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Patients who had had a cryptogenic stroke and had a PFO were randomly assigned to medical therapy or PFO closure. At a median of 5.9 years, the rate of recurrent ischemic strokes was lower in the PFO closure group than in the medical-therapy group.

In this study, closure of a patent foramen ovale versus medical therapy alone after cryptogenic stroke was not effective in preventing recurrent stroke. Secondary analyses suggested a possible benefit, but the study did not permit a definitive conclusion. It is unknown whether closure of a patent foramen ovale is effective in the prevention of recurrent stroke after a cryptogenic ischemic stroke. Observational studies and meta-analyses have suggested that closure is associated with a benefit; however, a randomized trial, Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale (CLOSURE I), failed to show the superiority of closure over medical therapy alone. 1 – 3 In observational studies, the Amplatzer PFO Occluder has been shown to have advantageous safety features as a closure device. 4 – . . .

In this trial, patients with patent foramen ovale and cryptogenic embolism were assigned to undergo closure with the use of a percutaneous device or to receive medical therapy. There was no significant difference in the rates of recurrent embolic events or death. Paradoxical embolism by means of a patent foramen ovale has been blamed as a cause of stroke and other systemic ischemic events since the 19th century. 1 The actual passage of a venous clot through a patent foramen ovale has been documented in a few cases and resulted in systemic embolic events such as ischemic stroke, transient ischemic attack (TIA), 2 – 6 or myocardial infarction. 7 Catheter-based closure of patent foramen ovale was introduced in 1992. 8 Observational long-term data suggest that closure of patent foramen ovale in patients with a history of ischemic stroke may reduce the risk of recurrent stroke as compared . . .

In a randomized trial involving 664 patients who had had a cryptogenic stroke, closure of a PFO combined with antiplatelet therapy resulted in significantly lower rates of subsequent stroke than antiplatelet therapy alone over a median follow-up of 3.2 years.

In patients with cryptogenic stroke and patent foramen ovale with atrial septal aneurysm or large interatrial shunt, closure of the PFO and administration of antiplatelet medications resulted in a lower rate of recurrent stroke than antiplatelet therapy alone.

Patients with a cryptogenic stroke or transient ischemic attack (TIA) who had a patent foramen ovale were randomly assigned to closure with a percutaneous device or to medical therapy. There was no significant between-group difference in the subsequent rate of stroke or TIA. As many as 40% of acute ischemic strokes have no identifiable cause and are classified as cryptogenic. 1 – 3 Some cryptogenic strokes or transient ischemic attacks (TIAs) may be the result of an embolus from the venous system traversing from the right to left atrium and into the systemic circulation through a patent foramen ovale — a phenomenon known as paradoxical embolism. Numerous studies have shown an association between patent foramen ovale and cryptogenic stroke. 4 – 14 The prevalence of patent foramen ovale at autopsy ranges from 20 to 26% in the general population, and it may be as high as 56% . . .

Background The association between migraine and patent foramen ovale (PFO) has led to investigations into percutaneous PFO closure as a potential therapeutic avenue. While existing trials with metal occluders have shown promise in reducing migraine burden, concerns over long-term complications and the impact of metal devices on migraine exacerbation have prompted the development of biodegradable alternatives. Methods The Comparison of Biodegradable and Metal Occluders in Patients with PFO and Migraine (BioMetal) trial is a prospective, multicenter, single-blind, randomized controlled, superiority study comparing a biodegradable occluder with a nickel-titanium alloy occluder in PFO patients with medication-refractory migraine with aura (ClinicalTrials.gov Identifier: NCT06203873). A total of 400 participants will be enrolled, randomized 1:1 to receive either the biodegradable or metal devices, and followed up for 24 months post-randomization. The primary endpoint is the change in monthly migraine days at 12 months compared to baseline. Discussion The BioMetal trial aims to address the ongoing debate surrounding PFO closure for migraine relief by evaluating the efficacy and safety of biodegradable versus metal devices, with the goal of providing valuable insights into the optimal approach for PFO closure in PFO patients with medication-refractory migraine with aura. The potential implications extend beyond migraine management, highlighting the significance of biocompatible and sustainable materials in interventional cardiology. Completion of this study is anticipated to inform future clinical practice and guide therapeutic strategies in this complex condition. Trial registration ClinicalTrials.gov NCT06203873 ( https://clinicaltrials.gov/study/NCT06203873 ). Registered on January 3, 2024

In the initial report of the Gore REDUCE trial of patent foramen ovale closure, with a median follow-up of 3.2 years, 18 patients had stroke recurrence (6 in the PFO closure group and 12 in the antiplatelet-only group). After a median follow-up of 5 years, 20 patients had stroke recurrence, with the two additional strokes occurring in the PFO closure group.

Background Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates. Methods The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements. Conclusion The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).

ABSTRACTPatent foramen ovale (PFO) describes a valve in the interatrial septum that permits shunting of blood or thrombotic material between the atria. PFOs are present in approximately 25% of the healthy population and are not associated with any pathology in the vast majority of cases. However, comparisons between patients with stroke and healthy controls suggest that PFOs may be causative of stroke in certain patients whose stroke is otherwise cryptogenic. Options for the diagnosis of PFO include transthoracic echocardiography, transesophageal echocardiography, and transcranial Doppler ultrasonography. PFOs associated with an interatrial septal aneurysm seem to be more strongly linked to risk of recurrent stroke. Therapeutic options for secondary stroke prevention in the setting of a PFO include antiplatelet therapy, anticoagulation, and percutaneous device closure. Recent randomized clinical trials suggest that percutaneous closure reduces the subsequent risk of stroke in appropriately selected patients, with a large relative benefit but small absolute benefit. Referral for percutaneous PFO closure should therefore be considered in certain patients after a multidisciplinary, patient centered discussion. Areas for future study include structural biomarkers to aid in determining the role of PFO closure in older people with possible PFO associated stroke, the role of direct oral anticoagulants, and very long term outcomes after device closure.