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BackgroundPatent foramen ovale (PFO) is implicated in the pathogenesis of clinical conditions such as cryptogenic stroke and migraine with aura. This study evaluated the challenges of sizing a PFO with different contemporary imaging modalities and assessed the relationship between PFO size and severity of the right-to-left shunt (RLS).MethodsPatients who were referred to interventional cardiology with the diagnosis of a PFO and had undergone intra-procedural balloon sizing (n = 147), transesophageal echocardiogram (TEE) imaging (n = 67), or intracardiac echocardiogram (ICE) imaging (n = 73) at the time of workup were included in this study. TEE and ICE were used to obtain PFO length and height during normal respiration. A sizing balloon was used to obtain PFO width and height after the septum primum was opened with balloon inflation.ResultsThe mean PFO length measured by TEE and ICE differed significantly (n = 27, 13.0 ± 4.1 vs. 9.9 ± 3.2 mm, p = .001). The mean PFO height measured by TEE and ICE (n = 27, 1.4 ± 0.6 vs. 1.7 ± 0.6 mm, p = .04), TEE and sizing balloon (n = 56, 1.5 ± 1.2 vs. 10.5 ± 4.2 mm, p

Percutaneous patent foramen ovale (PFO) closure is recommended for secondary prevention of paradoxical embolism through a PFO. In the United States, two Food and Drug Administration-approved PFO closure devices are currently available, and the choice depends on operator preference and PFO anatomy. Although these devices are easy to implant, there are several potential complications. As opposed to the Amplatzer PFO Occluder, there has been no published case of atrial erosion with Gore closure devices. This report describes two cases of pericardial tamponade due to perforation of the atrial wall induced by a wire frame fracture of the Gore Helex and Cardioform devices.

ObjectivesTo compare residual shunt rate and complications associated with six different devices used for PFO closure.BackgroundTranscutaneous PFO closure is an effective treatment for preventing recurrent stroke in patients with a history of cryptogenic stroke. The rate of residual shunt is one metric by which the technical success of PFO closure can be measured.MethodsPatients who underwent PFO closure at a single center between February 2001 and July 2019 were retrospectively enrolled in the study. Right-to-left shunt at baseline and during follow-up was assessed using transcranial Doppler (TCD) or transthoracic echocardiography (TTE). Periprocedural and device-related complications, including atrial fibrillation, were also assessed.ResultsOf 467 PFO closures performed during this period, 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure. The highest effective closure was achieved with the Cardioform device (100%, n = 104), followed by the Amplatzer Cribriform (93%, n = 14), Helex (90%, n = 137), Amplatzer ASO (88%, n = 17), CardioSEAL (86%, n = 14), and Amplatzer PFO (85%, n = 33) devices. The most common significant adverse event was atrial fibrillation, which was more common with the Cardioform device (13%) than the Helex (4%) or the Amplatzer PFO (4%) devices.ConclusionsThe Gore Cardioform Septal Occluder provides more robust closure of a PFO when compared to other devices but its effectiveness is offset by the higher prevalence of transient atrial fibrillation.

In the presence of a patent foramen ovale (PFO), a transient ischemic attack is indistinguishable from a complex migraine. Both have transient neurologic deficits with a normal MRI. The size of a PFO by echo should not be a criterion for closure. A stroke or peripheral embolus associated with a PFO is the indication for closure. Informed consent for PFO closure should include the warning that about 1 in 500 cases require device removal through open-heart surgery.

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.

A patent foramen ovale (PFO) is a communication across the inter-atrial septum and a right atrial septal pouch (RASP) is an indentation of the atrial septum caused by an incomplete fusion of the septum primum and septum secundum with its base opening into the right atrium. A 63-year-old male who had a history of two strokes and episodes of transient neurological deficit was diagnosed to have a small right-to-left shunt. At the time of PFO closure, an angiogram of the atrial septum revealed a small PFO associated with a RASP. The small PFO was crossed with a straight-tipped guide wire and was closed using a 25-mm GORE CARDIOFORM Septal Occluder (W.L. Gore and Associates, AZ). It is hypothesized that stagnant blood in the RASP may generate a clot that can cross the PFO and cause an infarct. © 2015 Wiley Periodicals, Inc.

In patients who have a cryptogenic stroke and have their PFO closed, the recurrence rate of "cerebral ischemia" is much greater in patients who are older than 55 years. Most of these recurrent events (2 strokes and 4TIAs) in the older age group were due to identifiable causes. These findings corroborate the long-term results from the RESPECT randomized clinical trial of PFO closure versus medical therapy.

BackgroundPlatypnea-orthodeoxia syndrome is a rare condition characterized by hypoxemia in the upright position that is improved in the supine position. Although several etiologies of platypnea-orthodeoxia exist, it is frequently associated with right-to-left shunting of blood at the cardiac or pulmonary level, usually via a patent foramen ovale (PFO). The aim of this study was to evaluate the incidence of platypnea-orthodeoxia syndrome in a select patient population with right-to-left shunting and to describe the outcomes after PFO closure.MethodsPatients with platypnea-orthodeoxia were prospectively identified from a population of patients who had a PFO and were referred to UCLA from 2001 to 2012. Those patients who elected to have their PFO closed were assessed for the severity of their symptoms and interval SaO2 changes. The changes in SaO2 before and after closure were compared in the supine and upright position. Patients were classified depending on the result of PFO closure as having "improved SaO2 " or "no change."ResultsOf 683 patients with PFO-associated conditions, 17 (2.5%) had platypnea-orthodeoxia and elected to close their PFO. The results in 11 of 17 patients (64.8%) were classified as having "improved SaO2 "; they experienced improvement or complete resolution of their dyspnea and hypoxemia (improved SaO2 from baseline 5.2 ± 4.7% when recumbent and 15.6 ± 3.0% when upright, P = 0.03 and P < 0.0001, respectively). Patients with no change after PFO closure predominantly had a pulmonary etiology for their hypoxia, with elevated mean pulmonary pressures measured before closure (51.4 ±16.8 mmHg, P = 0.06).ConclusionPFO closure may resolve symptomatic postural dyspnea and hypoxemia and is an effective method for treating platypnea-orthodeoxia, but is not effective when the primary etiology of the hypoxemia is due to a pulmonary cause.

BackgroundTranscranial Doppler (TCD) can detect a right-to-left shunt (RLS) with high sensitivity but has a 5% chance of a false negative study. TCD is usually performed with injection of agitated saline into an arm vein. We compared the sensitivity of TCD performed from the brachial versus femoral veins.MethodsPatients presenting to the cardiac catheterization laboratory for percutaneous closure of a patent foramen ovale (PFO) were enrolled. Power M-mode Transcranial Doppler (Terumo 150 PMD) was conducted. After injection of a mixture of 8 cc of agitated saline, 0.5 cc of air, and 1 cc of blood into the brachial vein, embolic tracks were counted over the middle cerebral arteries. The degree of RLS was evaluated by TCD at rest, and with Valsalva at 40 mmHg aided by visual feedback with a manometer device. The test was repeated using femoral venous injections.ResultsSixty five patients were enrolled, mean age 52, 43% male. TCD grades were significantly higher with femoral injections compared to brachial injections at rest (p

BackgroundPostmenopausal hormone therapy (HT) increases the risk of venous thrombosis and ischemic stroke.ObjectivesWe postulated that HT might increase the risk of ischemic stroke by promoting venous clots that travel to the brain through a right to left shunt (RLS).MethodsA total of 2,389 records were studied. After eliminating the premenopausal patients, and those with TIAs and non-ischemic strokes, the medical records of 1846 postmenopausal women hospitalized at four institutions for ischemic stroke were reviewed to identify those who had undergone an adequate study to assess for RLS. The proportion of women with a shunt in users and non-users of HT was compared in stroke patients and in a reference population consisting of postmenopausal women undergoing elective cardiac catheterization.ResultsThere were 363 (20%) records that had complete data and were included in the analysis. A shunt was more prevalent in patients with a cryptogenic stroke than in patients with a stroke of known cause (55/88 (63%) vs. 53/275 (19%), P

ObjectivesTo assess the effective closure rate among devices used for transcatheter patent foramen ovale (PFO) closure, and to discuss the management of patients with large residual shunts.BackgroundSeveral devices are used off-label for transcatheter closure of a PFO in the United States. The rate of residual shunting after PFO closure varies by device. Failure of effective closure poses risk of a recurrent cerebrovascular event, persistent migraine, or recurrent orthodeoxia.MethodsPatients who underwent PFO closure in the Cardiac Catheterization Laboratory at UCLA between 2001 and 2013 and had baseline and adequate follow-up transcranial Doppler studies following device placement were enrolled in the study.ResultsOf 167 patients whose records were analyzed, effective PFO closure occurred in 90% (150/167) of patients. The highest effective closure rate was with the Amplatzer Septal Occluder (ASO; 100%), followed by the Amplatzer Cribriform (93%), Gore Helex (90%), Amplatzer PFO (86%), and CardioSEAL (86%) device. The highest rate of residual shunting was observed after placement of the 30-mm Gore Helex device (55%). Of the 17 patients with a residual shunt, three required a repeat PFO closure procedure due to a significant residual shunt associated with recurrent pulmonary emboli or profound orthodeoxia. All three patients received an ASO which successfully closed the residual shunt.ConclusionsTranscatheter PFO closure has a high success rate, but a moderate residual shunt occurs in about 10% of cases. The observed incidence of residual shunting after PFO closure is significantly larger with the 30-mm Helex device. © 2014 Wiley Periodicals, Inc.

The purpose of this study was to understand why patients with adult congenital heart disease (CHD) but no obvious shunt have an increased frequency of migraine headaches (MH). CHD patients with no known cardiac shunts (CHD-NKS), based on their echocardiographic or angiographic procedures, were tested for a right-to-left shunt using agitated saline contrast transcranial Doppler (TCD). Medical records of 2,920 patients from the UCLA Adult CHD Center were screened to participate in a study to evaluate the prevalence of MH in adults with CHD; 182 patients (6.23%) had CHD-NKS; of these, 60 (30%) underwent a TCD; 23 (38%) tested positive and 37 (62%) tested negative for a right-to-left shunt (P = 0.01 compared with controls). The frequency of MH was 43% in CHD-NKS compared with 11% in controls (P < 0.0001). TCD demonstrated right-to-left shunting in approximately 2/3 of patients with pulmonary stenosis, the Marfan syndrome and congenitally corrected transposition of great vessels, 1/4 of patients with bicuspid aortic valve, 1/5 of patients with mitral valve prolapse and all patients with Ebstein's anomaly. Approximately half of these experienced MH. Patients who had MH did not show a higher frequency of right-to-left shunt when compared with patients without MH (P = 0.57). In conclusion, CHD patients with conditions usually not associated with a shunt have a higher than expected prevalence of PFO which permits intermittent right-to-left shunting undetected by standard non-contrast TTE and TEE; the increased prevalence of right-to-left shunting may partially explain the higher than expected frequency of migraines.

The HELEX device is approved for percutaneous closure of an atrial septal defect (ASD). It is also often used off-label to close patent foramen ovale (PFO). The device is well tolerated because it is very flexible, but this characteristic increases the likelihood of embolization of locked implants. While the company provides a mechanism to retrieve devices that do not lock correctly, retrieval of locked and released devices is much more difficult. A case of percutaneous retrieval of an embolized, locked HELEX device is reported. This device was successfully retrieved from the aorta by snaring the left atrial eyelet and unlocking the device. A variety of potential techniques for retrieval of these devices was explored on the bench top. Strategies which can be used to successfully retrieve embolized HELEX devices are described.

BackgroundA 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.Methods416 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.ResultsAs 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.ConclusionAlthough 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.

The results of the randomized clinical trial entitled: Migraine Intervention with Starflex Technology (MIST), produced surprising and disappointing results on the effect of PFO closure to decrease migraine headaches. There have been allegations of misrepresentation of the effectiveness of this device. These issues have significant implications in how randomized clinical trials are performed that will impact current and future planned trials of PFO closure to treat migraine headaches.