Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

Hakeem, Abdul; Marmagkiolis, Konstantinos; Hacıoğlu, Yalçın; Uretsky, Barry F.; Gündoğdu, Betül; Leesar, Massoud A.; Bailey, Steven R.; Çilingiroğlu, Mehmet

doi:10.1016/j.carrev.2013.08.010

Cited by 34 publications

(18 citation statements)

References 26 publications

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“…A meta‐analysis of previously reported studies comparing PFO closure with medical management (CLOSURE‐1, RESPECT, and PC), published up to 2013, had demonstrated a trend toward improved outcomes with PFO closure, but overall no statistical significance compared to medical management . Based on the evidence at that time, the American Heart Association in 2014 suggested PFO closure only in the setting of concurrent deep vein thrombosis .…”

Section: Discussionmentioning

confidence: 99%

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Hakeem

Çilingiroğlu

Katramados³

et al. 2018

Cathet Cardio Intervent

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Section: Discussionmentioning

confidence: 99%

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Hakeem

Çilingiroğlu

Katramados³

et al. 2018

Cathet Cardio Intervent

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“…Previous meta-analysis derived from the three above RCTs also indicated that there was a potential benefit effect from device closure in reducing the incidence of recurrence stroke [6] [12] [13] [20]. Moreover, some authors argued that there was no sufficient evidence to favor benefit or harm [21] [22]. There was no overwhelming evidence or consensus with respect to on the safety and effectiveness of PFO device closure for preventing a recurrent ischemic stroke.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous Patent Foramen Ovale Closure versus Medical Therapy in Cryptogenic Stroke: An Update Meta-Analysis of Randomized Controlled Trials

Luo¹,

Yan²,

Shao³

et al. 2018

WJCD

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Objectives: Concerns regarding the real efficacy of transcatheter patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke remained unresolved. We performed a meta-analysis using the randomized controlled trials on the efficacy and safety of transcatheter PFO closure in patients with cryptogenic stroke. Methods: Web of Science, EMBASE, PubMed, and the Cochrane Library were searched for relevant randomized controlled trials (RCTs). The primary outcome was recurrent stroke and transient-ischemic attack (TIA). Original data, hazard ratio (HR) with 95% confidence interval (95% CI) were abstracted to calculate a pooled effect size. Results: Our meta-analysis showed benefit with device closure when compared with medical therapy with an HR of 0.54 (95% CI: 0.39 -0.74, P = 0.108) in the intention-to-treat cohort, 0.44 (95% CI: 0.24 -0.82, P = 0.103) in the per-protocol populations, and 0.43 (95% CI: 0.31 -0.60, P = 0.019) in the as-treated populations. There was a significantly higher incidence of new-onset atrial fibrillation in PFO closure patients (OR = 4.53, 95% CI: 2.58 -7.97, P = 0.094). PFO Patients with an atrial septal aneurysm benefit from device closure (OR = 0.39, 95% CI: 0.22 -0.69, P = 0.053). Patients with a substantial PFO shunt benefit the greatest with device closure with a pooled OR of 0.27 (95% CI: 0.14 -0.56, P = 0.525). Conclusions: The meta-analysis concluded that PFO closure was associated with significantly lower risk of recurrent stroke in PFO patients with cryptogenic stroke than with medical therapy alone. The benefit of PFO closure was greater in patients with a substantial shunt and atrial septal aneurysm. PFO closure was associated with higher rates of new-onset atrial fibrillation.

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“…Several meta-analysis were published trying to explain these disappointing results[193536373839] and to systematically review the latest evidence on the efficacy and safety of percutaneous PFO closure. The following possible explanations were provided:…”

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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Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

Cited by 34 publications

References 26 publications

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data

Percutaneous Patent Foramen Ovale Closure versus Medical Therapy in Cryptogenic Stroke: An Update Meta-Analysis of Randomized Controlled Trials

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

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