Long-Term Experience and Outcomes With Transcatheter Closure of Patent Foramen Ovale

Inglessis, Ignacio; Elmariah, Sammy; Rengifo‐Moreno, Pablo; Margey, Ronan; O'Callaghan, Caitlin; Cruz-González, Ignacio; Baron, Suzanne J.; Mehrotra, Praveen; Tan, Timothy C.; Hung, Judy; Demirjian, Zareh; Buonanno, Ferdinando S.; Ning, MingMing; Silverman, Scott; Cubeddu, Roberto J.; Pomerantsev, Eugene; Schainfeld, Robert M.; Dec, GW; Palacios, Igor F.

doi:10.1016/j.jcin.2013.06.013

Cited by 57 publications

(49 citation statements)

References 32 publications

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“…1–3 Observational data suggest that percutaneous transcatheter closure of PFO for secondary stroke prevention is safe and effective 4–8 ; however, three recent randomized clinical trials failed to show a clear benefit in the intention-to-treat analysis of PFO closure over medical therapy. 9–11 Based on these data, the American Heart/Stroke Associations and the American Academy of Neurology currently do not recommended performing PFO closure for secondary stroke prevention outside of clinical trials, 12,13 but these recommendations may change with publication of long-term follow-up from existing clinical trials and new data from two recently completed randomized trials that found a benefit of PFO closure for secondary stroke prevention.…”

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confidence: 99%

“…14,15 While PFO closure continues to be debated, the procedure is routinely performed in the community. 4,16 In fact, the Food and Drug Administration (FDA) recently approved the use of the Amplatzer PFO occluder device to reduce ischemic stroke recurrence in patients with stroke presumed to be from paradoxical embolism. 17 The rate of adverse outcomes ranged from 1.5–6.7% in randomized trials, 9–11 but few data exist regarding the rate of adverse outcomes in real-world practice.…”

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confidence: 99%

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Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale

Merkler

Gialdini

Yaghi

et al. 2017

Stroke

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Background and Purpose We sought to evaluate the real-world rate of safety outcomes after patent foramen ovale (PFO) closure in patients with ischemic stroke or transient ischemic attack (TIA). Methods We performed a retrospective cohort study using administrative claims data on all hospitalizations from 2005–2013 in New York, California, and Florida. Using ICD-9-CM codes, we identified patients who underwent percutaneous transcatheter PFO closure within 1 year of ischemic stroke or TIA. Our outcome was an adverse event occurring during the hospitalization for PFO closure, defined as in prior studies as atrial fibrillation or flutter, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Crude rates were reported with exact confidence intervals. Results We identified 1,887 patients who underwent PFO closure after ischemic stroke or TIA. The rate of any adverse outcome during the hospitalization for PFO closure was 7.0% (95% CI, 5.9–8.2%). Rates of adverse outcomes varied by age and type of preceding cerebrovascular event. In patients >60 years of age, the rate of adverse outcomes was 10.9% (95% CI, 8.6–13.6%) versus 4.9% (95% CI, 3.8–6.3%) in patients ≤60 years of age. The rate of adverse outcomes was 9.9% (95% CI, 7.3–12.5%) in patients with preceding ischemic stroke versus 5.9% (95% CI, 4.7–7.1%) after TIA. Conclusions Approximately 1 in 14 patients who underwent percutaneous transcatheter PFO closure after ischemic stroke or TIA experienced a serious periprocedural adverse outcome or death. The risk of adverse outcomes was highest in older patients and in those with preceding ischemic stroke.

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confidence: 99%

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confidence: 99%

Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale

Merkler

Gialdini

Yaghi

et al. 2017

Stroke

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“…PFO closure symptomatically improved or completely relieved migraines with and without aura in 18/21 subjects [37]. Subsequently, over 11 observational reports with 1632 subjects have corroborated these findings [ Table 2] [23], [37], [38], [39], [40], [41], [42], [43], [44], [45], [46], [47] and [48].…”

Section: Pfo and Migrainesmentioning

confidence: 69%

“…On the ROPE scale, higher scores are assigned to younger patients without vascular risk factors and infarcts located superficially in the brain (infarcts deemed more likely to be embolic [80]) Furthermore, referral to a neurologist and cardiologist for PFO evaluation should be considered in high risk patients including those with ASAs and large shunts. Long term follow-up indicates that PFO closure is relatively safe with a mean follow-up of 7 years in some studies [44].…”

Section: Discussionmentioning

confidence: 99%

Patent foramen ovale: Unanswered questions

Mojadidi

Christia

Salamon

et al. 2015

European Journal of Internal Medicine

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The foramen ovale is a remnant of the fetal circulation that remains patent in 20-25% of the adult population. Although long overlooked as a potential pathway that could produce pathologic conditions, the presence of a patent foramen ovale (PFO) has been associated with a higher than expected frequency in a variety of clinical syndromes including cryptogenic stroke, migraines, sleep apnea, platypnea-orthodeoxia, deep sea diving associated decompression illness, and high altitude pulmonary edema. A unifying hypothesis is that a chemical or particulate matter from the venous circulation crosses the PFO conduit between the right and left atria to produce a variety of clinical syndromes. Although observational studies suggest a therapeutic benefit of PFO closure compared to medical therapy alone in patients with cryptogenic stroke, 3 randomized controlled trials (RCTs) did not confirm the superiority of PFO closure for the secondary prevention of stroke. However, meta-analyses of these RCTs demonstrate a significant benefit of PFO closure over medical therapy alone. Similarly, observational studies provide support for PFO closure for symptomatic relief of migraines. But one controversial randomized study failed to replicate the results of the observational studies while another two demonstrated a partial benefit. The goal of this review is to discuss the clinical conditions associated with PFO and provide internists and primary care physicians with current data on PFO trials, and clinical insight to help guide their patients who are found to have a PFO on echocardiographic testing. Embryology and anatomySince fetal lungs in utero are incapable of oxygenating blood, the fetus is dependent on the maternal circulation for oxygen delivery via the placenta. Oxygenated blood returning to the right atrium via the umbilical vein needs to be delivered to the brain and vital organs before further loss of oxygen occurs. To facilitate this rapid transit, an inter-atrial communication evolved in all mammals, known as the foramen ovale [1].After birth, the foramen ovale flap (the septum primum) physiologically closes against the septum secundum when pulmonary vascular resistance and right atrial pressure decrease. An atrial septal aneurysm (ASA), a saccular deformity of the atrial septum that protrudes 15 mm in the direction of either atria, is associated with 15% of PFOs and is often seen with the largest size PFO [3] and [4]. PFO imagingThe most accurate test for determining the presence of a PFO is a right heart catheterization with documentation of a guidewire crossing the atrial septum. The standard non-invasive method for diagnosing a PFO is transesophageal echocardiography (TEE) using agitated saline contrast [5]. Transcranial Doppler (TCD) is a more sensitive and less uncomfortable method for diagnosing PFO with a sensitivity of 97% and specificity of 93% [6]. Transthoracic echocardiogram (TTE) with bubble study is a less expensive, non-invasive test compared to TEE with comparable specificity [7] and [8]. Howeve...

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“…Indeed, the greater likelihood of effective closure might simply be due to medical ability to choose the best device for a given patient's PFO anatomy, a freedom that is not available with clinical trials. [41] …”

Section: Percutaneous Closurementioning

confidence: 99%

How to understand patent foramen ovale clinical significance - Part II: Therapeutic strategies in cryptogenic stroke

Falanga

Carerj

Oreto

et al. 2015

J Cardiovasc Echography

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In the first part of this review, we reminded that patent foramen ovale (PFO) is a slit or tunnel-like passage in the interatrial septum occurring in approximately 25% of the population and that a number of conditions have been linked to its presence, the most important being cryptogenic stroke (CS) and migraine. We have also shown how, in the setting of neurological events, it is not often clear whether the PFO is pathogenically-related to the index event or an incidental finding, and therefore we thought to provide some useful key points for understanding PFO clinical significance in a case by case evaluation. The controversy about PFO pathogenicity has consequently prompted a paradigm shift of research interest from medical therapy with antiplatelets or anticoagulants to percutaneous transcatheter closure, in secondary prevention. Observational data and meta-analysis of observational studies previously suggested that PFO closure with a device was a safe procedure with a low recurrence rate of stroke, as compared to medical therapy. However, so far, published randomized controlled trials (CLOSURE I®, RESPECT® and PC Trial®) have not shown the superiority of PFO closure over medical therapy. Thus, the optimal strategy for secondary prevention of paradoxical embolism in patients with a PFO remains unclear. Moreover, the latest guidelines for the prevention on stroke restricted indications for PFO closure to patients with deep vein thrombosis and high-risk of its recurrence. Given these recent data, in the second part of the present review, we aim to discuss today treatment options in patients with PFO and CS, providing an updating on patients’ management.

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Long-Term Experience and Outcomes With Transcatheter Closure of Patent Foramen Ovale

Cited by 57 publications

References 32 publications

Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale

Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale

Patent foramen ovale: Unanswered questions

How to understand patent foramen ovale clinical significance - Part II: Therapeutic strategies in cryptogenic stroke

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