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.     

Frequency of migraine headache relief following patent foramen ovale "closure" despite residual right-to-left shunt

Retrospective studies have shown improvement in migraines after patent foramen ovale (PFO) closure. To date, no study has evaluated whether the completeness of closure affects headache status; therefore, the objective of this study was to evaluate the impact of residual right-to-left shunt (RLS) on migraine symptoms after transcatheter PFO closure in migraineurs with and without aura. This was a small-series, single-center, retrospective analysis of late follow-up data on 77 patients with presumed paradoxical embolism and migraine who underwent PFO closure for secondary stroke prevention. Power M-mode transcranial Doppler was used to assess RLS at baseline and 6 and 12 months after closure. A standardized migraine questionnaire was administered at baseline and 6, 12, and 24 months after closure. Fifty-five (71%) patients had migraine with aura. Final closure and migraine status were available for 67 patients; 23 (34%) had incomplete PFO closure, defined as 30 embolic tracks detected at final power M-mode transcranial Doppler examination (median 366 days, 95% confidence interval 332 to 474). Migraine relief (> or = 50% reduction in frequency) was independent of closure status (77% complete closure vs 83% incomplete closure, p = 0.76) at late follow-up (540 days, 95% confidence interval 537 to 711). Migraineurs with aura were 4.5 times more likely to experience migraine relief than migraineurs without aura. In conclusion, migraine relief may occur despite residual RLS after transcatheter PFO closure, which may suggest a reduction in RLS burden below a neuronal threshold that triggers migraine; however, this warrants further investigation. Migraine with aura may be an independent predictor of relief after PFO closure.     

Patent foramen ovale and cerebrovascular diseases

Patent foramen ovale (PFO) has been linked to ischemic strokes of undetermined cause (cryptogenic strokes). PFO-a remnant of fetal circulation when the foramen ovale does not seal after birth-can permit microemboli to escape the pulmonary filter into the intracranial circulation, causing stroke. Coexistent atrial septal aneurysm, pelvic deep vein thrombosis and inherited clotting factor deficiencies could potentiate stroke risk in patients with PFO. Transcatheter PFO closure, a minimally invasive procedure, is one technique used to prevent recurrent cerebrovascular events. A connection between PFO and migraine headache has been conceptualized from retrospective evidence of reduced migraine frequency and severity after PFO closure; however, prospective randomized trials are needed to verify the efficacy of PFO closure on migraine prevention. In this review we discuss embryologic origins, diagnostic techniques and treatment options for prevention of paradoxical embolism thought to be related to PFO, and the relation of PFO to cryptogenic stroke and migraine.     

Five-year experience with percutaneous closure of patent foramen ovale

Patent foramen ovale (PFO) has been implicated in the pathogenesis of cryptogenic stroke, arterial desaturation, decompression illness, and migraine headache (MH). This study evaluated the safety of percutaneous transcatheter PFO closure in patients with cryptogenic stroke, transient ischemic attack, or arterial desaturation. Additionally, symptomatic reduction in MH was determined after interatrial shunt closure. Of the 252 patients referred to the University of California, Los Angeles, with PFO, 131 underwent closure of the interatrial communication with a CardioSEAL (n = 30) or Amplatzer (n = 101) device. PFO morphology was evaluated with transesophageal echocardiography. Follow-up was conducted at 1 to 2 months with echocardiography, with clinical assessment annually thereafter. At an average follow-up of 30 months, there was no recurrence of any thromboembolic event (transient ischemic attack, stroke, or peripheral). There was a reduction in MH, defined as the complete resolution of headache or a >50% reduction in the number of headache days, in 85% of patients after PFO closure. Temporary problems after device implantation, including chest discomfort and palpitations, were reported in 23% of patients and occurred more frequently in patients with nickel hypersensitivity (p <0.05). In conclusion, transcatheter PFO closure is an effective and safe therapeutic modality in the prevention of thromboembolic events and MH associated with interatrial shunting in patients who present with cryptogenic stroke. Pending randomized, controlled trials are necessary to determine if this invasive approach is preferable to medical therapy for the prevention of recurrent stroke or as primary treatment for patients with MH.     

Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale

ObjectivesThis study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt.BackgroundMany studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints.MethodsThe study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden.ResultsA total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017).ConclusionsLong-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden.     

Transcatheter Interatrial Shunt Closure as a Cure for Migraine: Can it be Justified by Paradoxical Embolism—Risk-Driven Criteria?

BackgroundSome ongoing trials have suggested that closure of the patent foramen ovale (PFO) may reduce migraine symptoms. We sought to assess the safety and effectiveness of migraine treatment by means of PFO transcatheter closure using paradoxical embolism risk-driven criteria.MethodsWe enrolled 75 patients (48 women and 27 men, mean age 40 ± 3.7 years) who were referred to our center over a 12-month period for a prospective study to evaluate severe disabling migraine, despite antiheadache therapy and the PFO. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence of migraine headache and severity. Criteria for intervention included all of the following: basal shunt, curtain shunt pattern on transcranial Doppler, presence of interatrial septal aneurysm, 3 to 4 class MIDAS score, symptomatic significant aura, coagulation abnormalities, migraine refractory to conventional drugs.ResultsOn the basis of the inclusion criteria, we shortlisted 20 patients (12 women, mean age 35 ± 6.7 years, mean MIDAS score 38.9 ± 5.8) for transcatheter closure of PFO and excluded the rest who were referred to the neurologist for medical therapy. The procedure was successful in all of the patients with no perioperative or in-hospital complications. After a mean follow-up of 10 ± 3.1 months (range 6–14), all patients’ migraine symptoms improved (mean MIDAS score 3.0 ± 2.1, P < 0.03) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound.ConclusionIn this small pilot series, we adopted the criteria which in our opinion best reflected the risk of paradoxical embolism in these patients. By adopting the proposed criteria, primary transcatheter closure of the PFO resulted in a significant reduction in migraine.     

Exclusion of patients with arteriosclerosis reduces long-term recurrence rate of presumed arterial embolism after PFO closure

BACKGROUND: Percutaneous transcatheter closure of patent interatrial communications after presumed paradoxical embolism is used as an alternative to surgery or long-term anticoagulation for the treatment of patients who are at risk for recurrent thromboembolism. To avoid atherosclerotic events to be judged as recurrent paradoxical embolism, we prospectively excluded all patients with detectable arteriosclerosis from our series and investigated long-term results. METHODS AND RESULTS: We report the outcome of 180 patients who underwent percutaneous transcatheter closure of patent foramen ovale (PFO), PFO like atrial septal defect (ASD), or an ASD because of paradoxical embolism. One hundred four patients had cerebral embolism, 57 had transient ischemic attacks, 16 coronary embolism, and 3 had peripheral embolism. Twenty-three patients experienced multilocal arterial embolism. One hundred twenty-five patients had a PFO, 63 of them with an atrial septal aneurysm (ASA), 24 a PFO-like ASD (7 of them with an ASA), and 31 had an ASD. After 18 months, only 5 patients (2.8%) showed a trivial residual shunt. At a mean follow-up of 40 months (range 4 to 88), resulting in 602 observed patient-years, only 1 patient experienced a presumed paradoxical (coronary) embolism (calculated annual risk to suffer a recurrent thromboembolic event: 0.16%). CONCLUSIONS: Percutaneous transcatheter closure of PFO/ASD is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. It is associated with a high success rate, low incidence of hospital complications, and very low frequency of recurrent systemic embolic events.     

Ischemic Attacks and Patent Foramen Ovale: Transcatheter Closure of Patent Foramen Ovale in Adults with Cryptogenic Systemic Embolism

In the presence of a patent foramen ovale with otherwise unexplained (cryptogenic) cerebral embolism, the usual therapy is oral anticoagulation or antiplatelet therapy. Surgery is considered only in cases of recurrence. Percutaneous transcatheter occlusion of the patent foramen ovale (PFO) is a new valuable alternative. This article presents the current knowledge and our data concerning nonsurgical closure of patent foramen ovale to prevent paradoxical arterial embolism. Transcatheter PFO closure represents an elegant therapeutic approach in patients with suspected paradoxical embolism because it avoids open heart surgery and is minimally invasive. Even if the recurrence rate of embolism were identical, transcatheter closure would be preferable to anticoagulation because the annual risk of bleeding complications of 2%-3% and the long-term costs of anticoagulation can be avoided. Randomized studies are needed to compare transcatheter closure of patent foramen ovale with anticoagulation, platelet inhibitors, or surgery.     

Migraine headache relief after percutaneous transcatheter closure of interatrial communications

BACKGROUND: Migraine headache (MHA) is present in 12% of adults, but has been reported to have a higher prevalence in patients with presumed paradoxical embolism and patent foramen ovale. PFO closure in these patients has been reported to improve migraine, but follow-up periods in previous studies have been relatively short and concomitant medical therapy as well as placebo effects might have influenced the results. This study investigated the long term course of MHA in a large cohort of patients after closure of PFO well beyond the initial phase of concomitant antiplatelet medication. METHODS: 191 consecutive patients with presumed paradoxical embolism underwent percutaneous transcatheter closure of patent interatrial communications for prevention of recurrent thromboembolism. We report the course of MHA before and after closure. RESULTS: Before the procedure, MHA was present in 24% of patients. At a mean follow-up of 38 months (range 6 to 82) after the procedure MHA had disappeared completely in 24% of patients, and in another 63% symptoms had improved. At a mean duration of follow-up of 38 months a significant reduction (p < 0.000) of number, intensity, duration of episodes, and in the number of accompanying symptoms during an MHA episode was found. CONCLUSIONS: Percutaneous transcatheter closure of patent interatrial communications results in significant amelioration of MHA in 87% of patients (complete resolution in 24% and significant improvement in symptoms in 63%). Ongoing randomized trials and larger epidemiologic surveys need to further elucidate the role of device therapy for MHA.     

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.     

Long-term efficacy of transcatheter patent foramen ovale closure on migraine headache with aura and recurrent stroke.

OBJECTIVES: To assess the long-term results of transcatheter patent foramen ovale (PFO) closure on migraine headache with aura (MHA) and on the risk of recurrent stroke. Background: Transcatheter PFO closure is associated with an early improvement of MHA, and a reduction or the risk of recurrent cerebral ischemia, but the long-term outcome after the procedure is unknown. METHODS: We analyzed follow-up data of 38 consecutive patients who had undergone transcatheter PFO closure at our institution because of cryptogenic stroke and had been followed-up for at least 3 years after the procedure. Mean age at closure was 43 +/- 13 years. Thirteen patients (34%) had a diagnosis of MHA made by the primary care physician or the referring neurologist. Migraine disability assessment questionnaire (MIDAS) was used to assess MHA incidence and severity. RESULTS: After a mean follow-up of 4.8 +/- 1.4 years, two patients had a recurrent stroke (13 and 15 months after the procedure, respectively). Recurrence rate 5 years after the procedure was 5.3%. After 4.9 +/- 1.4 years from the intervention, 12/13 patients (92%, 95% CI 65-99%) had complete resolution in their MHA. Overall, MIDAS score decreased significantly (38.6 +/- 26.3 vs. 4.4 +/- 5.1, P < 0.0001) after the procedure. One patient did not report any improvement of MHA after transcatheter PFO closure, whereas one patient reported a severe relapse of MHA about 1 year after PFO closure. Freedom from recurrent MHA 5 years after the procedure was 85% (95% CI 57-97%). CONCLUSIONS: The rate of recurrent cerebral ischemia and recurrent MHA seems to be low at long-term follow-up after transcatheter PFO closure. Recurrent cerebral ischemia and relapse of MHA seem to be confined to the first 15 months after the procedure.     

Characteristics of adult patients with atrial septal defects presenting with paradoxical embolism

Background : The association between patent foramen ovale (PFO), atrial septal aneurysm, and cryptogenic stroke due to paradoxical embolism has been established. The correlation between atrial septal defect (ASD) in adults and paradoxical embolism is less well defined. Methods : We examined our single center experience with 329 adult patients undergoing percutaneous device closure of interatrial communication defects to identify clinical and morphologic differences among adult patients with ASDs who presented with or without paradoxical embolism. Comparison was made with patients with PFO. Results : Although a significant left‐to‐right shunt was the predominant indication for ASD closure, 20 patients (14%) presented with a paradoxical embolism. These patients tended to be younger and had smaller defects (both by size and shunt ratio) than ASD patients without paradoxical embolism, and were more likely to be female than PFO patients. Conclusions : The incidence of adult patients with ASD who presented with paradoxical embolism is higher than expected and suggests that this diagnosis should be considered in patients with cryptogenic stroke. © 2009 Wiley‐Liss, Inc.     

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.     

Cryptogenic Stroke and Patent Foramen Ovale

Nearly one-half of patients with cryptogenic stroke have a patent foramen ovale (PFO). The dilemma of whether to close these PFOs percutaneously, in an effort to reduce the risk of recurrent paradoxical embolism, has been a matter of ongoing debate for more than a decade. Early randomized clinical trials failed to demonstrate a significant benefit of percutaneous PFO closure for secondary prevention of cryptogenic stroke in an intention-to-treat analysis. The long-term follow-up data from the RESPECT trial and 2 new randomized trials (CLOSE and REDUCE) have clarified these findings. They showed that with good patient selection, transcatheter PFO closure significantly reduces the risk of recurrent stroke compared with medical therapy in patients with cryptogenic stroke, with no increased risk of serious adverse events or influence on major bleeding.     

TTE联合右心声学造影筛查PFO的价值及介入封堵治疗中期疗效

目的 应用经胸超声心动图（transthoracic-echocardiography,TTE）及经胸右心声学造影（contrast transthoracic-echocardiography,cTTE）筛查隐源性卒中、不明原因晕厥及偏头痛患者中卵圆孔未闭（patent foramen ovale,PFO）的检出率及经皮介入封堵治疗PFO的中期疗效。 方法 选取167例临床诊断为隐源性卒中、不明原因晕厥及偏头痛的患者,均行TTE检查及cTTE检查,根据微气泡右向左分流（the right-to-left shunt,RLS）数量进行量化分级,分为I级、Ⅱ级和Ⅲ级。选取Ⅲ级RLS患者22例,右心选择性造影证实为PFO并根据形态选择合适封堵器行封堵治疗,术后1、3、6个月门诊及电话随访,术后6个月行cTTE复查。 结果 167例患者行cTTE,静息状态下RLS有67例（40.1%）,Valsalva动作后RLS有85例（50.9%）,其中I级分流23例（13.8%）,Ⅱ级分流12例（7.2%）,Ⅲ级分流50例（29.9%）。在3种不同疾病中,隐源性卒中并发PFO检出率为43.5%;不明原因晕厥并发PFO检出率68.0%;偏头痛并发PFO检出率为47.9%;22例行PFO封堵患者,随访6个月,临床症状改善,无并发症,复查cTTE均未见残余分流。 结论 TTE联合cTTE是筛查PFO重要的无创检查手段;两者结合对隐源性卒中、不明原因晕厥及偏头痛并发PFO有较高的检出率。介入封堵治疗PFO能有效预防隐源性卒中、晕厥再发、明显减轻偏头痛症状。     

The association of different right atrium anatomical-functional characteristics correlates with the risk of paradoxical stroke: an intracardiac echocardiographic study

Background: The contribution of different right atrium anatomical-functional characteristics to the risk of paradoxical stroke has not been extensively investigated, probably in part because of the limits of standard echocardiography.
Objective: We sought to assess, using intracardiac echocardiography (ICE), the right atrium anatomical-functional characteristics and their role in the pathophysiology of paradoxical embolism in a sample of patent foramen ovale (PFO) patients undergoing transcatheter PFO closure.
Methods: Over a 36-month period, we prospectively enrolled 114 consecutive patients (mean age 38+/− 10.5 years, 67 female) referred to our center for PFO catheter-based closure. On ICE study, all sensible characteristics other than PFO and mild ASA were recorded, including prominent EV or large CN, basal shunt without Valsalva maneuver, moderate to severe ASA, and multiperforated fossa ovalis.
Results: After TEE and ICE study and measurements, a prominent EV or CN was diagnosed on ICE in 73%, a basal shunt was present in 48%, a moderate to severe ASA in 47%, and a multiperforated FO in 24% of patients. A tight correlation between number of concurrent factors and proportion of patients with curtain pattern on TC Doppler, larger right-to-left shunt, recurrent cerebral paradoxical embolism before closure, and migraine with aura was clearly evident (r ≥= 0.97). Basal shunt and concurrent ≥= 3 anatomical functional right atrium characteristics resulted as independent predictors of recurrent paradoxical embolisms.
Conclusions: Our data suggest that right atrium anatomical-functional characteristics other than PFO and mild ASA as assessed by ICE deeply affect the pathophysiology of paradoxical stroke.     

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.     

Transcatheter patent foramen ovale closure is effective in reducing migraine independently from specific interatrial septum anatomy and closure devices design

BackgroundRelationships between migraine improvement after transcatheter patent foramen ovale (PFO) closure and both specific interatrial septum anatomy and different devices design have not been investigated yet. We sought to assess effectiveness of transcatheter PFO closure in reducing or curing migraine with aura in patients with previous paradoxical embolism in relation with specific interatrial septum anatomy and different closure devices.Methods and ResultsWe prospectively enrolled 34 patients (22 female and 12 male, mean age 40±3.7 years) who were referred to our centre over a 12-month period for PFO transcatheter closure and migraine with aura and previous paradoxical embolism. All procedures were performed using mechanical intracardiac echocardiographic guidance. Patients were assigned to Amplatzer PFO or ASD Multifenestrated Occluder and Premere Occlusion System implantation dependently from intracardiac echocardiography anatomical findings, which included short-channel with moderate atrial septal aneurysm (ASA) in 6 patients (17.6 %), long-channel with moderate ASA in 3 patients (8.8%), short-channel with huge ASA in 5 patients (14.7%), multifenestrated ASA in 4 patients (11.7%), long-channel PFO without ASA in 10 patients (29.4%), and long-channel PFO with mild ASA in 6 patients (17.6%). Accordingly, 18 patients received an Amplatzer Occluder (9 PFO Occluder and 7 ASD Multifenestrated Occluder), and 16 received a Premere Occlusion System. After a mean follow-up of 9.0±2.8 months, all patients improved their migraine symptoms (mean Migraine Disability Assessment Score 30±1.5 at baseline versus 6.0±2.9 in the follow up, P<.03) independently from specific interatrial septum anatomy and different closure devices.ConclusionAlthough our study had several limitations, it suggests that independently from interatrial septum anatomy and device type, PFO closure in patients with migraine with aura resulted in a high rate of migraine improvement.     

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept™ device

Objectives : This multi‐centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept? device. Background : PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo‐embolism. Currently, different devices are used for PFO closure. Methods : Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo‐embolism. Peri‐procedural and mid‐term complications were reported. Results : Four‐hundred thirty patients (mean age 50.7 ± 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow‐up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri‐procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid‐term follow‐up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). Conclusion : This multi‐centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo‐embolic events. © 2008 Wiley‐Liss, Inc.