Transcatheter Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: A Meta-Analysis of Randomized Controlled Trials

Abstract

Background: Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy. Method: A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items “PFO or patent foramen ovale”, “paradoxical embolism”, “PFO closure” and “stroke”. Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes. Result: Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I² heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20–0.91, p = 0.03). Conclusion: Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy.

Further Promotion of Stroke Treatment with Delayed or Unknown Time of Onset but Smaller Benefit from Patent Foramen Ovale Closure than Pre-Applauded

“…Despite first glance supportive results from 3 individual very long-lasting studies published last year, we still get increasing evidence after the presentation of several new meta-analysis suggesting that meaningful clinical results could only be achieved in very few patients aside of major severe side-effects in similar sized populations. A first meta-analysis was published in our last issue of Cerebrovascular Disease by Darmoch et al [6] from the USA.…”

Patent Foramen Ovale Closure: State of the Art

“…22 Meta-analyses of these trials confirm that PFO closure reduces the risk of ischaemic stroke in patients with a PFO and cryptogenic stroke. [23][24][25] Absolute risk reduction is low (1.0 stroke per 100 patient-years), but this needs to be weighed against the prolonged period that younger patients are likely to be at risk. Patients with atrial septal aneurysm or large shunts may obtain greater benefit.…”

<p>Long-term biocompatibility of fluorescent diamonds-(NV)-Z~800 nm in rats: survival, morbidity, histopathology, and particle distribution and excretion studies (part IV)</p>

“…Currently, patients in this clinical setting are treated presumptively based on indirect diagnostic findings such as patent foramen ovale and can be subject to potentially hazardous anticoagulation, or even surgical procedures, that could be avoided. 19,20 Finally, diagnostic tools that would allow direct clot visualization could be integrated into current imaging modalities, providing a significantly more accurate picture of TEEs and an aide to the operator performing interventional techniques.…”