Patent Foramen Ovale Closure In Patients Research Articles

Neurologic recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Abstract Background Patent foramen ovale (PFO) is associated with an increased risk of cryptogenic stroke, and interventional closure is recommended for secondary prevention. However, there is limited real-world data on long-term results. Our objective was to evaluate outcomes following successful transcatheter PFO occlusion. Methods Data from patients undergoing PFO closure for cryptogenic stroke between 2010 and 2015 were analysed to determine short- and long-term outcomes and to identify potential predictors of neurological recurrence. Results 330 patients underwent successful PFO closure. The mean age of patients was 49 (standard deviation (SD) ±12) years, and 55.5% were male. Any in-hospital adverse event was observed in eight patients (2.4%). During a median follow-up of 9.85 (SD ±2.5) years, the combined outcome of transient ischemic attack (TIA), stroke, or death from stroke was observed in 3.6% of patients (0.38 events per 100 person-years). After 5, 10, and 12 years the percentage of patients free of the composite outcome was 97.5%, 96.2%, and 96.2% respectively (Figure 1). New onset atrial fibrillation was detected in 10 patients (3.0%). A thorough analysis of the neurologic recurrences revealed a total number of six cryptogenic strokes (1.8%). Our results revealed that the Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.70, 95% confidence interval [CI]: 0.52 to 0.95; p=0.022) and the number of prior neurologic events (adjHR: 9.78, 95% CI: 2.66 to 35.99; p<0.001) were strong independent predictors of future recurrent neurologic events. Kaplan Meier survival analysis stratified by number of previous neurologic events proved to be statistically significant (p<0.001; Figure 2). Conclusion In this real-world cohort of patients with cryptogenic stroke we observed excellent safety and good efficacy of percutaneous PFO closure, similar to randomized controlled trials or other long-term cohort studies. The rate of recurrent neurological events was low, especially cryptogenic strokes. The RoPE score confirmed good predictive power; in particular, the number of previous neurological events should be taken more into account when determining the indication for closure.

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.

Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence. Data from patients undergoing PFO closure between 2010 and 2015 was collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up. 330 patients were included, mean age was 49 (±12) years and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p=0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p=0.042), and a history of prior neurological events (adjHR: 9.94; p<0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes. In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.

The Modern Clinician as an "Argonaut" Guiding Through the "Symplegades" of Evidence for PFO Closure in Patients With Migraine.

Patent foramen ovale (PFO) has been associated with migraine, especially migraine with aura, and 30-50% of individuals with migraine with aura have a PFO, suggesting it could be more than just an "innocent bystander''. Observational data showed a reduction of the frequency and severity of migraine attacks, particularly those with aura, following transcatheter PFO closure for established indications. Three small randomized controlled trials have demonstrated significant benefits of PFO closure in most of their secondary endpoints, such as reductions in the mean number of monthly migraine attacks and migraine days. Since a significant proportion of patients experience important side effects from traditional migraine medications and newer highly effective migraine prevention strategies may need to be instituted. PFO closure could in this regard to be a valuable add-on in the armamentarium of migraine treatment, improving the quality of life by alleviating the need for medications. The effect of percutaneous PFO closure on migraine treatment is needed to be clarified. As the underlying pathophysiology remains poorly understood and largely hypothetical, future investigations, focusing on the causal relationship between PFO and migraine, will help to define the subgroup of patients most likely to benefit from PFO closure. More accurate patient recruitment may lead to greater postprocedural benefits and more significant symptom improvement. Additionally, randomized controlled trials need to be reported adequately with more realistic endpoints, sufficient duration of follow-up, and statistical power to detect differences between closure and placebo groups to ensure precise and reliable findings.

European Stroke Organisation (ESO) Guidelines on the diagnosis and management of patent foramen ovale (PFO) after stroke.

Patent foramen ovale (PFO) is frequently identified in young patients with cryptogenic ischaemic stroke. Potential stroke mechanisms include paradoxical embolism from a venous clot which traverses the PFO, in situ clot formation within the PFO, and atrial arrhythmias due to electrical signalling disruption. The purpose of this guideline is to provide recommendations for diagnosing, treating, and long-term managing patients with ischaemic stroke and PFO. Conversely, Transient Ischaemic Attack (TIA) was not considered an index event in this context because only one RCT involved TIA patients. However, this subgroup analysis showed no significant differences between TIA and stroke outcomes. The working group identified questions and outcomes, graded evidence, and developed recommendations following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the European Stroke Organisation (ESO) standard operating procedure for guideline development. This document underwent peer-review by independent experts and members of the ESO Guideline Board and Executive Committee. The working group acknowledges the current evidentiary gap in delineating an unequivocal diagnostic algorithm for the detection of PFO. Although transoesophageal echocardiography is conventionally held as the most accurate diagnostic tool for PFO identification, its status as the 'gold standard' remains unsubstantiated by rigorously validated evidence. We found high-quality evidence to recommend PFO closure plus antiplatelet therapy in selected patients aged 18-60 years in whom no other evident cause of stroke is found but a PFO (i.e. PFO-associated stroke). The PASCAL classification system can be used to select such candidates for PFO closure. Patients with both a large right-to-left shunt and an atrial septal aneurysm benefit most from PFO closure. There is insufficient evidence to make an evidence-based recommendation on PFO closure in patients older than 60 and younger than 18 years. We found low quality evidence to suggest against PFO closure in patients with unlikely PFO-related stroke according to the PASCAL classification, except in specific scenarios (Expert Consensus). We suggest against long-term anticoagulation in patients with PFO-associated stroke unless anticoagulation is indicated for other medical reasons. Regarding the long-term AF monitoring after PFO closure, the working group concluded that there remains significant uncertainty regarding the risks and benefits associated with the use of long-term cardiac monitoring, such as implantable loop recorders. This document provides additional guidance, in the form of evidence-based recommendations or expert consensus statements, on diagnostic methods for PFO detection, and medical management after PFO closure.

Clinical Implications and Procedural Complications in Patients with Patent Foramen Ovale Concomitant with Atrial Septal Aneurysm

Atrial septal aneurysm (ASA) is defined as excursion of the atrial septum exceeding 10 mm beyond the atrial septum into the right or left atrium, or a combined total excursion of 15 mm on the right and left sides during the cardiac cycle. According to previous studies, 20–40% of patent foramen ovale (PFO) cases are accompanied by ASAs. ASA is associated with the presence of PFO, left atrial dysfunction, cryptogenic stroke, migraine, and arterial embolism, thus making closure of PFO in patients with concomitant ASA necessary but challenging. The anatomy of ASAs associated with PFO has crucial effects on complications after the closure procedure; therefore, several factors must be considered. Herein, we review the clinical implications of concomitant PFO and ASA; discuss the complications occurring after the closure procedure; and provide practical guidance for the closure of concomitant PFO and ASA.

Long-term clinical outcomes for patients with uncrossable patent foramen ovale.

Patent foramen ovale (PFO) closure is performed in selected patients with cryptogenic stroke to prevent recurrence. The prognosis of patients with uncrossable PFO after failed guidewire or catheter passage during the procedure remains unknown. We compared the long-term prognosis between uncrossable PFO and successful PFO closure in patients with high-grade PFO shunts. We analyzed patients who underwent PFO closure for stroke or transient ischemic attack (TIA) prevention at Gachon University Gil Medical Center between April 2010 and March 2022. The primary outcome was a composite of recurrent stroke or TIA. Secondary outcomes included stroke, TIA, all-cause death, and a composite of stroke, TIA, and all-cause death. Of 286 patients, 245 were included in the analysis after excluding those with transseptal puncture technique usage or concurrent atrial septal defect. Among them, 82 had uncrossable PFO, and 163 underwent successful PFO closure. Large shunts were more prevalent in the PFO closure group compared to the uncrossable PFO group (62.0% vs. 34.1%, P < 0.001), and resting shunts were also more common in the PFO closure group (17.8% vs. 2.4%, P < 0.001). Stroke or TIA occurred in 2 patients (2.4%) in the uncrossable PFO group and 8 patients (4.9%) in the PFO closure group (hazard ratio, 1.44; 95% confidence interval, 0.30-6.81; P = 0.647). Additionally, no disparities in the occurrence of stroke or TIA were found in subgroups divided by baseline characteristics, RoPE score, or shunt grade. Clinical outcomes for patients with uncrossable PFO seem similar to those with successful PFO closure.

Clinical Outcomes and Quality of Life after Patent Foramen Ovale (PFO) Closure in Patients with Stroke/Transient Ischemic Attack of Undetermined Cause and Other PFO-Associated Clinical Conditions: A Single-Center Experience.

The aim of this study was to assess clinical outcomes and quality of life after PFO closure in patients with previous stroke/TIA of undetermined cause and in patients with other complex PFO-associated clinical conditions. Between July 2009 and December 2019 at our University Cardiology Department, 118 consecutive patients underwent a thorough diagnostic work-up including standardized history taking, clinical evaluation, full neurological examination, screening for thrombophilia, brain magnetic resonance imaging (MRI), ultrasound-Doppler sonography of supra-aortic vessels and 24 h ECG Holter monitoring. Anatomo-morphological evaluation using 2D transthoracic/transesophageal echocardiography (TTE/TEE) color Doppler and functional assessment using contrast TTE (cTTE) in the apical four-chamber view and contrast transcranial Doppler (cTCD) using power M-mode modality were performed to verify the presence, location and amount of right-to-left shunting via PFO or other extracardiac source. Completed questionnaires based on the Quality-of-Life Short Form-36 (QoL SF-36) and Migraine Disability Assessment (MIDAS) were obtained from the patients before PFO closure and after 12 months. Contrast TTE/TEE and cTCD were performed at dismission, 1, 6 and 12 months and yearly thereafter. Brain MRI was performed at 1-year follow-up in 54 patients. Transcatheter PFO closure was performed in 106 selected symptomatic patients (mean age 41.7 ± 10.7 years, range 16-63, 65% women) with the following conditions: ischemic stroke (n = 23), transient ischemic attack (n = 22), peripheral and coronary embolism (n = 2), MRI lesions without cerebrovascular clinical events (n = 53), platypnea-orthodeoxia (n = 1), decompression sickness (n = 1) and refractory migraine without ischemic cerebral lesions (n = 4). The implanted devices were Occlutech Figulla Flex I/II PFO (n = 99), Occlutech UNI (n = 3), Amplatzer PFO (n = 3) and CeraFlex PFO occluders (n = 1). Procedures were performed under local anesthesia and rotational intracardiac monitoring (Ultra ICE) alone. The devices were correctly implanted in all patients. The mean fluoroscopy time was 15 ± 5 min (range = 10-45 min) and the mean procedural time was 55 ± 20 min (range = 35-90 min). The total occlusion rate at follow-up (mean 50 months, range 3-100) was 98.1%. No recurrent neurological events were observed in the long-term follow-up. The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure, showing long-term prevention of recurrent cerebrovascular events, significant reduction in migraine symptoms and substantial improvement in quality of life.

Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study

IntroductionAfter closure of patent foramen ovale (PFO) due to stroke, atrial fibrillation (AF) occurs in up to one in five patients. However, data are sparse regarding the possible pre-existence of...

Transcatheter Patent Foramen Ovale Closure in Stroke Patients with Thrombophilia: Current Status and Future Perspectives.

Transcatheter patent foramen ovale (PFO) closure is a safe and effective treatment for secondary prevention after a PFO-associated stroke as demonstrated in multiple large randomized clinical trials. However, these trials excluded a significant proportion of patients who could have benefited from percutaneous PFO closure due to coexisting potential confounders such as additional thromboembolic risk factors, namely thrombophilia. Since scarce and conflicting data existed on such patients, current clinical management guidelines on patients with PFO mainly recommended against PFO closure in patients with thrombophilia and failed to provide any recommendation on the type and duration of antithrombotic treatment after transcatheter PFO closure. In the past 2 years, there has been new evidence supporting transcatheter PFO closure as a clinically meaningful alternative (vs. medical treatment) in this high-risk group of patients, along with additional data supporting the important role of systematic screening for thrombophilia in PFO-associated cerebrovascular events. This review article provides an updated overview of the incidence, clinical characteristics and outcomes of PFO closure in patients with thrombophilia, also commenting on the most appropriate medical treatment after PFO closure and future perspectives in the field.

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery

Current Challenges and Future Directions in Handling Stroke Patients With Patent Foramen Ovale-A Brief Review.

The role of patent foramen ovale (PFO) in stroke was debated for decades. Randomized clinical trials (RCTs) have shown fewer recurrent events after PFO closure in patients with cryptogenic stroke (CS). However, in clinical practice, treating stroke patients with coexisting PFO raises some questions. This brief review summarizes current knowledge and challenges in handling stroke patients with PFO and identifies issues for future research. The rationale for PFO closure was initially based on the concept of paradoxical embolism from deep vein thrombosis (DVT). However, RCTs did not consider such details, limiting their impact from a pathophysiological perspective. Only a few studies explored the coexistence of PFO and DVT in CS with varying results. Consequently, the PFO itself might play a role as a prothrombotic structure. Transesophageal echocardiography thus appears most appropriate for PFO detection, while a large shunt size or an associated atrial septum aneurysm qualify for a high-risk PFO. For drug-based treatment alone, studies did not find a definite superiority of oral anticoagulation over antiplatelet therapy. Remarkably, drug-based treatment in addition to PFO closure was not standardized in RCTs. The available literature rarely considers patients with transient ischemic attack (TIA), over 60 years of age, and competing etiologies like atrial fibrillation. In summary, RCTs suggest efficacy for closure of high-risk PFO only in a small subgroup of stroke patients. However, research is also needed to reevaluate the pathophysiological concept of PFO-related stroke and establish strategies for older and TIA patients and those with competing risk factors or low-risk PFO.

Size of transcatheter patent foramen ovale closure device affects atrial function

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Interatrial communications such as patent foramen ovale (PFO) are common abnormalities. For most people they are accidental findings; however, in some cases lead to paradoxical embolization. Transcatheter closure of PFO in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke. The size of closure device is established according to anatomical features of atria. However, the impact of atrial septal closure on atrial remodelling is less known. Methods We prospectively enrolled 108 patients with cryptogenic ischemic stroke and PFO eligible for transcatheter PFO closure. Thirty-three patients had 6 month clinical follow-up examinations (mean age 46 ± 13 years, 34% females). National Institute of Health Stroke Score (NIHSS) was calculated as marker of clinical severity of the index stroke. Presence of any shunt, atrial volumes and functional parameters were evaluated including left atrial (LA) reservoir, conduit and contraction function before PFO closure and 6 months after procedure. Beyond conventional transthoracic echocardiography (Philips Epiq CVx Ultrasound), two dimensional speckle tracking method was used to assess body surface area-indexed LA maximal volume (LAVmaxi), LA minimal volume (LAVmini), LA volume before left atrial contraction (LApreAi), LA ejection fraction (LAEF), LA reservoir strain (LASres), LA conduit strain (LAScond), LA contraction strain (LAScontr), LA peak systolic strain rates (LASRs), LA peak early diastolic strain rate (LASRe) and LA peak late diastolic strain rate (LASRa) using dedicated software on separate workstation (Cardiac Performance; TomTec Imaging, Unterschleissheim, Germany). Zero reference point was set at the onset of QRS wave. Results The index stroke was modest and non-disabling, with an NIHSS 3.2 ± 2.6. Baseline LA volumes and functions were in normal range (LAVi 27.4 ± 10.3 ml/m2; LASres 46.85 ± 19.6 %; LAScond 25.6 ± 15.4%; LAScontr 21.35 ± 12.15 %; LASRa -1.9 ± 0.77 s-1). The 6 month clinical follow-up examinations revealed no significant differences (all p values &amp;gt;0.05) in atrial volumes and strain parameters. However, LASRa was significantly lower (-1.4 ± 0.82 s-1, p = 0.01). Closure device size (25mm vs 30mm) and smoking proved to be independent predictors of 25% decrease of LASRa (p = 0.06, p = 0.03, respectively). No new cerebral ischaemic events, aortic erosions, atrial fibrillation, significant residual shunts or device thrombosis and displacement were recorded during the follow-up. Conclusion PFO-associated strokes in young and middle-aged individuals are mainly non-disabling. Transcatheter interatrial closure was safe and effective in our study without promoting unfavourable anatomical atrial remodelling during short-term follow-up, however, it may affect active atrial contraction. Smoking and larger devices may decrease the rate of atrial deformation at short-term follow-up. Shorter PFO occluders are preferable in case of anatomical applicability.

Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder.

Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials. We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state. Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt. A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p=0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups. Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.

Dual-center experiences with interventional closure of patent foramen ovale: A medium-term follow-up study comparing two patient groups aged under and over 60 years.

BackgroundCurrent guidelines recommend interventional closure of patent foramen ovale (PFO) in patients with cryptogenic ischemic stroke who are under 60 years of age.HypothesisThe hypothesis of this study was to compare follow‐up results of PFO closure in patients over 60 years of age to those of patients under 60 years of age in order to determine whether the procedure is safe and effective for both age groups.MethodsWe included 293 patients who had a cryptogenic ischemic stroke and a PFO confirmed by transesophageal echocardiography (TEE) and who were scheduled for percutaneous closure of the PFO between 2014 and 2019. The device implantation was completed in all patients using an Amplatzer™, Occlutec™, or Cardia Ultrasept PFO occluder.ResultsFollow‐up TEE examinations were performed at intervals of 1, 3, and 6 months after implantation. Patients were followed for a median of 3.6 ± 1.2 years. Recurrent ischemic stroke or transient ischemic attack, cardiac death, arrhythmias, and residual shunt were reported equally in both groups.ConclusionsInterventional closure of PFO can be as safe and effective in patients over 60 years of age as it is in patients under 60 years of age regardless of the device used. In this older patient group, rigorous discussion and a case‐by‐case decision‐making process including cardiologists and neurologists is warranted to ensure optimal procedure selection.

Safety and efficacy of endovascular patent foramen ovale closure: the first results of a Russian multicenter study

Patent foramen ovale (PFO) is detectable in more than 25% of the adult population and is generally clinically insignificant. However, it can be a cause of paradoxical embolism in some cases. Randomized trials indicate that endovascular PFO closure in patients with a history of cryptogenic stroke is an effective method for the secondary prevention of catastrophic brain damage.Objective: to study the safety and efficiency of endovascular PFO closure in young patients with a history of cryptogenic stroke.Patients and methods. Sixty-two patients, including (22 males and 40 females) women, underwent percutaneous PFO closure in May 2018 to March 2020. The patients' mean age was 37.4±7.6 years. The inclusion criteria were a prior cryptogenic ischemic stroke lasting less than 12 months and PFO with a high risk for paradoxical embolism (PFO concurrent with atrial septal aneurysm or hypermobility; PFO, ≥2 mm size; the presence of the Chiari network and/or the Eustachian valve).Results and discussion. The technical success of the operation was achieved in all cases. In 50 (80.6%) patients, the right chamber of the heart was completely isolated from the left one in the first 3 months. During the first year, the atria were also completely isolated in 10 (16.1%) patients. A left-to-right shunt persisted in 2 (3.2%) patents 12 months later. Two patients were found to have main procedural complications: one had perioperative atrial fibrillation and the other had pseudoaneurysm formation at the puncture site.Conclusion. Endovascular PFO closure is a safe and effective operation for the secondary prevention of recurrent ischemic stroke. In our study, blood shunting through the PFO was stopped in 96.6% of patients at less than 6 months after surgery, which suggests that there is a rapid and effective reduction in the risk of paradoxical embolism.

Patent Foramen Ovale Closure: State of the Art.

Patent foramen ovale (PFO) is a common abnormality affecting between 20% and 34% of the adult population. For most people, it is a benign finding; however, in some people, the PFO can open widely to enable paradoxical embolus to transit from the venous to arterial circulation, which is associated with stroke and systemic embolisation. Percutaneous closure of the PFO in patients with cryptogenic stroke has been undertaken for a number of years, and a number of purpose-specific septal occluders have been marketed. Recent randomised control trials have demonstrated that closure of PFO in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke. After a brief overview of the anatomy of a PFO, this article considers the evidence for PFO closure in cryptogenic stroke. The article also addresses other potential indications for closure, including systemic arterial embolisation, decompression sickness, platypnoea–orthodeoxia syndrome and migraine with aura. The article lays out the pre-procedural investigations and preparation for the procedure. Finally, the article gives an overview of the procedure itself, including discussion of closure devices.

Percutaneous Closure of PFO in Patients with Reduced Oxygen Saturation at Rest and during Exercise: Short- and Long-Term Results.

Background A patent foramen ovale (PFO) is a rare cause of hypoxemia and clinical symptoms of dyspnea. Due to a right-to-left shunt, desaturated blood enters the systemic circulation in a subset of patients resulting in dyspnea and a subsequent reduction in quality of life (QoL). Percutaneous closure of PFO is the treatment of choice. Objectives This retrospective multicentre study evaluates short- and long-term results of percutaneous closure of PFO in patients with dyspnea and/or reduced oxygen saturation. Methods Patients with respiratory symptoms were selected from databases containing all patients percutaneously closed between January 2000 and September 2018. Improvement in dyspnea, oxygenation, and QoL was investigated using pre- and postprocedural lung function parameters and two postprocedural questionnaires (SF-36 and PFSDQ-M). Results The average follow-up period was 36 [12–43] months, ranging from 0 months to 14 years. Percutaneous closure was successful in 15 of the 16 patients. All patients reported subjective improvement in dyspnea immediately after device deployment, consistent with their improvement in oxygen saturation (from 90 ± 6% to 94 [92–97%] on room air and in upright position) (p < 0.05). Both questionnaires also indicated an improvement of dyspnea and QoL after closure. The two early and two late deaths were unrelated to the procedure. Conclusion PFO-related dyspnea and/or hypoxemia can be treated successfully with a percutaneous intervention with long-lasting benefits on oxygen saturation, dyspnea, and QoL.

Impact of percutaneous patent foramen ovale closure on migraine headaches in patients with history of ischemic neurological events.

IntroductionObservational studies have shown that migraine has been associated with patent foramen ovale (PFO). Whilst studies investigating PFO closure for the treatment of migraine have been neutral, there is some evidence that symptoms of migraine may improve if the PFO was closed after ischemic stroke.AimTo establish whether closure of PFO in patients with stroke or transient ischemic attack (TIA) is associated with reduction in the severity of co-existent migraine headaches.Material and methodsPatients with ischemic stroke or TIA, PFO suitable for percutaneous closure and migraine, were given migraine severity questionnaires prior to PFO closure. These were followed up at 6 and 12 months after closure with the same questionnaire. The primary endpoint was change in migraine severity using the Migraine Severity Scale (MIGSEV). Migraine episode frequency, disability (using the MIDAS scale), and pain intensity were also assessed.ResultsSixty-two patients were included in the analysis. MIGSEV scores reduced from 7 (7–8) at baseline to 4 (3.25–6) at 6-month follow-up, and 3 (0–4) at 12-month follow-up (p < 0.001). Other measures of migraine headache were also improved at both 6- and 12-month follow-up. Twenty-four (38%) patients were rendered migraine free at 12 months.ConclusionsPFO closure for stroke or TIA prevention in patients with migraine was associated with a reduction in markers of migraine headache severity.

Patent Foramen Ovale Closure in 2019.

Patent foramen ovale (PFO) is a common abnormality affecting between 20% and 34% of the adult population. For most people it is a benign finding; however, in some the PFO can open widely, enabling a paradoxical embolus to transit from the venous to arterial circulation, which is associated with stroke and systemic embolisation. Percutaneous closure of PFO in patients with cryptogenic stroke has been undertaken for a number of years, and a number of purpose-specific septal occluders have been marketed. Recent randomised controlled trials have demonstrated that closure of PFO in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke. After a brief overview of the anatomy of a PFO, this review considers the evidence for PFO closure in cryptogenic stroke. The review also addresses other potential indications for closure, including systemic embolisation, decompression sickness, platypnoea-orthodeoxia syndrome and migraine with aura. It lays out the pre-procedural investigations and preparation for the procedure. Finally, it gives an overview of the procedure itself, including discussion of closure devices.

Impact of Discontinuation of Antithrombotic Therapy Following Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism

No data exist on the optimal duration of antithrombotic therapy (AT) following patent foramen ovale (PFO) closure. We sought to assess the safety of AT discontinuation following PFO closure in patients with a cryptogenic ischemic event. A total of 453 consecutive patients (mean age: 48 ± 13years, men: 51%) who underwent PFO closure due to a cryptogenic ischemic event were included. All patients were on AT following PFO closure (antiplatelet therapy: 92.7%, anticoagulation: 7.3%). Ischemic and bleeding events, and AT were assessed at a median follow-up of 8 (IQR: 4 to 11) years, and follow-up was complete in 96% of patients. Stroke and transient ischemic attack occurred in 4 (0.9%) and 12 (2.6%) patients, respectively, and 27 (6.0%) patients had bleeding events (major in 6 [1.3%] patients, including 4 episodes of intracranial hemorrhage). All major bleeding events occurred under aspirin therapy. A total of 82 patients (18%) stopped the AT at a median of 7 (IQR: 5 to 34) months post-PFO closure (due to a bleeding event or gastrointestinal symptoms: 13 patients, no specific reason: 69 patients), and none of them had any ischemic event after a median time of 7 (IQR 3 to 10) years without any AT. A propensity score matched analysis including 46 patients who discontinued the AT within 1-year post-PFO closure and 120 patients with an ongoing AT showed the lack of differences in ischemic events between groups (0 vs 0.2 stroke/transient ischemic attack per 100 patient-years in the no-AT and AT groups, respectively). In conclusion, in young patients who underwent PFO closure, bleeding events occurred in ∼6% of patients after a median follow-up of 8years. AT was discontinued in about one fifth of patients (most of them within the year following PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up. These results suggest that, in patients without other co-morbidities increasing the risk of stroke, temporary AT following PFO closure may be a reasonable strategy.