Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: Meta-Analysis of Five Randomized Controlled Trials with 3440 Patients

Abstract

ObjectiveWe aimed to determine whether patent foramen ovale closure reduces the risk of stroke, also assessing some safety outcomes.IntroductionThe clinical benefit of closing a patent foramen ovale after a cryptogenic stroke has been an open question for several decades, so that it is necessary to review the current state of published medical data in this regard.MethodsMEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LI-LACS, Google Scholar and reference lists of relevant articles were searched for randomized controlled trials that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Five studies fulfilled our eligibility criteria and included 3440 patients (1829 for patent foramen ovale closure and 1611 for medical therapy).ResultsThe risk ratio (RR) for stroke in the "device closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "device closure" group (RR 0.400; 95% CI 0.183-0.873, P=0.021). There was no statistically significant difference between the groups regarding the safety outcomes death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "device closure group (RR 4.000; 95% CI 2.262-7.092, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke.ConclusionThis meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of effective closure.

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

“…In a recent meta-analysis, meta-regression analyses showed that the older patients or proportion of participants with hypertension or atrial septal aneurysm presented higher risks of stroke. 31 These results are in line with our findings concerning the age. Similarly, the presence of atrial septal aneurysm had no impact on the primary outcome in both the meta-analyses.…”

Cryptogenic Stroke Caused by a Newly Diagnosed Patent Foramen Ovale in a Healthy Young Adult

“…Paradoxical embolism from the right to the left side of the heart can occur through a PFO, causing a cryptogenic stroke or embolic stroke of an undetermined source in an otherwise healthy adult. There was a debate on the long-term benefits of closure; however, data from the randomized evaluation of the recurrent stroke comparing PFO closure to established current standard of care treatment (RESPECT) trial and two randomized trials (patent foramen ovale closure or anticoagulants versus antiplatelet therapy to prevent stroke recurrence (CLOSE) and reduction by dutasteride of prostate cancer events (REDUCE)) and several meta-analyses of these studies have clarified that there is a benefit to the closure of PFO [5][6][7][8][9].…”

“…A number of randomized trials have demonstrated that PFO closure is superior to medical therapy with antiplatelet therapy alone [9][10][11]. Multiple studies, including a meta-analysis of multiple trials (CLOSE 2017, CLOSURE 2013, RESPECT 2013, and PC 2013), showed that, in patients who had a cryptogenic stroke, thought to be due to a PFO, those assigned to device closure and antiplatelet therapy had reduced incidence of recurrent strokes and brain infarctions compared to those assigned to antiplatelet therapy alone [9][10][11]. In one study by Sondergaard et al, device-related complications occurred in 1.6% of the PFO closure group and 6.6% developed atrial fibrillation [10].…”

“…In another study by Mas et al, complications related to the device occurred in 4.6% of the device closure group, and transient atrial fibrillation occurred in 5.9% of the device closure group [11]. Atrial fibrillation is a reported complication after closure in multiple studies [9][10][11]. However, the benefits of device closure to prevent recurrent strokes outweighed the risk of complications [9][10][11].…”

Clinical Diagnosis and Treatment of Infants with Angular Cheilitis

“…After peeling, they like to use their small hands to tear it. Causes serious bacterial infections [6][7].…”