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

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

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

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

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

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

Interventional closure of an iatrogenic LAA-perforation by means of a PFO-occluder.

Atrial fibrillation (AF) is the most common rhythm disorder with a high risk for cardioembolic strokes. Interventional occlusion of the left atrial appendage (LAA) is an alternative to the widely established stroke prevention with oral anticoagulation. Complications through LAA closure (LAAC) are rare and usually occur periinterventional. We present a case of an 87-year-old patient who presents for elective LAAC. After placement of the LAA occluder (Amplatzer Amulet device 25 mm) in the LAA and partial resheathing, the patient developed a pericardial effusion (PE), became hemodynamically unstable and went into cardiac arrest with the need for cardiopulmonary resuscitation (CPR). After drainage of the PE, we closed the causative LAA-perforation using a persistent foramen ovale (PFO)-occluder device (Amplatzer Talisman, 25 mm). Thereby we were able to successfully seal the perforation and stabilize the patient. The patient was monitored at our intensive care unit for 2 days and left the hospital in good condition a few days after. Procedural complications during interventional LAAC are rare but can be serious. The most common complication, PE, requires percutaneous drainage and often cardiac surgery. We present a case in which a perforation and following PE with hemodynamic relevance and need for CPR was resolved with an interventional strategy through implantation of a PFO-occluder into the perforation. With this approach we were able to show that in the right setting even serious complications can be treated by interventional measures, thereby not only saving the patient's life, but also avoiding cardiac surgery.

Left atrial appendage occlusion and patent foramen ovale closure using a steerable sheath and intracardiac echocardiography.

A patient presenting with acute ischemic stroke associated with patent foramen ovale (PFO) had concurrent deep vein thrombosis, pulmonary embolism, and new-onset atrial fibrillation. Upon initiation of anticoagulation therapy, the patient developed hemorrhagic transformation of the stroke. The patient's multiple potential sources of embolic stroke were treated with concomitant left atrial appendage occlusion and PFO closure through the PFO, made possible by using the Steerable Amulet Sheath under 3D-intracardiac echocardiography guidance.

Updates on Patent Foramen Ovale (PFO) Closure.

PURPOSE OF REVIEW: Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure. RECENT FINDINGS: PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups.

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

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

Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management.

This comprehensive review explores the incidence, pathophysiology, and management of atrial fibrillation (AF) following percutaneous closure of patent foramen ovale (PFO). Although AF is considered a common adverse event post PFO closure, its incidence, estimated at <5%, varies based on monitoring methods. The review delves into the challenging task of precisely estimating AF incidence, given subclinical AF and diverse diagnostic approaches. Notably, a temporal pattern emerges, with peak incidence around the 14th day after closure and a subsequent decline after the 45th day, mimicking general population AF trends. The pathophysiological mechanisms behind post PFO closure AF remain elusive, with proposed factors including local irritation, device-related interference, tissue stretch, and nickel hypersensitivity. Management considerations encompass rhythm control, with flecainide showing promise, and anticoagulation tailored to individual risk profiles. The authors advocate for a personalized approach, weighing factors like age, comorbidities, and device characteristics. Notably, postclosure AF is generally considered benign, often resolving spontaneously within 45 days, minimizing thromboembolic risks. Further studies are required to refine understanding and provide evidence-based guidelines.

Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail.

BACKGROUND: Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates. METHODS: The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements. CONCLUSION: The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).

Patent foramen ovale closure versus drug therapy in patients over 60 years and a follow-up of 5 years.

BACKGROUND: The advantages of patent foramen ovale (PFO) closure as protection from a recurrence of stroke remains controversial compared to drug therapy, especially in patients over 60 years. HYPOTHESIS: The aim of the study is to compare recurrence of stroke in patients over 60 years old with PFO closure versus drug therapy alone. METHODS: We included 342 patients over 60 years who suffered a crytopgenic stroke, and were also accepted for a PFO closure. 199 patients refused a PFO closure and were treated with medical therapy alone, whereas 143 patients underwent a PFO closure procedure. RESULTS: The mean follow up time was 5.5 ± 1.5 years. All patients in Group B showed persistent shunt in the follow-up period (n = 199, 100%). In Group A, seven patients were diagnosed with residual shunt during echocardiography examination (5%). A new onset of atrial fibrillation occurred in seven patients in Group A (5%) and six patients in Group B (3%), p = .117. Recurrent stroke occurred in 3 patients in Group A (2%) and 11 patients in Group B (6%), p = .021. One patient died of unknown reason (1%) and two patients were lost due to neurological death (1%) in Group B, whereas no patients in Group A died during the follow-up period. CONCLUSION: Our results show that strict exclusion of patients over 60 years from PFO closure should be reconsidered. As life expectancies are increasing, patients should be considered for same treatment as younger patients, since the outcomes are improved compared to patients treated with medical therapy alone.

Paradoxical Embolic Stroke Following Percutaneous Transluminal Angioplasty in a Hemodialysis Patient.

Paradoxical embolism is a medical condition characterized by the migration of an embolus from a venous source into the systemic circulation. This occurs through a specific cardiac abnormality known as a right-to-left shunt, ultimately resulting in the possibility of arterial embolism. Patent foramen ovale (PFO) is the most common cause of intracardiac shunting. We reported a rare case of a 56-year-old man on hemodialysis with PFO and arteriovenous fistula dysfunction who suffered a paradoxical embolic ischemic stroke after percutaneous transluminal angioplasty. This case emphasized the potential risk of paradoxical embolism in hemodialysis patients with vascular access problems. We aimed to highlight the importance of searching for PFO, as it may serve as a possible source of embolism in these patients.

Various techniques for transcatheter retrieval of the atrial septal defect or patent foramen ovale closure devices: a systematic review.

Atrial septal abnormalities are common congenital lesions that remain asymptomatic in many patients until adulthood. Adults with atrial septal defects (ASD) most commonly have ostium secundum ASD. Transcatheter closure has become increasingly popular in recent years as a successful alternative method to surgery for treating ASD and patent foramen ovale (PFO). The overall rate of ASD transcatheter closure device embolization has been reported to be less than 1%; however, retrieving the device via surgery or by trans-catheter route can be necessary. The current manuscript describes a systematic review of the techniques used to retrieve ASD closure devices, as well as their success rates, complications, and limitations. A comprehensive search was performed covering various databases including PubMed, MEDLINE, SCOPUS, Google Scholar, and Cochrane Library from inception until April 2022 for English-published case reports, case series, and experimental studies investigating the indications, safety, and limitations of ASD closure and ASD device retrieval by trans-catheter approaches. Finally, 20 studies were included in our review. Our findings showed that most of the studies used a single snare technique; of these, all but one reported 100% success. Double tool retrieval methods (snare plus snare, snare plus bioptome, or snare plus forceps) and the gooseneck snare technique yielded 100% success. One study that used the lasso technique reported unsuccessful retrieval and the need for surgical intervention. More recently, the novel "coronary wire trap technique" was introduced, which provides a simpler method for embolized device removal by trapping the device for retrieval using coronary wire.

Flecainide to prevent atrial arrhythmia after patent foramen ovale closure, Rationale and design of the randomized AFLOAT study.

INTRODUCTION: Atrial arrhythmia is the most common complication of patent foramen ovale (PFO) closure. The real incidence of post-PFO closure atrial arrhytmia and whether this complication can be prevented is unknown. METHODS/DESIGN: The Assessment of Flecainide to Lower the PFO closure risk of Atrial fibrillation or Tachycardia (AFLOAT) trial is a prospective, national, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the endpoints (PROBE design). A total of 186 patients are randomized in a 1:1:1 ratio immediately after PFO closure to receive Flecainide (150 mg per day in a single sustained-release (SR) dose) for 6 months (Group 1), Flecainide (150 mg per day in a single SR dose) for 3 months (Group 2), or no additional treatment (standard of care) for 6 months (Group 3). The primary endpoint is the percentage of patients with at least one episode of symptomatic or asymptomatic atrial arrhythmia episode (≥30 s) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. Whether 3 months of treatment is sufficient compared to 6 months will be analysed as a secondary objective of the study. CONCLUSION: AFLOAT is the first trial to test the hypothesis that a short treatment with oral Flecainide can prevent the new-onset of atrial arrhythmia after PFO closure. CLINICAL TRIAL REGISTRATION: NCT05213104 (clinicaltrials.gov).