Patent Foramen Ovale Closure Research Articles

Thromboembolic diseases from a cardiological point of view

Thromboembolic disease is associated with a high mortality. It can be divided into two groups: embolism from a venous and embolism from an arterial side. This article gives an overview on thromboembolic disease (with a focus on pulmonary embolism and ischemic stroke) from a cardiologist's perspective.The therapeutic options for acute pulmonary embolism range from anticoagulation to fibrinolysis to interventional recanalization and surgery. The deciding factor for choice of therapy is the risk of early death. Besides clinical parameters, laboratory markers like cardiac troponin and right ventricular function on echocardiography or CTPA (computed tomography pulmonary angiography) are used to determine the early mortality risk. In hemodynamically instable patients, immediate thrombolysis is required, whereas patients with intermediate and low risk can be treated with anticoagulation. Interventional recanalization is currently being studied in patients at risk for development of CTEPH (chronic thromboembolic pulmonary hypertension) or an intermediate risk of early mortality.In ischemic stroke, early interdisciplinary workup involving a cardiologist is paramount. Post stroke screening should include monitoring for arrythmias (especially atrial fibrillation) and transthoracic echocardiography as well as sonography of extra- and intracranial arteries. If no embolic source can be detected (embolic stroke of undetermined source), transesophageal echo can be helpful to detect intracardiac shunts like patent foramen ovale (PFO) or intracardiac tumors. Post stroke care includes secondary prevention measures like risk factor modification and lipid lowering therapy as well as anticoagulation. In high risk for paradoxical embolization, interventional PFO closure can be performed. Interventional closure of the left atrial appendage (LAA) can be discussed in patients with both high thromboembolic and bleeding risk.

Management of Patients With Patent Foramen Ovale and Stroke: A National Survey of Interventional Cardiologists and Vascular Neurologists.

Background Results from multiple clinical trials support patent foramen ovale closure after cryptogenic stroke in select patients, but it remains unclear how new data and updated professional society guidelines have impacted clinical practice. Here, we aimed to compare how stroke neurologists and interventional cardiologists approach patients with cryptogenic stroke with patent foramen ovale and how critical anatomic and clinical factors influence decision making. Methods and Results An electronic survey was administered to 1556 vascular neurologists and 1057 interventional cardiologists throughout the United States. The survey addressed factors such as patient age, preclosure workup, and postclosure antithrombotics. Clinical vignettes highlighted critical variables and used a 5-point Likert scale to assess the providers' level of support for closure. There were 491 survey responses received from 301 (of 1556) vascular neurologists and 190 (of 1057) interventional cardiologists, with an overall response rate of 19%. Vascular neurologists were more likely to recommend against closure on the basis of older age (P<0.001). Interventional cardiologists are more supportive of closure across a range of clinical vignettes, including a very carefully selected patient with cryptogenic stroke (P<0.001), a patient with a high-risk alternative stroke cause (P<0.001), and a range of cases highlighting clinical variables where data are lacking. The majority of interventionalists (88%) seek neurology consultation before pursuing patent foramen ovale closure. Conclusions lnterventional cardiologists are more likely than vascular neurologists to support patent foramen ovale closure across a range of situations. This emphasizes the importance of collaboration and shared decision making, but also reveals an opportunity for professional society educational outreach.

Synchronous multimode ultrasound for assessing right-to-left shunt: a prospective clinical study.

Right-to-left shunt (RLS) is associated with several conditions and causes morbidity. In this study, we aimed to evaluate the effectiveness of synchronous multimode ultrasonography in detecting RLS. We prospectively enrolled 423 patients with high clinical suspicion of RLS and divided them into the contrast transcranial Doppler (cTCD) group and synchronous multimode ultrasound group, in which both cTCD and contrast transthoracic echocardiography (cTTE) were performed during the same process of contrast-enhanced ultrasound imaging. The simultaneous test results were compared with those of cTCD alone. The positive rates of grade II (22.0%:10.0%) and III (12.7%:10.8%) shunts and the total positive rate (82.1748%) in the synchronous multimode ultrasound group were higher than those in the cTCD alone group. Among patients with RLS grade I in the synchronous multimode ultrasound group, 23 had RLS grade I in cTCD but grade 0 in synchronous cTTE, whereas four had grade I in cTCD but grade 0 in synchronous cTTE. Among patients with RLS grade II in the synchronous multimode ultrasound group, 28 had RLS grade I in cTCD but grade II in synchronous cTTE. Among patients with RLS grade III in the synchronous multimode ultrasound group, four had RLS grade I in cTCD but grade III in synchronous cTTE. Synchronous multimode ultrasound had a sensitivity of 87.5% and specificity of 60.6% in the patent foramen ovale (PFO) diagnosis. Binary logistic regression analyses showed that age (odds ratio [OR] = 1.041) and risk of paradoxical embolism score ≥ 7 (OR = 7.798) were risk factors for stroke recurrence, whereas antiplatelets (OR = 0.590) and PFO closure with antiplatelets (OR = 0.109) were protective factors. Synchronous multimodal ultrasound significantly improves the detection rate and test efficiency, quantifies RLS more accurately, and reduces testing risks and medical costs. We conclude that synchronous multimodal ultrasound has significant potential for clinical applications.

Paradoxical Embolism Is an Unusual Etiology of Acute Limb Ischemia in Patients Suffering from COVID-19 Infection.

Acute limb ischemia (ALI) is a large contributor to morbidity and mortality annually and can be managed either operatively or medically. ALI is most often caused by arterial embolism or in situ thrombosis and treatment is often dependent upon the severity. Anticoagulation is considered standard of care and first line therapy. However, more severe cases of ALI require surgical intervention.Paradoxical emboli are a rare and potentially under-appreciated cause of ALI. They arise when venous emboli, from a variety of sources, traverse a patent foramen ovale (PFO) to enter the arterial system, compromising blood flow to the affected end organ. In most cases, they can only be proven if the thrombus is identified as it crosses the cardiac defect, at which point it is an indication for surgery requiring PFO closure, management for the ischemia itself, and possible intervention for the embolism.In this report, we identify and discuss management of a series of cases where ALI was precipitated by PFOs that were discovered in the context of a pulmonary emboli that developed into paradoxical emboli. All patients had a confirmed diagnosis of COVID-19 which has been associated with a state of hypercoagulability and subsequent thrombus formation.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up

BackgroundPercutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). MethodsConsecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. ResultsOverall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. ConclusionsFigulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

World Stroke Organization Brain & hEart globAl iniTiative Program

Introduction: The World Stroke Organization (WSO) Brain & Heart Task Force developed the Brain & hEart globAl iniTiative (BEAT), a pilot feasibility implementation program to establish clinical collaborations between cardiologists and stroke physicians who work at large healthcare facilities. Methods: The WSO BEAT pilot project focused on atrial fibrillation (AF) and patent foramen ovale (PFO) detection and management, and poststroke cardiovascular complications known as the stroke-heart syndrome. The program included 10 sites from 8 countries: Brazil, China, Egypt, Germany, Japan, Mexico, Romania, and the USA The primary composite feasibility outcome was the achievement of the following 3 implementation metrics (1) developing site-specific clinical pathways for the diagnosis and management of AF, PFO, and the stroke-heart syndrome; (2) establishing regular Neurocardiology rounds (e.g., monthly); and (3) incorporating a cardiologist to the stroke team. The secondary objectives were (1) to identify implementation challenges to guide a larger program and (2) to describe qualitative improvements. Results: The WSO BEAT pilot feasibility program achieved the prespecified primary composite outcome in 9 of 10 (90%) sites. The most common challenges were the limited access to specific medications (e.g., direct oral anticoagulants) and diagnostic (e.g., prolonged cardiac monitoring) or therapeutic (e.g., PFO closure devices) technologies. The most relevant qualitative improvement was the achievement of a more homogeneous diagnostic and therapeutic approach. Conclusion: The WSO BEAT pilot program suggests that developing neurocardiology collaborations is feasible. The long-term sustainability of the WSO BEAT program and its impact on quality of stroke care and clinical outcomes needs to be tested in a larger and longer duration program.

Long-term risk of atrial fibrillation or flutter after transcatheter patent foramen ovale closure: a nationwide Danish study.

Transcatheter closure of patent foramen ovale (PFO) is the recommended stroke prevention treatment in patients ≤60 years with cryptogenic ischemic stroke and PFO. Atrial fibrillation or flutter (AF) is a known potential procedure-related complication, but long-term risk of developing AF remains unknown. This paper studied the long-term risk of developing AF following PFO closure. A Danish nationwide cohort study was conducted. During 2008-2020, this study identified a PFO closure cohort, a PFO diagnosis cohort without PFO closure, and a general population comparison cohort matched 10:1 to the PFO closure cohort on age and sex. The outcome was first-time AF diagnosis. Risk of AF and multivariable-adjusted hazard ratio (HR) of the association between PFO closure or PFO diagnosis and AF were calculated. A total of 817 patients with PFO closure, 1224 with PFO diagnosis, and 8170 matched individuals were identified. The 5 year risk of AF was 7.8% [95% confidence interval (CI): 5.5-10] in the PFO closure cohort, 3.1% (95% CI: 2.0-4.2) in the PFO diagnosis cohort, and 1.2% (95% CI: 0.8-1.6) in the matched cohort. The HR of AF comparing PFO closure with PFO diagnosis was 2.3 (95% CI: 1.3-4.0) within the first 3 months and 0.7 (95% CI: 0.3-1.7) thereafter. The HR of AF comparing PFO closure with the matched cohort was 51 (95% CI: 21-125) within the first 3 months and 2.5 (95% CI: 1.2-5.0) thereafter. Patent foramen ovale closure was not associated with any substantial increased long-term risk of developing AF beyond the well-known procedure-related short-term risk.

Short- and Long-Term Outcomes in Patients With Thrombophilia Undergoing Transcatheter Closure of Patent Foramen Ovale

BackgroundPatients with thrombophilia are underrepresented in studies evaluating outcomes after closure of patent foramen ovale (PFO). Real-world data on long term outcomes in this population are very limited. ObjectivesThis study compared outcomes in patients with and without thrombophilia undergoing PFO closure, using data from a large, clinical database linked to population-based databases. MethodsThis retrospective cohort study included consecutive patients who had a transcatheter PFO closure and had preprocedural thrombophilia screening. Data from a retrospective, clinical registry were linked to population-based administrative databases in Ontario Canada to evaluate outcomes. Outcomes were reported as rates per 100 person-years and compared using Poisson regression. ResultsWe included 669 patients, with a mean age of 56.4 years, 97.9% of whom underwent PFO closure for a cryptogenic stroke. Thrombophilia was diagnosed among 174 (26.0%), of which 86% had inherited mutations. In-hospital, procedural complications were observed in 3.1% of patients with no difference by thrombophilia status. Similarly, no differences were observed in 30-day emergency department visits and readmissions. Over the median follow-up of 11.6 years, the most common adverse outcome was new-onset atrial fibrillation (1.0 per 100 person-years; 95% CI: 0.8-1.2), followed by recurrent cerebrovascular events (0.8 per 100 person-years; 95% CI: 0.6-1.1) with no differences between the groups (P > 0.05). ConclusionsAfter PFO closure, no differences were observed in long-term adverse outcomes between patients with and without thrombophilia. Though these patients have been excluded from randomized clinical trials of PFO closure in the past, real-world evidence supports their eligibility for the procedure.

Surgical Closure of Patent Foramen Ovale for Cryptogenic Stroke

Foramen ovale is an essential interatrial channel during foetal life allowing oxygenated placental blood to reach the developing embryo. Incomplete postnatal fusion leads to patent foramen ovale (PFO). It is present in approximately 25% of the adult population and increases the risk of cryptogenic strokes. About 40% of the cryptogenic strokes have a PFO.

Positive Bubble Study But No Evidence of Interatrial Defect in a Patient with Recurrent Cryptogenic Stroke.

Pulmonary arteriovenous malformations (PAVMs) can be asymptomatic or result in a range of complications such as brain abscesses or cryptogenic emboli, which can contribute to morbidity and mortality if not diagnosed and treated in a timely manner. To date, there have been several reports of delayed diagnosis of PAVMs, which have been largely attributed to the misconception that PAVMs are too rare to be of clinical significance. Furthermore, because intracardiac shunting secondary to a patent foramen ovale (PFO) or atrial septal defect (ASD) also results in a positive saline contrast study with echocardiography, PAVM can be easily misdiagnosed as an intracardiac right-toleft shunt. However, there are unique echocardiographic features that differentiate between intracardiac shunting due to a PFO or ASD and extracardiac shunting such as in PAVM. This case details the course of a patient with recurrent cryptogenic strokes that was initially misattributed to a PFO and was only correctly diagnosed with multiple PAVMs after two failed attempts at PFO closure. This case serves as a reminder of an alternative etiology of right-to-left shunt and its presentation on imaging, which echocardiographers must be familiar with.

Patent Foramen Ovale Closure in a Nonagenarian With Platypnoea-Orthodeoxia Syndrome

Patent foramen ovale (PFO) is a common congenital cardiac abnormality that affects one-quarter of the general population. Hypoxaemia, because of large right-to-left shunt, is a rare complication of PFO and occurs under exceptional physiological conditions. Case: This 90-year-old lady presented with progressive dyspnoea over several months. At presentation to hospital, she was hypoxaemic with pO2 of 53 mmHg and oxygen saturation of 89% despite 15L of oxygen via a mask. While lying supine for a computed tomography pulmonary angiogram (CTPA), it was noted that her oxygen saturation normalised. The CTPA excluded pulmonary embolus and intrapulmonary vascular anomaly. Intermittent intracardiac shunt was suspected and confirmed on formal shunt testing with a shunt fraction calculated at 32%. Transthoracic echocardiogram and cardiac CT failed to demonstrate an intracardiac shunt. Transoesophageal echocardiogram confirmed a PFO with dynamic right-to-left shunting on colour Doppler and with agitated saline. She underwent percutaneous closure with a 25-mm Amplatzer PFO Occluder, with a good procedural result and resolution of her symptoms. At the 2-month follow-up she remained well with no breathlessness and no device-related complications. This case illustrates an unusual cause of platypnoea-orthodeoxia syndrome due to PFO in a nonagenarian. It was hypothesised that a prominent Eustachian valve, and anatomical factors including enlarged tortuous aorta and pectus excavatum, had gradually progressed over time, distorting the cardiac anatomy, and contributing to significant shunting. Percutaneous PFO closure resulted in immediate symptomatic benefit.

Effects of morphological characteristics of patent foramen ovale by transesophageal echocardiography on minimalist transcatheter closure in southern China.

Transcatheter closure has become one of the main treatment methods for patent foramen ovale (PFO). However, the population in southern China is generally thin and the size of PFO is small, so the application of minimalist surgery is challenging. This study aimed to analyze the morphological characteristics of PFOs in southern China by transesophageal echocardiography (TEE), and to explore the influence on minimalist transcatheter closure. About 110 patients with PFO closure in our hospital were selected. All cases were examined by TEE including the PFO size, length, septum secundum thickness, color characteristic and surrounding structures, and morphologically classified. During the operation, the procedure time, number of times for the guidewire attempting to pass the interatrial septum and the success rate of simply using J guidewire to cross the interatrial septum were recorded. About 110 cases of PFO were classified into two categories and four subtypes, including 55 cases with Uniform Channel Type (UCT, 50.0%), 16 cases with Irregular Channel Type (ICT, 14.6%), 15 cases with Right Funnel Type (RFT, 13.6%), and 24 cases with Left Funnel Type (LFT, 21.8%). According to the complexity of the procedure, they were divided into simple procedure (n=73) and complex procedure (n=37). Multivariate logistic regression showed that the anatomical types of PFO, the tunnel entrance size, and the tunnel entrance size <2mm were independent factors affecting the complexity of procedure [OR=2.819, 95% CI (1.124, 7.066), p=.027; OR=.027, 95% CI (.004, .208), p=.001; OR=4.715, 95% CI (1.028, 21.619), p=.046]. With ICT and LFT groups, the procedure duration was relatively long (p<.001), number of times for the guidewire attempting to pass the interatrial septum was significantly increased (p<.001), and the success rate of simply using J guidewire to cross the interatrial septum was relatively low (p<.001). The PFO size in southern China was relatively small and characterized by large tunnel tension. It was concluded that TEE could clearly show the morphological characteristics of PFO, which could provide guidance for making more reasonable surgical plans in clinical practice, shorten the procedure time and improve the success rate of PFO closure.

Antiplatelet Therapy May Be Insufficient to Prevent Stroke Recurrence Before Percutaneous Patent Foramen Ovale Closure.

Antiplatelet Therapy May Be Insufficient to Prevent Stroke Recurrence Before Percutaneous Patent Foramen Ovale Closure.

Robotic-assisted mitral valve surgery without aortic cross-clamping: a safe and feasible technique.

The primary objective of this study was to evaluate the safety and feasibility of robotic-assisted mitral valve surgery without aortic cross-clamping. From January 2010 to September 2022, 28 patients underwent robotic-assisted mitral valve surgery without aortic cross-clamping in our center using DaVinci Robotic Systems. Clinical data during the perioperative period and early outcomes of the patients were recorded. Most patients were in New York Heart Association (NYHA) class II and III. Mean age and EuroScore II of the patients were 71.5 ± 13.5 and 8.4 ± 3.7 respectively. The patients underwent either mitral valve replacement (n = 16, 57.1%) or mitral valve repair (n = 12, 42.9%). Concomitant procedures were performed including tricuspid valve repair, tricuspid valve replacement, PFO closure, left atrial appendage ligation, left atrial appendage thrombectomy and cryoablation for atrial fibrillation. Mean CPB times were 140.9 ± 44.6 and mean fibrillatory arrest duration was 76.6 ± 18.4. Mean duration of ICU stay was 32.5 ± 28.8 h and mean duration of hospital stay 9.8 ± 8.3 days. One patient (3.6%) underwent revision due to bleeding. New onset renal failure was observed in one (3.6%) patient and postoperative stroke in one (3.6%) patient. Postoperative early mortality was observed in two (7.1%) patients. Robotic-assisted mitral valve surgery without cross-clamping is a safe and feasible technique in high-risk patients undergoing redo mitral surgery with severe adhesions as well as in primary mitral valve cases that are complicated with ascending aortic calcification.

Transesophageal echocardiography-guided versus fluoroscopy-guided patent foramen ovale closure: A single center registry.

Percutaneous closure of patent foramen ovale (PFO) is conventionally performed under continuous transesophageal echocardiographic (TEE) guidance. We aimed to evaluate whether a simplified procedural approach, including pure fluoroscopy-guidance and final TEE control, as well as an aimed 'next-day-discharge' is comparable with the conventional TEE-guided procedure in terms of periprocedural and intermediate-term outcomes. All patients who underwent a PFO closure at our center between 2010 and 2022 were retrospectively included. Prior to June 2019 cases were performed with continuous TEE guidance (TEE-guided group). Since June 2019, only pure fluoroscopy-guided PFO closures have been performed with TEE insertion and control just prior to device release (fluoroscopy-guided group). We analyzed procedural aspects, as well as long term clinical and echocardiographic outcomes. In total 291 patients were included in the analysis: 197 in the TEE-guided group and 94 in the fluoroscopy-guided group. Fluoroscopy-guided procedures were markedly shorter (48±20 min vs. 25±9 min; p<.01). There was no difference in procedural complications, including death, major bleeding, device dislodgement, stroke or clinically relevant peripheral embolization between the two groups (.5% vs. 0%; p=.99). Hospital stay was also shorter with the simplified approach (2.5±1.6 vs. 3.5±1.2 days; p< .01), allowing 85% same-day discharges during the last 12 months of observation period. At 6±3 months echocardiographic follow-up a residual leakage was described in 8% of the TEE-guided cases and 2% of the fluoroscopy-guided cases (p= .08). While a complete TEE-free PFO closure might have potential procedural risks, our approach of pure fluoroscopy-guided with a brisk final TEE check seems to be advantageous in terms of procedural aspects with no sign of any acute or intermediate-term hazard and it could offer an equitable compromise between the two worlds: a complete TEE procedure and a procedure without any TEE.

Anatomical predictors for suture-based closure of the patent foramen ovale: A multicenter experience.

NobleStitch EL is a novel suture-based technique used for patent foramen ovale(PFO) closure and an alternative to traditional double-disc devices without the need for antithrombotic therapy. However, successful closure rates are still unknown, and certain anatomies may be unfavorable for successful closure. We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure. We included 55 patients who underwent PFO closure with the NobleStitch EL in The Netherlands and Switzerland. Successful closure was defined as residual right-to-left shunt grade ≤1 with Valsalva maneuver at a cardiac ultrasound. Predefined possible anatomical determinants for effective closure included PFO length, atrial septal aneurysm, PFO entry- and exit diameter. Successful closure was achieved in 33 patients (60%). The PFO length was shorter in patients with successful closure compared to unsuccessful closure with a median length of 9.6 mm (IQR 8.0-15.0) versus 13.3 mm (IQR 11.4-18.6) on preprocedural ultrasound (p = 0.041) and 9.9 mm (IQR 8.0-13.1) versus 12.5 mm (IQR 9.7-15.4) on angiography (p = 0.049). Additionally, the PFO exit diameter and PFO volume were smaller in patients with successful closure than unsuccessful closure, with a mean diameter of 7.0 ± 3.1 mm versus 9.5 ± 3.8 mm (p = 0.015) and a median volume of 381 mm3 (IQR 286-894) versus 985 mm3 (IQR 572-1550) (p = 0.016). In our study cohort, the successful PFO closure rate using NobleStitch EL was relatively low (60%). With this alternative procedure, patients with a small PFO driven by a short PFO tunnel length and small exit diameter seem to be eligible for successful suture-based closure.

P466 PREDICTORS OF RECURRENT CEREBRAL ISCHEMIA AFTER PATENT FORAMEN OVALE CLOSURE: A SINGLE CENTER EXPERIENCE WITH A LONG–TERM FOLLOW–UP

Abstract Aims Transcatheter patent foramen ovale (PFO) closure has been shown to lower recurrent stroke in patients with cryptogenic stroke (CS) or transient ischemic attack (TIA) with an indication for closure. However, the incidence of recurrent stroke is not negligible and underlying pathogenic mechanisms remain largely unknown. We sought to evaluate the prevalence of recurrent CS/TIA and to assess its predictors after transcatheter PFO closure. Methods We enrolled consecutive patients who underwent PFO closure for secondary prevention of neurological ischemic events at the University Hospital of Parma between 2006 and 2021. For each subject, CS/TIA index event was diagnosed after exclusion of alternative etiologies, PFO features were characterized by transesophageal echocardiography (TEE), the Risk of Paradoxical Embolism (ROPE) score was retrospectively assessed and the presence of migraine was investigated. Clinical follow–up was scheduled with outpatient visits at 3 – 12 months and yearly thereafter device implantation; the primary outcome was the recurrence of any ischemic neurological event. Results We enrolled a total of 169 patients with mean Risk of Paradoxical Embolism (ROPE) score at hospital admission of 6.4 ± 1.5. The primary indication for PFO closure was previous CS (94 [55.6%] subjects), followed by TIA (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], ROPE score &amp;lt; 7 [OR 5.991, p = 0.035] and migraine [OR = 5.932 p = 0.012] were independent positive predictors of recurrent stroke/TIA after PFO closure. Conclusion In our study, recurrent cerebral events after PFO closure were not negligible, with an annualized rate of 0.92/100 patients, consistent with prior research. Multiple heterogeneous predictors were identified: the presence of obesity, ROPE score &amp;lt; 7 and migraine were independent positive predictors of recurrent stroke/TIA after PFO closure

P51 PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE IN CHILDREN :SINGLE CENTER EXPERIENCE

Abstract Background Transcatheter patent foramen ovale (PFO) closure is a validated strategy to prevent recurrent cerebral events in adult patients; limited data are available for children. Methods This is a retrospective analysis including pediatric population underwent to percutaneous treatment of PFO in our center. Results From 2006 to 2021, 21 transcatheter PFO closures have been performed in children (mean age: 14 +3 years; female: 58%, weight: 59 + 20 kg). Indications for the closure of PFO consisted in the occurrence of cryptogenic ischemic events for 18 patients (86%), in disabling migraine symptoms for 2 patients (9,5%) and in prophylactic measure to prevent paradoxical embolism in high risk abdominal surgery for 1 patient (4,5%). Transcatheter PFO closure was performed under general anesthesia with transesophageal ultrasound guidance. Complex anatomies of PFO included atrial septal aneurysm in 4 cases (with accessory fenestration of atrial membrane in 2 of these cases) and long and stiff PFO tunnel in one case. Single device was used in 20 procedures. ASD closure device was required for 5 cases because of anatomic characteristics of PFO. In one case of large multifenestrated atrial septal aneurysm, percutaneous treatment was performed using both PFO closure device and ASD closure device. No peri and/or post procedural complications have been reported . All patients were treated with Acetylsalicylic acid and Clopidogrel for the first six months after the procedure. Conclusions Transcatheter PFO closure is a safe procedure in pediatric patients in high volume center that should be used for preventing recurrent cerebral events also in children.

C50 VERY LONG TERM FOLLOW UP OF PRIMARY TRANSCATHETER PATENT FORAMEN OVALE CLOSURE FOR MIGRAINE CURE

Abstract Background Results of previous trials about PFO closure as a treatment for migraine are still doubtful and inconclusive. We sought to evaluate the long–term (&amp;gt;10 years) effectiveness of migraine treatment by means of patent foramen ovale (PFO) closure. Methods From 2006 to 2010, 86 patients (68 female, mean age 40.0 ±3.7 years) with disabling, medication–refractory migraine and PFO were enrolled in a prospective study over a 48–month period. Criteria for transcatheter closure were all the following: presence of a permanent right–to–left shunt (RLS) having a shower/curtain pattern, presence of interatrial septal aneurysm and Eustachian valve, 3 to 4 class Migraine Disability Assessment Score (MIDAS), coagulation abnormalities, and medication–refractory migraine with or without aura. Results Forty patients (46.5%) (34 females, mean age 35.0±6.7 years, mean MIDAS 35.8 ± 4.7) underwent transcatheter closure. After a mean follow–up of 118.2 ±19.1 months (range 96 to 144), 37 patients continued the follow–up and experienced symptomatic improvement: aura was abolished in the totality of patients along with a durable improvement of migraine throughout the extended follow up also in patients without aura. The mean MIDAS significantly decreased in the closure group (p&amp;lt;0.0001) (Figure 1). Patients with complete migraine resolution presented a shorter history of migraine, a more severe thrombophilic profile, more severe RLS and larger left atrial diameter and volume. Conclusions Primary transcatheter PFO closure in selected high–risk patients having disabling refractory migraine resulted in abolition of aura and in a sustained reduction in migraine in the very long–term period.

Patent foramen ovale closure in non-elderly and elderly patients with cryptogenic stroke: a hospital-based cohort study.

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. 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. 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 lower median mRS at 180 days (p = 0.002). The rate of safety outcome was similar between the non-elderly and elderly groups. 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.