Migraine headache relief after transcatheter closure of patent foramen ovale

OBJECTIVES: The purpose of this study was to determine the effects of transcatheter patent foramen ovale (PFO) closure on migraine frequency in patients with paradoxical cerebral embolism. BACKGROUND: The prevalence of migraine headache is higher in cryptogenic stroke patients with PFO than in the general population. Previous studies have suggested that closure of the PFO may reduce migrainous symptoms. METHODS: Between April 2001 and December 2003, 162 consecutive patients with paradoxical cerebral embolism underwent transcatheter PFO closure for prevention of recurrent cryptogenic stroke or transient ischemic attack. A one-year retrospective analysis of migraine symptoms before and after PFO closure was performed. RESULTS: Active migraine was present in 35% (57 of 162) of patients, and 68% (39 of 57) experienced migrainous aura; 50 patients were available for analysis at one year. Complete resolution of migraine symptoms occurred in 56% (28 of 50) of patients, and 14% (7 of 50) of patients reported a significant (>or=50%) reduction in migraine frequency. Patients reported an 80% reduction in the mean number of migraine episodes per month after PFO closure (6.8 +/- 9.6 before closure vs. 1.4 +/- 3.4 after closure, p < 0.001). Results were independent of completeness of PFO closure at one year. CONCLUSIONS: In patients with paradoxical cerebral embolism, migraine headaches are more frequent than in the general population, and transcatheter closure of the PFO results in complete resolution or marked reduction in frequency of migraine headache.     

Transcatheter closure of patent foramen ovale in patients with cerebral ischemia

OBJECTIVES: The present study was conducted to determine the safety of the transcatheter closure of a patent foramen ovale (PFO) in patients with cryptogenic cerebral ischemia and the midterm follow-up of recurrent thromboembolic events after interventional PFO closure. BACKGROUND: Current therapeutic options for stroke prevention in patients with PFO and a history of thromboembolic events include chronic antithrombotics and more invasive treatments such as surgical closure or minor invasive transcatheter permanent closure of the PFO. Promising preliminary and pilot data with the Amplatzer Septal Occluder or the PFO-Star Occluder have been reported. Systematic and long-term data are still missing. METHODS: A total of 276 consecutive patients with a PFO and a history of at least one thromboembolic event were recruited in four medical centers and underwent percutaneous PFO closure with the PFO-Star device. Follow-up data were analyzed over an average of 15.1 months, equivalent to 345 patient-years. RESULTS: The implantation was successful in all 276 patients. Peri-interventional reversible complications included transient ST-segment elevations (1.8%) and transient ischemic attack (TIA) (0.8%). Two devices have been removed surgically. During follow-up the annual recurrence rate of thromboembolic events was 1.7% for TIA, 0% for stroke and 0% for peripheral emboli. CONCLUSIONS: Interventional PFO closure with the PFO-Star device appears to be a reliable and promising technique resulting in a low recurrence rate of thromboembolic events, especially stroke in patients with a history of cryptogenic ischemia presumably due to paradoxical embolization. To our knowledge, this is the largest coherent and prospective study for interventional PFO closure.     

Patent Foramen Ovale Closure vs Medical Therapy for Stroke Prevention: Meta-analysis of Randomized Trials and Review of Heterogeneity in Meta-analyses

Background

Patent foramen ovale (PFO) might be a risk factor for unexplained (“cryptogenic”) stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke.

Methods

We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed.

Results

Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09).

Conclusions

Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks.     

PFO and paradoxical embolism producing events other than stroke

Background: A patent foramen ovale (PFO) is a risk factor for cerebral events such as cryptogenic stroke, transient ischemic attacks, and migraine headaches. Far less commonly, PFO is associated with non‐cerebral, paradoxical systemic embolic events such as myocardial infarction (MI), renal infarct, and limb ischemia. This report details the incidence of systemic paradoxical emboli at our institution. Methods: 416 patients were referred for evaluation of PFO related conditions from 2001 to 2009. Clinical history and medical records of the patients were reviewed for incidence of cryptogenic stroke, transient ischemic attack (TIA), migraine headache, arterial desaturation, and noncerebral systemic embolism. Results: As the primary presenting symptom, 219 patients had a diagnosis of cryptogenic stroke, 38 patients had migraine headaches, and 80 patients had transient neurologic deficits consistent with a TIA or complex headache. Twelve patients (2.9% of the total population) presented with a presumptive diagnosis of systemic embolism. Eight of these patients had acute MI diagnosed by elevated cardiac biomarkers, electrocardiogram changes, and/or imaging evidence of a left ventricular wall motion abnormality, without evidence of obstructive coronary disease on angiography. Four patients had evidence of peripheral embolism to a systemic artery, including the popliteal artery, ophthalmic artery, and brachial artery. PFO closure was performed in 197 patients (47.4% of the total population), including eight patients in the systemic embolism group. All closure procedures were successful. Conclusion: Although most paradoxical emboli travel to the brain, noncerebral paradoxical embolism is also associated with PFO. In addition to embolism of thrombus, there may be paradoxical passage of vasoactive chemicals that induce intense coronary spasm and myocardial infarction. Diagnosis is often challenging, given the lack of definitive criteria and the need to exclude other potential etiologies. © 2011 Wiley‐Liss, Inc.     

Transcatheter closure of patent foramen ovale: Current evidence and future perspectives

Recent prospective controlled studies have demonstrated that transcatheter closure of a patent foramen ovale (PFO) reduces recurrent stroke risk in select patients, especially in patients younger than 60 years with PFO and embolic-appearing infarct and where no other mechanism of stroke was identified. Detection of PFO depends on the intensity of the Valsalva maneuver, and not all PFOs can be diagnosed using transesophageal echocardiography. Transthoracic contrast echocardiography using abdominal compression during the Valsalva maneuver is an easy method that can increase the detection sensitivity of PFO shunt. PFO with two or more of the following factors is most likely considered a “high-risk PFO” and as such, has a significantly higher probability of cryptogenic stroke: (1) a long-tunnel PFO (≥10 mm in length), (2) atrial septal aneurysm and/or hypermobile interatrial septum, (3) prominent Eustachian valve or Chiari’s network, (4) large right-to-left shunt at rest and during the Valsalva maneuver, and (5) low-angle PFO. In order to establish the benefit of catheter-based PFO closure as a safe and effective treatment in clinical practice, the degree of accuracy of PFO diagnosis and its long-term safety need to be confirmed.     

Closing patent foramen ovale in cryptogenic stroke: The underscored importance of other interatrial shunt variants

Recent trials and metanalysis even not fully conclusive and still debated, at least suggested that mechanical device-based closure of patent foramen ovale (PFO) is more effective than medical therapy in prevent recurrence of stroke. In a proportion ranging from 20% to nearly 40% of patients in literature, PFO is associated to atrial septal aneurysm (ASA): ASA is a well-known entity often associated with additional fenestration. Additionally small atrial septal defects (“Flat ASD”) can present with signs of paradoxical embolism and cannot be easily detected by transthoracic echocardiography or even by transesophageal echocardiography and are usually discovered by intracardiac echocardiography at the moment of transcatheter closure. This evidence might change potentially the anatomical diagnosis from PFO to fenestrated ASA or as we called it to “hybrid defect”, being a bidirectional flow through a small ASD or/and an additional fenestration, often present. Despite the differences in anatomy, pathophysiology and haemodynamic paradoxical embolism may occur in both entities and also may be the first appearance of fenestrated ASA. Because some overlapping do really exist between PFO and hybrid defects, which are often not clearly differentiable by standard diagnostic tools, it is likely that a proportion of patients evaluated for potential transcatheter closure of PFO had actually a different anatomical substrate. These different anatomical and pathophysiologic entities have not been address in any of the previous trials, potentially having an impact on overall results despite the similar mechanical treatment. Neurologists and general cardiologists in charge of clinical management of PFO-related cryptogenic stroke should be aware of the role of hybrid defects in the pathophysiology of paradoxical embolism - mediated cerebral ischemic events in order to apply the correct decision - making process and avoid downgrading of patients with paradoxical embolism-related interatrial shunt variants different from PFO.     

卵圆孔未闭与原因不明性卒中

流行病学研究显示,原因不明性卒中患者中的卵圆孔未闭(patent foramen ovale,PFO)患病率显著高于普通人群,二者之间的密切联系支持反常性栓塞为卒中病因的假说.然而,在原因不明性卒中患者中,单纯检测到PFO并不能确立反常性栓塞的诊断.当PFO与其他一些因素共存时,会显著增高缺血性卒中风险.一些研究显示,伴有PFO的原因不明性卒中患者的MRI病灶模式与无PFO者并无显著差异,特别是多发性缺血灶,因此不支持反常性栓塞作为PFO患者卒中病因的理论.PFO的检测方法包括经胸壁超声心动图、经食管超声心动图(transesophageal echocardiography,TEE)和经颅多普勒(transcranial Doppler,TCD).TCD与TEE具有良好的一致性,因此应被推荐为一种简单、无创和可靠的技术,而TEE仅应在经过选择的患者中进行.PFO的治疗选择包括抗血小板药、抗凝药、经皮血管内封堵术和开胸手术.在几项重要的大样本随机对照试验完成之前,对于伴有PFO的原因不明性卒中患者,经皮封堵术仅应考虑用于治疗在接受内科治疗过程中仍然出现复发性事件、对内科治疗存在禁忌证以及某些高危解剖学风险的PFO.     

卵圆孔未闭与原因不明性卒中

流行病学研究显示,原因不明性卒中患者中的卵圆孔未闭(patent foramen ovale,PFO)患病率显著高于普通人群,二者之间的密切联系支持反常性栓塞为卒中病因的假说.然而,在原因不明性卒中患者中,单纯检测到PFO并不能确立反常性栓塞的诊断.当PFO与其他一些因素共存时,会显著增高缺血性卒中风险.一些研究显示,伴有PFO的原因不明性卒中患者的MRI病灶模式与无PFO者并无显著差异,特别是多发性缺血灶,因此不支持反常性栓塞作为PFO患者卒中病因的理论.PFO的检测方法包括经胸壁超声心动图、经食管超声心动图(transesophageal echocardiography,TEE)和经颅多普勒(transcranial Doppler,TCD).TCD与TEE具有良好的一致性,因此应被推荐为一种简单、无创和可靠的技术,而TEE仅应在经过选择的患者中进行.PFO的治疗选择包括抗血小板药、抗凝药、经皮血管内封堵术和开胸手术.在几项重要的大样本随机对照试验完成之前,对于伴有PFO的原因不明性卒中患者,经皮封堵术仅应考虑用于治疗在接受内科治疗过程中仍然出现复发性事件、对内科治疗存在禁忌证以及某些高危解剖学风险的PFO.     

Does patent foramen ovale promote cryptogenic stroke and migraine headache?

Cryptogenic stroke is a diagnosis of exclusion. These are strokes that occur in people who are usually less than 55 years old, without an identifiable cause. Our sensitivity to these events has been heightened because of the new definitions of a transient ischemic attack. Transient ischemic attack (TIA) is a clinical diagnosis of a neurologic deficit without MRI abnormalities: if there is an MRI abnormality, whether or not that person is symptomatic, it is now defined as a stroke. With these new definitions, and the sensitivity of MRI, we are seeing more cryptogenic strokes. It has been hypothesized that many cryptogenic strokes are caused by small emboli that travel from the legs to the right atrium; during straining (such as a Valsalva maneuver) these emboli can go across a PFO into the left atrium and then travel to the brain, producing a stroke. The problem is that these are very small emboli, approximately 1 to 3 mm, and we can't actually show these small emboli crossing from right to left. However, large emboli have been observed by echocardiography to be trapped in the PFO. So the diagnosis of cryptogenic stroke is a diagnosis of exclusion that is impossible to verify. What is the scope of the problem? Of the 700,000 strokes per year in the United States, 80% of them are ischemic, and 20% of those are defined as cryptogenic. The prevalence of PFO among this cryptogenic stroke population is about 40% to 50%; in the general population, it's only about 20%. Current estimates are that somewhere between 30,000 and 60,000 strokes per year in the U.S. are caused by paradoxical embolism through a PFO. There are some other fascinating associations: scuba divers with PFOs are more susceptible to decompression illness. Platypnea-orthodeoxia is a condition of desaturation that occurs when you're standing up but not when you're lying down; these patients are quite symptomatic, with arterial saturations in the low 80s. They also frequently have PFOs; if you close the PFO, the arterial desaturation is alleviated. Fat emboli during orthopedic surgery or air emboli during neurosurgery may also travel through the venous system. If you don't have a PFO, the fat or the air is trapped in the lungs and doesn't cause much of a problem unless it's massive; but if you have a PFO, then the embolus can go from right to left atrium up to the brain, with devastating neurologic consequences.     

Multidisciplinary assessment of PFO with substantial right‐to‐left shunting and medium‐term follow‐up after PFO device closure: A single‐center experience

Objectives

To describe the multidisciplinary assessment of patent foramen ovale (PFO) with substantial right‐to‐left shunting (RLS) and medium‐term follow‐up after PFO closure for stroke or transient ischemic attack (TIA).

Background

PFO closure is a therapeutic option to prevent recurrent ischemic event in patients with cryptogenic stroke and TIA. The apparent lack of benefit seen in previous studies was in part due to the inclusion of patients with alternate mechanisms of stroke/TIA. However, the long‐term follow‐up results of RESPECT trial confirmed that PFO closure could reduce the recurrence rate of stroke compared to medical therapy. The obvious difference between RESPECT and the other studies is that RESPECT recruited more relevant patients with substantial RLS.

Methods

From May 2013 to October 2015, all subjects diagnosed as cryptogenic stroke or TIA with substantial RLS who underwent PFO closure at our institution were included. All patients underwent multidisciplinary assessment to exclude stroke/TIA with definite etiology. Baseline characteristics, clinical manifestations, procedural, and follow‐up data were reviewed.

Results

A total of 219 consecutive patients with substantial RLS undergoing PFO closure were identified. There were no procedure‐related deaths, strokes, or TIA. Mean follow‐up was 2.0 ± 0.7 years. Early residual shunting was visible in 9 patients (4.1%); however, during follow‐up, only 3 patients (1.4%) had residual RLS detected by contrast transthoracic echocardiography (cTTE). The annual risk of recurrent ischemic stroke or TIA was 0.457%.

Conclusions

PFO closure can be performed safely and effectively in patients with cryptogenic stroke or TIA. In selected patients with substantial RLS, following appropriate multidisciplinary assessment, excellent results with low incidence of recurrent events may be achieved.     

Platypnea-orthodeoxia syndrome in a patient with a pre-existing patent foramen ovale successfully treated with an atrial septal occluder

Platypnea orthodeoxia syndrome is associated with dyspnea and arterial oxygen desaturation accentuated by an upright posture. It can be secondary to an intracardiac shunt. We report a case of platypnea-orthodeoxia syndrome (POS) in a 58-year old male patient who had a pre-existing patent foramen ovale (PFO) and substantial pulmonary pathologies. He was successfully treated by percutaneous transcatheter closure of the PFO. Our case highlights the importance of recognition of this rare syndrome in patients who present with unexplained hypoxia for whom transcatheter closure of the interatrial shunt can be safely carried out.     

Percutaneous Closure of Patent Foramen Ovale in Patients with Cryptogenic Stroke — An Updated Comprehensive Meta-Analysis

BackgroundThe ideal treatment strategy for patients with cryptogenic stroke and patent foramen ovale (PFO) is not yet clear. Previous randomized controlled trials (RCTs) comparing transcatheter PFO closure with medical therapy in patients with cryptogenic stroke to prevent recurrent ischemic stroke showed mixed results. This meta-analysis aims to compare rates of recurrent stroke, transient ischemic attack (TIA) and all-cause mortality with PFO closure and medical therapy vs. medical therapy alone.MethodsPubMed and the Cochrane Center Register of Controlled Trials were searched for studies published through June 2018, comparing PFO closure plus medical therapy versus medical therapy alone. Six RCTs (n = 3750) comparing PFO closure with medical therapy were included in the analysis. End points were recurrent stroke, TIA and all-cause mortality. The odds ratios (OR) with 95% confidence interval (CI) were computed and p < 0.05 was considered as a level of significance.ResultsA total of 1889 patients were assigned to PFO closure plus medical therapy and 1861 patients were assigned to medical therapy only. Risk of recurrent stroke was significantly lower in the PFO closure plus medical therapy group compared to medical therapy alone. (OR 0.47, 95% CI 0.33–0.67, p < 0.0001). Rate of TIA was similar between the two groups (OR 0.76, 95% CI 0.52–1.14), p = 0.18). There was no difference in all-cause mortality between two groups (OR 0.73, CI 0.33–1.58, p = 0.42). Patients undergoing PFO closure were more likely to develop transient atrial fibrillation than medical therapy alone (OR: 5.85; CI: 3.06–11.18, p ≤0.0001) whereas the risk of bleeding was similar between the groups (OR: 0.93; CI: 0.55–1.57, p = 0.78).ConclusionsThe results of this meta-analysis suggest that transcatheter closure of PFO plus medical therapy is superior to medical therapy alone for the prevention of recurrent cryptogenic stroke. However, PFO closure in these patients has not been shown to reduce the risk of recurrent TIA or all-cause mortality. There is a higher rate of transient atrial fibrillation post PFO closure device placement, the long-term effects of which have yet to be studied.     

Antiphospholipid antibodies are common in patients referred for percutaneous patent foramen ovale closure.

Very little is known about any interaction between patent foramen ovale (PFO) and various hypercoagulable disorders that have been associated with cryptogenic stroke. Percutaneous PFO closure for secondary prevention of paradoxical thromboembolization is receiving increasing attention. Hypercoagulability may affect the potential risks and expected benefits of percutaneous PFO closure. Consecutive patients undergoing percutaneous PFO closure at a single center were screened for the presence of antiphospholipid antibodies, elevated lipoprotein(a), hyperhomocysteinemia, and dysfibrinogenemia. Sixteen of 34 patients (47%) with complete arterial hypercoagulability screening had laboratory evidence of arterial hypercoagulability. Thirteen of these patients (38%) had antiphospholipid antibodies. Antiphospholipid antibodies appear to be common in patients referred for percutaneous PFO closure for secondary prevention of systemic thromboembolic events. Thorough testing based on established recommendations is warranted. Further studies are needed regarding the interaction between PFO and various hypercoagulable disorders that have been associated with cryptogenic stroke.     

Patent foramen ovale using the Premere device: the results of the CLOSEUP trial

OBJECTIVES: The CLOSEUP trial was conducted to determine the safety and effectiveness of the Premere closure device in closure of patent foramen ovale (PFO). BACKGROUND: PFO is a relatively common congenital condition, associated with cryptogenic stroke and migraine with aura. The Premere device is specifically designed to close PFO of variable size and length, with right and left anchor arms connected by a flexible tether. The device has an open architecture, a low profile, and a small surface area on the left atrial side which may discourage thrombus formation. METHODS: Patients between 18 and 65 years of age who had a cryptogenic ischemic stroke or a transient ischemic attack and a PFO underwent percutaneous PFO closure using the Premere device. RESULTS: Of the 73 enrolled patients, six patients had atrial anatomy not appropriate for the Premere; 27 patients received the 15 mm and 40 patients received the 20 mm device. Implantation was successful in all patients. At 6 months of follow-up, 86% of patients had no shunt that could be provoked with Valsalva as assessed during contrast echocardiography. Closure rates were better with the 20 mm versus the 15 mm device, and three patients with residual shunt had atrial septal aneurysms at baseline. One patient had transient atrial fibrillation which resolved by 3 months. There were no instances of thrombus, death, or stroke. CONCLUSIONS: These data demonstrate that the Premere device can safely and effectively close PFO. Additional studies should be undertaken to demonstrate the effectiveness of PFO closure in reducing thrombo-embolic events such as stroke.     

Patent foramen ovale closure following cryptogenic stroke or transient ischaemic attack: Long‐term follow‐up of 301 cases

Patent foramen ovale has been identified as a conduit for paradoxical embolism resulting in cryptogenic stroke or transient ischemic attack (TIA). We aimed to establish rates of death, recurrent stroke or TIA among patients undergoing PFO closure for stroke or TIA at our unit. A retrospective analysis of all PFO closure patients was performed between May 2004 and January 2013. Follow up was performed by mortality tracing using the Medical Research Information Service of the Office of National Statistics. With regard to stroke or TIA recurrence, written consent forms and questionnaires were mailed with follow up telephone calls. Medical notes and imaging records were consulted where adverse events were noted. 301 patients aged 48.6 ± 11.0 years, 54.4% male, with ≥1 thromboembolic neurovascular event had percutaneous PFO closure with one of eight devices, with successful implantation in 99% of cases. Follow‐up duration was 40.2 ± 26.2 months (range 1.3–105.3); complete in 301 patients for mortality (100%) and 283 patients (94.0%) for neurovascular events. Two patients died during follow‐up (respiratory failure n = 1; road traffic accident n = 1). Recurrent stroke (MRI or CT confirmed) was observed in five patients (0.5%; 0.55 per 100 person‐years) and TIA in 9 (1.1%; 0.98 per 100 person‐years). Atrial fibrillation requiring treatment was documented in 14 patients (1.7%). Percutaneous PFO closure in patients with cryptogenic stroke or TIA is a safe treatment with a low incidence of procedural complications and recurrent neurovascular events. Registry data like these may help to demonstrate the utility of PFO closure in stroke. © 2015 Wiley Periodicals, Inc.     

Role of real-time three-dimensional transoesophageal echocardiography for guiding transcatheter patent foramen ovale closure

Patent foramen ovale (PFO) is a relatively common congenitalcondition which has been implicated in cryptogenic stroke asa result of paradoxical thromboembolism by right-to-left shunting.Many studies have demonstrated that transcatheter PFO closuresignificantly reduced the incidence of recurrent strokes ina small group of high-risk patients with PFO and atrial septalaneurysm compared with antithrombotic drugs. Two-dimensionaltransoesophageal echocardiography (2D TEE) has become the electiontechnique for guiding patent foramen ovale closure. Real-timeThree-dimensional transoesophageal echocardiography (3D TEE)may be potentially superior to 2D TEE in the accurate assessmentof the morphology and efficacy of transcatheter closure devicesbecause of a better spacial orientation.     

Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke

OBJECTIVES: The purpose of this study was to compare the efficacy of medical treatment with percutaneous closure of patent foramen ovale (PFO). BACKGROUND: Patients with cryptogenic stroke and PFO are at risk for recurrent cerebrovascular events. METHODS: We compared the risk of recurrence in 308 patients with cryptogenic stroke and PFO, who were treated either medically (158 patients) or underwent percutaneous PFO closure (150 patients) between 1994 and 2000. RESULTS: Patients undergoing percutaneous PFO closure had a larger right-to-left shunt (p < 0.001; 95% confidence interval [CI] 1.38 to 3.07) and were more likely to have suffered more than one cerebrovascular event (p = 0.03; 95% CI 1.04 to 2.71). At four years of follow-up, percutaneous PFO closure resulted in a non-significant trend toward risk reduction of death, stroke, or transient ischemic attack (TIA) combined (8.5% vs. 24.3%; p = 0.05; 95% CI 0.23 to 1.01), and of recurrent stroke or TIA (7.8% vs. 22.2%; p = 0.08; 95% CI 0.23 to 1.11) compared with medical treatment. Patients with more than one cerebrovascular event at baseline and those with complete occlusion of PFO were at lower risk for recurrent stroke or TIA after percutaneous PFO closure compared with medically treated patients (7.3% vs. 33.2%; p = 0.01; 95% CI 0.08 to 0.81, and 6.5% vs. 22.2%; p = 0.04; 95% CI 0.14 to 0.99, respectively). CONCLUSIONS: Percutaneous PFO closure appears at least as effective as medical treatment for prevention of recurrent cerebrovascular events in cryptogenic stroke patients with PFO. It might be more effective than medical treatment in patients with complete closure and more than one cerebrovascular event.     

Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients

The purpose of this study was to assess the safety and feasibility of percutaneous interventional closure of patent foramen ovale (PFO) with or without atrial septal aneurysm (ASA) in symptomatic patients. Between June 1999 and June 2002, we performed transcatheter closure of PFO in 256 consecutive symptomatic patients (female/male = 1.45; mean age 48 +/- 16 years; range 14-75): ischemic stroke (n = 101), transient ischemic attack (n = 144), peripheral and coronary arterial embolism (n = 17); multiple events (n = 23); platypnea-orthodeoxia syndrome (n = 2); refractory hypoxemia (n = 1); and migraine aura (n = 27). The implanted devices were an Amplatzer PFO Occluder (n = 248), a Gore-HELEX Septal Occluder (n = 4), and PFO STAR (n = 4). Most procedures (n = 176.69%) were done under two-dimensional intracardiac echocardiography (ICE) guidance alone; in the last 30 patients, 3D/4D ICE reconstruction (TomTec Imaging Systems) 6mbH was obtained. In 30 cases, ICE and contrast enhanced-TCD have been used simultaneously in the catheterization laboratory. The devices were placed correctly in all patients. Mean fluoroscopy time was 9.45 +/- 5 minutes (range = 2.5-35 minutes); mean procedural time was 57 +/- 21 minutes (range = 15-135 minutes). Total occlusion rate at follow-up (mean 19 months, range 1-33) was 98.1%. No significant recurrent neurological events were observed. Transcatheter closure of PFO with or without ASA is a safe and effective, minimally invasive procedure that ensures high closure rate and avoids life-long anticoagulation. Mid-term follow-up results appear favorable with respect to recurrent thromboembolic events.     

Percutaneous closure of patent foramen ovale in young patients with cryptogenic stroke: long-term follow-up

Percutaneous closure of patent foramen ovale (PFO) has been proposed as a therapeutic option for cryptogenic stroke. The aim of this article was to describe the experience with this treatment at our center. Up until February 2006, percutaneous closure of PFO was carried out in 52 patients who presented with one or more cryptogenic strokes or transient ischemic attacks. The procedure was carried out under anesthesia and was guided by transesophageal echocardiography. The overall success rate was 100%. Transesophageal echocardiography carried out immediately after device implantation found no evidence of right-to-left shunting in 27 patients. During a mean follow-up of 26 months in 49 patients, none presented with a new ischemic episode or with complications attributable to the device. Echocardiographic follow-up showed that the foramen ovale had been completely sealed in all cases.     

Patent foramen ovale: the known and the to be known

The patent foramen ovale (PFO) is a normal interatrial communication during fetal life that persists after birth in approximately 1 of every 4 adults. PFO is a potential route for embolic transit from the systemic venous circulation to the brain. Though there is compelling circumstantial evidence implicating PFO, the precise role of PFO in the pathogenesis of cryptogenic stroke is not yet established. Several randomized trials of transcatheter PFO closure versus medical management are ongoing. Results of these trials may improve our ability to select the best treatment for individual patients. Further well-designed studies are necessary to address several unresolved issues related to PFO stroke and PFO migraine pathophysiology, and to identify the patients who would most likely benefit from PFO closure. The purpose of this review is to summarize contemporary understanding, discuss current treatments, and explore some of the knowledge gaps pertaining to the clinical significance of PFO.