The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

The article has been co-published with permission in the European Heart Journal and EuroIntervention. All rights reserved. V C The Author(s) 2018. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article.

Transcranial Doppler (TCD) is a very sensitive tool for detecting microembolic signals (MES) in the brain vessels after injection of air-mixed saline in case of right-to-left shunt (RLS). Patent foramen ovale (PFO) can be found in nearly one-half of migraineurs with aura, and, reciprocally, the prevalence of migraine in patients with stroke with PFO is exceedingly high. We aimed to monitor the passage of MES in the brain vessels during transcatheter closure of PFO and to subsequently follow-up patients for both the efficacy of the procedure and the severity of migraine. Seventeen patients suffering from migraine with aura (MA+, n = 8) or without aura (MA-, n = 9) scheduled to undergo transcatheter closure of PFO with Amplatzer PFO occluder devices for paradoxical cerebral embolism were monitored with contrast TCD (DWL, Germany) before, during, and after the procedure to estimate the magnitude of the shunt. Spontaneous embolization to the brain was also recorded. The patients were thereafter followed-up at 1, 3, and 6 months. A composite score of migraine severity, which included frequency, duration, and intensity of the attacks in the previous 3 months (range 0-10), was obtained at the time of the procedure and at the follow-up visits. Complete occlusion of PFO was achieved in all patients after 1 month in most cases. Preoperatively, the migraine score was 6.75 in MA+ and was 6 in MA--patients. After closure, the score dropped to 2.5 in MA+ and to 4.2 in MA--patients at the 6-month follow-up visit, the difference being statistically highly significant in both groups. Overall, 5 of 17 patients no longer complained of migraine, 10 of 17 were substantially improved, and two of 17 were unchanged at 6 months. Migraine aura disappeared in six of eight patients. Closure rate was very satisfactory, from a preoperative average bubble count of 42 to an average of 4 bubbles in the four patients in whom a small residual shunt was still detectable at the 6-month follow-up visit. TCD monitoring provides the most accurate assessment of RLS at the brain level. Closure of PFO with transcatheter devices results in the substantial relief of migraine in patients with stroke with large RLS.

Several devices are available for transcatheter occlusion of atrial septal defect. This report describes the international experience with the buttoned device. During a 4.5-year period ending in February 1993, 180 transcatheter atrial septal defect occlusions were performed with the buttoned device. Patient age varied between 0.6 and 76 years and stretched atrial defect diameter between 5 and 25 mm. The defects were closed with 25 to 50 mm devices delivered through 8F (148 patients) or 9F (32 patients) sheaths. Twelve patients were adults whose defects were closed to prevent recurrence of cerebrovascular accidents caused by presumed paradoxic embolism. In the remaining patients the atrial defect was closed to treat the left-to-right shunt. The atrial septal defects were effectively occluded as demonstrated by (1) decrease in pulmonary-to-systemic flow ratio from 2.1 +/- 0.6 (mean +/- SD) to 1.05 +/- 0.1 (p < 0.01) by oximetry; (2) normalized S2 and disappearance of the diastolic murmur by auscultation; and (3) improvement in right ventricular volume overloading by echocardiogram. However, trivial to small shunts could be detected by color Doppler studies in 76 (45%) of 168 patients in whom such data are available. Complications included unbuttoning in 13 and whole-device embolization in 1. All patients remained stable, and retrieval of the device and surgical closure of the atrial septal defect were accomplished in 10 patients. Transcatheter retrieval was used in the remaining 4 patients. The incidence of unbuttoning, a major complication of the procedure, appeared to decrease with the increasing experience of the investigators and with device modification (third-generation). The follow-up duration varied between 1 month and 4 years. Six patients required surgery during the follow-up period. In the remaining patients (n = 160), clinical examination did not reveal signs of atrial shunts. Color Doppler studies revealed either complete disappearance of the previously demonstrated shunts or further diminution of their size. The results indicate that transcatheter occlusion of the atrial septal defects with buttoned devices is feasible, relatively safe, and effective, and it appears to be a viable alternative to surgery for some patients with secundum atrial septal defect. Complications are infrequent and should improve with experience.

Background and Purpose-Transcatheter closure of patent foramen ovale (PFO) has been reported to improve migraine in patients with cerebrovascular disorders in noncontrolled studies. The aim of the study was to compare the course of migraine assessed prospectively over a 12-month period in symptomatic (for cerebrovascular disease) and asymptomatic patients undergoing PFO closure and in patients with PFO treated medically. Methods-Twenty-three stroke symptomatic (SS; 39Ϯ10 years of age; males/females [M/F] 5/18) and 27 stroke asymptomatic (SA; 40Ϯ12 years of age; M/F 5/22) patients with migraine underwent PFO closure. Twenty-seven patients with migraine and PFO (controls [CTRLS]; 36Ϯ11 years of age; M/F 4/23) were followed up medically. Migraine severity was assessed at baseline with a scale that takes into account the frequency, duration, and intensity of the attacks and the occurrence of aura (score range 0 to 10). Six months later, the patients were given a structured diary to annotate monthly with the same scale the characteristics of the attacks for the next 6 months. By the end of 1 year, the migraine score was averaged for the last 6 months.

The authors analyzed the extent of right-to-left shunting in patients with migraine, patients with cryptogenic stroke, and controls. Patients with both migraine and stroke had larger shunts than did patients with migraine without stroke (p = 0.038), patients with no migraine with stroke (p = 0.007), and control patients (p < 0.0001). Patients with migraine have overall larger shunts than nonmigraineurs, particularly if they have had a stroke. Right-to-left shunting may be causally related to migraine and to the increased stroke risk of migraine.

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.

The ICE evaluation of ASDs allows quantitative and qualitative information for both proper ASO selection and optimal device placement, thus eliminating the cumbersome balloon-sizing maneuver and the need for general anesthesia during TEE monitoring.