scholarly journals Cryptogenic Stroke: To Close a Patent Foramen Ovale or Not to Close?

2018 ◽  
Vol 10 ◽  
pp. 117957351881947 ◽  
Author(s):  
Santhosh J Kottoor ◽  
Rohit R Arora
Keyword(s):  
Randomized Controlled Trials ◽  
Patent Foramen Ovale ◽  
Anticoagulation Therapy ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Significant Benefit ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

A patent foramen ovale (PFO) has been shown to be highly prevalent in patients diagnosed with strokes of unknown cause, which are also called cryptogenic strokes (CSs). It has been a long-running controversy as to whether a PFO should be closed or not to prevent recurrent strokes in patients diagnosed with CS. A paradoxical embolism that is produced through a PFO is hypothesized to be a leading cause of CS, especially in younger patients with low risk factors for stroke. It remains controversial as to which anticoagulation therapy, defined as antithrombin or antiplatelet therapy, is better for patients with CS and a PFO. In addition, surgical and transcutaneous closure of a PFO has been proposed for the secondary prevention of stroke in patients with CS with PFO. Several randomized controlled trials have been conducted in recent years to test whether a PFO closure gives a significant benefit in the management of CS. Three earlier randomized controlled trials failed to show a statistically significant benefit for a PFO closure; thus, many investigators believed that a PFO was an incidental bystander in patients with CS. However, meta-analyses and more recent specific trials have eliminated several confounding factors and possible biases and have also emphasized the use of a shunt closure over medical therapy in patients with CS. Therefore, these latest studies (the CLOSE and REDUCE trials) can possibly change the treatment paradigm in the near future.

scholarly journals Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials

Cardiology ◽  
2019 ◽  
Vol 144 (1-2) ◽  
pp. 40-49 ◽  
Author(s):  
Aakash Garg ◽  
Mohammed Thawabi ◽  
Amit Rout ◽  
Chris Sossou ◽  
Marc Cohen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20–0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32–12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16–0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29–1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

scholarly journals Percutaneous Closure versus Medical Therapy Alone for Cryptogenic Stroke Patients with a Patent Foramen Ovale: Meta-Analysis of Randomized Controlled Trials

2014 ◽  
Vol 41 (4) ◽  
pp. 357-367 ◽  
Author(s):  
Christopher A. Pickett ◽  
Todd C. Villines ◽  
Michael A. Ferguson ◽  
Edward A. Hulten
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Number Needed To Treat ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Pfo Closure

Of cryptogenic stroke patients younger than 55 years of age, up to 61% have had a patent foramen ovale (PFO). Observational studies have revealed reductions in recurrent neurologic events through PFO closure versus medical therapy, and randomized controlled trials have shown nonsignificant trends toward benefit. We systematically searched for randomized controlled trials of percutaneous PFO closure with medical therapy versus medical therapy alone in patients with cryptogenic stroke and performed a meta-analysis of treatment outcomes. The primary endpoint was combined death, stroke, and transient ischemic attack. We included 3 trials. Of 2,303 total patients, 1,150 underwent PFO closure and 1,153 received medical therapy (median follow-up period, 2.6 yr). The pooled incidence of the primary endpoint was 1.2 events per 100 patient-years in the closure group (95% confidence interval [CI], 0.2–2.3) and 1.8 in the therapy group (95% CI, 0.7–2.9) (P=0.32); the number needed to treat was 167 (range, 100–500). The corresponding pooled hazard ratio was 0.67 (95% CI, 0.44–1.01; P=0.054) in favor of closure. Closure was associated with an increased risk of atrial fibrillation: relative risk=3.51 (95% CI, 1.44–8.55; P=0.006). When stratified by device, use of the Amplatzer™ PFO Occluder resulted in significant stroke-prevention benefit over medical therapy alone: hazard ratio=0.44 (95% CI, 0.21–0.95; P=0.037). When compared with medical therapy alone, PFO closure with medical therapy showed a trend toward a decreased hazard of combined events, although the absolute event reduction was small and the number needed to treat was high.

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