Percutaneous Patent Foramen Ovale Closure Research Articles

Device-Associated Left Atrial Thrombosis Despite Oral Anticoagulation After Percutaneous Patent Foramen Ovale Closure

Device-Associated Left Atrial Thrombosis Despite Oral Anticoagulation After Percutaneous Patent Foramen Ovale Closure

Interatrial Septal Tear After Patent Foramen Ovale Closure With the NobleStitch Device

A 46-year-old woman underwent percutaneous patent foramen ovale closure at another institution for recurrent cerebral transient ischemic attacks in the context of hereditary thrombophilia. Because anatomy was considered appropriate, the novel suture-based “deviceless” NobleStitch EL (Kardia,

The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

Closing the gap on patent foramen ovale and cryptogenic stroke

ABSTRACTIntroduction: The treatment options for prevention of recurrent of cryptogenic stroke in patients with patent foramen ovale (PFO) have been intensely debated in the recent decades. The suggested options were percutaneous closure of PFO versus medical therapy. However, up to these date there is a controversy regarding the indication of percutaneous closure. Multiple meta-analysis and recent randomized control trials showed the benefit of PFO closure when compared with medical therapy alone.Areas covered: The article reviews the prevalence, physiology, diagnosis and treatment options of PFO after cryptogenic stroke. Furthermore, it will discuss the results of randomized control trials that compared the PFO closure to medical therapy.Expert opinion: The association between PFO and unexplained cryptogenic stroke has been well established in the multiple studies. The diagnosis and management of PFO might be challenging in some cases. Although multiple studies showed that PFO closure is associated with lower rates of recurrent stroke in patients presenting with cryptogenic stroke, the indication and patient selection for this intervention are not well established yet in the guidelines.

Percutaneous closure of patent foramen ovale under transthoracic echocardiography guidance-midterm results.

Conventional percutaneous closure of patent foramen ovale (PFO) is usually performed under the guidance of fluoroscopy. Whether closure of PFO under transthoracic echocardiography (TTE) guidance only is safe and effective is unknown. The present study therefore aimed to assess the safety and efficacy of percutaneous closure of PFO under TTE guidance only. This study retrospectively enrolled a total of 52 consecutive patients (55.8% male, mean age 34.0±13.0 years, range, 10-59 years) with PFO treated at our institution from June 2015 to September 2017 by percutaneous closure under echocardiographic guidance only. The patients mean body weight was 58.7±10.8 kg. Patients underwent follow-up by TTE immediately post procedure by electrocardiogram and TTE at 1, 3, 6 and 12 months after discharge and annually thereafter, and by clinical evaluation at all time points. Of the 52 patients, 47 (90.4%) were successfully treated by percutaneous closure under TTE guidance. The mean procedure duration (from puncture to sheath removal) was 21.0±6.2 (range, 11-33) minutes. A trivial residual shunt which disappeared 24 hours later was observed in only 1 (1.9%) patient immediately post procedure. Median hospital stay was 3.0 days without severe complications such as peripheral vascular injury or cardiac perforation at discharge. At median 15.5 (11.3, 18.0) months follow-up, there were no complications such as death, stroke, transient ischemic attack (TIA) and residual shunt. In this single center study of mostly lean patients, percutaneous closure of PFO under TTE guidance as the only imaging tool appeared effective at midterm follow-up, while avoiding radiation exposure, endotracheal intubation and contrast agent use.

Patent Foramen Ovale Treatment Strategies Correspond to an Index Predicting Pathogenicity

Background: Percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic stroke (CS) may reduce the risk of recurrent stroke. By performing closure only in those with high risk of recurrent PFO related strokes, patient selection may be improved. The Risk of Paradoxical Embolism (RoPE) score is a point-based index developed to estimate the probability that the index CS was attributable to patent foramen ovale. We aimed to evaluate whether management strategies using conventional clinical judgement for patients with CS and PFO corresponded with RoPE scores.Methods: We performed a single-centre retrospective chart review of adult patients with CS or transient ischemic attack who were evaluated for PFO closure from January 1, 2011 to December 31, 2017. Patients were categorized based on the treatment strategy of percutaneous closure or medical management. RoPE scores were computed and clinical outcomes evaluated.Results: A total of 154 patients were included: 63 patients underwent percutaneous closure and 91 patients were treated medically. Mean RoPE scores for closure and medical groups were 6.9±1.5 and 4.7±1.9, respectively (p<0.001). For patients who underwent percutaneous closure, successful device delivery was achieved in all patients and there were no immediate complications.Conclusion: In this single-centre study, patients selected for percutaneous PFO closure based on conventional clinical judgement were more likely to have elevated PFO attributable risk, based on the RoPE score.

“Liver or Let Die”: Percutaneous PFO Closure Through Hepatic Vein Access

A 73-year-old farmer presented with platypnoea-orthodeoxia syndrome (POS). A transoesophageal echocardiogram (TOE) disclosed a patent foramen ovale (PFO) with significant right-to-left shunt on assuming upright posture. An initial attempt at PFO closure through the femoral vein was abandoned due to a completely occluded inferior vena cava. A second attempt through the internal jugular vein was also unsuccessful due to the steep angulation between superior vena cava and septum primum flap. Because of disabling symptoms, an attempt through a hepatic vein (HV) was scheduled and performed under general anaesthesia with TOE guidance. Ultrasound-guided access through an intercostal window to a peripheral HV was performed and the position confirmed with contrast injections. The PFO was easily crossed with a glide wire which was exchanged to a stiffer guide wire. A 25mm closure device was successfully deployed across the PFO. After retrieval of the delivery system, haemostasis of the HV was attained with a contrast-guided Gelfoam (Pfizer, New York, NY, USA) injection. Unfortunately, the patient had to undergo subsequent emergency coiling to an iatrogenically injured hepatic artery branch leading to full recovery and significant clinical improvement. Subsequent echocardiography demonstrated a well-positioned device with no residual shunt. This case illustrates that percutaneous PFO closure through a HV is a feasible procedure and should be considered in anatomy that is otherwise prohibitive for conventional approach. Extra care should be taken with initial vascular access into the HV and final haemostasis of the access site.

Cost-effectiveness of percutaneous closure of a patent foramen ovale compared with medical management in patients with a cryptogenic stroke: from the US payer perspective

Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60 years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability.Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%.Results: At 5 years, overall costs and quality-adjusted life-years (QALYs) obtained from PFO closure compared with medical management were $16,323 vs $7,670 and 4.18 vs 3.77, respectively. At 5 years, PFO closure achieved an ICER of $21,049, beneficially lower than the conventional threshold of $50,000. PFO closure reached cost-effectiveness at 2.3 years (ICER = $47,145). Applying discount rates of 0% and 6% had a negligible impact on base-case model findings. Furthermore, PFO closure was 95.4% likely to be cost-effective, with a willingness-to-pay (WTP) threshold of $50,000 and a 5-year time horizon.Limitations: From a cost perspective, our economic model employed a US patient sub-population, so cost data may not extrapolate to other non-US stroke populations.Conclusion: Percutaneous PFO closure plus medical management represents a cost-effective approach for lowering the risk of recurrent stroke compared with medical management alone.

Insertable cardiac monitor detection of silent atrial fibrillation in candidates for percutaneous patent foramen ovale closure.

An underlying atrial vulnerability or a preexisting misdiagnosed atrial fibrillation in some patients who are candidates for patent foramen ovale (PFO) closure may lead to an unnecessary percutaneous intervention. The aim of this work was to define paroxysmal atrial fibrillation rate, through a 6-month insertable loop-recorder monitoring, in patients over 55 years old with cryptogenic stroke and PFO. PFO closure criteria: significant right-to-left shunt and at least one high-risk feature (permanent right-to-left shunt, atrial septal aneurysm, prominent Eustachian valve, recurrent brain ischemia, previous deep vein thrombosis, thrombophilia). Insertable cardiac monitoring criteria: previous cryptogenic stroke, more than 55 years and at least one atrial fibrillation risk factor (heart failure, hypertension, age older than 65 years, diabetes, atrial runs, left atrium dilatation, left ventricle hypertrophy, pulmonary disease, thyroid disease, obesity). Atrial fibrillation detection threshold: arrhythmia duration longer than 5 min. From January 2008 to March 2017, 195 patients underwent to loop-recorder monitoring. A total of 70 (36%) patients were candidates for PFO closure. The 6-month silent atrial fibrillation rate was 11.4%. In the arrhythmia-free cohort, 28 patients (45.2%) underwent percutaneous foramen ovale closure (group A) and 34 (54.8%) were medically treated (group B). Atrial fibrillation detection rate was 14.3% in group A and 0% in group B. The 36-month atrial fibrillation-free survival was 76%. An occult preexisting atrial fibrillation may lead to unnecessary percutaneous foramen ovale closure in a significant proportion of patients. A 6-month loop-recorder monitoring may improve the patient oriented decision-making.

New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials.

New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials.

SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke: The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists.

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high-quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi-disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient-centered care.

The Fragility Index in Randomized Controlled Trials for Patent Foramen Ovale Closure in Cryptogenic Stroke

Background and Purpose: The routine use of percutaneous transcatheter patent foramen ovale closure (PPFOC) to prevent recurrent stroke in patients with cryptogenic stroke is still a matter of debate after completion major randomized controlled trials (RCTs). Methods: The fragility index of RCTs evaluating effect of PPFOC against medial therapy alone in stroke prevention was calculated to assess the robustness of statistically significant findings. Results: Literature search with PubMed identifies 6 RCTs on PPFOC. Median number of patients who underwent PPFOC and medical treatment were 340 and 229, respectively. Median number of the patients lost to follow-up was 20 in PPFOC and 18 in medical group. Fragility index was 0 for 4 studies. Median fragility index was also 0 for both “stroke” (interquartile range: 0-5.3) and “combined stroke and TIA” (interquartile range: 0-2) endpoints. In all studies except CLOSE, fragility index was smaller than or equal to the number of the subjects lost to follow-up. Conclusions: Recent positive results of PFO closure studies should be interpreted cautiously because of their fragile characteristics. Routine PFO closure should be reserved for prevention of recurrence when suspicion for paradoxical embolism is high. Detailed individualized decision-making is crucial before ordering PPFOC for stroke prevention in patients with cryptogenic embolism.

Percutaneous transcatheter closure of high-risk patent foramen ovale in the elderly

The efficacy of percutaneous transcatheter closure for preventing recurrent cerebrovascular events in elderly patients with high-risk patent foramen ovale (PFO) remains unclear, whereas in young patients, it has been shown to effectively prevent the recurrence of embolic stroke. The aim of this study was to investigate the safety and efficacy of percutaneous PFO closure in elderly patients with high-risk PFO. Between September 2012 and October 2018, 14 patients ≥ 60 years old with high-risk PFO underwent percutaneous closure to prevent recurrence of cerebrovascular events. The primary end point was recurrence of cerebrovascular events after closure in elderly patients with high-risk PFO, and the secondary end points were occurrence of device-related complications, cerebral hemorrhage, and new-onset atrial fibrillation (AF). The mean patient age and number of cerebrovascular events before closure were 75.2 ± 6.5 years and 1.7 ± 0.7, respectively. All procedures were successfully performed under general anesthesia by transesophageal echocardiography and using a 25-mm Amplatzer Cribriform device. No procedure-related complications occurred. Patients were followed up for a mean 2.6 ± 1.8 years. No patients experienced device-related complications or recurrent cerebrovascular events. However, one patient had AF-related device closure complications at 1 month postoperatively. In addition, other patient had a cerebral hemorrhage with unknown relationship to PFO closure 3 years postoperatively. Percutaneous closure of high-risk PFO in elderly patients may be as effective and safe as in younger patients. It is crucial to evaluate PFO morphology regardless of age in cases of paradoxical embolism.

Patent foramen ovale closure: how to choose the right device for the right patient

Percutaneous patent foramen ovale (PFO) closure is an intervention aimed to prevent cardioembolic stroke. It recently proved to be superior to antiplatelet therapy in preventing recurrent strokes in a well-selected population of patients with a previous cryptogenic cerebral ischemic event. A large part of the clinical advantage of PFO transcatheter therapy derives from the very high efficacy and safety of the maneuver. Various types of devices with different characteristics are currently available for the use of the interventionists. Recently, a direct PFO suture device has been added to the device list, allowing for PFO closure without implanting any prosthesis. This article describes the procedure of PFO closure with a particular focus on the main characteristics of the various devices available. A road-map of choice among the various prostheses is also provided, keeping in mind the patient's clinical features and the various PFO anatomies.

A CURIOUS CASE OF POST-TUSSIVE PARADOXICAL PARALYSIS

40-50% of cryptogenic strokes are found to have a patent foramen ovale (PFO) which are seen in 20% of the population. Newer evidence is warranting a change in management of cryptogenic strokes via percutaneous closure of PFO's. A 23 year old male presented with a coughing spell that led to a

CASES OF PULMONARY ARTERIOVENOUS MALFORMATIONS DISCOVERED DURING PATENT FORAMEN OVALE CLOSURE

A patent foramen ovale (PFO) is present in 25-34% of adults and may allow paradoxical embolization of venous thrombi leading to cerebral vascular accidents (CVA). In 2017, three trials of percutaneous closure of PFO in younger patients with cryptogenic strokes demonstrated a reduction in recurrent

Patent Foramen Ovale Closure in 2019.

Patent foramen ovale (PFO) is a common abnormality affecting between 20% and 34% of the adult population. For most people it is a benign finding; however, in some the PFO can open widely, enabling a paradoxical embolus to transit from the venous to arterial circulation, which is associated with stroke and systemic embolisation. Percutaneous closure of PFO in patients with cryptogenic stroke has been undertaken for a number of years, and a number of purpose-specific septal occluders have been marketed. Recent randomised controlled trials have demonstrated that closure of PFO in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke. After a brief overview of the anatomy of a PFO, this review considers the evidence for PFO closure in cryptogenic stroke. The review also addresses other potential indications for closure, including systemic embolisation, decompression sickness, platypnoea-orthodeoxia syndrome and migraine with aura. It lays out the pre-procedural investigations and preparation for the procedure. Finally, it gives an overview of the procedure itself, including discussion of closure devices.

Provocative maneuvers to improve patent foramen ovale detection: A brief review of the literature.

Patent foramen ovale (PFO) is the most common type of inter-atrial shunt, with prevalence as high as 30%. Detection of PFO has implications in patients with stroke, peripheral embolism, decompression illness, and other conditions. Transesophageal echo (TEE) with saline contrast injection is the current standard for PFO detection, but even with TEE, PFOs are sometimes missed. With advances in percutaneous PFO closure therapies and proven long-term benefit of closure, accurate PFO detection takes on cardinal importance. Various provocative maneuvers to enhance PFO detection are in clinical use and have been studied. The Valsalva maneuver has long-held position as the ideal provocation to unmask PFO, but other maneuvers such as cough, sniff, Müller's, and more have gained relevance. In this article, we will examine various maneuvers and discuss their utility in PFO detection.

Amplatzer patent foramen ovale occluder: safety and efficacy

ABSTRACTIntroduction: The patent foramen ovale (PFO) is a common anatomical variant in humans (prevalence 25%). Most often asymptomatic, it may engender paradoxically embolic strokes, myocardial infarctions, or visceral or peripheral ischemia. It is causatively related to migraine, positional or exertional hypoxemia with dyspnea, diving incidents, high altitude edema, and sleep apnea. Percutaneous closure of atrial septal defects was first performed in the seventies. A dedicated PFO occluder (Amplatzer PFO Occluder) was first used on 10 September 1997 by Kurt Amplatz and Bernhard Meier. Since, percutaneous PFO closure has evolved into one of the most common and the simplest and safest catheter-based intervention in adult cardiology. Randomized studies have proved its benefit for prevention of recurrent ischemic events (particularly strokes) in patients without competing stroke etiology. There are also supportive clinical data for PFO closure in other situations.Areas covered: The Amplatzer PFO Occluder, the first, most implanted, and best-studied PFO occluder, is reviewed, presenting implantation technique, possible complications, and pertinent scientific data of efficacy and safety.Expert commentary: Percutaneous PFO closure has grown to one of the most common procedures in interventional cardiology. Implantation of the Amplatzer PFO Occluder is simple, safe, and effective.

Results From the First Hundred Percutaneous Patent Foramen Ovale Closures in Christchurch

Results From the First Hundred Percutaneous Patent Foramen Ovale Closures in Christchurch