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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 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.

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 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 . . .

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.

Percutaneous closure of patent foramen ovale (PFO) has been shown to be superior to medical treatment alone for prevention of recurrent stroke after cryptogenic transient ischaemic attack or non-disabling stroke in patients aged 60 years or younger. The justification for trials in older patients with transient ischaemic attack or stroke depends on whether PFO is shown to be associated with cryptogenic events at older ages, for which existing evidence is conflicting, and on the population burden of PFO-associated events. Therefore, we did a population-based screening study using contrast-enhanced transcranial Doppler (bubble-TCD) to detect probable PFO as indicated by a right-to-left shunt (RLS); we also did a systematic review and meta-analysis to compare our results with previous studies. In this population-based study, nested in the Oxford Vascular Study (OXVASC), we established the prevalence of any RLS, and of large RLS (>20 microbubbles), in consecutive patients attending a rapid-access transient ischaemic attack and stroke clinic, or at 1-month follow-up after stroke unit admission, with transient ischaemic attack or non-disabling ischaemic stroke, comparing cryptogenic events with those of known cause (according to Trial of Org 10172 in Acute Stroke Treatment [TOAST] criteria). We stratified participants by age, and extrapolated data to the UK population. We also did a systematic review of published studies of PFO prevalence (using transthoracic or transoesophageal echocardiography or bubble-TCD) according to stroke subtype, which included older patients and reported age-specific results, and determined by meta-analysis (including the OXVASC data) the pooled odds ratio (95% CI) of finding PFO of any size in cryptogenic events compared with events of known cause, stratified by screening modality (transthoracic or transoesophageal echocardiography or bubble-TCD). The study protocol is registered with PROSPERO, number CRD42018087074. Among 572 consecutive patients with transient ischaemic attack or non-disabling stroke between Sept 1, 2014, and Oct 9, 2017 (439 [77%] patients aged >60 years, mean age 70·0 years [SD 13·7]), bubble-TCD was feasible in 523 patients (91%) of whom 397 were aged older than 60 years. Compared with those with transient ischaemic attack or stroke of known cause, patients with cryptogenic events had a higher prevalence of RLS overall (odds ratio [OR] 1·93, 95% CI 1·32–2·82; p=0·001), and in those aged older than 60 years (2·06, 1·32–3·23; p=0·001). When we pooled the OXVASC data with that from two previous smaller studies of bubble-TCD in patients aged 50 years or older, we found an association between RLS and cryptogenic events (OR 2·35, 95% CI 1·42–3·90; p=0·0009; pheterogeneity=0·15), which was consistent with the equivalent estimate from transoesophageal echocardiography studies (2·20, 1·15–4·22; p=0·02; pheterogeneity=0·02). No data on large RLS in patients with TOAST-defined cryptogenic events compared with other events were available from previous studies, but we found no evidence that the association was diminished in such cases. Of 41 patients with large RLS and cryptogenic transient ischaemic attack or non-disabling stroke in our study, 25 (61%) were aged older than 60 years, which extrapolates to 5951 patients per year in the UK (data from mid-2016). Bubble-TCD was feasible in most older patients with transient ischaemic attack or non-disabling stroke, the association of RLS with cryptogenic events remained at older ages, and the population burden of PFO-associated events is substantial. Randomised trials of PFO closure at older ages are required and should be feasible. National Institute for Health Research, Oxford Biomedical Research Centre, Wellcome Trust, and Wolfson Foundation.

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% . . .

Phrenic nerve paralysis caused by herpes zoster infection is an exceptionally rare condition associated with severe respiratory complications. An even rarer phenomenon is the development of hypoxemia due to a right-to-left shunt through a patent foramen ovale (PFO), triggered by mediastinal shift and redirection of venous flow caused by right diaphragmatic elevation. We report the case of a 74-year-old woman admitted to the intensive care unit with severe hypoxemia refractory to oxygen therapy, requiring mechanical ventilation, following a recent herpes zoster infection affecting the C4 dermatome. Imaging revealed right hemidiaphragm elevation due to phrenic nerve paralysis, leading to mediastinal shift and a right-to-left shunt through a PFO without an interatrial pressure gradient. Transesophageal echocardiography confirmed a massive shunt. Emergency percutaneous PFO closure was performed, resulting in immediate improvement in oxygenation. In this article, the authors provide a framework for navigating the diagnostic reasoning and management of this rare condition. In conclusion, this case emphasizes the importance of considering phrenic nerve paralysis and PFO-related shunting in the differential diagnosis of unexplained hypoxemia, particularly in patients with recent cervical herpes zoster infections. Early screening for diaphragmatic dysfunction and transesophageal echocardiography are essential diagnostic tools, and percutaneous PFO closure offers a safe and effective solution for severe shunt-related hypoxemia.

Residual shunt after patent foramen ovale (PFO) occlusion is associated with recurrent stroke, and limited literature address the specific management of such cases. Herein we report our experience with secondary interventional treatment. From July 2020 to January 2023, patients who underwent PFO occlusion for more than one year with residual right-to-left shunting (rRLS) screened by contrast transthoracic echocardiography (cTTE) constituted the study population. A retrospective analysis of the basic, procedural, and follow-up data was performed. A total of 35 patients with large rRLS were admitted to our center. Fourteen patients underwent transcatheter rRLS closure. Transesophageal echocardiography (TEE) clearly showed the color blood flow profile, and cTEE showed a large rRLS in 12 cases. TEE showed a small outlet near the left exit of the rRLS, and cTEE showed a small rRLS in two cases. Type I rRLS accounted for 71.4%, residual PFO, and residual atrial septal defect (ASD) for 14.3%, respectively. Secondary transcatheter interventions were successful in 12 patients (85.7%). No complications were observed. Six cases of type I rRLS were closed with ASD occluders and two with an ADO-II device. Two residual PFO and two residual ASD were implanted with PFO occluders. cTTE was performed six months after the procedure, with complete closure in 12 patients. TEE not only helps to improve interventional strategies to reduce residual shunt in primary occlusion but also helps in the screening of patients who are truly suitable for secondary intervention. ASD occluders can be considered as an alternative device for type I rRLS.