Cryptogenic stroke and patent foramen ovale: Clinical clues to paradoxical embolism

Özdemi̇r, Atilla Özcan; Tamayo, Arturo; Munoz, Claudio; Dias, Bryan; Spence, J. David

doi:10.1016/j.jns.2008.08.018

Cited by 107 publications

(97 citation statements)

References 47 publications

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“…Because of inconsistent data collection across the component databases, we were unable to include in our predictive model several variables that may be predictive of PFO among CS patients. 6,8,19 These include obesity, index stroke severity, a history of deep venous thrombosis or pulmonary embolism, hypercoagulable states, prolonged travel/forced immobility, migraine, Valsalva at stroke onset, and "wake up" stroke/TIA. 20 Thus, further improvement in stratification and discrimination may be possible.…”

Section: Discussionmentioning

confidence: 99%

An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke

et al. 2013

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Objective: We aimed to create an index to stratify cryptogenic stroke (CS) patients with patent foramen ovale (PFO) by their likelihood that the stroke was related to their PFO.Methods: Using data from 12 component studies, we used generalized linear mixed models to predict the presence of PFO among patients with CS, and derive a simple index to stratify patients with CS. We estimated the stratum-specific PFO-attributable fraction and stratum-specific stroke/TIA recurrence rates.Results: Variables associated with a PFO in CS patients included younger age, the presence of a cortical stroke on neuroimaging, and the absence of these factors: diabetes, hypertension, smoking, and prior stroke or TIA. The 10-point Risk of Paradoxical Embolism score is calculated from these variables so that the youngest patients with superficial strokes and without vascular risk factors have the highest score. PFO prevalence increased from 23% (95% confidence interval [CI]: 19%-26%) in those with 0 to 3 points to 73% (95% CI: 66%-79%) in those with 9 or 10 points, corresponding to attributable fraction estimates of approximately 0% to 90%. Kaplan-Meier estimated stroke/TIA 2-year recurrence rates decreased from 20% (95% CI: 12%-28%) in the lowest Risk of Paradoxical Embolism score stratum to 2% (95% CI: 0%-4%) in the highest. Conclusion:Clinical characteristics identify CS patients who vary markedly in PFO prevalence, reflecting clinically important variation in the probability that a discovered PFO is likely to be stroke-related vs incidental. Patients in strata more likely to have stroke-related PFOs have lower recurrence risk. Case-control studies suggest that patent foramen ovale (PFO) is a common cause of cryptogenic stroke (CS), likely through a paradoxical (venous-to-arterial) embolism.1,2 However, CS has many potential causes, and PFO is a common anatomical variant found in approximately 25% of the general population.3 Thus, a PFO discovered in the setting of a CS may be incidental or stroke-related.Percutaneous mechanical closure of a PFO is frequently considered in patients with CS and PFO. The recently reported CLOSURE trial, however, found no benefit for this approach over medical therapy. 4 Nonetheless, stroke recurrence rates were low overall (limiting statistical power) and most stroke recurrence in both treatment groups was due to stroke of known mechanism, suggesting that many patients with incidental PFOs may have been enrolled.The premise of the Risk of Paradoxical Embolism (RoPE) Study 3 is that only patients with a high attributable recurrence risk have the opportunity to benefit from PFO closure for secondary

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Section: Discussionmentioning

confidence: 99%

An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke

et al. 2013

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“…Various clinical, neuroimaging, and anatomic criteria have been suggested to increase the likelihood that a stroke is because of paradoxical embolism through a PFO. 5,6 We found no significant effect of atrial septal aneurysm or the degree of shunting on the outcome with respect to the primary trial end point. Selected subgroups, such as patients aged <45 years, with no risk factors and only cortical infarcts by MRI at baseline will likely have even lower recurrent event rates, requiring larger sample sizes or length of follow-up >2 years.…”

Section: Discussionmentioning

confidence: 68%

“…This indicates that cryptogenic stroke comprises a heterogeneous group of pathogeneses and speaks to the difficulty of precisely diagnosing paradoxical embolism. 5,6 Indeed, a key finding of our trial was that an alternative explanation for recurrent stroke or TIA, unrelated to paradoxical embolism, was usually apparent.…”

Section: Discussionmentioning

confidence: 78%

PFO Closure: CLOSURE

Furlan

2013

Stroke

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“…6 -8,11 Various criteria have been suggested to increase the likelihood that a stroke is caused by a paradoxical embolism through a PFO. 21 The annual rate of recurrent transient ischemic attack (TIA) or stroke in patients with PFO being treated with medical therapy varies from 3.8% to 12%. [22][23][24][25] The best medical therapy (BMT) for stroke prevention in patients with PFO is unknown.…”

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confidence: 99%

Study Design of the CLOSURE I Trial

Furlan

Reisman

Massaro

et al. 2010

Stroke

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Background and Purpose-Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. Study Design-This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from Ն31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. Conclusions-This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

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Cryptogenic stroke and patent foramen ovale: Clinical clues to paradoxical embolism

Cited by 107 publications

References 47 publications

An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke

An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke

PFO Closure: CLOSURE

Study Design of the CLOSURE I Trial

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