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BACKGROUND: Migraine is a chronic neurovascular disease with high incidence rate and medical-social significance. Despite more than half a century of studying the disease, the pathogenesis of migraine is not yet completely clear. The results of separate research works demonstrate the inter-relation of migraine with the presence of patent foramen ovale and circulation shunting from the right side to the left one. AIM: Detailing the incidence rates and the clinical characteristics of migraine, as well as the effects of endovascular installation of the occluding device into the patent foramen ovale in terms of migraine course in a cohort of patients that had an ischemic stroke episode according to the mechanism of paradoxical embolism due to having a functionally significant patent foramen ovale. METHODS: The examined population included 97 patients aged from 18 to 50 years old (mean age 32.29±2.19 years; 70.8% females), undergoing examination procedures at the Research Center of Neurology from January 2018 until October 2023. All the patients previously had an ischemic stroke that had involved the mechanism of paradoxical embolism, associated with the presence of patent foramen ovale and high functional significance shunting. All the patients underwent an assessment of their conditions associated with the presence of a patent foramen ovale — migraine with or without aura, other procedures included the detailing of headache characteristics and of the effects of migraine on social adaptation. The endovascular intervention was performed in 61 patients. Dynamic follow-up data were obtained for 36 patients, of which 24 migraine patients had an assessment of headache characteristics before and after the foramen ovale closure. RESULTS: Within the cohort of patients with patent foramen ovale accompanied with functionally significant shunting and with a previous episode of ischemic stroke, the incidence of migraine was 39.2% (no aura — 21 patients or 55%; with aura — 17, or 45%), while the proportions of women and men being 1.9:1. The rate of headache attacks was 4 [1; 7] days per month. In 6 months after the installation of the foramen ovale occluder, migraine patients were showing a significant decrease in the rate of headache onsets from 4 [2; 24] to 2 [1; 5] days a month (р=0.009); a decrease was reported for pain intensity from 7 [7; 9] to 3 [3; 7] points of the visual analogue scale for pain (р=0.0001) along with a decrease in the degree of migraine affecting the patients’ everyday activity from 20 [6; 89] to 17 [2; 26] points (р=0.019) of the MIDAS questionnaire. CONCLUSION: The present research has confirmed the high incidence found in a cohort of patients with patent foramen ovale. Installation of the occluder resulted in a decrease in the rate and intensity of headache along with a decrease of migraine affecting the social adaptation. The research limitations were a small number of patients and the absence of data on the residual shunting circulation.

BackgroundPatients who had a cryptogenic stroke (CS) suspected to be causally related to a patent foramen ovale (PFO) are candidates for percutaneous PFO closure. In such patients, it is important to screen for atrial fibrillation (AF). Limited guidance is available regarding AF monitoring strategies in CS patients with PFO addressing optimal monitoring technology and duration.AimTo provide a narrative review of cardiac rhythm monitoring in CS patients considered for PFO closure, including current practices, stroke recurrences after CS, findings from monitoring studies in CS patients, and predictors for AF detection published in the literature. To propose a personalized strategy for cardiac monitoring in CS patients, accounting for aspects predicting AF detection.Summary of reviewAF detection in CS patients is predicted by age, left atrial enlargement, prolonged PR interval, frequent premature atrial contractions, interatrial conduction block, diabetes, prior brain infarctions, leukoaraiosis, elevated B-type natriuretic peptide (BNP)/N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, and a family history of AF, as well as composed scores (e.g. CHA2DS2-VASc, atrial fibrillation in embolic stroke of undetermined source (AF-ESUS)). The causal role of the PFO may be accounted for by the risk of paradoxical embolism (RoPE) score and/or the PFO-Associated Stroke Causal Likelihood (PASCAL) classification.ConclusionA personalized approach to AF detection in CS patients is proposed, accounting for the likelihood of AF detection and aimed at obtaining sufficient confidence regarding the absence of AF in patients considered for PFO closure. In addition, the impact of high-risk PFO features on the monitoring strategy is discussed.

Purpose of Review: Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure. Recent Findings: PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. Summary: PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups. [ABSTRACT FROM AUTHOR]

Patent foramen ovale (PFO) is a flaplike opening in the fossa ovalis; between the septum primum and secundum. It is highly prevalent with approximately 25% of the population having a PFO. It is usually asymptomatic but can rarely cause paradoxical embolism leading to stroke and/or significant right to left shunting causing hypoxia. The complications of PFO closure with a percutaneous device include embolization, cardiac perforation, and thrombosis. These are all early complications. We describe the case of a patient with a history of PFO closure who had device thrombosis 3 years after implantation. Management includes anticoagulation with warfarin. Repeat cardiac imaging to document the resolution of thrombosis is recommended.

Objective: The choice between the use of antiplatelet (APT) treatment and oral anticoagulant (OAC) treatment for the prevention of ischemic stroke recurrence in patients with patent foramen ovale (PFO) requires clarification. Materials and Methods: A total of 5 randomized controlled trials comparing the preventive effect of APT and OAC therapies, including the use of non-vitamin-K OACs (NOACs), on stroke recurrence in patients with PFO were extracted from a systematic literature search. A standard meta-analysis and determination of fragility indexes were conducted. Results: The meta-analysis showed that the effectiveness of secondary stroke prophylaxis was higher, albeit remained insignificant, in patients treated with OAC (n = 828) than in patients treated with APT (n = 889; relative risk ratio: 0.76, 95% confidence interval: 0.49–1.19); the difference was not statistically significant, and the publication bias level was acceptable. However, the fragility index of all studies (all negative when assessed individually) was determined as zero. The fragility of the performed meta-analysis was 6 (18.2%), which was 4.6x above the observed value (3.98%) for stroke prevention. Conclusion: Research data on the use of warfarin or NOAC versus aspirin in secondary stroke prophylaxis in patients with PFO is weak and fragile. A randomized controlled trial could solve this issue.

Objective: The choice between the use of antiplatelet (APT) treatment and oral anticoagulant (OAC) treatment for the prevention of ischemic stroke recurrence in patients with patent foramen ovale (PFO) requires clarification. Materials and Methods: A total of 5 randomized controlled trials comparing the preventive effect of APT and OAC therapies, including the use of non-vitamin-K OACs (NOACs), on stroke recurrence in patients with PFO were extracted from a systematic literature search. A standard meta-analysis and determination of fragility indexes were conducted. Results: The meta-analysis showed that the effectiveness of secondary stroke prophylaxis was higher, albeit remained insignificant, in patients treated with OAC (n = 828) than in patients treated with APT (n = 889; relative risk ratio: 0.76, 95% confidence interval: 0.49--1.19); the difference was not statistically significant, and the publication bias level was acceptable. However, the fragility index of all studies (all negative when assessed individually) was determined as zero. The fragility of the performed meta-analysis was 6 (18.2%), which was 4.6x above the observed value (3.98%) for stroke prevention. Conclusion: Research data on the use of warfarin or NOAC versus aspirin in secondary stroke prophylaxis in patients with PFO is weak and fragile. A randomized controlled trial could solve this issue. [ABSTRACT FROM AUTHOR]

Abstract Background A significant proportion of patients with epilepsy have an unknown etiology and lack effective targeted therapeutic drugs. Patent Foramen Ovale (PFO) induces hypoxia and microembolism, leading to cerebral neurological dysfunction and increased epilepsy risk. This study aims to assess the efficacy and safety of PFO closure for relieving epileptic seizures in patients with refractory epilepsy associated with PFO. Methods/design Recruitment takes place at the West China Hospital of Sichuan University, China, for an open-label, randomized controlled clinical trial. The trial will include 110 patients with refractory epilepsy and PFO. Disease diagnoses will conform to the diagnostic criteria of the International League Against Epilepsy (ILAE) for refractory epilepsy and the American Society of Echocardiography (ASE) for PFO. Refractory epilepsy and high-grade right-to-left shunt (RLS) of the PFO will be further diagnosed using 24-hour video electroencephalogram and transthoracic echocardiography with contrast injection, respectively. Eligible participants require a secondary or higher volume of RLS. Trial registration Chinese Clinical Trial Registry (ChiCTR2200065681). Registered on November 11, 2022.

ObjectivesTo compare residual shunt rate and complications associated with six different devices used for PFO closure.BackgroundTranscutaneous PFO closure is an effective treatment for preventing recurrent stroke in patients with a history of cryptogenic stroke. The rate of residual shunt is one metric by which the technical success of PFO closure can be measured.MethodsPatients who underwent PFO closure at a single center between February 2001 and July 2019 were retrospectively enrolled in the study. Right-to-left shunt at baseline and during follow-up was assessed using transcranial Doppler (TCD) or transthoracic echocardiography (TTE). Periprocedural and device-related complications, including atrial fibrillation, were also assessed.ResultsOf 467 PFO closures performed during this period, 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure. The highest effective closure was achieved with the Cardioform device (100%, n = 104), followed by the Amplatzer Cribriform (93%, n = 14), Helex (90%, n = 137), Amplatzer ASO (88%, n = 17), CardioSEAL (86%, n = 14), and Amplatzer PFO (85%, n = 33) devices. The most common significant adverse event was atrial fibrillation, which was more common with the Cardioform device (13%) than the Helex (4%) or the Amplatzer PFO (4%) devices.ConclusionsThe Gore Cardioform Septal Occluder provides more robust closure of a PFO when compared to other devices but its effectiveness is offset by the higher prevalence of transient atrial fibrillation.

Background: A significant proportion of patients with epilepsy have an unknown etiology and lack effective targeted therapeutic drugs. Patent Foramen Ovale (PFO) induces hypoxia and microembolism, leading to cerebral neurological dysfunction and increased epilepsy risk. This study aims to assess the efficacy and safety of PFO closure for relieving epileptic seizures in patients with refractory epilepsy associated with PFO. Methods/design: Recruitment takes place at the West China Hospital of Sichuan University, China, for an open-label, randomized controlled clinical trial. The trial will include 110 patients with refractory epilepsy and PFO. Disease diagnoses will conform to the diagnostic criteria of the International League Against Epilepsy (ILAE) for refractory epilepsy and the American Society of Echocardiography (ASE) for PFO. Refractory epilepsy and high-grade right-to-left shunt (RLS) of the PFO will be further diagnosed using 24-hour video electroencephalogram and transthoracic echocardiography with contrast injection, respectively. Eligible participants require a secondary or higher volume of RLS. Trial registration: Chinese Clinical Trial Registry (ChiCTR2200065681). Registered on November 11, 2022. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of patent foramen ovale (PFO) closure in the elderly population is unclear. We aimed to investigate the efficacy and safety of PFO closure in non-elderly and elderly patients. Methods: Patients over 18 years of age with cryptogenic stroke (CS) or transient ischemic attack and PFO were prospectively enrolled and classified into two groups according to treatment: (1) closure of PFO (the PFOC group) and (2) medical treatment alone (the non-PFOC group). The primary outcome was a composite of recurrent cerebral ischemic events and all-cause mortality during the follow-up period. A modified Ranking Scale [mRS] at 180 days was recorded. The safety outcomes were procedure-related adverse events and periprocedural atrial fibrillation. The results between the PFOC and non-PFOC groups in non-elderly (<60 years) and elderly (≥60 years) patients were compared. Results: We enrolled 173 patients, 78 (45%) of whom were elderly. During a mean follow-up of 2.5 years, the incidence of primary outcome was significantly lower in the PFOC group (6.2% vs. 17.1%, hazard ratio[HR] = 0.35, 95% CI 0.13-0.97, p = 0.043) in adjusted Cox regression analysis. Compared with the non-PFOC group, the PFOC group had a numerically lower risk of the primary outcome in both the elderly (HR 0.26, 95% CI 0.07-1.01, p=0.051) and the non-elderly (HR 0.61, 95% CI 0.11-3.27, p = 0.574) groups. In addition, patients with PFO closure in the elderly group had a lowermedianmRS at 180 days (p = 0.002). The rate of safety outcome was similar between the non-elderly and elderly groups. Discussion: PFO closure was associated with a reduced risk of the primary outcome in patients with PFO and CS in our total cohort, which included non-elderly and elderly patients. Compared to those without PFO closure, elderly patients with PFO closure had a better functional outcome at 180 days. PFO closure might be considered in selected elderly patients with PFO. [ABSTRACT FROM AUTHOR]

Introduction: It is unknown whether patent foramen ovale (PFO) reopening in the peri-operative setting of cardiac surgery affects the risk for stroke and post-operative outcomes. Methods: We performed a single-center, retrospective study based on a prospectively collected database in a tertiary cardiac surgery center. Using logistic regression, we assessed risk factors of PFO finding around surgery and subsequent clinical complications. Results: Between January 2007 and July 2019, 11034 patients who underwent cardiac surgery in our center were included. A total of 233 patients (2.1%) presented a finding of PFO including 138 per-operative disclosures and 95 post-operative finding for hypoxemia. In the whole cohort, the mean age was 68.4 ± 11.5 years including 73.9% of men. Post-operative PFO finding was associated with more ischemic strokes compared with per-operative finding and control group [7(7.4%) vs. 3(2.2%) vs. 236(2.2), respectively; p = 0.003].Moreover, patients with post-operative PFOreopening experienced a higher rate of pneumonia, reintubation, and longer length of stay in the ICU. Post-operative reopening of PFO, but not per-operative finding, was independently associated with ischemic strokes {adjusted odds-ratio = 3.5, 95% confidence interval (CI) [1.6-7.8]; p = 0.002}. Other variables associated with stroke incidence included age, mitral valve surgery, and ascending aorta surgery. Per- or post-operative PFO closure was associated with reduced adverse respiratory outcomes and a trend of the lower cerebral ischemic event. Conclusion: Patent foramen ovale finding incidence in peri-operative cardiac surgery care was rare (2%) but post-operative finding of PFO was associated with a increased risk of ischemic strokes, worsened respiratory outcomes, and prolonged hospitalization. [ABSTRACT FROM AUTHOR]

The number of structural heart disease interventions has greatly increased in the past decade. Moreover, interest in the sex-specific outcomes of various cardiovascular conditions and procedures has increased. In this review, we discuss the sex differences in the clinical profiles and outcomes of patients undergoing the most commonly performed structural procedures: transcatheter aortic valve replacement, transcatheter edge to edge repair of the mitral and tricuspid valve, transcatheter pulmonary valve replacement, patent foramen ovale closure and left atrial appendage occlusion. We shed light on potential reasons for these differences and emphasize the importance of increasing the representation of women in randomized clinical trials, to understand these differences and support the application of these cutting-edge technologies. [ABSTRACT FROM AUTHOR]

IntroductionIt is unknown whether patent foramen ovale (PFO) reopening in the peri-operative setting of cardiac surgery affects the risk for stroke and post-operative outcomes.MethodsWe performed a single-center, retrospective study based on a prospectively collected database in a tertiary cardiac surgery center. Using logistic regression, we assessed risk factors of PFO finding around surgery and subsequent clinical complications.ResultsBetween January 2007 and July 2019, 11034 patients who underwent cardiac surgery in our center were included. A total of 233 patients (2.1%) presented a finding of PFO including 138 per-operative disclosures and 95 post-operative finding for hypoxemia. In the whole cohort, the mean age was 68.4 ± 11.5 years including 73.9% of men. Post-operative PFO finding was associated with more ischemic strokes compared with per-operative finding and control group [7(7.4%) vs. 3(2.2%) vs. 236(2.2), respectively; p = 0.003]. Moreover, patients with post-operative PFO reopening experienced a higher rate of pneumonia, reintubation, and longer length of stay in the ICU. Post-operative reopening of PFO, but not per-operative finding, was independently associated with ischemic strokes {adjusted odds-ratio = 3.5, 95% confidence interval (CI) [1.6–7.8]; p = 0.002}. Other variables associated with stroke incidence included age, mitral valve surgery, and ascending aorta surgery. Per- or post-operative PFO closure was associated with reduced adverse respiratory outcomes and a trend of the lower cerebral ischemic event.ConclusionPatent foramen ovale finding incidence in peri-operative cardiac surgery care was rare (2%) but post-operative finding of PFO was associated with a increased risk of ischemic strokes, worsened respiratory outcomes, and prolonged hospitalization.

BackgroundIn 2019, there were 28. 76 million patients with stroke in China, with ~25% of them suffering from cryptogenic stroke (CS). Patent foramen ovale (PFO) is related to CS, and PFO closure can reduce recurrent stroke. To date, no study has investigated the cost-effectiveness of PFO closure vs. medical therapy among such populations in China.MethodsA Markov model with a cycle length of 3 months was established to compare the 30-year cost-effectiveness of PFO closure and medical therapy. The transition probability of recurrent stroke was derived from the RESPECT study, and the costs and utility were obtained from domestic data or studies conducted in China. The primary outcome of this study was the incremental cost-effectiveness ratio (ICER), which represents the incremental cost per quality-adjusted life year (QALY). PFO closure was considered cost-effective if the ICER obtained was lower than the willingness-to-pay (WTP) threshold of 37,654 USD/QALY; otherwise, PFO closure was regarded as not being cost-effective. One-way and probabilistic sensitivity analyses were performed to test the robustness of the results.ResultsAfter a simulation of a 30-year horizon, a cryptogenic stroke patient with PFO was expected to have QALY of 13.15 (15.26 LY) if he received PFO closure and a corresponding value of 11.74 QALY (15.14 LY) after medical therapy. The corresponding costs in both cohorts are US $8,131 and US $4,186, respectively. Thus, an ICER of 2783 USD/QALY and 31264 USD/LY was obtained, which is lower than the WTP threshold. One-way and probabilistic sensitivity analyses showed that the results were robust.ConclusionWith respect to the WTP threshold of three times per capita GDP in China in 2021, PFO closure is a cost-effective method for Chinese cryptogenic stroke patients with PFO, as shown in the 30-year simulation.

Background: Individuals with patent foramen ovale (PFO) routinely undergo transcatheter closure (TC) for secondary prevention of recurrent stroke. However, some evidence suggests that TC may increase the risk of new-onset atrial fibrillation (AF).Objective: The purpose of this study was to evaluate the risk of new-onset AF following PFO closure and to explore predictors of AF development.Methods: We created a retrospective cohort of all Ontarians over 18 years of age who received TC between October 2002 and December 2017 using administrative health data and the CorHealth cardiac registry. Poisson regression determined event rates of AF and secondary outcomes such as stroke and mortality per 1000 person-years. A multivariable Cox proportional hazards model identified predictors of new-onset AF following TC.Results: Of 1533 patients, 96 (6.26%) developed new-onset AF following PFO closure, over average follow-up time of 8.2 years. Age >60 years (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.76-4.51; P <.001) and diabetes (HR 2.49; 95% CI 1.48-4.18; P <.001) were statistically significant, independent predictors of AF according to the Cox model.Conclusions: The incidence of new-onset AF after PFO closure was relatively low. Having diabetes and age >60 years were the most important factors associated with new-onset AF in this population. [ABSTRACT FROM AUTHOR]

• Support of cryptogenic ischemic event. • Clinical and economic value provided by patent foramen ovale closure. • Evaluation of the cost-effectiveness of medical intervention versus medical therapy alone. A patent foramen ovale (PFO) is formed when the ovale foramen does not close spontaneously or re-opens leaving the right and left atrium connected. The present study was conducted to analyze the cost-effectiveness of PFO closure with Amplatzer device plus medical therapy (MT) compared to MT alone in the French reimbursement system for PFO patients with a prior history of stroke, using the RESPECT study data. A multi-state Markov model was used. The analysis was conducted from a collective perspective over a 10-year time horizon with 4% discount applied for costs and health effects. The simulated population included adult patients with PFO. Sub-group analysis was limited to patients with atrial septal aneurysm and/or a large-shunt. Clinical inputs were derived from the RESPECT study and literature. Costs associated with the device, drugs, and management were sourced from literature and national databases. The outcomes of analyses included life-years (LYs), quality-adjusted LYs (QALYs), incremental cost-effectiveness ratio (ICER), and number of recurrent strokes avoided. Scenario and sensitivity analyses were conducted to assess the robustness of the results. The use of Amplatzer plus MT provided additional QALYs (0.16) at an incremental cost of 7301€, generating an ICER of 46,288€/QALY for Amplatzer vs. MT alone. In the sub-group analysis, Amplatzer plus MT provided additional QALYs (0.20) at an incremental cost of 5818€, generating an ICER of 28,624€/QALY for Amplatzer plus MT vs. MT alone. Amplatzer plus MT led to lower number of recurrent strokes in comparison to MT alone in both populations. Scenario and sensitivity analyses confirmed the robustness of the results. Amplatzer plus MT represents a cost-effective treatment option and is associated with lower stroke recurrence compared to MT alone for PFO patients with a prior history of stroke. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The potential correlation between patent foramen ovale (PFO) and migraine has been previously reported, but whether PFO closure plays a role in reducing migraine burden has not reached an agreement. Method: We searched PubMed, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Science Technology Periodical Database and China Biology Medicine Database (CBM) through September 30, 2021 to identify associations between PFO closure and outcome of migraine burden. The control groups consisted of drug treatment or sham procedure. Result: Three randomized clinical trials (RCT) and 9 case-control studies were eligible for inclusion (1754 participants), of which 7 reported nonrecurrence of migraine, 4 reported reduced migraine-frequency and migraine-days, and 5 reported HIT-6 score and 4 reported MIDAS score. The mean (SD) age of participants was 40.68 (3.81) years and 1340 (76.39%) were women. PFO closure was significantly associated with a reduced risk of migraine-recurrence by 4.47 (95% CI, 2.94–6.80; I2 = 12%), frequency of migraine by 0.35 (95% CI, 0.17–0.53; I2 = 0%) and monthly migraine days by 0.28 (95% CI, 0.10–0.46), and decreased score of HIT-6 (SMD 1.23, 95 %CI 0.52–1.95, I2 = 93%). Conclusion: Transcatheter PFO closure is significantly associated with burden reduction of migraine headache.

Cryptogenic stroke (CS) represents one-third of all ischaemic strokes. Studies have shown approximately that half of patients with CS have concomitant patent foramen ovale (PFO), with clear data supporting paradoxical embolization as an aetiology of CS. This article is the first of a multi-part review and will detail the history of PFO closure and the clinical trials that have evaluated the efficacy of PFO device closure. Data favour PFO closure in CS for reducing stroke in appropriate patients and should be considered as a treatment modality. [ABSTRACT FROM AUTHOR]

This study aimed to construct and validate a nomogram model that predicts the remission of migraine attacks by screening factors that affect the prognosis of migraine patients with patent foramen ovale (PFO) after closure. Retrospective analysis was conducted in migraine patients with PFO who underwent PFO closure in the Department of Cardiology of Jiangsu Province Hospital from September 2020 to April 2023. Based on the Migraine Disability Assessment (MIDAS) scores from the 1-year follow-up after PFO closure, all patients who met the inclusion criteria were categorized into a remission group and a non-remission group. The primary efficacy endpoint was remission of migraine headache. After collecting clinical data, transcranial doppler sonography (TCD) results and MIDAS scores, LASSO (least absolute shrinkage and selection operator) regression and multivariable logistic regression analysis were used to filter variables predictive to migraine remission and construct the nomogram model. The Nomogram's accuracy and consistency were respectively assessed through Receiver Operating Characteristic (ROC) curves and calibration curves. Additionally, an analysis of decision curves (DCA) was conducted to evaluate the clinical utility of this newly developed model. A total of 241 consecutive patients were included in the study. The remission group included 21 males and 93 females, with a median age of 39 (30.25,50) years. The non-remission group included 26 males and 101 females, with a median age of 35 (25.5,47.5) years. All Patients were randomly divided into a training cohort and a validation cohort. Multivariable logistic regression analysis showed that 5 independent predictors, including MIDAS before closure (p = 0.0002), mitigating factors (p = 0.0057), number of attacks/month (p = 0.0058), TCD (p = 0.0093) and Platelet Crit (PCT) (p = 0.0351), played a significant role in the prediction of remission of migraine patients with PFO after closure. Based on these independent predictors, the predictive nomogram model of migraine remission in PFO patients was constructed. The application of the nomogram in the training cohort exhibited good discrimination (area under the ROC curve was 0.7763[95% CI 0.7108–0.8418]), which was confirmed in the validation cohort (AUC was 0.704[95% CI 0.5533–0.8547]). The calibration curve showed that the nomogram model demonstrated good calibration performance. Additionally, the decision curve analysis indicated the clinical utility of the nomogram model. The construction of the nomogram model had a considerable predictive accuracy for migraine remission in patients after PFO closure, which may provide constructive guidance for clinical decision making. • There is currently no large Clinical randomized controlled trials confirming the superiority of PFO closure over medication in migraine remission. Our study focused on identifying factors affecting remission of migraine in PFO patients and who are the best beneficiaries. • Our study utilized Lasso-Logistic regression analyses to screen variables predictive of migraine remission and further construct a nomogram model and yielded predictive factors, including MIDAS before PFO closure, mitigating factors, number of attacks/month, TCD and PCT. • After further validation, the construction of the nomogram model had a considerable predictive accuracy for migraine remission in patients after PFO closure, which may provide constructive guidance for clinical decision making. [ABSTRACT FROM AUTHOR]

So far, there has been no generally accepted diagnostic and therapeutic algorithm for patients with embolic stroke of undetermined source (ESUS). As recent clinical trials on secondary stroke prevention in ESUS did not support the use of oral anticoagulation and the concept of ESUS comprises heterogeneous subgroups of patients, including a wide age range, concomitant patent foramen ovale (PFO), variable cardiovascular risk factors as well as a variable probability for atrial fibrillation (AF), an individualized clinical approach is needed. In this context, we here present a case of recurrent stroke in a young patient with ESUS and PFO. During treatment according to our Catch-up-ESUS registry study, prolonged cardiac monitoring diagnosed AF, and PFO closure was omitted.

The management recommendations for patent foramen ovale (PFO) closure in cryptogenic stroke are rapidly evolving. The data has expanded recently with four major trials demonstrating superiority of percutaneous device closure over medical management in preventing cryptogenic stroke recurrence. This paper aims to review the current literature for referring physicians who may encounter patients with patent foramen ovale before referring these patients to stroke specialists and/or interventional cardiologists. For this Narrative review, we conducted a broad literature search with expert selection of relevant data. Our search included a review of the currently available trials, guideline statements, position papers, cost-effectiveness of device closure data, as well as the impact of device closure on quality of life. Most European societies are now in favor of evaluating all patients aged 60 years or younger with recent cryptogenic stroke in the setting of a PFO after careful consideration of the patient's echocardiographic and clinical risk factors. On the other hand, American societies, except for the American Academy of Neurology, have not yet passed official updated recommendations. PFO closure can be considered for the prevention of recurrent cryptogenic stroke in patients aged ≤60 years after a thorough evaluation and discussion about benefits and potential risks (including but not limited to atrial fibrillation) of the procedure. Accumulating evidence supports prognostic, quality of life, and economic benefit from percutaneous PFO closure with newer generation closure devices in the right subset of patients. Data from 4 major trials (RESPECT, CLOSE, DEFENSE-PFO, REDUCE) demonstrates the superiority of PFO closure over medical management alone in preventing cryptogenic stroke recurrence. Trials investigated mostly patients ≤60 years old, and therefore results may not be generalizable to the entire population. Further randomized trials evaluating the safety and efficacy of PFO closure in patients older than 60 years are warranted. Atrial fibrillation is one of the most common "occult" causes of cryptogenic stroke and should be excluded by ambulatory electrocardiographic monitoring. It is important to also rule out other causes of stroke, including hypercoagulable states, atherosclerotic lesions, other cardioembolic sources, and arterial dissection. Complications of PFO procedure include new-onset AF, development of scar tissue, risk of aortic root dilation and subsequent erosions, and potential thrombi formation on the device. PFO closure with medical therapy is more cost-effective than medical therapy alone. Patients who underwent PFO closure had lower rates of depression, anxiety, and stress compared to those who did undergo closure. Development of the RoPE score has helped clinicians identify patients with cryptogenic stroke and PFO who might be a candidate for PFO closure. A score of 7, 8, and 9–10 corresponds to a causal risk of 72%, 84%, and 88%, respectively, and defines a subset of patients who may benefit from PFO closure. Current guidelines recommend determining the need for PFO closure on a case-by-case basis, depending on risk factors, in patients age 60 or less with recent cryptogenic stroke in the setting of PFO. [ABSTRACT FROM AUTHOR]

A 41-year-old woman who had suffered an acute stroke underwent closure of a persistent patent foramen ovale (PFO) two months later. Eleven months after PFO closure the patient was hospitalized with signs of cardiogenic shock due to cardiac tamponade. Imaging studies showed a correct position of the left occluder disc, whereas the right atrial disc was in direct contact with the aortic root. At day 6, the patient underwent surgery via a minimally invasive route under cardiopulmonary bypass. The left atrial disc of the occluder was in a correct position. A too big right atrial disc together with a sharp angle misalignment toward the right atrial wall led to an erosion of the right atrial wall and of the wall of the aortic root. The occluder was explanted and the PFO closed by direct suture. Given the increasing number of procedures performed, serious and potentially life-threatening complications – even if rare – deserve special attention. Even though device oversizing was the most likely factor causing the erosion, other factors may play a role, as the patient used whole-body vibration starting three months before the incident. This could explain why the event happened as late as 11 months after the initial PFO closure. < Learning objective: Recent trials have shown that patent foramen ovale (PFO) closure reduces the risk of recurrent stroke after an initial event of cryptogenic stroke in patients younger than 60 years. If PFO closure is performed more frequently, even rare complications have to be considered. Device-induced erosion of adjacent cardiac structures remains a possible short- or long-term complication after PFO closure. This is an unlikely (0.018%) but potentially life-threatening event. An oversized and misaligned device is the central mechanism.> [ABSTRACT FROM AUTHOR]

Purpose: A patent foramen ovale (PFO), present in up to 25% of adults, is an embryologic remnant which allows for right to left shunting and has been implicated in cryptogenic stroke (Neill and Lin, Methodist Debakey Cardiovasc J. 13(3):152–159, 2017; Bass 2015). The current standard of care for selected patients with PFO and cryptogenic stroke is transcatheter closure, but the risk of post-closure, new-onset atrial fibrillation (AF) is unknown (Vaidya et al., Cardiovasc Diagn Ther. 8(6):739–753, 2018; Kjeld et al., Acta Radiol Open. 7(9):2058460118793922, 2018; Staubach et al., Catheter Cardiovasc Interv. 74(6):889–95, 2009). This systematic review and meta-analysis synthesized evidence on AF development post transcatheter PFO closure and predictors of AF development, and assessed existing knowledge gaps. Methods: Randomized controlled trials and observational studies were selected according to the inclusion criteria of adults that underwent a transcatheter PFO closure without a history of AF. Studies were retrieved from electronic databases from inception until February 2019. A Freeman-Tukey arcsine transformation was performed for meta-analysis of AF incidence rate. Results: From 765 studies, 45 were included in quantitative data synthesis. Study sample sizes ranged between 20 and 1887 individuals, and average patient age between 37 to 67 years across studies. The overall incidence rate was 0.013 person-years, and 0.014 person-years for the within 6 months follow-up subgroup. There was no consistency in reported predictors of AF development. Conclusions: The incidence of AF post-PFO closure was low across studies, with a high level of between-study heterogeneity. Until a concerted effort is made to improve accurate AF diagnosis, it will be difficult to gauge the association between transcatheter PFO closure and incidence of AF. [ABSTRACT FROM AUTHOR]

Right ventricular failure (RVF) is a common complication that occurs after a left ventricular assist device (LVAD) is implanted. We report an interesting case of severe and refractory hypoxia during the early postoperative period after HeartMate3 (HM3) (Abbott Laboratories, Lake Forest, IL) implantation resulting in the unmasking of a right-to-left intracardiac shunt through a patent foramen ovale (PFO), triggered by early RVF. Importantly, the patient had a small left-to-right shunt after receiving a left-sided Impella 5.5 micro-axial pump (Abiomed, Danvers, MA, USA) pre-LVAD implantation. We observed improved hypoxia but worsening RVF after percutaneous PFO closure, necessitating right-sided mechanical circulatory support. We outline potential reasons for the significant PFO-related shunting seen after HM3 implantation, but not after Impella 5.5 placement. Uncertainty exists regarding the approach to a PFO in patients undergoing LVAD implantation. We propose an approach based on existing literature., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Pillai et al.)

Competing Interests: Conflict of interest: None declared.

Background: Migraine is a widespread neurological disorder. The patent foramen ovale (PFO) is a remnant of the fetal circulation. Multiple studies suggest that migraine is more prevalent in subjects with PFO and vice versa. It is unclear if there is a causal relationship or simply a co-existence of these two conditions. Furthermore, the treatment of migraine with percutaneous closure PFO remains controversial.Methods: We reviewed studies pertaining to the relationship between PFO and migraine as well as the effects of treatments on migraine attacks.Results: We briefly summarized potential pathophysiological mechanisms of migraine, and elaborated on migraine type, frequency, and clinical symptoms of migraine with PFO and the clinical features of PFO with migraine. We also addressed the effects of PFO closure on migraine attacks.Conclusion: The evidence supports a “dose-response” relationship between migraine and PFO although more work needs to be done in terms of patient selection as well as the inclusion of an antiplatelet control group for PFO closure interventions to uncover possible beneficial results in clinical trials.

Objective: This study aimed to develop and validate a nomogram to predict cessation of patent foramen ovale (PFO) patients with migraine headache after percutaneous closure.Methods: A total of 247 eligible patients with PFO and migraine after percutaneous closure between May, 2016 and May, 2018 were divided into a development cohort (n = 149) and a validation cohort (n = 98). The primary end point was cessation of migraine at follow-up of 1 year after the procedure measured by the Migraine Disability Assessment Score (MIDAS). In the development cohort, the LASSO regression was used data dimension reduction. A multivariable logistic regression analysis was used to develop the predicting nomogram. The performance of the nomogram was assessed by concordance index (C-index), calibration and clinical usefulness. The results were validated in the validation cohort.Results: Migraine with aura, history of antiplatelet, and the right-to-left shunt (RLS) at rest were identified as significant predictors based on the analysis of multivariate logistic regression. The nomogram incorporating these variables showed good calibration and discrimination in the development cohort with C-index of 0.906 (95% CI: 0.847–0.965), which was confirmed using the validation cohort with C-index of 0.827 (95% CI: 0.751–0.903). The nomogram showed good agreement between prediction by nomogram and actual observation. Furthermore, the decision curve indicated that the novel nomogram was clinically useful.Conclusion: The novel nomogram showed favorable predictive accuracy for cessation of migraine among patients with PFO after percutaneous closure and might provide constructive guidance in clinical decision making.

Cardiac embolism continues to be a leading etiology of ischemic strokes worldwide. Although pathologies that result in cardioembolism have not changed over the past decade, there have been significant advances in the treatment and stroke prevention methods for these conditions. Atrial fibrillation remains the prototypical cause of cardioembolic strokes. The availability of new long-term monitoring devices for atrial fibrillation detection such as insertable cardiac monitors has allowed accurate detection of this leading cause of cardioembolism. The non-vitamin K antagonist oral anticoagulants have improved our ability to prevent strokes for many patients with non-valvular atrial fibrillation (NVAF). Advances in left atrial appendage closure and the U.S. Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device for stroke prevention in NVAF patients who have an appropriate rationale for a nonpharmacological alternative, have revolutionized the field and provided a viable option for patients at higher hemorrhagic risk. The role of patent foramen ovale closure for secondary prevention in selected patients experiencing cryptogenic ischemic strokes at a relatively young age has become clearer thanks to the very recent publication of long-term outcomes from three major studies. Advances in the management of infective endocarditis, heart failure, valvular diseases, and coronary artery disease have significantly changed the management of such patients, but have also revealed new concerns related to assessment of ischemic versus hemorrhagic risk in the setting of antithrombotic use. The current review article aims to discuss these advances especially as they pertain to the stroke neurology practice.

Recently published long-term data from randomized controlled trials have provided evidence for the prevention of recurrent embolic stroke of undetermined source by percutaneous closure of the patent foramen ovale. However, most data were obtained from Caucasian populations and evidence on patent foramen ovale closure in Asian-Pacific patients is limited. The relative paucity in clinical data from this population, as well as the fact that Asian-Pacific patients may have higher bleeding risks than Caucasians, complicates clinical decision-making. This document, resulting from a consensus meeting of Asian-Pacific clinical experts, states the consensus among these experts about how to treat Asian-Pacific patients who had an embolic stroke of undetermined source and have a patent foramen ovale, based on currently available evidence and expert opinions. In addition, uncertainties and the need for clinical data regarding patent foramen ovale closure for prevention of recurrent embolic stroke of undetermined source in general, and specifically for Asian-Pacific patients, are identified. [ABSTRACT FROM AUTHOR]

Background: Migraine is a widespread neurological disorder. The patent foramen ovale (PFO) is a remnant of the fetal circulation. Multiple studies suggest that migraine is more prevalent in subjects with PFO and vice versa. It is unclear if there is a causal relationship or simply a co-existence of these two conditions. Furthermore, the treatment of migraine with percutaneous closure PFO remains controversial. Methods: We reviewed studies pertaining to the relationship between PFO and migraine as well as the effects of treatments on migraine attacks. Results: We briefly summarized potential pathophysiological mechanisms of migraine, and elaborated on migraine type, frequency, and clinical symptoms of migraine with PFO and the clinical features of PFO with migraine. We also addressed the effects of PFO closure on migraine attacks. Conclusion: The evidence supports a "dose-response" relationship between migraine and PFO although more work needs to be done in terms of patient selection as well as the inclusion of an antiplatelet control group for PFO closure interventions to uncover possible beneficial results in clinical trials. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to develop and validate a nomogram to predict cessation of patent foramen ovale (PFO) patients with migraine headache after percutaneous closure. Methods: A total of 247 eligible patients with PFO and migraine after percutaneous closure between May, 2016 and May, 2018 were divided into a development cohort (n = 149) and a validation cohort (n = 98). The primary end point was cessation of migraine at follow-up of 1 year after the procedure measured by the Migraine Disability Assessment Score (MIDAS). In the development cohort, the LASSO regression was used data dimension reduction. A multivariable logistic regression analysis was used to develop the predicting nomogram. The performance of the nomogram was assessed by concordance index (C-index), calibration and clinical usefulness. The results were validated in the validation cohort. Results: Migraine with aura, history of antiplatelet, and the right-to-left shunt (RLS) at rest were identified as significant predictors based on the analysis of multivariate logistic regression. The nomogram incorporating these variables showed good calibration and discrimination in the development cohort with C-index of 0.906 (95% CI: 0.847–0.965), which was confirmed using the validation cohort with C-index of 0.827 (95% CI: 0.751–0.903). The nomogram showed good agreement between prediction by nomogram and actual observation. Furthermore, the decision curve indicated that the novel nomogram was clinically useful. Conclusion: The novel nomogram showed favorable predictive accuracy for cessation of migraine among patients with PFO after percutaneous closure and might provide constructive guidance in clinical decision making. [ABSTRACT FROM AUTHOR]

Background: Detailed multidimensional assessment of patent foramen ovale (PFO) size with transesophageal echocardiography (TOE) may help to determine PFO pathogenicity in cryptogenic stroke patients. We explored the potential additive value of Live xPlane and three‐dimensional (3D) TOE anatomical PFO sizing techniques. Methods: Imaging data of 45 patients who underwent a 3D TOE‐assisted percutaneous PFO closure were studied. The two‐dimensional (2D) PFO separation distance and right‐to‐left (RL) contrast shunt magnitude were assessed on preprocedural TOE recordings. Peri‐procedural measurements of the triangular anatomical PFO opening (base, height, and area) were performed after positioning of a stiff guidewire (SW) through the PFO, using Live xPlane imaging and 3D Zoom mode. Results: The PFO SW base appeared on average 5 times larger than the preprocedural 2D PFO separation (median difference [IQR] = 13[5] mm; P <.001). For a same PFO separation, the width of the PFO base may vary significantly. The PFO SW base was significantly larger in patients with a large versus a small‐to‐moderate PFO RL contrast shunt (18 vs 15 mm; P =.007) and in those with a spontaneous versus a provoked shunt (18 vs 14 mm; P =.003). Conclusion: Live xPlane and 3D Zoom TOE allow peri‐procedural measurement of the largest dimension of a PFO, which is the PFO base. Patients with a large or spontaneous RL contrast shunt appear to have a larger PFO base. The anatomical PFO base dimension may be taken into account for optimization of device and patient selection strategies. [ABSTRACT FROM AUTHOR]

Introduction: Observational 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. Aim: To 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 methods: Patients 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. Results: Sixty-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. Conclusions: PFO closure for stroke or TIA prevention in patients with migraine was associated with a reduction in markers of migraine headache severity. [ABSTRACT FROM AUTHOR]

Background: Dilatation of the ascending aorta has an important role in the anatomical conformation of interatrial septum (IAS) especially when a patent foramen ovale (PFO) is present. The aim of the study was to investigate the relationship between ascending aortic dilation and PFO‐related cryptogenic stroke in a cohort of cryptogenic strokes. Methods: It is a retrospective, single‐center echocardiographic study assessing aortic root dilatation in 315 consecutive patients with cryptogenic stroke between January 2011 and January 2019. Aortic root dilatation was defined by a diameter of the Valsalva sinuses of the proximal aorta >40 mm. Predictive factors of PFO were assessed by a multivariate analysis. Propensity score matching was applied to account for clinical differences. Results: Of the 315 patients, 68 (22%) had an aortic root dilatation and 167 (53%) had a PFO. In the aortic root dilation group, PFO was more often diagnosed (n = 47/68 [69%], vs n = 120/247 [49%], P =.004). In the PFO group with aortic dilatation, IAS was more mobile (n = 37/47[79%] vs n = 69/120[57%], P <.012) and smaller (2.3 ± 0.5 vs 2.5 ± 0.5 mm, P <.009). On multivariate analysis, aortic root dilatation (OR: 2.6; 95% CI [1.2–5.6]; P =.001) and IAS hypermobility (OR: 5.2 95% CI [2.7–10]; P =.001) were associated with PFO. After propensity matching, aortic root dilatation remained strongly associated with PFO (n = 34/107 [32%] vs 15/107[14%], P =.002). Conclusion: Aortic root dilation and IAS hypermobility were strongly associated with PFO‐related cryptogenic stroke. [ABSTRACT FROM AUTHOR]

Background: The association between patent foramen ovale (PFO) and migraine has been reported. However, whether transcatheter PFO closure is effective in alleviating migraine remains controversial. The objective of this study was to investigate the efficacy of PFO closure in alleviating migraine in a 5-year follow-up.Methods: Migraineurs with PFO from 2013 to 2015 were included and divided into PFO closure group and non-PFO closure group according to their therapy. Contrast-enhanced transcranial Doppler (c-TCD) was performed to evaluate the degree of the right-to-left shunt (RLS), and headache impact test (HIT-6) questionnaire was administered to assess the disability of migraine at 1- and 5-year follow-up.Results: Of 192 patients, 91 patients underwent PFO closure, and 101 patients refused. The HIT-6 scores of patients in the PFO closure group were significantly lower than those of the non-PFO closure group at both 1- and 5-year follow-up. These results were more pronounced in patients younger than 45 years. Furthermore, in patients with large RLS, the HIT-6 scores of patients in the PFO closure group were significantly lower at both 1- and 5-year follow-up compared with those of the non-PFO closure group. However, in patients with moderate RLS, this difference was significant only at 5-year follow-up.Conclusions: PFO closure is effective in alleviating migraine in the long term. This effect is more obvious when patients are younger than 45 years and RLS is large.

Objectives: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders., Methods: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up., Results: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively., Conclusions: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

So far, there has been no generally accepted diagnostic and therapeutic algorithm for patients with embolic stroke of undetermined source (ESUS). As recent clinical trials on secondary stroke prevention in ESUS did not support the use of oral anticoagulation and the concept of ESUS comprises heterogeneous subgroups of patients, including a wide age range, concomitant patent foramen ovale (PFO), variable cardiovascular risk factors as well as a variable probability for atrial fibrillation (AF), an individualized clinical approach is needed. In this context, we here present a case of recurrent stroke in a young patient with ESUS and PFO. During treatment according to our Catch-up-ESUS registry study, prolonged cardiac monitoring diagnosed AF, and PFO closure was omitted. [ABSTRACT FROM AUTHOR]

Background: The association between patent foramen ovale (PFO) and migraine has been reported. However, whether transcatheter PFO closure is effective in alleviating migraine remains controversial. The objective of this study was to investigate the efficacy of PFO closure in alleviating migraine in a 5-year follow-up. Methods: Migraineurs with PFO from 2013 to 2015 were included and divided into PFO closure group and non-PFO closure group according to their therapy. Contrast-enhanced transcranial Doppler (c-TCD) was performed to evaluate the degree of the right-to-left shunt (RLS), and headache impact test (HIT-6) questionnaire was administered to assess the disability of migraine at 1- and 5-year follow-up. Results: Of 192 patients, 91 patients underwent PFO closure, and 101 patients refused. The HIT-6 scores of patients in the PFO closure group were significantly lower than those of the non-PFO closure group at both 1- and 5-year follow-up. These results were more pronounced in patients younger than 45 years. Furthermore, in patients with large RLS, the HIT-6 scores of patients in the PFO closure group were significantly lower at both 1- and 5-year follow-up compared with those of the non-PFO closure group. However, in patients with moderate RLS, this difference was significant only at 5-year follow-up. Conclusions: PFO closure is effective in alleviating migraine in the long term. This effect is more obvious when patients are younger than 45 years and RLS is large. [ABSTRACT FROM AUTHOR]

Objectives: To report long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure. Methods: A retrospective study of 370 consecutive patients undergoing LAAC procedures using the Watchman (WM) device. Data were compared between 330 cases only with LAAC procedure (Group I) and 25/5 (PFO/ASD) cases with sequential procedures of LAAC and PFO/ASD closure (Group II). Results: Compared to Group I, Group II had more males (86.7% vs. 65.8%, p < 0.05) and a higher rate of stroke (33.3% vs. 10.6%, p < 0.01), but there were no statistical differences in the remaining patient characteristics. During the follow-up period, there were no significant differences between the two groups in embolism events (6.1% vs. 0%, p = 0.39), device related thrombus (5.8% vs 3.3%, p = 1.0), major bleeding (9.4% vs. 6.7%, p = 1.0) and cardiac death (3.6% vs. 0%, p = 0.61). The observed rate of all thromboembolic events by Kaplan–Meier analysis was decreased by 39.9% and 100% and the observed annual rate of bleeding was reduced by 32.9% and 57.6% in Group I and Group II, respectively. Conclusions: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD. [ABSTRACT FROM AUTHOR]

• Recurrent cerebral ischemia after PFO closure is not rare (0.92/100 patients/year). • Obesity, ROPE score < 7 and migraine were predictors of recurrent stroke/TIA. • Future studies are required to refine prevention of recurrent stroke after PFO closure. Transcatheter patent foramen ovale closure lowers recurrent stroke in patients with cryptogenic stroke or transient ischemic attack with an indication for closure. However, the incidence of recurrent stroke is not negligible and underlying pathophysiology remains largely unknown. We sought to evaluate the prevalence of recurrent ischemic neurological events and to assess its predictors after transcatheter patent foramen ovale closure. We enrolled consecutive patients who underwent patent foramen ovale closure for secondary prevention of neurological ischemic events at the University Hospital of Parma between 2006 and 2021. Clinical and procedure-related features were collected for each patient. The incidence of recurrent ischemic neurological events was assessed at follow-up. We enrolled a total of 169 patients with mean Risk of Paradoxical Embolism score at hospital admission of 6.4 ± 1.5. The primary indication was previous cryptogenic stroke (94 [55.6 %] subjects), followed by transient ischemic attack (75 [44.4 %]). Among patients with complete outcome data (n= 154), after a median follow-up of 112 months, recurrent cerebral ischemia occurred in 13 [8.4 %], with an annualized rate of 0.92/100 patients. The presence of obesity [OR 5.268, p = 0.018], Risk of Paradoxical Embolism score < 7 [OR 5.991, p = 0.035] and migraine [OR = 5.932 p = 0.012] were independent positive predictors of recurrent stroke/ transient ischemic attack after patent foramen ovale closure. The presence of obesity, Risk of Paradoxical Embolism score < 7 and migraine were independent positive predictors of recurrent ischemic neurological events after patent foramen ovale closure. [ABSTRACT FROM AUTHOR]

We describe the patient selection, intraprocedural imaging, and procedural technique for transseptal puncture through the Gore® Cardioform interatrial septal occluder. Due to new indications for PFO closure and increasing need for access to the left atrium via percutaneous approach, we expect an increasing need for utilization of a trans-septal puncture technique through these devices. [ABSTRACT FROM AUTHOR]