Patent Foramen Ovale Research Articles

TCT-111 Transcranial Doppler as a Screening Test for Evaluation of Residual Shunt After Patent Foramen Ovale Closure

TCT-111 Transcranial Doppler as a Screening Test for Evaluation of Residual Shunt After Patent Foramen Ovale Closure

Impact of Non-Valvular Atrial Fibrillation on Mitral Valve Anatomic Features: A Study of Three-Dimensional Mitral Valve by Transesophageal Echocardiography and Automatic Analysis Software.

Mitral regurgitation (MR) is frequently observed in non-valvular atrial fibrillation (NVAF) patients and is a significant risk factor for its progression. This study aims to investigate the three-dimensional anatomical characteristics of the mitral valve (MV) in patients with different types of NVAF to elucidate the underlying mechanisms of MR. A retrospective analysis was conducted on 82 paroxysmal atrial fibrillation patients (PAF group) and 66 persistent atrial fibrillation patients (PerAF group) who underwent real-time three-dimensional transesophageal echocardiography (RT 3D-TEE) before initial ablation. Additionally, 30 patients undergoing RT 3D-TEE for the assessment of patent foramen ovale were selected as the control group. Basic echocardiographic variables were measured, left atrioventricular volume and strain parameters were calculated using automated software (Dynamic-HeartModel and AutoStrain). MV anatomic features were analyzed using the 4D-MV Assessment software (TomTec Imaging Systems). The maximum left atrial volume (LAVmax) was highest in the PerAF group, followed by the PAF and control groups, with statistically significant differences (p<0.01). Left atrial reservoir strain (LASr) showed an opposite trend, being the lowest in the PerAF group (p<0.01). The proportion of moderate to severe MR was significantly higher in the PerAF group (27.3%) compared to the PAF group (11.0%) (p<0.01). Compared to controls, the AF groups exhibited mitral annular (MA) dilation, flattening of the MA plane, and increased leaflet area (all p<0.05). Correlation analysis between effective regurgitant orifice area (EROA) and left atrioventricular structure and function parameters, as well as various annular parameters, showed that EROA was significantly correlated with left ventricular end-diastolic volume (LVEDV), LAVmax, LASr, anterior and posterior diameter, annular area, ratio of annular height to commissural diameter (AH/CD ratio), posterior leaflet area, posterior leaflet length, and the C-shaped annulus length (all p<0.05). Significant remodeling of the MV apparatus occurs in NVAF patients, with more pronounced changes in PerAF patients, contributing to a higher incidence of moderate to severe MR. RT 3D-TEE-based MV automated assessment offers significant advantages in accurately diagnosing MV remodeling and supporting the evaluation of MR in NVAF patients.

TCT-113 Patent Foramen Ovale Closure in Patients >60 Years: Age Stratified Results From U.S. Medicare Beneficiaries

TCT-113 Patent Foramen Ovale Closure in Patients >60 Years: Age Stratified Results From U.S. Medicare Beneficiaries

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

BackgroundThe 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...

Patent Foramen Ovale and Other Cardiopathies as Causes of Embolic Stroke With Unknown Source.

In patients with stroke caused by cardiac embolism, the responsible heart diseases include atrial fibrillation, acute myocardial infarction, sick sinus syndrome, valvular disease, and significant heart failure. When there is no clear source of the embolism, the condition is referred to as "embolic stroke with unknown source (ESUS)." Recent studies have shown that the most common cause of ESUS is a right-to-left cardiac shunt through a patent foramen ovale (PFO). However, considering that PFOs are found in up to 25% of the general population, their presence does not necessarily indicate causality. In patients with ESUS associated with a PFO, either anticoagulants or antiplatelets are used for the prevention of future strokes or transient ischemic attacks. However, it currently remains unclear which treatment is superior. Nevertheless, recent randomized clinical trials have shown that percutaneous closure of the PFO more effectively reduces the incidence of recurrent strokes compared to medical therapy alone in patients with PFO-related strokes. This benefit is especially significant when the PFO carries high-risk features, such as a large shunt or the presence of an atrial septal aneurysm. Furthermore, the effectiveness of PFO closure has been well documented in young patients (<60 years) with a high-risk PFO development. In other cases, the therapeutic decision should be made through discussion among neurologists, cardiologists, and patients. Notably, in ESUS patients without a PFO, the underlying heart condition itself may be the source of embolism, with left atrial enlargement being the most important factor. Theoretically, anticoagulants such as non-vitamin K antagonist oral anticoagulants (NOACs) would be an effective therapy in these cases. However, recent trials have failed to show that NOACs are superior to antiplatelets in preventing further strokes in these patients. This may be due to the still uncertain definition of emboligenic cardiopathy and the presence of other potential embolic sources, such as mild but emboligenic arterial diseases. Overall, further research is needed to elucidate the source of embolism and to determine an effective management strategy for patients with ESUS.

Advances in the Study of the Correlation Between Patent Foramen Ovale and Migraine.

This article examines the relationship between patent foramen ovale (PFO) and migraine, emphasizing the mechanisms underlying the connection and the historical status of transcatheter PFO closure as a treatment for migraine. Patent foramen ovale is the most prevalent congenital cardiac defect in adults and frequently co-occurs with migraine, particularly migraine with aura. This article reviews several studies that have identified a significant prevalence of PFO in patients with migraine, implying that PFO and migraine may be more closely associated than previously thought. The underlying mechanisms of this association involve the transfer of emboli from the venous system to systemic circulation through the PFO, which can result in a range of clinical conditions. Transcatheter PFO closure therapy has demonstrated benefits in some patients with migraine; however, additional research is required to determine its effectiveness and safety. This article offers a comprehensive review of the current understanding of the link between PFO and migraine and emphasizes the need for further research in this field.

Multimodal ultrasound imaging for patent foramen ovale and pulmonary arteriovenous malformation in patients with cryptogenic stroke or migraine: A prospective diagnostic study.

Right-to-left shunt (RLS) caused by patent foramen ovale (PFO) and pulmonary arteriovenous malformations (PAVM) have been associated with a variety of diseases, and reliable techniques for detecting RLS are essential for diagnosis. This study aimed to compare the diagnostic accuracy of multimodal ultrasound imaging, including transthoracic echocardiography (TTE) plus contrast transthoracic echocardiography (CTTE) and transesophageal echocardiography (TEE) plus contrast transesophageal echocardiography (CTEE) for PFO and PAVM in patients with cryptogenic stroke or migraine. This prospective study enrolled patients with cryptogenic stroke or migraine admitted to First Hospital of Shanxi Medical University between July 2018 and April 2023. The TTE + CTTE + TEE + CTEE multimodal ultrasound imaging was defined as the gold standard. A total of 230 patients with cryptogenic stroke (108) or migraine (122) were enrolled. The TEE + CTEE generated a better area under the receiver operator characteristic (ROC) curves (AUC) than TTE + CTTE [0.995 (0.988-1.000) vs 0.975 (0.767-0.984), P < .001], indicating better identification of PFO and PAVM. The sensitivity and specificity of the TTE + CTTE were 89.4% and 85.7%, respectively, whereas the sensitivity and specificity of TEE + CTEE were 99.1% and 100%, respectively. The missed diagnosis rate of TTE + CTTE and TEE + CTEE was 65.7 % and 12.5%, respectively. The combination of TEE + CTEE may be a more reliable and sensitive tool to detect PFO and PAVM than TTE + CTTE in patients with cryptogenic stroke or migraine.

Overview and Future Direction of Embolic Stroke of Undetermined Source from the Insights of CHALLENGE ESUS/CS Registry.

Cryptogenic stroke (CS) accounts for approximately one-fourth of acute ischemic strokes, with most cases derived from embolic etiologies. In 2014, embolic stroke of undetermined source (ESUS) was advocated and the efficacy of anticoagulant therapy was anticipated. However, 3 large-scale clinical trials failed to demonstrate the superiority of direct oral anticoagulants (DOACs) over aspirin, potentially due to the heterogeneous and diverse pathologies of ESUS, including paroxysmal atrial fibrillation (AF), arteriogenic sources such as nonstenotic carotid plaque and aortic complicated lesion (ACL), patent foramen oval (PFO), and nonbacterial thrombotic endocarditis (NBTE) related to active cancer.Transesophageal echocardiography (TEE) is one of the most effective imaging modalities for assessing embolic sources in ESUS and CS. The Mechanisms of Embolic Stroke Clarified by Transesophageal Echocardiography for Embolic Stroke of Undetermined Source/Cryptogenic Stroke (CHALLENGE ESUS/CS) registry is a multicenter registry that enrolled consecutive patients with CS who underwent TEE at 8 hospitals in Japan between April 2014 and December 2016. Their mean age was 68.7±12.8 years, and 455 patients (67.2%) were male. The median National Institutes of Health Stroke Scale (NIHSS) score was 2. Since 7 analyses have been conducted from each institution to date, novel and significant insights regarding embolic origins and pathophysiologies of ESUS and CS were elucidated from this multicenter registry. This review discusses the diagnosis and treatment of ESUS and CS, tracing their past and future directions. Meaningful insights from the CHALLENGE ESUS/CS registry are also referenced and analyzed.

Apixaban as a Secondary Prophylaxis Agent for Patent Foramen Ovale-Associated Stroke.

Background: The purpose of this case report is to describe a case of switching warfarin to apixaban in a patient on anticoagulant prophylaxis for a patent foramen ovale (PFO)-associated stroke. Case Summary: An 86-year-old Afro-Latina female with a past medical history of cerebrovascular accident (CVA) in 2012 secondary to PFO and diagnosed Atrial Fibrillation (AF). Patient was switched from warfarin to apixaban after 3months of labile international normalized ratio (INR) levels. The patient's INR was monitored at a pharmacist-led anticoagulation clinic. As the patient's INR remained subtherapeutic while on warfarin, a shared decision was made to switch the patient to apixaban 2.5mg twice daily due to consistently painful enoxaparin injections, inconsistent vitamin K intake, frequent clinic visits and unstable renal function. Patient tolerated the anticoagulant switch well and reported satisfaction with decreased clinic visits and variable vitamin K diet. At 12months post-switch, the patient's complete blood count remains stable, no reported signs and symptoms of bleeding, and no new CVA or venous thromboembolism (VTE) events identified. Based on an improvement in renal function, the dose was increased to 5mg twice daily.

Clinical Efficacy of Transcatheter Closure of Patent Foramen Ovale with Positive Foaming Test

Background and Aims: To explore and evaluate the clinical therapeutic effect of interventional occlusion in the treatment of patent foramen ovale (PFO) with positive foaming test in the prevention and treatment of cryptogenic stroke (CS) and to provide clinical basis for individualized treatment of CS patients with PFO. Methods: A total of 151 patients who was admitted to Beijing Anzhen Nanchong Hospital Hospital from January 2019 to June 2021 were divided into two groups: drug therapy group (n = 63) and interventional occlusion + drug therapy group (n = 88). The general clinical data of the patients were collected by retrospective study, including sex, age, body weight, right to left shunt (RLS) magnitude, the degree of migraine before treatment, and telephone follow-up of all patients after treatment. Results: There was no significant difference in general clinical data (p &gt; 0.05). In the interventional occlusion + drug therapy group, the stroke recurrence rate within 6th month after operation was significantly lower than that in the drug therapy group, and the difference was statistically significant (p &lt; 0.05); The degree of migraine was lower than that in the drugs treatment group at the 3rd month after operation and the difference was statistically significant (p &lt; 0.01); The degree of migraine at the 6th month was lower than that in the drug therapy group but the difference was not statistically significant (p &gt; 0.05). The results of comprehensive generalized analysis showed that the risk of moderate or severe headache in the interventional occlusion + drug therapy group decreased by 40% (odds ratio [OR] = 0.60, p &lt; 0.05). The degree of migraine in female patients was statistically lower after three and six months postoperatively (p &lt; 0.05 and p = 0.01, respectively). Combined with generalized analysis, the risk of moderate or severe migraine in female patients was reduced by 55%. There were significant differences in the migraine before operation, migraine at the 3rd month and migraine at the 6th month in patients with three different kinds RLS grades (p &lt; 0.01, p &lt; 0.01, p &lt; 0.05). Compared with the preoperative migraine and the migraine at the 3rd month, patients with RLS grade 3 had the most obvious migraine relief at the 6th month after operation than those with RLS grade 2. Conclusion: Compared with the drug therapy, interventional occlusion + drug therapy can reduce the risk of CS recurrence, improve the prognosis and significantly reduce the degree of migraine. Patients of different genders had different degrees of migraine, women had a lighter degree of migraine and a reduced risk of moderate or severe migraine, women benefited more after treatment. Patients with different RLS grades have different postoperative migraine relief. Patients with preoperative RLS grade 3 have the most obvious postoperative migraine relief and patients with preoperative RLS grade 3 benefit more after treatment.

Artificial intelligence diagnosis of patent foramen ovale in contrast transthoracic echocardiography

Artificial intelligence diagnosis of patent foramen ovale in contrast transthoracic echocardiography

Ischemic Stroke in Adults With Congenital Heart Disease: Cumulative Incidence and Associated Factors.

When more patients with congenital heart disease reach adult age, increased incidence of long-term complications, including ischemic stroke, are expected. The aim of this study was to analyze cumulative incidence of ischemic stroke, associated factors, and case fatality in adult congenital heart disease. The study is based on Swedish national registers on congenital heart disease and stroke. Patients with congenital heart disease were followed between 2001 and 2018 for first-ever ischemic stroke events (ischemic stroke due to patent foramen ovale excluded). Factors possibly associated with ischemic stroke were analyzed using Cox regression models. Out of 8914 adult patients with congenital heart disease, 108 suffered ischemic stroke over a mean period of 7.6±4.7 years. The mean age at ischemic stroke was 53.8 years, and the cumulative incidence was 0.15% at 1 year, 0.5% at 5 years, and 1.5% at 10 years. In multivariable analysis, age (hazard ratio [HR], 1.04 [95% CI, 1.03-1.06]), diabetes (HR, 2.9 [95% CI, 1.3-6.4]), ejection fraction <50% (HR, 1.9 [95% CI, 1.1-3.4]), atrial septal defect (HR, 3.0 [95% CI, 1.03-8.5]), and aortic valve lesions (HR, 4.8 [95% CI, 1.6-14.1]) were associated with increased risk. Among those with ischemic stroke, approximately half were on antithrombotic treatment (anticoagulants or antiplatelets) before admission. Case fatality was 6.5%. The cumulative incidence of ischemic stroke was 1.5% after 10 years. In adult congenital heart disease, the type of heart lesion, diabetes, ejection fraction <50%, and age were important factors associated with ischemic stroke. Despite a relatively young age, mortality is a significant threat. At time of the ischemic stroke event, approximately half of the patients were on antithrombotic treatment.

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

BackgroundYoung 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...

Role of interatrial block in modulating cryptogenic stroke risk in patients with patent foramen ovale: a retrospective study

BackgroundThe patent foramen ovale (PFO) and interatrial block (IAB) are associated with cryptogenic stroke (CS). However, the role of the interaction between PFO and IAB in CS remains unclear.MethodsThis case–control study enrolled 256 patients with CS and 156 individuals without a history of stroke or transient ischemic attack. IAB was defined as P wave duration > 120 ms. PFO was evaluated by contrast transesophageal echocardiography, and classified as no-PFO, low-risk PFO and high-risk PFO. Multiplicative and additive interaction analysis were used to assess the interaction between PFO and IAB in CS.ResultsMultiplicative interaction analysis unveiled a significant interaction between IAB and low-risk PFO in CS (OR for interaction = 3.653, 95% CI, 1.115–12.506; P = 0.037). Additive interaction analysis indicated that 68.4% (95% CI, 0.333–1.050; P < 0.001) of the increased risk of CS related to low-risk PFO was attributed to the interaction with IAB. The results were robust in multivariate analysis. However, but no significant multiplicative or additive interaction was observed between IAB and high-risk PFO. When stratified by IAB, high-risk PFO was associated with CS in both patients with IAB (OR, 4.186; 95% CI, 1.617–10.839; P = 0.003) and without IAB (OR, 3.476; 95% CI, 1.790–6.750; P < 0.001). However, low-risk PFO was only associated with CS in patients with IAB (OR, 2.684; 95% CI, 1.007–7.149; P = 0.048) but not in those without IAB (OR, 0.753; 95% CI, 0.343–1.651; P = 0.479).ConclusionThe interaction between IAB and PFO might play an important role in CS, particularly in cases with low-risk PFO.

Transcranial Doppler With Microbubbles: Screening Test to Detect and Grade Right-to-Left Shunt After an Ischemic Stroke: A Literature Review.

Right-to-left shunt, mainly due to patent foramen ovale (PFO), is likely responsible for ≈5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Randomized clinical trials demonstrated that, in selected young and middle-aged patients with otherwise cryptogenic acute ischemic stroke and high-risk PFO, percutaneous PFO closure is more effective than antiplatelet therapy alone in preventing recurrence. However, PFO is generally a benign finding and is present in about one-quarter of the population. Therefore, in clinical practice, identifying PFOs that are likely to be pathogenetic is crucial for selecting suitable patients for PFO closure to prevent recurrent stroke and to avoid potentially harmful and costly overtreatment. Contrast transthoracic echocardiography has a relatively low sensitivity in detecting PFO, whereas transesophageal echocardiography is currently considered the gold standard for PFO detection. However, it is a relatively invasive procedure and may not always be easily feasible in the subacute setting. Contrast transcranial Doppler is a noninvasive, inexpensive, accurate tool for the detection of right-to-left shunt. We conducted a literature review on the use of contrast transcranial Doppler to detect and grade right-to-left shunt after an acute ischemic stroke and present a clinical workflow proposal for young and middle-aged patients.

Patent foramen ovale closure for stroke prevention.

Patent foramen ovale closure for stroke prevention.

Flecainide to Prevent Atrial Arrhythmia after Patent Foramen Ovale Closure, the AFLOAT Study: A Randomized Clinical Trial.

The real incidence of atrial arrhythmia (AA) after patent foramen ovale (PFO) closure and whether this complication can be prevented remain unknown. This study assessed if flecainide is effective to prevent AA during the first 3 months after PFO closure, and if 6 months treatment by flecainide is more effective than 3 months to prevent AA after PFO closure. AFLOAT is a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). Patients were randomized in a 1:1:1 ratio after PFO closure to receive flecainide (150 mg once a day in a sustained-release (SR) dose) for 3 months, flecainide (150 mg od SR dose) for 6 months, or no additional treatment (standard-of-care) for 6 months. The primary endpoint was the percentage of patients with at least one episode AA (≥30s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor (ICM). The secondary endpoint was the percentage of patients with at least one episode of AA (≥30s) recorded with ICM during the 3-6 months period after PFO closure. 186 patients were included (mean age 54 years, male 68.8%) and AA (≥30s) occurred in 53 (28.5%) patients during the 6-month follow-up; 86.8% of these AA events occurred in the first month after PFO closure. The primary outcome occurred in 33/123 (26.8%) and 16/63 (25.4%) patients receiving flecainide for at least 3 months or standard of care, respectively [Risk Difference (RD) 1.4%; 95% confidence interval (CI) -12.9% to 13.8%, NS]. The secondary endpoint occurred in 3/60 (5.0%), 4/63 (6.3%), and 5/63 (7.9%) patients receiving flecainide 6 months, 3 months or standard of care, respectively [RD -2.9%; 95% CI -12.7% to 6.9%, and RD -1.6%; 95% CI -11.8% to 8.6%, respectively]. In the first 6 months following successful PFO closure, AA (≥30s) occurred in 28.5% of cases, mostly in the first month after the procedure. Flecainide did not prevent AA after PFO closure.

Interatrial Wall Abnormality is Associated with Adverse Same-Admission Outcomes Following Total Knee Arthroplasty.

Total knee arthroplasty (TKA) is the most common joint arthroplasty procedure and is shown to be a reliable and efficacious way to improve quality of life. Individuals with interatrial wall abnormalities (IAWAs), such as atrial septal defect or patent foramen ovale (PFO), are at increased baseline risk for stroke and overall lifetime morbidity. The purpose of our study was to elucidate the association between IAWAs and perioperative TKA outcomes.We performed a retrospective cohort study utilizing the Healthcare Cost and Utilization Project National Inpatient Sample database. Admissions for TKA between 2010 and 2019 were identified using the international classification of disease (ICD)-9 and ICD-10 procedure codes. Patients with ICD-9-clinical modification (CM) diagnosis code 7455 or ICD-10-CM diagnosis code Q211 were assigned to the IAWA cohort, the primary exposure. Confounding variables included basic demographics, baseline health status, and surgical facility characteristics. The primary outcomes studied were medical complications, implant-related complications, and admission mortality. Univariate and adjusted multivariable regression analyses were used to identify associations.Compared to patients in the non-IAWA cohort, those in the IAWA cohort had significant risks for same-admission medical complications (odds ratio [OR] 5.77, 95% confidence interval [CI] 4.59-7.15; p < 0.001), implant-related complications (OR 1.55, 95% CI 1.09-2.12; p = 0.009), stroke (OR 77.46, 95% CI 58.4-101.2; p < 0.001), venous thromboembolism (VTE; OR 3.78 95% CI 2.47-5.51; p < 0.001), and mortality (OR 8.36, 95% CI 3.54-16.52; p < 0.001) following TKA.Compared to patients without IAWAs, those with IAWAs who undergo TKA have higher risks for same-admission medical and implant-related complications as well as same-admission mortality. Similarly, these patients have higher risks for same-admission stroke and VTE. Further research on perioperative TKA management in patients with IAWAs is needed.Level of Evidence is III: retrospective cohort study.

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

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. 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. 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. PFO screening and treatment may be considered feasible for patients with SVT who undergo TIPS placement.

Risk of early clinical deterioration and 30-day mortality in pulmonary embolism intermediate-high-risk patients with patent foramen ovale.

We assess the prognostic role of patent foramen ovale (PFO) for the estimation of 30-day mortality and risk of 48-h clinical deterioration since admission, in intermediate-high-risk pulmonary embolism (PE) patients. A post-hoc analysis of intermediate-high-risk PE patients enrolled in the Italian Pulmonary Embolism Registry (IPER) (Trial registry: ClinicalTrials.gov; No.: NCT01604538) was performed. The entire cohort was divided according to the presence or absence of PFO after transthoracic echocardiography (TTE) evaluation. Among 450 intermediate-high-risk PE patients (mean age 71.4 ± 13.8years, 298 males), PFO was diagnosed in 68 (15.1%) cases. A higher mortality rate (29.4% vs. 3.1%, p < 0.001) as well as occurrence of clinical deterioration within 48h from admission (38.2% vs. 3.6%, p < 0.001) were observed in intermediate-high-risk PE patients with PFO compared to those without multivariate Cox regression analysis showed that the presence of a PFO predicts 30-day mortality (HR: 3.21, 95% CI 3.16-3.27, p < 0.001) and was also associated with a significantly higher risk of 48-h clinical deterioration [HR: 2.24 (95% CI 2.20-2.29), p < 0.0001] in intermediate-high-risk PE patients. The presence of a PFO in intermediate-high-risk PE patients is associated with a higher risk of clinical deterioration within 48h from admission and 30-day mortality.