-cryptogenic-stroke-recurrence

  Many cardiologists would disagree with points three and four and the overall recommendation above, particularly given the results from the extended follow-up of the RESPECT trial, which showed a significant reduction in stroke with PFO closure and low rates of bleeding (0.57%), atrial fibrillation (0.25%), and deep venous thrombosis or pulmonary embolism (0.57%). […] Therefore, it is reasonable to consider PFO closure in patients aged 18 to 60 years with neurologist-confirmed cryptogenic stroke and a high RoPE score. In patients older than 60 years, the treatment effect of PFO closure is likely outweighed by other causes of stroke. […] The FDA panel strongly advised that any decision regarding PFO closure be considered by a neurologist and cardiologist, and this recommendation was included in the approved indications for use for the Amplatzer PFO occluder: The Amplatzer PFO Occluder is indicated for percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

• #7 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  Objective: To update the 2016 American Academy of Neurology (AAN) practice advisory for patients with stroke and patent foramen ovale (PFO). […] Major recommendations: In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke (level B). In patients with a higher risk alternative mechanism of stroke identified, clinicians should not routinely recommend PFO closure (level B). Clinicians should counsel patients that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B).

• #8 AAN Patent Foramen Ovale and Secondary Stroke Prevention Guideline Summary

  https://www.guidelinecentral.com/guideline/300170/

  In patients being considered for PFO closure, clinicians may use TCD agitated saline contrast as a screening evaluation for right-to-left shunt, but this does not obviate the need for TTE and TEE to rule out alternative mechanisms of cardio embolism and confirm that right-to-left shunting is intracardiac and transseptal (level C). […] Before undergoing PFO closure, patients should be assessed by a clinician with expertise in stroke 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). […] In patients with a PFO detected after stroke and no other etiology identified after a thorough evaluation, clinicians should counsel that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B).

• #9 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).

• #10 European Position Paper on Management of PFO

  https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2018/11/15/14/19/European-Position-Paper-on-the-Management-of-PFO

  PFO is present in about 25% of the general population. PFO can play a pathogenic role in cryptogenic left circulation thromboembolism. […] There are no definitive data to guide the selection of an antiplatelet versus oral anticoagulation (OAC) with vitamin K antagonists for secondary stroke prevention after PFO-related stroke. While OAC may be superior to antiplatelets in preventing PFO-related stroke, OAC also increases the risk of both intracranial and major extracranial hemorrhage. OAC may be preferred if the patient has a low hemorrhagic risk, high compliance is expected, and proper anticoagulant monitoring can be guaranteed. […] It is the position of the authors that patients ages 18-65 years with a confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism with a high probability of a causal role of their PFO should undergo percutaneous PFO closure. […] Antibiotic prophylaxis against endocarditis before an invasive procedure or surgical intervention should be pursued for all patients within the first 6 months after closure.

• #11 Management of Patent Foramen Ovale | USC Journal

  https://www.uscjournal.com/articles/update-management-patent-foramen-ovale-2017-indication-closure-and-literature-review?language_content_entity=en

  Thus, whether a PFO is present or not, it is important to carefully monitor for paroxysmal atrial fibrillation in cryptogenic stroke patients and initiate appropriate anticoagulation for the prevention of recurrent stroke. […] The updated 2014 American Heart Association/American Stroke Association (AHA/ASA) guidelines have a Class I, Level of Evidence (LOE) B indication for antiplatelet therapy in ischemic stroke/TIA patients with a PFO as well as a Class I, LOE A for anticoagulation in patients with an ischemic stroke/ TIA with a PFO and an established PFO. […] Despite medical therapy, the stroke recurrence rate in ischemia stroke patients with PFO is estimated at 4.5 % within a 4-year period. […] Therefore, in addition to medical therapy, the utility of secondary preventative treatment options such as percutaneous PFO closure has been a topic of debate.

• #12 SciELO Brazil – The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

  https://www.scielo.br/j/ijcs/a/K4Qbr99fBTDFQtCYkV7YbGs/?lang=en

  Patent foramen ovale (PFO) closure has been compared to medical therapy for secondary prevention of recurrent cryptogenic stroke. […] PFO closure, as compared with medical therapy alone, demonstrated superiority in reducing the rate of recurrent stroke (risk ratio with PFO closure vs. medical therapy, 0.37; 95% confidence interval [CI], 0.17 to 0.78; p = 0.01). […] In patients with cryptogenic stroke who had a patent foramen ovale, a protective effect of closure was seen concerning the risk of recurrent stroke, but not regarding the prevention of TIA. […] In the present updated meta-analysis, transcatheter PFO closure in cryptogenic strokes was shown to be superior to medical therapy in reducing recurrent stroke, although the risk of TIA was similar between the two groups. […] At the present stage, patent foramen ovale closure seems to be superior to medical treatment in reducing recurrent stroke in patients with cryptogenic stroke.

• #13 Stroke Prophylaxis by Percutaneous Closure of Patent Foramen Ovale and Left Atrial Appendage | ICR Journal

  https://www.icrjournal.com/articles/stroke-prophylaxis-percutaneous-closure-patent-foramen-ovale-and-left-atrial-appendage?language_content_entity=en

  Innovative percutaneous procedures for stroke prevention have emerged in the last two decades. Transcatheter closure of the patent foramen ovale (PFO) is performed in patients who suffered a cryptogenic stroke or a transient ischaemic attach (TIA) in order to prevent recurrence of thromboembolic events. […] The role of PFO and LAA in the occurrence of cerebrovascular events and the interventional device-based therapies to occlude the PFO and LAA are discussed. […] The mainstay of treatment for preventing ischaemic stroke is antiplatelet therapy and/or oral anticoagulation (OAC). In patients with AF, OAC with vitamin K antagonists (warfarin) reduces the stroke rate by two-thirds, whereas acetylsalicylic acid (aspirin) reduces the risk by one-fifth. […] Regarding PFO, AHA and American Stroke Association (ASA) guidelines recommend antiplatelet agents as a reasonable therapy for patients who had a cryptogenic stroke and were diagnosed with a PFO and advise that warfarin may be offered to patients who have other indications for OAC.

• #14 PFO Closure for Prevention of Recurrent Cryptogenic Stroke – Cardiac Interventions Today

  https://citoday.com/articles/2008-oct-nov/CIT1108_07-php

  Despite this, we still do not have convincing evidenced-based data to support this practice. […] For us to assume that thrombus or platelet abnormalities in the venous system are involved in recurrent cryptogenic stroke, we must also assume the involvement of a „door” for them to cross to the arterial side. […] Many data are available to confirm a strong association between the presence of a PFO and the cryptogenic stroke patient population. […] PFO with atrial septal aneurysm was found in 48% of the patients. […] Therefore, the presence of atrial septal aneurysm in PFO was thought to be a significant predictor of an increased risk of recurrent stroke. […] Traditional medical therapy has been either antithrombotic with warfarin or antiplatelet, including aspirin, dipyridamole, or clopidogrel.

• #15 Management of Patent Foramen Ovale | USC Journal

  https://www.uscjournal.com/articles/update-management-patent-foramen-ovale-2017-indication-closure-and-literature-review?language_content_entity=en

  Thus, whether a PFO is present or not, it is important to carefully monitor for paroxysmal atrial fibrillation in cryptogenic stroke patients and initiate appropriate anticoagulation for the prevention of recurrent stroke. […] The updated 2014 American Heart Association/American Stroke Association (AHA/ASA) guidelines have a Class I, Level of Evidence (LOE) B indication for antiplatelet therapy in ischemic stroke/TIA patients with a PFO as well as a Class I, LOE A for anticoagulation in patients with an ischemic stroke/ TIA with a PFO and an established PFO. […] Despite medical therapy, the stroke recurrence rate in ischemia stroke patients with PFO is estimated at 4.5 % within a 4-year period. […] Therefore, in addition to medical therapy, the utility of secondary preventative treatment options such as percutaneous PFO closure has been a topic of debate.

• #16

  https://www.clinicalcorrelations.org/2011/03/09/stroke-prevention-in-the-setting-of-a-patent-foramen-ovale-a-%E2%80%9Chole%E2%80%9D-in-the-evidence/

  Although the PICSS trial found similar hazard ratios between patients with and without PFOs who were on medical therapy, given the large number of patients with PFOs who do not experience a cryptogenic stroke, there are currently no recommendations for primary prevention. […] The second question to consider is whether antiplatelet therapy is sufficient or is full anticoagulation necessary for secondary prevention of cryptogenic strokes in the setting of PFOs. […] Given that warfarin has a more significant risk of bleeding than aspirin, and both the PICSS and WARSS trials found no significant advantage to either medical therapy, aspirin has become the recommended modality for secondary prevention in patients with PFOs. […] Conflicting data exists on the role of surgical and percutaneous device closures in PFOs.

• #17 European Position Paper on Management of PFO

  https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2018/11/15/14/19/European-Position-Paper-on-the-Management-of-PFO

  PFO is present in about 25% of the general population. PFO can play a pathogenic role in cryptogenic left circulation thromboembolism. […] There are no definitive data to guide the selection of an antiplatelet versus oral anticoagulation (OAC) with vitamin K antagonists for secondary stroke prevention after PFO-related stroke. While OAC may be superior to antiplatelets in preventing PFO-related stroke, OAC also increases the risk of both intracranial and major extracranial hemorrhage. OAC may be preferred if the patient has a low hemorrhagic risk, high compliance is expected, and proper anticoagulant monitoring can be guaranteed. […] It is the position of the authors that patients ages 18-65 years with a confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism with a high probability of a causal role of their PFO should undergo percutaneous PFO closure. […] Antibiotic prophylaxis against endocarditis before an invasive procedure or surgical intervention should be pursued for all patients within the first 6 months after closure.

• #18 Patent foramen ovale, stroke and antithrombotic treatment – GuíaSalud

  https://portal.guiasalud.es/egpc/prevencion_secundaria_ictus_patent_forame_ovale/

  The weak recommendation for the intervention (PFO closure followed by antiplatelet therapy) in the context of the Spanish National Health Service was the result of weighing the health effects (it being considered that the balance was in favour of the intervention) as well as the values and preferences of patients (who preferred prevention of stroke over prevention of other complications). […] In patients opting for medical treatment alone, without PFO closure, we suggest either antiplatelet or anticoagulation therapy, given that the result of the comparison indicates that the two types of treatment have similar effects. […] In patients with cryptogenic stroke and PFO, no differences were found between the use of anticoagulation and antiplatelet therapy in terms of desirable effects (reduction in the risk of stroke and TIA) or in the occurrence of adverse effects (bleeding or major bleeding), and hence, there was no basis for recommending anticoagulation over antiplatelet therapy.

• #19 Secondary Prevention of Cryptogenic Stroke and Outcomes Following Surgical Patent Foramen Ovale Closure Plus Medical Therapy vs. Medical Therapy Alone: An Umbrella Meta-Analysis of Eight Meta-Analyses Covering Seventeen Countries | Patel | Cardiology Rese

  https://cardiologyres.org/index.php/Cardiologyres/article/view/1526/1489

  In patients with CS, PFO closure, in addition to medical therapy, reduces the risk of recurrence. […] Our umbrella meta-analysis showed that PFO closure plus medical therapy had a 64% lower risk of recurrent strokes than medical therapy alone (pooled RR: 0.36). […] Given the greater benefits of PFO closure in addition to medical therapy, more research is needed to assess the efficacy of early closure and specific risk profiles that would benefit from early intervention to reduce the burden of stroke.

• #20

  https://journals.lww.com/md-journal/fulltext/2018/08240/patent_foramen_ovale_closure_or_medical_therapy.75.aspx

  It was under debate whether cryptogenic stroke patients benefited from patent foramen ovale (PFO) closure. We sought to determine secondary prevention strategy in these patients. […] PFO closure, as compared with medical therapy, was associated with decreased risk of recurrent stroke and increased risk of atrial fibrillation in cryptogenic stroke patients with PFO. […] Therefore, physicians have shown great interest in the role of PFO closure in secondary prevention of cryptogenic stroke. […] The aim of this meta-analysis was to compare outcomes of PFO closure and medical therapy in these patients, offering physicians a more comprehensive picture of management strategies in these patients. […] Our analysis demonstrated that PFO closure was associated with significant improvement in recurrent stroke and composite of stroke and TIA, which was similar with results of some previous observational studies, randomized controlled trials and meta-analyses.

• #21 Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke – REDUCE PFO

  https://www.acc.org/latest-in-cardiology/clinical-trials/2017/09/18/10/01/reduce-pfo

  The REDUCE trial showed that PFO closure with the Gore Septal Occluder was superior to medical management in reducing recurrent strokes. […] The results of the REDUCE trial indicate that PFO closure with the Gore Septal Occluder is superior to medical management in reducing recurrent strokes in patients with presumed cryptogenic stroke and evidence of a PFO on 24-month follow-up. […] Based on the extended follow-up duration of the RESPECT trial, the US Food and Drug Administration (FDA) approved the use of the Amplatzer PFO occluder in patients between ages 18-60 years with a cryptogenic stroke.

• #22

  https://link.springer.com/article/10.1007/s11739-018-1909-8

  The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. […] PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.380.81; I2=40%]. […] There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. […] More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.

• #23

  https://www.termedia.pl/Closure-of-patent-foramen-ovale-for-secondary-prevention-of-cryptogenic-stroke-current-perspectives,19,34954,0,1.html

  Patent foramen ovale (PFO) has been reported to be associated with cryptogenic stroke in young patients. […] In September, 2017, three large randomized trials were published showing superiority of PFO closure over standard medical therapy in prevention of recurrent stroke. […] While PFO closure should not be routinely performed in all patients with cryptogenic stroke and a PFO, it is reasonable to consider this for younger patients with a high risk of paradoxic embolism, especially with a large PFO and at least moderate right- to- left shunt.

• #24 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).

• #25 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).

• #26 Practice advisory update: Patent foramen ovale and secondary stroke prevention

  https://www.aan.com/Guidelines/home/GuidelineDetail/991

  This practice advisory updates the AAN’s 2016 practice advisory on closure of patent foramen ovale (PFO). […] Importantly, there is also a small upfront risk of procedural complication and an increased risk of developing atrial fibrillation after the procedure. Clinicians should discuss risks and benefits of PFO closures with patients.

• #27 PFO Closure for Prevention of Recurrent Cryptogenic Stroke – Cardiac Interventions Today

  https://citoday.com/articles/2008-oct-nov/CIT1108_07-php

  The published major bleeding risk for warfarin is approximately 2% to 13% per year, which is higher than the 1% procedural risk for device closure of a PFO. […] In general, studies do not favor one medical treatment regimen over another in the cryptogenic stroke patient population. […] There are currently no occluder devices approved in the US for PFO, and there are currently three clinical trials underway assessing patients for closure with catheter-placed devices versus medical management to prevent recurrent stroke. […] Without argument, PFO is a potential source for transient right-to-left intracardiac shunting and subsequent embolization to the brain. […] Finally, without argument, the association between PFO as the etiology of paradoxical embolism will always be presumptive.

• #28

  https://journals.lww.com/md-journal/fulltext/2021/06250/meta_analysis_of_patent_foramen_ovale_closure.80.aspx

  The optimal treatment strategy for patent foramen ovale (PFO) patients with cryptic stroke remains controversial. We performed this meta-analysis to evaluate the effect of PFO closure versus different types of medical therapy. […] Compared with antiplatelet therapy, PFO closure significantly reduced the risk of composite outcome (odds ratio [OR] 0.37, 95% confidence interval [CI] 0.270.51), stroke (OR 0.22, 95% CI 0.130.36], and TIA (OR 0.57, 95% CI 0.340.98); Compared with the mixed medical therapy group (consist of antiplatelet therapy, anticoagulant therapy, or both), PFO closure still showed some benefits, but the effect was not as significant as that of antiplatelet therapy (composite outcome: OR 0.53, 95% CI 0.410.69; stroke: OR 0.48, 95% CI 0.340.68; TIA: OR 0.69, 95% CI 0.500.96); Compared with anticoagulant therapy, PFO closure showed no benefit (composite outcome: OR 0.77, 95% CI 0.461.28; stroke: OR 0.59, 95% CI 0.281.25; TIA: OR 1.01, 95% CI 0.502.04).

• #29 AAN Patent Foramen Ovale and Secondary Stroke Prevention Guideline Summary

  https://www.guidelinecentral.com/guideline/300170/

  Ischemic stroke may be caused by a variety of heterogeneous mechanisms, and secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. […] In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke, as was performed in all positive PFO closure trials (level B). […] In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution, assessing for an embolic pattern or a lacunar infarct (typically involving a single deep perforator, 1.5 cm in diameter) (level B). […] In patients being considered for PFO closure, clinicians should obtain complete vascular imaging (MRA or CTA) of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B).

• #30 Patent Foramen Ovale Closure for Stroke Prevention: Key Principles for Clinical Practice – Neurology Advisor

  https://www.neurologyadvisor.com/features/patent-foramen-ovale-closure-for-stroke-prevention-key-principles-for-clinical-practice/

  The risk for device implantation is modest. […] Patients and clinicians should be aware of this risk to detect and treat the arrhythmia, although the role of anticoagulation for periprocedural atrial fibrillation is uncertain. […] Neurologists must carefully evaluate patients to confirm that the stroke is truly cryptogenic and attributable to the PFO, and cardiologists must choose and skillfully implant the device that ideally suits the anatomy.

• #31

  https://www.termedia.pl/Closure-of-patent-foramen-ovale-for-secondary-prevention-of-cryptogenic-stroke-current-perspectives,19,34954,0,1.html

  Patent foramen ovale (PFO) has been reported to be associated with cryptogenic stroke in young patients. […] In September, 2017, three large randomized trials were published showing superiority of PFO closure over standard medical therapy in prevention of recurrent stroke. […] While PFO closure should not be routinely performed in all patients with cryptogenic stroke and a PFO, it is reasonable to consider this for younger patients with a high risk of paradoxic embolism, especially with a large PFO and at least moderate right- to- left shunt.

• #32 PFO Closure Strategies to Prevent Cryptogenic Stroke Recurrence – Cardiac Interventions Today

  https://citoday.com/articles/2017-may-june/pfo-closure-strategies-to-prevent-cryptogenic-stroke-recurrence

  Many cardiologists would disagree with points three and four and the overall recommendation above, particularly given the results from the extended follow-up of the RESPECT trial, which showed a significant reduction in stroke with PFO closure and low rates of bleeding (0.57%), atrial fibrillation (0.25%), and deep venous thrombosis or pulmonary embolism (0.57%). […] Therefore, it is reasonable to consider PFO closure in patients aged 18 to 60 years with neurologist-confirmed cryptogenic stroke and a high RoPE score. In patients older than 60 years, the treatment effect of PFO closure is likely outweighed by other causes of stroke. […] The FDA panel strongly advised that any decision regarding PFO closure be considered by a neurologist and cardiologist, and this recommendation was included in the approved indications for use for the Amplatzer PFO occluder: The Amplatzer PFO Occluder is indicated for percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

• #33 Patent foramen ovale and cryptogenic stroke: diagnosis and updates in secondary stroke prevention | Stroke and Vascular Neurology

  https://svn.bmj.com/content/3/2/84

  A number of studies have examined the clinical clues that predict PFOs propensity for paradoxical embolism. […] A history of DVT or PE, prolonged travel, migraine, Valsalva manoeuvre preceding onset of stroke symptoms, sleep apnoea and waking up with stroke/TIA have been described as independent risk factors for PFO-associated cerebrovascular events. […] The data on shunt size and risk of stroke have been nebulous: while some studies suggest larger shunt increases the risk of stroke, others note no difference based on shunt size. […] Recent RCTs have included variables such as large shunt size and associated ASA; however, the verdict on how PFO closure affects those with large shunt size is incongruent among RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) (those with ASA and large shunts fare better),

• #34 Patent foramen ovale and cryptogenic stroke: diagnosis and updates in secondary stroke prevention | Stroke and Vascular Neurology

  https://svn.bmj.com/content/3/2/84

  Despite these overall negative results, a pooled analysis of individual data from the three RCTs showed that recurrent strokes were significantly fewer with PFO closure than with medical therapy alone. […] For patients 1860 years old with cryptogenic stroke, few vascular risk factors, and high-risk PFO characteristics such as large shunt and ASA, percutaneous PFO closure will reduce recurrent stroke risk, provided that the institutional procedural complication rate is low and minor risk of AF is understood. […] The decision to proceed with PFO closure should be made in conjunction with the patient, stroke neurologist and cardiologist. […] There are insufficient data on the efficacy of AP versus AC in stroke prevention in patients with cryptogenic stroke with PFO, so barring another reason for anticoagulation, starting with AP therapy as long-term therapy is reasonable, regardless of whether PFO is closed.

• #35 AAN Patent Foramen Ovale and Secondary Stroke Prevention Guideline Summary

  https://www.guidelinecentral.com/guideline/300170/

  Ischemic stroke may be caused by a variety of heterogeneous mechanisms, and secondary stroke prevention is optimized by targeting the most likely etiology of the preceding event. […] In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke, as was performed in all positive PFO closure trials (level B). […] In patients being considered for PFO closure, clinicians should obtain brain imaging to confirm stroke size and distribution, assessing for an embolic pattern or a lacunar infarct (typically involving a single deep perforator, 1.5 cm in diameter) (level B). […] In patients being considered for PFO closure, clinicians should obtain complete vascular imaging (MRA or CTA) of the cervical and intracranial vessels to look for dissection, vasculopathy, and atherosclerosis (level B).

• #36 AAN Patent Foramen Ovale and Secondary Stroke Prevention Guideline Summary

  https://www.guidelinecentral.com/guideline/300170/

  In patients being considered for PFO closure, clinicians must perform a baseline ECG to look for atrial fibrillation (level A). […] Select patients being considered for PFO closure thought to be at risk of atrial fibrillation should receive prolonged cardiac monitoring for at least 28 days (level B). […] In patients being considered for PFO closure, clinicians should assess for cardioembolic sources using TTE followed by TEE assessment if the first study does not identify a high-risk stroke mechanism. […] In patients being considered for PFO closure, clinicians should perform hypercoagulable studies that would be considered a plausible high-risk stroke mechanism that would lead to a change in management such as requiring lifelong anticoagulation (e.g., persistent moderate- or high-titer antiphospholipid antibodies in a younger patient with cryptogenic stroke) (level B).

• #37 Patent Foramen Ovale: Risk Factors and Diagnostic Comparison of Transcranial Doppler versus Echocardiography for Secondary Stroke Prevention

  https://www.j-nn.org/journal/view.php?number=97

  A thorough clinical history remains paramount to correlate symptom onset that coincides with above-mentioned activities that lends support to PFO causality. […] The evaluation of PFO relies on a detailed assessment with the use of various diagnostic modalities. […] TTE remains as the preferred initial diagnostic modality, the poor image quality does not permit a detailed cardiac evaluation. […] TCD is an established, cost-effective, and a valid imaging modality for PFO detection. […] TEE remains as the gold standard diagnostic modality for detection of PFO. […] Treatment options available for secondary stroke prevention in patients with cryptogenic ischemic stroke and PFO include antiplatelet therapy (APT), oral anticoagulation (OAC), and percutaneous PFO closure. […] Recent emergence of randomized data has ushered a new enthusiasm, confirming PFO closure with a genuine benefit in carefully selected young and middle-aged patients with cryptogenic ischemic stroke.

• #38 Patent Foramen Ovale: Risk Factors and Diagnostic Comparison of Transcranial Doppler versus Echocardiography for Secondary Stroke Prevention

  https://www.j-nn.org/journal/view.php?number=97

  Various factors correlated to PFO that tend to increase its causal relationship with cryptogenic ischemic stroke include: young age, valsalva maneuver (VM), recent prolonged immobility, concomitant DVT in legs or pelvis, presence of atrial septal aneurysm (ASA), history of migraine with aura, and neuroimaging demonstrating solitary cortical or bilateral embolic pattern. […] PFO has a higher prevalence (~5060%) among young and middle-aged (age, 1860 years) patients with cryptogenic ischemic stroke. […] The risk of cryptogenic stroke tends to exponentially increase in the presence of PFO, ASA, and combined PFO with ASA. […] Blood flow across the PFO additionally determines the risk of cryptogenic stroke. […] Increased RLS likely occurs in patients with a large PFO size and chronic pulmonary hypertension that fosters paradoxical flow in cardiac chambers.

• #39

  https://www.clinicalcorrelations.org/2011/03/09/stroke-prevention-in-the-setting-of-a-patent-foramen-ovale-a-%E2%80%9Chole%E2%80%9D-in-the-evidence/

  Although the PICSS trial found similar hazard ratios between patients with and without PFOs who were on medical therapy, given the large number of patients with PFOs who do not experience a cryptogenic stroke, there are currently no recommendations for primary prevention. […] The second question to consider is whether antiplatelet therapy is sufficient or is full anticoagulation necessary for secondary prevention of cryptogenic strokes in the setting of PFOs. […] Given that warfarin has a more significant risk of bleeding than aspirin, and both the PICSS and WARSS trials found no significant advantage to either medical therapy, aspirin has become the recommended modality for secondary prevention in patients with PFOs. […] Conflicting data exists on the role of surgical and percutaneous device closures in PFOs.

• #40 Patent foramen ovale closure for stroke prevention: A myriad of unanswered questions

  https://www.hcplive.com/view/september-2008-abouchebl-commentary

  Patent foramen ovale (PFO) is also common, found in 20% to 25% of the population. This anatomic anomaly has been associated with stroke in young individuals, and, more recently, with migraines with aura. […] Based on these results, the author concludes that PFO closure should be performed for primary prevention of stroke with the added benefit of reducing migraines. […] Considerably more studies need to be conducted before it is possible to conclude that PFO closure is a safe, effective, and appropriate procedure for primary or secondary prevention of stroke and migraines. […] PFO closure certainly may reduce the risk of stroke in some patients, and it is logical to reason that it should be considered in those who have recurrent events despite medical therapy or in those who have undergone an extensive evaluation by a stroke neurologist to exclude other causes of stroke. […] Regarding primary prevention, there are no data to guide treatment. The risk of stroke in such patients is unknown, but is likely very low and may be lower than the risk of the procedure. […] For this very reason, large, randomized, prospective studies are needed.

• #41 Patent foramen ovale: indications for closure and techniques | EuroIntervention

  https://eurointervention.pcronline.com/article/patent-foramen-ovale-indications-for-closure-and-techniques

  Non-surgical closure of the patent foramen ovale (PFO) has been possible for 40 years and proved safe in probably a million cases performed worldwide. […] The most compelling respective randomised data have been gathered so far in the realm of secondary prevention of cerebral attacks and migraine. […] PFO closure may not convey the projected amount of benefit. This even opens the door for primary prevention in some PFOs with high-risk characteristics. […] Considering that PFO closure is a safe, technically simple, and effective procedure that can be carried out by a single operator in less than 15 minutes, it is our opinion that this intervention is underutilised, especially in a high-risk subgroup of patients who could even benefit from PFO closure for primary prevention. […] PFO closure should also be considered for primary prevention in patients at high risk of paradoxical embolism due to the tendency for venous thrombosis, vocational or recreational activities fostering right to left shunts, in the presence of high-risk PFO, or those who can expect a collateral benefit (e.g., patients suffering from migraine, sleep apnoea, etc.). […] In our opinion a more proactive role in PFO closure for secondary prevention (and even for primary prevention in a specific subset of patients) is mandated.

• #42 Further Calls to Update Guidelines for PFO Closure in Stroke Prevention | tctmd.com

  https://www.tctmd.com/news/further-calls-update-guidelines-pfo-closure-stroke-prevention

  Two more meta-analyses have concluded that a change in guidelines is warranted for the management of cryptogenic stroke, giving percutaneous patent foramen ovale (PFO) closure a more prominent role. […] Now we have the scientific evidence that PFO closure is better than medical therapy in patients with cryptogenic stroke. […] Moreover, the European researchers say they believe that the new evidence warrants a revision of current practice guidelines, with Indolfi adding that these two studies will be the conceptual scientific framework for that change. Current US societal guidelines give PFO closure a class III indication. […] In addition, De Rosa and colleagues propose, this finding of efficacy of PFO closure for patients with cryptogenic stroke might ignite further discussion regarding extending this treatment to primary prevention. […] In patients with PFO and cryptogenic stroke, transcatheter device closure of PFO decreases the risk for recurrent stroke, Shah and colleagues conclude.

• #43 Patent foramen ovale: indications for closure and techniques | EuroIntervention

  https://eurointervention.pcronline.com/article/patent-foramen-ovale-indications-for-closure-and-techniques

  Non-surgical closure of the patent foramen ovale (PFO) has been possible for 40 years and proved safe in probably a million cases performed worldwide. […] The most compelling respective randomised data have been gathered so far in the realm of secondary prevention of cerebral attacks and migraine. […] PFO closure may not convey the projected amount of benefit. This even opens the door for primary prevention in some PFOs with high-risk characteristics. […] Considering that PFO closure is a safe, technically simple, and effective procedure that can be carried out by a single operator in less than 15 minutes, it is our opinion that this intervention is underutilised, especially in a high-risk subgroup of patients who could even benefit from PFO closure for primary prevention. […] PFO closure should also be considered for primary prevention in patients at high risk of paradoxical embolism due to the tendency for venous thrombosis, vocational or recreational activities fostering right to left shunts, in the presence of high-risk PFO, or those who can expect a collateral benefit (e.g., patients suffering from migraine, sleep apnoea, etc.). […] In our opinion a more proactive role in PFO closure for secondary prevention (and even for primary prevention in a specific subset of patients) is mandated.

• #44 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention

  https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism

  The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.

• #45 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  Objective: To update the 2016 American Academy of Neurology (AAN) practice advisory for patients with stroke and patent foramen ovale (PFO). […] Major recommendations: In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke (level B). In patients with a higher risk alternative mechanism of stroke identified, clinicians should not routinely recommend PFO closure (level B). Clinicians should counsel patients that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B).

• #46 New guidelines on the diagnosis and management of PFO after stroke – VJNeurology

  https://www.vjneurology.com/video/sw-euiifiwq-new-guidelines-on-the-diagnosis-and-management-of-pfo-after-stroke/

  For patients aged 18-60 with a stroke, PFO closure is strongly recommended. […] Regarding treatment, we gave a clear indication that patients between 18 and 60 needs to be closed. So if there is a PFO and a stroke, the patient needs to be closed. […] When there’s a high suspicion of a PFO-related stroke and the PASCAL shows you that it’s possible or probable, then you have to close the PFO. […] We stated as an evidence-based recommendation that DAPT (double antiplatelets) should be done for 1-6 months, followed by at least 5 years of single antiplatelet therapy.

• #47 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  Objective: To update the 2016 American Academy of Neurology (AAN) practice advisory for patients with stroke and patent foramen ovale (PFO). […] Major recommendations: In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke (level B). In patients with a higher risk alternative mechanism of stroke identified, clinicians should not routinely recommend PFO closure (level B). Clinicians should counsel patients that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B).

• #48 Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32350058/

  In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).

• #49 European Position Paper on Management of PFO

  https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2018/11/15/14/19/European-Position-Paper-on-the-Management-of-PFO

  PFO is present in about 25% of the general population. PFO can play a pathogenic role in cryptogenic left circulation thromboembolism. […] There are no definitive data to guide the selection of an antiplatelet versus oral anticoagulation (OAC) with vitamin K antagonists for secondary stroke prevention after PFO-related stroke. While OAC may be superior to antiplatelets in preventing PFO-related stroke, OAC also increases the risk of both intracranial and major extracranial hemorrhage. OAC may be preferred if the patient has a low hemorrhagic risk, high compliance is expected, and proper anticoagulant monitoring can be guaranteed. […] It is the position of the authors that patients ages 18-65 years with a confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism with a high probability of a causal role of their PFO should undergo percutaneous PFO closure. […] Antibiotic prophylaxis against endocarditis before an invasive procedure or surgical intervention should be pursued for all patients within the first 6 months after closure.

• #50 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention

  https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism

  The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions. […] Recent randomised clinical trials (RCTs) have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. […] To address these concerns, the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee invited eight European scientific societies and international experts to develop shared and rational position statements on the management of PFO to help clinicians in decision making. […] The management we propose in this paragraph applies to systemic thromboembolism as well as to all PFO-associated syndromes. […] For patients with the highest probability of both, closure of the PFO should be advised.

• #51 Overview | Percutaneous closure of patent foramen ovale to prevent recurrent cerebral embolic events | Guidance | NICE

  https://www.nice.org.uk/guidance/ipg472

  Evidence-based recommendations on percutaneous closure of the patent foramen ovale for the prevention of cerebral embolic stroke. This involves placing a small device into the heart to close the hole. […] This guidance replaces previous NICE interventional procedures guidance on percutaneous closure of patent foramen ovale for the secondary prevention of recurrent paradoxical embolism (IPG109).

• #52 New guidelines on the diagnosis and management of PFO after stroke – VJNeurology

  https://www.vjneurology.com/video/sw-euiifiwq-new-guidelines-on-the-diagnosis-and-management-of-pfo-after-stroke/

  For patients aged 18-60 with a stroke, PFO closure is strongly recommended. […] Regarding treatment, we gave a clear indication that patients between 18 and 60 needs to be closed. So if there is a PFO and a stroke, the patient needs to be closed. […] When there’s a high suspicion of a PFO-related stroke and the PASCAL shows you that it’s possible or probable, then you have to close the PFO. […] We stated as an evidence-based recommendation that DAPT (double antiplatelets) should be done for 1-6 months, followed by at least 5 years of single antiplatelet therapy.

• #53 New guidelines on the diagnosis and management of PFO after stroke – VJNeurology

  https://www.vjneurology.com/video/sw-euiifiwq-new-guidelines-on-the-diagnosis-and-management-of-pfo-after-stroke/

  For patients aged 18-60 with a stroke, PFO closure is strongly recommended. […] Regarding treatment, we gave a clear indication that patients between 18 and 60 needs to be closed. So if there is a PFO and a stroke, the patient needs to be closed. […] When there’s a high suspicion of a PFO-related stroke and the PASCAL shows you that it’s possible or probable, then you have to close the PFO. […] We stated as an evidence-based recommendation that DAPT (double antiplatelets) should be done for 1-6 months, followed by at least 5 years of single antiplatelet therapy.

• #54 European Position Paper on Management of PFO

  https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2018/11/15/14/19/European-Position-Paper-on-the-Management-of-PFO

  PFO is present in about 25% of the general population. PFO can play a pathogenic role in cryptogenic left circulation thromboembolism. […] There are no definitive data to guide the selection of an antiplatelet versus oral anticoagulation (OAC) with vitamin K antagonists for secondary stroke prevention after PFO-related stroke. While OAC may be superior to antiplatelets in preventing PFO-related stroke, OAC also increases the risk of both intracranial and major extracranial hemorrhage. OAC may be preferred if the patient has a low hemorrhagic risk, high compliance is expected, and proper anticoagulant monitoring can be guaranteed. […] It is the position of the authors that patients ages 18-65 years with a confirmed cryptogenic stroke, transient ischemic attack, or systemic embolism with a high probability of a causal role of their PFO should undergo percutaneous PFO closure. […] Antibiotic prophylaxis against endocarditis before an invasive procedure or surgical intervention should be pursued for all patients within the first 6 months after closure.

• #55 Ischemic Stroke and Patent Foramen Ovale Closure in a Young Adult Patient | Rush

  https://www.rush.edu/ischemic-stroke-and-patent-foramen-ovale-closure-young-adult-patient

  Echocardiographic studies exhibited a patent foramen ovale (PFO) with a right-to-left shunt, along with moderate aortic regurgitation and a bicuspid aortic valve. […] The PFO was closed by Dr. Kavinsky with the NobleStitch EL device in June 2022. […] After the successful PFO closure, the patient was able to resume all of his normal physical activities. He continued on aspirin for secondary stroke prevention. […] He was also seen in Rushs Stroke Prevention Clinic to educate him about additional ways to increase secondary stroke prevention, such as dietary modification.

• #56 Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence – PubMed

  https://pubmed.ncbi.nlm.nih.gov/38134261/

  Patent foramen ovale (PFO) is frequently identified in young patients with ischemic stroke. Randomized controlled trials provide robust evidence supporting PFO closure in selected patients with cryptogenic ischemic stroke; however, several questions remain unanswered. This report summarizes current knowledge on the epidemiology of PFO-associated stroke, the role of PFO as a cause of stroke, and anatomic high-risk features. […] We further highlight areas for future research in PFO-associated stroke including the efficacy and safety of PFO closure in the elderly population, incidence, and long-term consequences of atrial fibrillation post-PFO closure, generalizability of the results of clinical trials in the real world, and the need for assessing the effect of neurocardiology teams on adherence to international recommendations. Other important knowledge gaps such as sex, race/ethnicity, and regional disparities in access to diagnostic technologies, PFO closure devices, and clinical outcomes in the real world are also discussed as priority research topics.

• #57 Secondary Prevention of Cryptogenic Stroke and Outcomes Following Surgical Patent Foramen Ovale Closure Plus Medical Therapy vs. Medical Therapy Alone: An Umbrella Meta-Analysis of Eight Meta-Analyses Covering Seventeen Countries | Patel | Cardiology Rese

  https://www.cardiologyres.org/index.php/Cardiologyres/article/view/1526

  In patients with CS, PFO closure, in addition to medical therapy, reduces the risk of recurrence. […] More research is needed to assess the efficacy of early closure as well as specific risk profiles that would benefit from early intervention to reduce the burden of stroke.

• #58 Patent Foramen Ovale Management for Secondary Stroke Prevention: State-of-the-Art Appraisal of Current Evidence – PubMed

  https://pubmed.ncbi.nlm.nih.gov/38134261/

  Patent foramen ovale (PFO) is frequently identified in young patients with ischemic stroke. Randomized controlled trials provide robust evidence supporting PFO closure in selected patients with cryptogenic ischemic stroke; however, several questions remain unanswered. This report summarizes current knowledge on the epidemiology of PFO-associated stroke, the role of PFO as a cause of stroke, and anatomic high-risk features. […] We further highlight areas for future research in PFO-associated stroke including the efficacy and safety of PFO closure in the elderly population, incidence, and long-term consequences of atrial fibrillation post-PFO closure, generalizability of the results of clinical trials in the real world, and the need for assessing the effect of neurocardiology teams on adherence to international recommendations. Other important knowledge gaps such as sex, race/ethnicity, and regional disparities in access to diagnostic technologies, PFO closure devices, and clinical outcomes in the real world are also discussed as priority research topics.

• #59 Patent Foramen Ovale (PFO) Closure for Prevention of Stroke | Frontiers Research Topic

  https://www.frontiersin.org/research-topics/11323/patent-foramen-ovale-pfo-closure-for-prevention-of-strokeundefined

  Patent Foramen Ovale (PFOs) are more common among patients with cryptogenic strokes compared to the general population. […] However, four new randomized clinical trials (RCT) and many meta-analyses now support that PFO closure may be a better option for these patients. […] Current and future research attempts from the cardiovascular and neurology communities examine the optimal managements of patients with PFO closure in terms of accurate diagnosis and classification, and ideal selection of patients who can benefit from PFO closure vs. antithrombotic regimens, for the preventions of new stroke episodes. […] We welcome articles that will help the scientific community reach safe conclusions to the following fields: i) The classification of ideal candidates for PFO closure among patients with history of cryptogenic stroke; ii) The optimal antithrombotic regimen for these patients; iii) The safest and most efficient way to triage and diagnose patients with PFO.

• #60 SCAI Guidelines for the Management of Patent Foramen Ovale | SCAI

  https://scai.org/publications/clinical-documents/scai-guidelines-management-patent-foramen-ovale

  These evidence-based guidelines and accompanying technical review aim to support patients, clinicians, and other stakeholders in decisions about management of PFO. […] Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. […] The panel has also identified future research priorities to advance the field.

• #61 Secondary Prevention of Cryptogenic Stroke and Outcomes Following Surgical Patent Foramen Ovale Closure Plus Medical Therapy vs. Medical Therapy Alone: An Umbrella Meta-Analysis of Eight Meta-Analyses Covering Seventeen Countries | Patel | Cardiology Rese

  https://www.cardiologyres.org/index.php/Cardiologyres/article/view/1526

  In patients with CS, PFO closure, in addition to medical therapy, reduces the risk of recurrence. […] More research is needed to assess the efficacy of early closure as well as specific risk profiles that would benefit from early intervention to reduce the burden of stroke.

• #62

  https://journals.lww.com/md-journal/fulltext/2021/06250/meta_analysis_of_patent_foramen_ovale_closure.80.aspx

  With the addition of anticoagulants, the benefit of PFO closure decreased gradually. Patient groups that adopt individualized medical therapy strategies may benefit more. […] The optimal treatment strategy for PFO patients with cryptic stroke has long been controversial. […] Our results showed that with the addition of anticoagulants, the benefit of PFO closure decreased gradually, and the risk of bleeding could be effectively reduced through the discretion of physicians, which provided guidance and basis for the formulation of medical therapy strategies. […] Whether PFO closure is superior to medical therapy for the prevention of recurrent ischemic neurological events may depend on the proportion of anticoagulant therapy in medical-treated patients; antiplatelet therapy or anticoagulation therapy should be personalized based on the risk of patients own bleeding. Based on the full assessment of adverse events and the formulation of the optimal treatment strategy, medical therapy may be more beneficial.

• #63 PFO Closure Strategies to Prevent Cryptogenic Stroke Recurrence – Cardiac Interventions Today

  https://citoday.com/articles/2017-may-june/pfo-closure-strategies-to-prevent-cryptogenic-stroke-recurrence

  Thus, best practice in 2017 comprises careful exclusion of known causes of ischemic stroke (including monitoring for atrial arrhythmias), evaluation of the likelihood of PFO relatedness using the RoPE score, risk factor and lifestyle modification, and involvement of the patient and the multidisciplinary team in the decision-making process.

• #64 European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism | EuroIntervention

  https://eurointervention.pcronline.com/article/european-position-paper-on-the-management-of-patients-with-patent-foramen-ovale-general-approach-and-left-circulation-thromboembolism

  Interdisciplinary involvement in decision making regarding PFO management is axiomatic and should include an interventional cardiologist and other specialists dictated by the patients clinical manifestations. […] The diagnosis of PFO is required only for deciding on a treatment. […] A PFO is seen in ~25% of the general population and may therefore coexist by chance in a patient with an unexplained left circulation embolism. […] A meta-analysis of observational studies showed a stronger relative association of PFO with cryptogenic stroke in patients. […] The risk of paradoxical embolism (RoPE) score represents an attempt to assign a causal relationship probability to individual PFOs in the setting of stroke of unknown cause and may be useful in helping to guide management decisions.

• #65 PFO Closure Strategies to Prevent Cryptogenic Stroke Recurrence – Cardiac Interventions Today

  https://citoday.com/articles/2017-may-june/pfo-closure-strategies-to-prevent-cryptogenic-stroke-recurrence

  Many cardiologists would disagree with points three and four and the overall recommendation above, particularly given the results from the extended follow-up of the RESPECT trial, which showed a significant reduction in stroke with PFO closure and low rates of bleeding (0.57%), atrial fibrillation (0.25%), and deep venous thrombosis or pulmonary embolism (0.57%). […] Therefore, it is reasonable to consider PFO closure in patients aged 18 to 60 years with neurologist-confirmed cryptogenic stroke and a high RoPE score. In patients older than 60 years, the treatment effect of PFO closure is likely outweighed by other causes of stroke. […] The FDA panel strongly advised that any decision regarding PFO closure be considered by a neurologist and cardiologist, and this recommendation was included in the approved indications for use for the Amplatzer PFO occluder: The Amplatzer PFO Occluder is indicated for percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

• #66 Patent Foramen Ovale Closure for Stroke Prevention: Key Principles for Clinical Practice – Neurology Advisor

  https://www.neurologyadvisor.com/features/patent-foramen-ovale-closure-for-stroke-prevention-key-principles-for-clinical-practice/

  The risk for device implantation is modest. […] Patients and clinicians should be aware of this risk to detect and treat the arrhythmia, although the role of anticoagulation for periprocedural atrial fibrillation is uncertain. […] Neurologists must carefully evaluate patients to confirm that the stroke is truly cryptogenic and attributable to the PFO, and cardiologists must choose and skillfully implant the device that ideally suits the anatomy.

• #67 Patent Foramen Ovale: Risk Factors and Diagnostic Comparison of Transcranial Doppler versus Echocardiography for Secondary Stroke Prevention

  https://www.j-nn.org/journal/view.php?number=97

  In comparison to medical management, practice guidelines have echoed strong recommendations for PFO closure followed by APT. […] Future management of cryptogenic stroke patients calls for collaborative efforts among neurologists and cardiologists for further reduction in stroke recurrence via detailed etiologic evaluations.

• #68 Patent foramen ovale and cryptogenic stroke: diagnosis and updates in secondary stroke prevention | Stroke and Vascular Neurology

  https://svn.bmj.com/content/3/2/84

  Despite these overall negative results, a pooled analysis of individual data from the three RCTs showed that recurrent strokes were significantly fewer with PFO closure than with medical therapy alone. […] For patients 1860 years old with cryptogenic stroke, few vascular risk factors, and high-risk PFO characteristics such as large shunt and ASA, percutaneous PFO closure will reduce recurrent stroke risk, provided that the institutional procedural complication rate is low and minor risk of AF is understood. […] The decision to proceed with PFO closure should be made in conjunction with the patient, stroke neurologist and cardiologist. […] There are insufficient data on the efficacy of AP versus AC in stroke prevention in patients with cryptogenic stroke with PFO, so barring another reason for anticoagulation, starting with AP therapy as long-term therapy is reasonable, regardless of whether PFO is closed.

• #69 PFO Closure Strategies to Prevent Cryptogenic Stroke Recurrence – Cardiac Interventions Today

  https://citoday.com/articles/2017-may-june/pfo-closure-strategies-to-prevent-cryptogenic-stroke-recurrence

  Many cardiologists would disagree with points three and four and the overall recommendation above, particularly given the results from the extended follow-up of the RESPECT trial, which showed a significant reduction in stroke with PFO closure and low rates of bleeding (0.57%), atrial fibrillation (0.25%), and deep venous thrombosis or pulmonary embolism (0.57%). […] Therefore, it is reasonable to consider PFO closure in patients aged 18 to 60 years with neurologist-confirmed cryptogenic stroke and a high RoPE score. In patients older than 60 years, the treatment effect of PFO closure is likely outweighed by other causes of stroke. […] The FDA panel strongly advised that any decision regarding PFO closure be considered by a neurologist and cardiologist, and this recommendation was included in the approved indications for use for the Amplatzer PFO occluder: The Amplatzer PFO Occluder is indicated for percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

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