Transcatheter Closure Of Patent Foramen Ovale Research Articles

Transcatheter PFO closure for cryptogenic stroke: current approaches and future considerations

Patent Foramen Ovale (PFO) is a common congenital atrial septal defect present in 20%–35% of the general population. Although generally considered a benign anatomic variant, a PFO may facilitate passage of a thrombus from the venous to arterial circulation, thereby resulting in cryptogenic stroke or systemic embolization. A PFO is detected in nearly one half of patients presenting with cryptogenic stroke and often considered the most likely etiology when other causes have been excluded. In this review, we discuss the contemporary role of transcatheter closure of PFO in the treatment of cryptogenic stroke, including devices currently available for commercial use in the United States (Amplatzer PFOTM Occluder and GoreTM Cardioform Septal Occluder) and a novel suture-mediated device (NobleStitchTM EL) under clinical investigation. To provide the best care for cryptogenic stroke patients, practitioners should be familiar with the indications for PFO closure and corresponding treatment options.

Pediatric frequent relapsing nephrotic syndrome with multiple cerebral infarctions accompanied by patent foramen ovale and cerebral venous sinus thrombosis: a case report

BackgroundIdiopathic nephrotic syndrome (NS) presents as a hypercoagulable state, of which thromboembolism (TE) is a well-known life-threatening complication. Although TE is more likely to occur in venous vessels than arterial vessels, arterial TE is important because it may cause after-effects, including tissue necrosis and cerebral infarction (CI); therefore, prompt diagnosis and appropriate treatment are required. We report a pediatric NS case with multiple CIs.Case presentationA 14-year-7-month-old Japanese girl was diagnosed with frequent relapsing NS, accompanied by headache and disturbance of consciousness during the second relapse. Brain magnetic resonance imaging (MRI) and four-dimensional computed tomography revealed multiple CIs, vasogenic edema, and cerebral venous sinus thrombosis (CVST). The patient had no underlying thrombophilia other than hypercoagulability due to NS and prednisolone (PSL), and no cardiac arrhythmia; however, a right-to-left shunt through the patent foramen ovale (PFO) was observed with the Valsalva maneuver by echocardiography. Therefore, we assumed that a potential cause of multiple CIs might be an embolic stroke, caused by thrombosis formed from a hypercoagulable state due to NS and PSL treatment and reached through PFO. Antiplatelet and anticoagulant therapies were administered for TE. She was treated with PSL and mycophenolate mofetil (MMF) for NS. Rituximab (RTX) was administered to prevent NS relapse after complete remission (CR). She underwent transcatheter PFO closure at age 14 years and 9 months because we considered that the right-to-left shunt through the PFO would be one of the risks for recurrent cerebral embolism when NS relapses. One year after the onset of CIs, an MRI indicated that the CVST had resolved, leaving no neurological sequelae due to CI; therefore, anticoagulant therapy was discontinued. And then she has been in CR for NS with only MMF therapy.ConclusionsCI is a serious complication in patients with NS. The pathogenesis of multiple CIs is various, including right-to-left shunt through PFO, in addition to the hypercoagulability due to NS. It is important to investigate and manage underlying risks such as PFO, besides preventing the relapses of NS by aggressive treatments using MMF and RTX, in patients with NS.

Assessment of the Characteristics of Patent Foramen Ovale Associated with Cryptogenic Stroke.

This study aims to comprehensively assess the characteristics of patent foramen ovale (PFO) in relation to Cryptogenic Strok (CS) by utilizing transesophageal echocardiography (TEE) and contrast transthoracic echocardiography (c-TTE) and to identify high-risk factors associated with PFO-related CS. Transcatheter PFO closure has demonstrated its effectiveness in preventing PFO-related CS. Therefore, understanding the specific structural attributes of PFO associated with CS is imperative. Enrollment comprised 113 test patients who experienced CS in conjunction with PFO and 117 control patients diagnosed with migraine with PFO but without a history of stroke. The characteristics of the PFO were observed by TEE and c-TTE. A comparative analysis was undertaken to assess the variations in PFO characteristics between the test patients and controls, and to uncover the independent factors relevant to CS. The patients in the test group were older than the controls. Both the height and length of the PFO during Valsalva exhibited greater dimensions in the test group when contrasted with controls. Notably, the test group presented higher incidence rates of low-angle PFO (defined as an angle between the inferior vena cava (IVC) and PFO ≤ 10°) and atrial septal aneurysm (ASA) as contrasted with the control group. Right-to-left shunt (RLS) III during Valsalva demonstrated a significantly elevated occurrence within the test group as opposed to the controls. Conversely, RLS II during Valsalva exhibited a significantly higher frequency in the controls in contrast to the tests. No significant disparities were observed between the two groups with respect to RLS I during Valsalva and all grades of RLS at rest. Multivariate analysis revealed that the length of the PFO during Valsalva, the presence of ASA, RLS III during Valsalva and low-angle PFO were independent relevant factors associated with CS. The length of the PFO tunnel, low-angle PFO, RLS III during Valsalva and the presence of ASA were independent risk factors for CS. The combined utilization of TEE and c-TTE may prove valuable in identifying PFO patients at a heightened risk of CS and in facilitating the screening process for transcatheter PFO closure.</p>.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

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

Experimental study of the bilateral asymmetric single-rivet occluder device for transcatheter patent foramen ovale closure with reserved interatrial septal puncture area.

To evaluate a noval bilateral asymmetric single-rivet occluder with reserved interatrial septal puncture area for treating patent foramen ovale (PFO). The study established a pig model of patent foramen ovale (PFO) by puncturing the oval fossa and then performing high-pressure balloon dilation. A specially designed bilateral asymmetric occluder for the reserved interatrial septal puncture area was then. used to close the PFO through catheter-based intervention. The pigs were kept for 3 months before undergoing a second catheter-based intervention, involving interatrial septal puncture using a newly developed occluder in the reserved interatrial septal puncture area. During 6 months, the experimental pigs underwent assessment using digital subtraction angiography (DSA), echocardiography, and histological evaluation. A patent foramen ovale (PFO) model was successfully established in 6 pigs using the puncture atrial septum high-pressure balloon dilation method. The diameter of the unclosed PFO was measured (3.56 ± 0.25 mm). Using the newly developed occluder device, all 6 pigs with unclosed PFO underwent successful catheter-based closure surgeries, with intraoperative and postoperative transesophageal echocardiography showing excellent device positioning and complete closure without residual shunting. After 3 months of implantation, the catheter-based interatrial septal puncture was performed through the reserved interatrial septal puncture area, and all procedures were successful. Immediately following euthanasia, a histological examination revealed intact and undamaged occluder devices with visible puncture holes in the reserved interatrial septal puncture area. No fracture of the nitinol wire was observed, and the surface of the occluder device showed coverage of endothelial and connective tissues. Utilizing a bilateral asymmetric single-rivet occluder device implanted through the reserved interatrial septal puncture area has proven effective in closing PFO. After implantation, the occluder device allows subsequent interatrial septal puncture procedures through the reserved area. The novel occluder device demonstrated excellent closure performance, biocompatibility, and puncturability in the experiment. This indicates the feasibility of conducting further catheter-based interventions on the interatrial septum.

Predictors of recurrent cerebral ischemia after patent foramen ovale closure: A single center observational study

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

Abstract 17264: PFO Cover Index by 3D-TEE Predicts Residual Shunting After Transcatheter Closure

Introduction: Proper defect sizing and device size selection are imperative for ensuring successful clinical outcomes after transcatheter patent foramen ovale (PFO) closure. However, with current sizing techniques, residual shunting remains as high as 25% and is associated with an increased risk of recurrent neurologic events. Since 2017, we adopted a PFO sizing strategy based on right atrial (RA) tunnel “width” oversizing utilizing three-dimensional transesophageal echocardiography (3D-TEE). Hypothesis: We hypothesized that the PFO tunnel width at the RA opening and a cover index based on this dimension would predict residual shunting at long term follow-up. Methods: Sixty-four patients underwent transcatheter PFO closure (60 patients utilizing a 3D-TEE based oversizing strategy) at our institution between 2015 and 2022. PFO tunnel length, tunnel width at RA opening, and tunnel width at left atrial opening were determined by 3D-TEE either before or at the time of closure. We determined an absolute PFO “cover index” for each patient as follows: RA disc diameter - RA tunnel width. Receiver operating characteristic (ROC) curve analysis was used to determine the predictive ability of 3D-TEE derived PFO dimensions and the PFO cover index to predict residual shunting at follow-up. Results: Fifty-one of sixty-four patients had a long-term follow-up bubble study (mean follow-up time 8.0±3.7 months). Of the 47 patients closed utilizing a 3D-TEE based sizing strategy and with a follow-up bubble study, only 5 patients (10.6%) had residual shunting at follow-up. Of the three 3D-TEE based PFO dimensions, only the RA tunnel width was predictive of residual shunting at follow-up (AUC 0.84, p=0.004). A cutoff of 15.5 mm or greater for RA tunnel width had the best combination of sensitivity (86%) and specificity (73%). The PFO cover index was also strongly predictive of residual shunting at follow-up (AUC 0.87, p=0.002). A cutoff of 9.5 mm or less had the best combination of sensitivity (86%) and specificity (82%). Conclusions: A larger PFO tunnel width at the right atrial opening and a lower cover index based on this dimension predict residual shunting at follow-up. Our findings have important implications for improving sizing strategies for transcatheter PFO closure.

Abstract 17951: Infective Endocarditis of an Amplatzer PFO Occluder: A Rare and Devastating Complication

Introduction: Patent foramen ovale (PFO) closure is indicated for secondary prevention of ischemic strokes in select patients. PFO closure devices are rarely complicated by infective endocarditis (IE). We present the case of a patient with a closure device infected by Methicillin-sensitive Staphylococcus Aureus (MSSA). Case: A 60-year-old woman with a history of ischemic stroke status post transcatheter PFO closure with a 25 mm Amplatzer occluder eight months prior to presentation was admitted for a two week history of lower back pain, bilateral lower extremity weakness, and urinary incontinence. She denied dental procedures following device implantation. MRI of the spine revealed L3-L4 osteomyelitis with an adjacent epidural abscess which was immediately drained. Blood and intra-operative cultures revealed MSSA. There was no evidence of endocarditis on transthoracic echocardiogram (TTE). Given persistent bacteremia, a transesophageal echocardiogram (TEE) was performed, revealing large, highly mobile vegetations measuring up to 3 cm in length, attached to both the left and right atrial surfaces of the Amplatzer occluder. Urgent surgical removal of the Amplatzer occluder and PFO closure was performed. She received a 4-week course of Cefazolin. Discussion: Despite periprocedural antibiotics and prophylaxis for dental procedures for six months after implantation, IE of PFO occluders can rarely occur days to years after implantation. In patients with PFO occluders and persistent bacteremia or fevers, TEE is the diagnostic modality of choice as TTE are often negative. Management consists of urgent surgical excision and long-term antibiotics.

Abstract 16411: Patent Foramen Ovale Combined With Solitary Pulmonary Arteriovenous Malformation

Introduction: A transthoracic echocardiogram (TTE) with bubble study is standard during evaluation of patients presenting with cryptogenic stroke to evaluate for the presence of a patent foramen ovale (PFO). However, other uncommon conditions, such as solitary pulmonary arteriovenous malformations (sPAVM), can also present with stroke and abnormal bubble study. We examine a case of a woman who presented with an acute ischemic stroke and was found to have both a PFO and sPAVM. Case: A 64-year-old woman with hypertension presented with acute onset facial droop, left arm paresis, and aphasia. A computed tomography (CT) scan of her head did not show an intracerebral hemorrhage or large vessel occlusion. However, magnetic resonance imaging showed acute infarction of the right thalamus. During initial work up, a chest x-ray was also obtained and there was concern for possible pulmonary malignancy. A subsequent contrast-enhanced CT of her chest revealed a right lower lobe PAVM. A TTE with bubble study showed bubbles in the left atrium, which was attributed to PAVM. Interventional radiology was consulted, and the patient underwent PAVM embolization. TTE was repeated and continued to show bubbles in the left atrium. Transesophageal echocardiogram (TEE) revealed an atrial septal aneurysm with PFO. After interdisciplinary discussion and shared decision making, she eventually underwent successful transcatheter PFO closure with an Amplatzer PFO occluder. Genetic testing for hereditary hemorrhagic telangiectasia was negative. Discussion: This case highlights the importance of evaluating for less common causes of stroke such as sPAVMs and multidisciplinary approach to complex cases. The American Heart/Stroke Associations recommend PFO closure for patients presenting with ischemic stroke and no other identifiable cause. However, there is not clear guidance on the management of patients who present with stroke and have both PFO and PAVMs. Although PFOs are commonly ruled out with TTE/TEE and bubble study, there may be utility in also ruling out PAVMs as they are an important and reversible cause of paradoxical emboli. Further studies should the evaluate the management of patients with both PAVM and PFO with a focus on the optimal strategy for sequence of closure.

Coronary air embolism during transcatheter patent foramen ovale closure for platypnea-orthodeoxia syndrome in a patient with severe respiratory disorder: a case report

Abstract Background Coronary air embolism (CAE) is a rare and life-threatening complication of endovascular procedures, mostly due to procedure-related causes. Case summary A 70-year-old man with severe respiratory disorder presented with patent foramen ovale (PFO)-related platypnea-orthodeoxia syndrome (POS). Transcatheter PFO closure was performed under local anaesthesia and intracardiac echocardiographic guidance. After a 5-Fr catheter was passed through the PFO via a 7-Fr femoral vein sheath, the patient suddenly coughed and breathed deeply. Thereafter, intracardiac echocardiography showed massive microbubbles in all cardiac chambers and the ascending aorta, and an electrocardiogram showed ST-segment elevations in the anterior and inferior leads. Emergency coronary angiography confirmed occlusion of the mid-left anterior descending artery, suggesting CAE. As the intracoronary infusion of saline, nitroglycerine, and nicorandil was ineffective, we performed air aspiration using a thrombectomy device, achieving coronary blood flow improvement and ST-segment resolution. Thereafter, positive pressure support using manual bag-valve-mask ventilation under intravenous sedation supported successful transcatheter PFO closure without further air embolization. Discussion In this case with severe respiratory dysfunction, spontaneous deep breathing (spontaneous Valsalva manoeuvre) caused negative intrathoracic pressure and large drops in intravascular pressure. This phenomenon might have induced air contamination during device advancement, either by entrapping or leaving residual air in the gaps between the catheter and the sheath. Additionally, PFO with right-to-left shunts is more likely to cause paradoxical air embolization. Thus, the spontaneous Valsalva manoeuvre should be avoided with appropriate respiratory management to prevent paradoxical air embolization, including CAE, during transcatheter PFO closure under local anaesthesia in severe respiratory dysfunction patients.

Safety of Same-Day Hospital Discharge Post Patent Foramen Ovale Closure: Findings from a Multicenter Study

Transcatheter patent foramen ovale (PFO) closure is indicated for patients with cryptogenic stroke. Although procedural safety is well established, there are limited data on the safety of same-day (SD) discharge. We aimed to review the outcomes of PFO closure with SD. Patients who underwent transcatheter PFO closure between January 2011 and May 2022 at 4 large US hospitals were retrospectively analyzed, comparing outcomes of SD versus delayed discharge (DD). The primary end point was a composite of access-site complication, stroke, device embolization, atrial arrhythmia, and bleeding. Secondary analysis comparing imaging modality and outcomes was performed. 554 patients (49.2% female) were analyzed (382 discharged SD). Average age was 54.3 ± 15. Baseline characteristics in both groups were broadly similar. Previous stroke (78.0% SD vs 76.2% DD, p=0.32) was the commonest indication for PFO closure. In the SD group, there was less general anesthesia use (5.5% vs 16.9%, p <0.001). Intraprocedural intracardiac echocardiography was used more frequently in SD cases (95.0% vs 81.4%, p <0.001). In the DD group, median stay was 1 night, and 34.9% stayed beyond 1 night. At 30days, there was no difference in the primary composite end point (14.9% vs 11.6%, p=0.15). There was no inter-group difference in individual adverse events (all p >0.05). When comparing imaging modality and outcomes, there was no difference in composite end points between transesophageal and intracardiac echocardiography (6.5% vs 14.7%, p=0.063). In conclusion, SD discharge after transcatheter PFO closure appears safe. This efficient approach may be advantageous in optimizing workflow and minimizing hospital occupancy.

Cerebrovascular Events in Older Patients With Patent Foramen Ovale: Current Status and Future Perspectives.

Patent foramen ovale (PFO) closure, along with medical therapy, has emerged as the therapeutic gold standard in younger (<60-year-old) patients with a PFO-related stroke for preventing recurrent events. However, PFO management guidelines lack definite recommendations for older (>60 years) patients with a PFO-related cerebrovascular event, a complex group of patients who were mostly excluded from PFO closure clinical trials. Nevertheless, several studies have shown a higher prevalence of PFO among older patients with cryptogenic stroke, and its presence has been associated with an increased risk of recurrent events. Furthermore, older patients exhibit a higher prevalence of high-risk PFO anatomical features, present inherent age-related risk factors that might increase the risk of paradoxical embolism through a PFO, and have a higher incidence of ischemic events after a PFO-related event. Additionally, observational studies have shown the safety and preliminary efficacy of PFO closure in older PFO-related stroke patients. Yet, higher rates of recurrent cerebrovascular events and new-onset atrial fibrillation were observed in some studies among older patients compared to their younger counterparts. After careful case-by-case evaluation, including the assessment of hidden potential cardioembolic sources of a cryptogenic stroke other than PFO, transcatheter PFO closure might be a safe and effective therapeutic option for preventing recurrent thromboembolic events in patients >60 years with a high-risk PFO-associated stroke. Ongoing trials will provide important insights into the role of PFO closure in the elderly population.

Comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: Conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography

BackgroundRecent randomized trials have demonstrated a consistent reduction in recurrent stroke after percutaneous transcatheter patent foramen ovale closure versus medical therapy in patients with recent cryptogenic stroke. AimTo compare the safety and efficacy of intracardiac echocardiography-guided and microprobe transoesophageal echocardiography-guided patent foramen ovale closure under local anaesthesia with transoesophageal echocardiography-guided patent foramen ovale closure under general anaesthesia. MethodsThis prospective observational single-centre study included 194 consecutive patients scheduled for patent foramen ovale closure for secondary prevention of stroke from February 2018 to December 2019. Patients were asked to choose between an intracardiac echocardiography-guided, microprobe transoesophageal echocardiography-guided or transoesophageal echocardiography-guided procedure. The primary endpoint was the rate of successful closure at 6 months, defined as correct positioning of the device without severe shunt on 6-month contrast echocardiography. ResultsSuccessful closure was high and did not differ between groups: 97.8% (95% confidence interval 88.5–99.9%) in the intracardiac echocardiography-guided group versus 96.9% (95% confidence interval 83.8–99.9%) in the microprobe transoesophageal echocardiography-guided group and 99.1% (95% confidence interval 95.3–99.9%) in the transoesophageal echocardiography-guided group (P=0.63). Adverse events related to patent foramen ovale closure were low and did not differ between groups. ConclusionOur preliminary real-world experience suggests good efficacy and safety with intracardiac echocardiography and microprobe transoesophageal echocardiography guidance compared with conventional transoesophageal echocardiography guidance for percutaneous transcatheter patent foramen ovale closure in recurrent stroke prevention.

Clinical Outcomes and Quality of Life after Patent Foramen Ovale (PFO) Closure in Patients with Stroke/Transient Ischemic Attack of Undetermined Cause and Other PFO-Associated Clinical Conditions: A Single-Center Experience.

The aim of this study was to assess clinical outcomes and quality of life after PFO closure in patients with previous stroke/TIA of undetermined cause and in patients with other complex PFO-associated clinical conditions. Between July 2009 and December 2019 at our University Cardiology Department, 118 consecutive patients underwent a thorough diagnostic work-up including standardized history taking, clinical evaluation, full neurological examination, screening for thrombophilia, brain magnetic resonance imaging (MRI), ultrasound-Doppler sonography of supra-aortic vessels and 24 h ECG Holter monitoring. Anatomo-morphological evaluation using 2D transthoracic/transesophageal echocardiography (TTE/TEE) color Doppler and functional assessment using contrast TTE (cTTE) in the apical four-chamber view and contrast transcranial Doppler (cTCD) using power M-mode modality were performed to verify the presence, location and amount of right-to-left shunting via PFO or other extracardiac source. Completed questionnaires based on the Quality-of-Life Short Form-36 (QoL SF-36) and Migraine Disability Assessment (MIDAS) were obtained from the patients before PFO closure and after 12 months. Contrast TTE/TEE and cTCD were performed at dismission, 1, 6 and 12 months and yearly thereafter. Brain MRI was performed at 1-year follow-up in 54 patients. Transcatheter PFO closure was performed in 106 selected symptomatic patients (mean age 41.7 ± 10.7 years, range 16-63, 65% women) with the following conditions: ischemic stroke (n = 23), transient ischemic attack (n = 22), peripheral and coronary embolism (n = 2), MRI lesions without cerebrovascular clinical events (n = 53), platypnea-orthodeoxia (n = 1), decompression sickness (n = 1) and refractory migraine without ischemic cerebral lesions (n = 4). The implanted devices were Occlutech Figulla Flex I/II PFO (n = 99), Occlutech UNI (n = 3), Amplatzer PFO (n = 3) and CeraFlex PFO occluders (n = 1). Procedures were performed under local anesthesia and rotational intracardiac monitoring (Ultra ICE) alone. The devices were correctly implanted in all patients. The mean fluoroscopy time was 15 ± 5 min (range = 10-45 min) and the mean procedural time was 55 ± 20 min (range = 35-90 min). The total occlusion rate at follow-up (mean 50 months, range 3-100) was 98.1%. No recurrent neurological events were observed in the long-term follow-up. The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure, showing long-term prevention of recurrent cerebrovascular events, significant reduction in migraine symptoms and substantial improvement in quality of life.

Comparison of the short-term efficacy of different Amplatzer models and similar occluders in the treatment of patent foramen ovale.

To compare the recent efficacy and safety of different Amplatzer models and similar occluder in the treatment of patent foramen ovale (PFO). Patients with PFO complicated with cryptogenic stroke or migraine who underwent transcatheter closure of PFO in the First Affiliated Hospital of Nanjing Medical University from September 2019 to March 2021 were selected. Patients were grouped according to the type of occluder device. The basic data of the patients were collected and followed up within 1 year after occlusion. Effectiveness was defined as no recurrence of stroke/remission of migraine symptoms and a negative postoperative foaming test, and safety events were counted as the combined results of serious adverse events. A total of 92 patients were selected, including 45 cases in the symmetrical group and 47 cases in the asymmetric group. There were no serious adverse events in the 2 groups during follow-up. 3 days and 1 month after occlusion, the number of shunt patients in the asymmetric group was significantly less than that in the symmetric group (χ2 = 5.484, P = 0.019; χ2 = 5.146, P = 0.023). The negative rate of blocked residual shunts in the asymmetric group was higher than that in the symmetric group at 1, 3, 6 and 12 months after occlusion (χ2 = 6.473, P = 0.011; χ2 = 4.305, P = 0.038; χ2 = 4.842, P = 0.027; χ2 = 4.034, P = 0.045). Headache in migraine patients in the asymmetric group was significantly better than headache in patients in the symmetric group (P = 0.038; P = 0.049). Asymmetric Amplatzer and similar occluders provide greater efficacy in short-term occlusion than symmetric ones.

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.

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.

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

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.