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Concept: Ostium primum


A patent foramen ovale (PFO) is common and found in nearly 25% of healthy individuals. The majority of patients with PFO remain asymptomatic and they are not at increased risk for developing a stroke. The presence of PFO, however, has been found to be higher in patients with cryptogenic stroke, suggesting there may be a subset of patients with PFO who are indeed at risk for stroke. Paradoxical embolization of venous thrombi through the PFO, which then enter the arterial circulation, is hypothesized to account for this relationship. Although aerated-saline transesophageal echocardiography is the gold standard for diagnosis, aerated-saline transthoracic echocardiography and transcranial Doppler are often used as the initial diagnostic tests for detecting PFO. Patients with cryptogenic stroke and PFO are generally treated with antiplatelet therapy in the absence of another condition for which anticoagulation is necessary. Based on the findings of 3 large randomized clinical trials, current consensus guidelines do not recommend percutaneous closure, though this is an area of controversy. The following review discusses the relationship of PFO and cryptogenic stroke, focusing on the epidemiology, pathophysiological mechanisms, diagnostic tools, associated clinical/anatomic factors and treatment.

Concepts: Epidemiology, Doppler echocardiography, Echocardiography, Contrast-enhanced ultrasound, Atrial septal defect, Foramen ovale, Ostium primum, Cardiac shunt



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.

Concepts: Systemic circulation, Atrial septal defect, Foramen ovale, Ostium primum, Evidence, Interatrial septum


Background. Device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) are both associated with short- and long-term complications. Our knowledge of the complication rates of ASD and PFO closure is limited. Our objective was to review the peri-procedural and long-term complications of ASD and PFO closure. Methods. Medline, EMBASE, and Scopus databases were searched between 1973 and 2012. A total of 28142 patients from 203 case series were included. Of these 203 articles, 111 were reporting ASD closure, 61 were reporting PFO closure, and 31 were reporting both. Pooled incidence rates of cardiac complications were calculated separately for peri-procedural and at follow-up. Results. Peri-procedural major complications were reported from 0% to 9.4%, with a pooled estimate rate of 1.4% (95% CI: 1.3% to 1.6%). It was 1.6% (95% CI, 1.4-1.8) in ASD group, 1.1% (95% CI, 0.9-1.3) in PFO group, and 1.3% (95% CI, 0.9-1.9) in ASD/PFO group. The most common major complication was the device embolization requiring surgery. Peri-procedural minor complications were reported with a pooled estimate rate of 1.4% (95% CI, 1.2-1.7). It was 1.6% (95% CI, 1.2-2.1) in ASD group, 1.3% (95% CI, 1.0-1.7) in PFO group, and 1.5% (95% CI, 1.1-1.2.1) in ASD/PFO group. The most frequent major complications at follow-up were cerebrovascular events (1.3% (95% CI: 1.1% to 1.6%)) and device thrombosis (1.2% (95% CI: 1.0% to 1.4%)). Both were more frequent in PFO group. Conclusion. Device closure of ASD and PFO are associated with non-negligible serious complications, both in early and long-term. © 2013 Wiley Periodicals, Inc.

Concepts: Ventricular septal defect, Atrial septal defect, Foramen ovale, Ostium primum


Iatrogenic erosion of the septum primum after foramen ovale closure is an anecdotal event. We report the case of a 39-year-old woman admitted to our institution for multifocal cryptogenic cerebral ischemia and a patent foramen ovale (PFO) associated with an aneurysm of the septum primum. The patient underwent percutaneous closure of the PFO with an Amplatzer PFO Occluder device. At the 6-months follow up, the device was in the right position, but a jagged defect of the septum primum and evidence of significant left-to-right shunting was detected. The atrial septal defect was then repaired by a surgical approach. Although this event is not life-threatening, it should be considered as a therapeutic pitfall, resulting in a risk of paradoxical embolism recurrences and long-term hemodynamic impairment. © 2013 Wiley Periodicals, Inc.

Concepts: Ventricular septal defect, Atrial septal defect, Foramen ovale, Ostium primum, Cardiac shunt


Clinical outcomes for transcatheter and operative closures of atrial septal defects (ASDs) are similar. Economic cost for each method has not been well described.

Concepts: Ventricular septal defect, Atrial septal defect, Foramen ovale, Ostium primum, Ostium secundum



We describe the case of a 27-year-old gentleman who developed late-onset clubbing and cyanosis. Transoesophageal echocardiography revealed a 27-mm ostium secundum atrial septal defect and a large, floppy Eustachian valve directing right atrial blood to the left side of the heart.

Concepts: Blood, Heart, Pulmonary artery, Ventricular septal defect, Atrial septal defect, Foramen ovale, Ostium primum, Cardiac shunt


We present our experience with the Cera (CO) and the CeraFlex occluder (CFO) in transcatheter closure of interatrial communications (IAC). Between 2013 and 2016, 201 patients (75 males, 16 with patent foramen ovale), aged 27 ± 19 (5-75) years, underwent percutaneous closure of IAC using CO or CFO in our institution. After transoesophageal imaging, the procedure was aborted in 7 young paediatric (6-13 years old) patients (3 multiple holes, 3 too small septum, 1 leak with 38 mm occlusion balloon). The occluder was removed prior to release in 11 patients (5.7%), while occlusion was successful in 183 patients (94.3%) with 44 CO, 136 CFO, and 3 Cera multifenestrated occluders. There were no deaths, embolizations, or major complications. Small residual shunts were demonstrated in 8 patients immediately after implantation, 4 (8.5%) with CO and 4 (2.9%) with CFO, all disappearing after 3 months. Over 1.8 ± 1.7 year follow-up, all patients improved with 2 asymptomatic, transient pericardial effusions and 5 adults with transient supraventricular arrhythmias, treated medically for 6 months. IAC closure with CO and CFO proved safe with favourable success rates and few, nonserious complications. The CFO flexible rotation feature helped in conforming to various septal anatomies, minimising manoeuvres and possibly post-occlusion leaks.

Concepts: Physician, Ventricular septal defect, Atrial septal defect, Foramen ovale, Ostium primum, Interatrial septum, Septum, Cardiac shunt


Background The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. Methods In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging. Results We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure. Conclusions Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE number, NCT00738894 .).

Concepts: Clinical trial, Medical statistics, Stroke, Atrial fibrillation, Traumatic brain injury, Atrial septal defect, Foramen ovale, Ostium primum