Patent Foramen Ovale Closure Research Articles

The discovery of in situ thrombus attached to the patent foramen ovale channel in myocardial infarction with normal coronary arteries

Objective: Paradoxical embolism caused by a patent foramen ovale (PFO) is a rare cause of myocardial infarction (MI) in individuals presenting with normal coronary arteries on angiography; however, the deduction is often made due to the inability to identify the exact thrombus that penetrates the atrial septum. Previous studies using optical coherence tomography (OCT) have reported in situ thrombi attached to PFO tunnel in patients with cryptogenic stroke. However, the presence of such thrombi in patients with cryptogenic MI (without a definite cause) remains uncertain. Method: We retrospectively analyzed OCT data collected from February to July 2023 on PFO tunnels in MI adults with normal coronary arteries on angiography. Results: Three patients diagnosed with cryptogenic MI and a PFO underwent OCT examination. These patients exhibited varying OCT findings. White thrombi and endocardial abnormalities in the channel were observed in two patients with MI. No thrombus or anomalous morphology on the endocardial surface was noted in the third patient. PFO closure was performed on all patients, and follow-up was completed by October 1, 2023. None of the patients reported recurrence of chest pain. Conclusion: In situ thrombus was identified within the PFO channel in patients with cryptogenic MI, potentially serving as a novel etiological factor for coronary thrombosis.

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

Impact of Post-Procedural Atrial Fibrillation on Anti-Thrombotic Therapy After Percutaneous Patent Foramen Ovale Closure

Fluoroscopy-only guided transcatheter patent foramen ovale closure: the importance of pre-procedural echocardiography.

Percutaneous closure of a patent foramen ovale (PFO) to prevent recurrent paradoxical thromboembolic events has become the standard of care. However, it remains uncertain if transesophageal echocardiography (TOE) guidance improves procedural success with an existing comprehensive pre-procedural TOE. The aim of the study was to compare the effectiveness of percutaneous PFO closure guided by fluoroscopy (FS) only vs TOE plus FS. Consecutive patients undergoing percutaneous PFO closure between February 2017 and April 2023 were analyzed. Based on pre-procedural echocardiography, patients were scheduled either for an FS-only or TOE/FS-guided procedure. The primary-endpoint was effective PFO-closure (residual-shunt grade 0/1 at 6-month follow-up). The secondary-endpoints included procedural safety/efficacy and major adverse cardiovascular events during hospital stay and at the 6-month follow-up. Two hundred-three patients (mean age 51.8 ± 12.5 years, 39.4% women, Risk of Paradoxical Embolism score = 7 [IQR = 6-7]) underwent PFO closure with FS-only guidance (88 patients, 43.3%) or TOE/FS guidance (115 patients, 56.7%). The main indications for PFO closure were cryptogenic stroke (179 patients, 88.2%) and peripheral embolism (13 patients, 6.4%). At baseline, a right-to-left shunt of grade 2 or higher was present in 199 patients (98%). The procedure time in the FS group was shorter (13 minutes in the FS group vs 16.5 minutes in the TOE/FS group, P = .002). The immediate procedural success was 99.5%. At 6 months, effective closure was achieved in 195 patients (96.1% [FS group: 97.7% vs TOE/FS group 97.8%, P = .29]). The rates of atrial fibrillation and recurrent thromboembolic events were not different among the procedural strategies (3.9% [P = .47] and 0.5% [P = .43]). After comprehensive pre-procedural echocardiography workup, PFO closure with FS guidance only seems equally safe and effective as TOE/FS guidance. A standardized pre-procedural echocardiography protocol facilitates procedural planning with excellent echocardiographic and clinical outcomes.

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.

Beware of Bubbles: Coronary Air Embolism During Transcatheter Patent Foramen Ovale Closure

Beware of Bubbles: Coronary Air Embolism During Transcatheter Patent Foramen Ovale Closure

A Detailed Systematic Review Comparing Patent Foramen Ovale Closure vs Medical Therapy for the Prevention of Recurrent Cryptogenic Stroke.

Cryptogenic stroke refers to a type of ischemic stroke with no identifiable cause despite extensive diagnostic testing. Patent foramen ovale (PFO) treatment modality for the prevention of cryptogenic stroke has been controversial. We undertook this systematic review to compare the efficacy of PFO closure versus medical therapy in preventing recurrent cryptogenic stroke and to provide insight into the most effective treatment modality. Inclusion criteria included patients who had PFO, papers written in English language or had translation available, and papers focusing on medical therapy including drug and surgical treatment for PFO for the prevention of recurrent stroke. Exclusion criteria included articles in which full text could not be obtained and articles in which only one treatment modality was mentioned, either surgical closure or drug therapy. The databases used were PubMed, Cochrane, Embase, and ClinicalTrials.gov. We conducted a bias assessment through the modified Jadad scale for randomized controlled trials (RCTs) and AMSTAR.Ca for meta-analysis and systematic review. The literature search identified a total of 277 papers. After screening, 12 papers were selected for the review. Among these, five were RCTs, five were meta-analyses, one was a systematic review, and one was a systematic review with network meta-analysis. The RCTs included a total of 3,336 participants, while the meta-analyses included 21,813 participants. These finalized papers examined the outcomes of PFO closure compared to medical therapy in preventing recurrent strokes.

Ізольована гіпоплазія правого шлуночка: діагностика, лікування та досвід спостереження пацієнтів дитячого віку

Isolated hypoplasia of the right ventricle (IHRV) is a rare congenital heart defect characterized by a reduction of the right ventricular cavity due to hypoplasia of its trabecular part. Aim - to analyze the anatomical variants of IHRV and their influence on the choice of treatment tactics based on the experience of observing pediatric patients. Materials and methods. This retrospective study included 11 consecutive patients diagnosed with IHRV from 2012 to 2024. Patients were divided into 3 groups based on the ratio of RV to left ventricle (LV) length. The Group I (n=4): mild IHRV (RV/LV length ratio >0.8). The Group II (n=4): moderate IHRV (RV/LV length ratio = 0.7-0.8). The Group III (n=3): severe IHRV (RV/LV ventricle length ratio <0.67). Results. From the Group I (n=4), one patient required medication therapy with beta-blockers and others did not require any treatment. From the Group II (n=4), one patient underwent Glenn shunt and patent foramen ovale (PFO) closure, another - Glenn shunt and PFO closure with fenestration. Two patients have stable clinical conditions. Patients from the Group III (n=3) had duct-dependent pulmonary blood flow in the neonatal period. One patient received treatment with beta-blockers; the second patient underwent patent ductus arteriosus stenting; and the third - systemic-to-pulmonary shunt. Conclusions. Patients with severe IHRV may have critical hemodynamic disturbances requiring urgent cardiac surgical interventions, whereas patients with mild and moderate hypoplasia may require medical treatment with possible surgical intervention at a later age. Long-term follow-up in this defect reveals a slow progressive growth of the right heart chambers. The research was carried out in accordance with the principles of the Declaration of Helsinki. Informed consent of the child and child's parents was obtained for the research. The authors declare no conflict of interest.

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

BackgroundAnatomic 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. MethodsConsecutive 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. ResultsA 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). ConclusionsPatients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

NET burden in left atrial blood is associated with biomarkers of thrombosis and cardiac injury in patients with enlarged left atria.

Emerging data suggest an association between left atrial (LA) enlargement, thrombus formation, and ischemic stroke. However, it is unknown what may mediate such clot formation in LA dysfunction. Neutrophils promote large vessel occlusion and microthrombosis via neutrophil extracellular trap (NET) release, thus lying at the interface of inflammation, thrombosis, and fibrosis. We conducted a prospective all-comers cohort study in patients undergoing catheterization procedures with atrial transseptal access (MitraClip, MC; left atrial appendage closure, LAAC; pulmonary vein ablation, PVA; patent foramen ovale closure, PFO). We measured NETs, cytokines, thrombotic factors, and cardiac injury markers in paired blood samples collected from peripheral blood and within the left atrium. We correlated these biomarkers with echocardiographic measures of LA structure and function (including left atrial volume index, LAVI). Data were analyzed by procedure type, and stratified by LAVI or atrial fibrillation (AF) status. We enrolled 70 patients (mean age 64years, 53% women). NETs, but not other markers, were elevated in LA compared to peripheral blood samples. Most thrombotic, inflammatory, and cardiac damage markers were elevated in LAs from MC or LAAC compared to PFO patients. Overall, NET biomarkers positively correlated with VWF, LAVI, and markers of cardiac injury and negatively with ADAMTS13 activity. LA enlargement and the presence of AF similarly stratified patients based on thromboinflammation measurements, but this was not limited to AF at the time of sample collection. Elevated NETs and VWF in patients with enlarged LA or AF suggest enhanced thromboinflammation within the LA.

Updates on Patent Foramen Ovale (PFO) Closure.

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. 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.

Patent Foramen Ovale Occlusion in Elderly Patients: Is It Worth It? A Large, Single-Center Retrospective Analysis.

Background: Patent foramen ovale (PFO) is often diagnosed in patients with cryptogenic stroke, aged > 60-65 years, but few data report the outcomes of PFO closure in elderly patients. Methods: Consecutive patients undergoing PFO closure at a single institution between January 2006 and December 2011 were included. Baseline clinical features and cerebral imaging data were collected, and a RoPE score was calculated for each patient. Procedural data were recorded as well as medical therapy upon discharge. All-cause death, ischemic stroke, TIA and systemic embolism recurrence at long-term follow-up were investigated, as well as new atrial fibrillation onset. Results: Overall, 462 patients were included, of whom 64 (13.8%) were aged ≥ 65 years. Female gender was slightly more prevalent in the younger group while hypertension was more frequent among elderly patients. Previous stroke/TIA was the indication for PFO closure in 95.3% of older patients and 80.4% of younger patients, whereas other indications were more frequent among younger patients. RoPE scores were lower in older patients (median RoPE score of 5 vs. 7), and atrial septal aneurysm was more frequently detected among elderly patients. All procedures were technically successful. Procedural or in-hospital complications equally occurred in 5 (7.8%) older patients (4 AF and 1 device embolization) and 30 (7.5%) young patients (29 AF or other supraventricular arrhythmias and 1 device embolization). The follow-up duration was longer among younger patients. All-cause mortality was higher in older patients (16 deaths vs. 4 at follow-up, log-rank p < 0.001), no recurrent strokes occurred, and 2 TIAs were reported among non-elderly patients. New-onset atrial fibrillation occurred in three elderly and eight young patients. Conclusions: PFO closure is a safe procedure in patients aged ≥ 65 years, associated with favorable long-term follow-up and the prevention of ischemic neurologic recurrences.

Prevalence of right-to-left shunt in stroke patients with cancer.

Cancer is associated with an increased risk of acute ischemic stroke (AIS) and venous thromboembolism. The role of a cardiac right-to-left shunt (RLS) as a surrogate parameter for paradoxical embolism in cancer-related strokes is uncertain. We sought to investigate the relationship between the presence of an RLS and cancer in AIS patients. We included consecutive AIS patients hospitalized at our tertiary stroke center between January 2015 and December 2020 with available RLS status as detected on transesophageal echocardiography (TEE). Active cancers were retrospectively identified and the association with RLS was assessed with multivariable logistic regression and inverse probability of treatment weighting to minimize the ascertainment bias of having a TEE obtained. Of the 2236 AIS patients included, 103 (4.6%) had active cancer, of whom 24 (23%) were diagnosed with RLS. An RLS was present in 774 out of the 2133 AIS patients without active cancer (36%). After adjustment and weighting, the absence of RLS was associated with active cancer (adjusted odds ratio (aOR) 2.29; 95% confidence interval (CI), 1.14-4.58). When analysis was restricted to patients younger than 60 years of age or those with a high-risk RLS (Risk of Paradoxical Embolism Score ⩾ 6), there was no association between RLS and cancer (aOR, 3.07; 95% CI, 0.79-11.88 and aOR, 0.56; 95% CI, 0.10-3.10, respectively). RLS was diagnosed less frequently in AIS patients with cancer than in cancer-free patients, suggesting that arterial sources may play a larger role in cancer-related strokes than paradoxical venous embolization. Future studies are needed to validate these findings and evaluate potential therapeutic implications, such as the general indication, or lack thereof, for patent foramen ovale (PFO) closure in this patient population.

Every Patent Foramen Ovale Should Be Closed.

At present, the patent foramen ovale (PFO) does not receive the deserved medical attention. The PFO poses a serious threat to health and even the life of mankind. The first respective case report in the medical literature dates back to the 19th century. It led to death. The fact that a PFO is present in roughly 25% of people underscores its overall potential to cause harm. Yet at the same time, the sheer number discourages the medical community from screening for it and from treating it. About 5% of the population have particularly dangerous forms of PFOs. Such PFOs portray a high enough risk for clinical events, the likes of death, stroke, myocardial infarction, or ocular, visceral, and peripheral embolism, to justify screening for them. Highly significant health incidents being at stake, it appears obvious that PFO closure should be used for primary prevention. This is supported by the fact that closing a PFO is the simplest intervention in cardiology, with presumably the highest clinical yield. Being mainly a preventive measure, PFO closure represents a mechanical vaccination. When closing PFOs for one of the rarer therapeutic indications (migraine, platypnea orthodeoxia, etc.), patients automatically profit from the collateral benefit of getting, at the same time, mechanically vaccinated for life against paradoxical embolism. Vice versa, closing a PFO for the prevention of paradoxical embolism betters or cures migraine or exercise dyspnea not infrequently, thereby improving quality of life as a collateral benefit.

The Incidence of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure Detected by Implantable Loop Recorders

BackgroundPatent foramen ovale (PFO) is seen in 25% of the general population but in up to 50% of patients ≤60 years old with cryptogenic strokes. Trials have shown that PFO closure vs medical therapy reduces the risk of future strokes. PFO closure may cause atrial fibrillation (AF), with prior trials reporting an incidence of 2% to 11.9%. However, the true incidence of AF after PFO closure is unknown due to limitations in prior studies for long-term monitoring. MethodsThis is a retrospective observational study at a single center. Patients who underwent PFO closure and had an implantable loop recorder prior to PFO closure were included. The final review included 38 patients who had at least 2 months of implantable loop recorder data post-PFO closure. ResultsTen out of 38 (26%) patients developed AF post-PFO closure. The median time to the first episode of AF was 3.95 weeks, with 40% having their first AF episode after 3 months. Median duration of AF episodes was 1 hour. One hundred percent had spontaneous termination of AF. Of the AF patients, 70% were started on oral anticoagulant therapy. ConclusionsOur review shows a higher incidence of AF post-PFO closure as compared with most reported prior studies. We recommend larger prospective studies to explore the true incidence of AF post-PFO closure, its clinical impact, and subsequent stroke risk.

Atrial fibrillation after patent foramen ovale closure in patients with embolic stroke of undetermined source.

Atrial fibrillation after patent foramen ovale closure in patients with embolic stroke of undetermined source.

Feasibility and safety of cryoballoon ablation for atrial fibrillation and closing patent foramen ovale without implantation：A pilot study

BackgroundPatent foramen ovale (PFO) affects 20%–34% of adults and is associated with strokes and other disorders. The conventional treatment of PFO-related strokes is a closure procedure. The metal device is associated with some adverse events. ObjectiveOur aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI). MethodsWe divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. Standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in group 1 had cryoablation for 120–150 seconds, whereas patients in group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events. ResultsThere were no differences in procedure-related adverse events between the 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up. ConclusionCryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.

Safety and efficacy of antiplatelet cessation after transcatheter patent foramen ovale closure

Safety and efficacy of antiplatelet cessation after transcatheter patent foramen ovale closure

Antithrombotic treatment after transcatheter patent foramen ovale closure in patients with previous cryptogenic stroke

Antithrombotic treatment after transcatheter patent foramen ovale closure in patients with previous cryptogenic stroke

Trends in antithrombotic treatment after cryptogenic stroke and prior transcatheter patent foramen ovale closure

Trends in antithrombotic treatment after cryptogenic stroke and prior transcatheter patent foramen ovale closure