Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure.

BACKGROUND: The benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC in non-recent cryptogenic strokes. AIMS: The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient's most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE). METHODS: We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC, <9 months) for secondary prevention versus a delayed closure (DC, ≥9 months). Recurrence of CVE/SE following PFOC was evaluated as the primary endpoint. RESULTS: 496 patients were included (65% in the EC and 35% in the DC group). With the exception of a larger defect size in the DC group (tunnel width 6 (4-14) vs 12 (6-16) mm, p=0.005), similar clinical and echocardiographic baseline features were observed between the groups. No differences were observed regarding the type of devices used for PFOC, procedural success rate (99.4 in EC vs 98.8% DC group) and periprocedural complications (2.1% vs 0.8%). Median follow-up was 2.0 (1.2-4.2) years in the whole study population. Recurrence of CVE/SE (3.9% vs 2.6%, p=0.443), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment strategy were comparable in both groups during follow-up. A subanalysis comparing very delayed PFOC (≥24 months) also showed no differences in recurrence (4.2% in the <24-month vs 3.4% in the ≥24-month group, p=0.770). CONCLUSION: Patients undergoing PFOC before and after 9 months after the index event had a comparable recurrence rate of CVE/SE. These findings suggest that PFOC might be recommended in cryptogenic CVE/SE which are more remote than 9 months.

Risk of Ischemic Stroke After Patent Foramen Ovale Closure.

BACKGROUND: Transcatheter patent foramen ovale (PFO) closure is the recommended treatment for patients age 18 to 60 years with cryptogenic stroke having a high probability of being PFO-related. Limited data exist on stroke recurrence after PFO closure outside clinical trials. OBJECTIVES: The purpose of this study was to examine stroke recurrence after PFO closure in routine clinical practice. METHODS: We used nationwide population-based Danish registries to conduct a cohort study of all patients with PFO closure during 2008 to 2021 (n = 1,162) and a birth year and sex-matched comparison cohort from the general population (n = 11,620). We calculated absolute and relative risks of ischemic stroke within 4 years after PFO closure. We used weighted Cox regression to estimate adjusted HRs of the association between PFO closure vs the general population and ischemic stroke. RESULTS: The absolute risks of ischemic stroke in patients with PFO closure and in the general population, respectively, were 1.4% (95% CI: 0.8%-2.3%) and 0.1% (95% CI: 0.0%-0.1%) at 1 year, 1.4% (95% CI: 0.8%-2.3%) and 0.2% (95% CI: 0.2%-0.4%) at 2 years, 2.2% (95% CI: 1.3%-3.5%) and 0.4% (95% CI: 0.2%-0.5%) at 3 years, and 2.5% (95% CI: 1.5%-4.0%) and 0.4% (95% CI: 0.3%-0.6%) at 4 years. Thus, the absolute 4-year risk of ischemic stroke was 2.1% (95% CI: 0.9%-3.3%) higher in patients with PFO closure than in the general population, corresponding to an adjusted HR of 6.3 (95% CI: 3.1-12.6). CONCLUSIONS: The 4-year risk of ischemic stroke after routine PFO closure for cryptogenic stroke was comparable to that observed in clinical trials, but remained higher than in the general population.

Registry of Percutaneous Closure of Patent Foramen Ovale in the Secondary Prevention of Stroke. / Registro de Fechamento Percutâneo do Forame Oval Patente na Prevenção Secundária de Acidente Vascular Cerebral.

BACKGROUND: The foramen ovale remains patent in about 25% of the adult population. In adult life, thrombi form in the venous circulation and can cross the interatrial septum and trigger an ischemic stroke - called paradoxical embolism. The treatment can be performed through percutaneous closure of the patent foramen ovale (PFO), but still rarely performed in Brazil because it is not available in the public health care. OBJECTIVES: To evaluate the reproducibility of clinical trial results in real-life studies due to the low number of records published about the topic. METHODS: This study is a retrospective cohort study including 121 patients who underwent percutaneous PFO closure for secondary prophylaxis of ischemic stroke between January 2012 and June 2022. RESULTS: We observed a mean age of 50.3 years and most females . Severe interatrial shunt was observed in 82.6% and the presence of atrial septal aneurysm in 84.2%. After 6 months of the procedure, no patient still had a residual shunt. There were no serious bleeding or vascular complications. Recurrence of a new cerebrovascular event occurred in 1.6% of patients. CONCLUSION: We observed a low recurrence of new ischemic neurological events and lack major complications related to the procedure.

FUNDAMENTO: O forame oval permanece pérvio em cerca de 25% da população adulta. Na vida adulta, trombos se formam na circulação venosa e podem atravessar o septo interatrial e desencadear um acidente vascular cerebral isquêmico ­ fenômeno chamado de embolia paradoxal. O tratamento pode ser realizado através do fechamento percutâneo do forame oval patente (FOP), porém ainda é pouco realizado no Brasil por não estar disponível na rede pública. OBJETIVOS: Avaliar a reprodutibilidade dos resultados dos ensaios clínicos em estudos de vida real devido ao escasso número de registros publicados sobre o tema. MÉTODOS: Este estudo é uma coorte retrospectiva onde foram incluídos 121 pacientes submetidos ao fechamento percutâneo do FOP para profilaxia secundária de acidente vascular cerebral isquêmico entre janeiro de 2012 e junho de 2022. RESULTADOS: Observamos idade média de 50,3 anos e a maioria do sexo feminino. O shunt interatrial grave foi observado em 82,6% e a presença de aneurisma de septo atrial em 84,2%. Após 6 meses do procedimento, nenhum paciente permaneceu com shunt residual. Não houve complicações hemorrágicas ou vasculares graves. A recidiva de novo evento cerebrovascular isquêmico ocorreu em 1,6% dos pacientes. CONCLUSÃO: Observamos uma recidiva de novos eventos neurológicos isquêmicos muito baixa e ausência de complicações graves associadas ao procedimento.

Snare device retrieval of occluder embolized in patent foramen ovale closure: A case report.

RATIONALE: Transcatheter interventional closure therapy is the main treatment method for patent foramen ovale (PFO). However, occluder abscission is a serious complication in PFO interventional therapy. Thus, timely and effective management of the occluder detachment is crucial for improving patient prognosis. PATIENT CONCERNS: A 52-year-old female patient was admitted to the Department of Neurology mainly due to "right upper limb weakness for two days, which aggravated for eight hours." The patient had no history of any other diseases. DIAGNOSES: The patient was diagnosed with an atrial septal defect (foramen ovale type) and cerebral infarction. INTERVENTIONS AND OUTCOMES: The occluder abscission was successfully removed after several attempts with the help of the snare device. LESSONS: When the PFO occlusion device is detached, interventional treatment would lead to minimal trauma, fast postoperative recovery, and a definite therapeutic effect. Based on mastering the indications and standardizing the operational process, this is a safe and effective minimally invasive treatment method.

Resolution of Migraine with Aura Post-PFO Closure in a Young Female: A Case Report.

BACKGROUND Migraine, a prevalent primary headache disorder, often disrupts daily life, particularly when accompanied by visual auras. While the etiology of migraines remains elusive, emerging evidence suggests a correlation with cardiovascular anomalies. CASE REPORT This case involves a 35-year-old woman experiencing migraine with aura. Imaging studies, including MRI/A, revealed small-vessel ischemic damage in the right frontal region and historical microbleeds in the right occipital area. The patient's RoPE score was a high 9 out of 10, and a grade 4 (severe) PFO was diagnosed following a TEE+bubble test. A transfemoral PFO closure was successfully performed using a 25-mm Amplatzer PFO occluder device via an antegrade transvenous approach without fluoroscopy. The patient was discharged in stable condition, with no migraine episodes reported at 5-month follow-up. The detection of PFO in young migraineurs, particularly those with aura, is crucial and warrants thorough investigation during their assessment and treatment. CONCLUSIONS This case underscores the importance of incorporating cardiac evaluations in the diagnostic regimen for young individuals presenting with migraine and aura to uncover and rectify potential contributory structural heart defects like PFO. After PFO closure, this patient's significant improvement, evidenced by the absence of migraine recurrence, highlights the potential therapeutic benefit of addressing cardiac anomalies in such patients. It is important to note that current evidence does not support PFO closure as a treatment for migraines unless there are findings suggestive of ischemic stroke.

Migraine Headache and Patent Foramen Ovale: Observational Studies, the Randomized Clinical Trials, and the GORE RELIEF Clinical Study.

The pathophysiology of migraine remains poorly understood. Like most migraine preventive therapies, patent foramen ovale (PFO) closure was never intended for the treatment of migraine. After closure of PFO for other reasons, migraine symptom reduction/elimination was noted in some patients. Subsequent small trials failed to prove its benefit. There is significant evidence suggesting a platelet-mediated mechanism linking migraines to PFO. The GORE RELIEF Clinical Study is a randomized, blinded, placebo- and sham-controlled trial, currently enrolling. The study design is meant to optimize patient selection using thienopyridine responsiveness as an inclusion criterion.

Patent Foramen Ovale and Decompression Illness: The Present and Future.

Presence of patent foramen ovale (PFO), particularly if high-grade, increases the risk of decompression illness (DCI) and its severe forms. In unprovoked or recurrent DCI, neurologic, cutaneous, or cardiopulmonary DCI, testing for PFO is indicated with bubble contrast echocardiography or transcranial Doppler using provocative maneuvers. In patients with PFO and history of DCI, evaluation by a cardiologist with expertise in diving medicine is recommended. Consideration should be given to PFO closure if cessation of diving or conservative diving cannot be achieved. Prospective studies evaluating long-term outcomes in patients who continue to dive after PFO closure are required.

Practical Aspects of Patent Foramen Ovale Closure: Ultrasound and Fluoroscopic Guidance.

Percutaneous PFO closure is a well-established medical procedure to mitigate paradoxic embolism and the future risk of stroke in a well-selected patient clientele. When it comes to procedural guidance during PFO closure, various modalities exist, each with its own advantages and disadvantages. Guidance by transesophageal echocardiography (in combination with fluoroscopy) offers high-resolution 2D/3D imaging, however, it requires the presence of a peri-interventional imager and conscious sedation (or endotracheal intubation). Intracardiac echocardiography and fluoroscopy guidance can be performed by a single operator and omits the need for conscious sedation (or endotracheal intubation).

Persistence of residual shunt at 6 and 12 months after transoesophageal echocardiography-guided percutaneous closure of a patent foramen ovale for cryptogenic stroke.

BACKGROUND: Young patients suffering from cryptogenic stroke alongside a patent foramen ovale (PFO) are often considered for percutaneous device closure to reduce the risk of stroke recurrence. Residual right-to-left shunt after device closure may persist in approximately a quarter of the patients at 6 months, and some may close at a later time point. This study aimed to assess the prevalence and persistence of residual right-to-left shunt after percutaneous PFO closure. METHODS: Consecutive patients undergoing transoesophageal echocardiography-guided PFO closure for cryptogenic stroke between 2006 and 2021, with echocardiographic follow-up including contrast bubble study and Valsalva manoeuvre, were enrolled. Follow-up transthoracic echocardiography was performed at 6 months and repeated at 12 months in case of residual right-to-left shunt. Primary outcomes included the prevalence and grade of residual right-to-left shunt at 6 and 12 months after percutaneous PFO closure. RESULTS: 227 patients were included with a mean age of 43±11 years and 50.2% were women. At 6-month follow-up, 72.7% had no residual right-to-left shunt, 12.3% small residual right-to-left shunt, 6.6% moderate residual right-to-left shunt and 8.4% large residual right-to-left shunt. At 12-month follow-up, the presence of residual right-to-left shunt in all patients was 12.3%, of whom 6.6% had small residual right-to-left shunt, 2.6% had moderate residual right-to-left shunt and 3.1% had large residual right-to-left shunt. CONCLUSIONS: Residual right-to-left shunts are common at 6 months after percutaneous closure of PFO. However, the majority are small and two-thirds of residual right-to-left shunts achieve complete closure between 6 and 12 months.

Impact of patent foramen ovale with left-to-right shunt on atrial fibrillation ablation in young patients.

OBJECTIVE: The CABANA study shows that atrial fibrillation (AF) paitents younger than 65 years benefit more from the AF radiofrequency catheter ablation (RFCA) procedure. The aim of this study is to investigate the impact of inherent patent foramen ovale (PFO) with a Left-to-Right Shunt on the RFCA procedure in young AF patients. METHODS: Based on the presence or absence of inherent PFO, the AF patients were divided into the PFO groups and the non-PFO group. Clinical follow-up was also investigated. RESULTS: A total of 285 AF patients were enrolled. PFO was detected by TEE in 42 patients. The age of patients at initial AF onset was younger in the PFO group than in the non-PFO group (58.3 ± 8.9 vs. 62.3 ± 9.6 years, P = 0.012). There were more AF patients aged <55 years in the PFO group than in the non-PFO group. For the 9 AF patients with PFO who experienced AF recurrence and the left-to-right shunts decreased in size in 5 of the patients aged <65 years. The LAD decreased in those patients. In the PeAF patients, 53/64 patients aged <65 years and 23/40 patients aged older than 65 years were free of AF (82.8 % vs. 57.5 %, respectively; P = 0.005). CONCLUSION: Success is not affected when AF is combined PFO compared with AF without PFO. Young patients have better PeAF RFCA outcomes. AF in young patients with left atria enlargement and a serious AF burden, may lead to reduced EF and render PFO easy to detect.

Determinants of adverse outcomes following patent foramen ovale closure in elderly patients.

BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Transjugular intrahepatic portosystemic shunt in patients with splanchnic vein thrombosis: Prevalence and management of patent foramen ovale.

BACKGROUND AND AIMS: Transjugular intrahepatic portosystemic shunt (TIPS) is an established procedure for the treatment of several complications of portal hypertension (PH), including non-neoplastic portal vein thrombosis (PVT). Selection criteria for TIPS in PVT are not yet well established. Despite anecdotal, cases of thromboembolic events from paradoxical embolism due to the presence of patent foramen ovale (PFO) after TIPS placement have been reported in the literature. Therefore, we aimed at describing our experience in patients with non-neoplastic splanchnic vein thrombosis (SVT) who underwent TIPS following PFO screening. METHODS: We conducted a single-centre retrospective study, including consecutive patients who underwent TIPS for the complications of cirrhotic and non-cirrhotic portal hypertension (NCPH) and having SVT. RESULTS: Of 100 TIPS placed in patients with SVT, 85 patients were screened for PFO by bubble-contrast transthoracic echocardiography (TTE) with PFO being detected in 22 (26%) cases. PFO was more frequently detected in patients with non-cirrhotic portal hypertension (NCPH) (23% in the PFO group vs. 6% in those without PFO, p = .04) and cavernomatosis (46% in the PFO group vs. 19% in those without PFO, p = .008). Percutaneous closure was effectively performed in 11 (50%) after multidisciplinary evaluation of anatomical and clinical features. No major complications were observed following closure. CONCLUSIONS: PFO screening and treatment may be considered feasible for patients with SVT who undergo TIPS placement.

Updates on Patent Foramen Ovale (PFO) Closure.

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. 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.

Left atrial appendage closure in a patient previously implanted with an interatrial shunt device: a case report.

Patients with previous interatrial shunt device (IASD) implantation may face greater challenges during future left atrial interventional procedures. Herein, we report the first case of left atrial appendage closure (LAAC) in a patient with previous IASD implantation. The patient successfully underwent LAAC using the LAmbre device without complications.

Association between patent foramen ovale morphology and clinical outcomes following transcatheter closure.

BACKGROUND: Anatomic variations of the patent foramen ovale (PFO) are commonly observed, yet limited research has investigated their impact on clinical outcomes following transcatheter closure. We aimed to explore the association between PFO morphology and clinical outcomes. METHODS: Consecutive patients with cryptogenic stroke who underwent PFO closure were prospectively enrolled at a single center from September 2019 to April 2023. Patients were categorized into simple and complex groups based on PFO morphology. Composite events were compared between the two groups during a median follow-up of 24 months, including all-cause mortality, recurrent stroke, residual moderate or severe shunt, and symptomatic atrial fibrillation. RESULTS: A total of 247 patients were enrolled, with a mean age of 41.9 ± 13.0 years and 45.3% males. Ninety-one (36.8%) patients had complex PFO. These individuals were older (45.4 ± 12.5 years vs. 39.9 ± 12.9 years; P = 0.001), more males (56.0% vs. 39.1%; P = 0.010), had longer procedure times (54 ± 32 min vs 46 ± 29 min; P = 0.044), and had a higher rate of using delivery sheath-assisted crossing of the PFO (22.0% vs 12.8%; P = 0.040) than those with simple PFO. The estimated event rates were 27.9% and 11.3% (P = 0.006) in the complex and simple PFO groups, respectively (12.9 events and 5.2 events per 100 person-years; P = 0.001). After adjusting for age, sex, hypertension, diabetes, smoking, device type, and left atrial diameters, complex PFO remained independently associated with composite events (HR 2.10, 95%CI 1.06-4.17, P = 0.034). CONCLUSIONS: Patients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure.

A woman in her thirties with dyspnoea two weeks after abdominoplasty. / En kvinne i 30-årene med dyspné to uker etter bukplastikkoperasjon.

Background: While most cases of venous thromboembolism follow a benign course, occasionally the condition may manifest a complex clinical presentation and need a comprehensive diagnostic workup to identify the underlying cause and provide the patient with appropriate treatment. Case presentation: A woman in her late thirties presented to the emergency department with a five-day history of dyspnoea. She had recently undergone liposuction surgery after pregnancy. Upon admission, initial investigations revealed a pulmonary embolism with right heart strain, and she was treated with anticoagulants. The following day, she complained of acute-onset right flank pain without fever or other accompanying symptoms. A CT scan of the abdomen confirmed a right-side renal infarction. Further investigations revealed patent foramen ovale between the right and left atria of the heart, believed to be the source of a right-to-left shunt of arterial emboli. Although the patient had not suffered a clinical stroke, it was decided to close this defect using percutaneous technique. Interpretation: Patent foramen ovale is a common condition in adults, but in most cases it remains asymptomatic. However, patients with patent foramen ovale have an elevated risk of arterial emboli affecting multiple organs. The diagnosis depends on thorough assessment to prevent potentially fatal outcomes.