ReviewIs Transcatheter Closure Better than Medical Therapy for Cryptogenic Stroke with Patent Foramen Ovale? A Meta-analysis of Randomised Trials
Introduction
Epidemiological studies have found a prevalence of 44–66% of patent foramen ovale (PFO) in patients with cryptogenic stroke as compared with 27% in autopsy series of all-cause deaths [1]. The higher prevalence of PFO in patients with cryptogenic stroke suggests that at least in some patients with cryptogenic stroke, the cause of stroke might be paradoxical thromboembolism. The optimal management strategy for treating patients with cryptogenic stroke (CS) who are discovered to have a patent foramen ovale (PFO) remains to be defined. The advent of percutaneously implantable devices has offered a widely applicable closure approach not requiring open heart surgery. Catheter-based closure of patent foramen ovale was introduced in 1992 [2]. Percutaneous closure has been available for over 20 years with very little hard evidence to guide patient and device selection. Investigators have used their own clinical judgement to decide when and how to percutaneously close PFO.
Observational long-term data suggest that closure of patent foramen ovale in patients with a history of ischaemic stroke may reduce the risk of recurrent stroke as compared with medical therapy alone [3], [4]. CLOSURE 1 trial [5] failed to demonstrate any significant difference in recurrent neurological events with PFO closure compared with medical management with antiplatelet or anticoagulation therapy.
Recently three randomised trials have reviewed the benefit of closure over optimal medical therapy. We synthesised the available evidence from the randomised trials on secondary stroke prevention in patients with patent foramen ovale and cryptogenic stroke and primarily focus on the comparison of the two strategies.
Section snippets
Study Protocol
We followed the Preferred Reporting Items for Systematic reviews and Meta-analyses PRISMA guidelines where possible in performing our systematic review [6]. We performed a systematic search through MEDLINE (from 1950), PubMed (from 1946), EMBASE (from 1949), Current Contents Connect (from 1998), Cochrane library, Google scholar, Science Direct, and Web of Science to May 2013. The search terms included “patent foramen ovale,” “PFO,” “atrial septal aneurysm,” “ASA transcatheter closure,” “heart
Results
The original search strategy retrieved 412 studies (Fig. 1). The excluded studies included one meta-analysis [11], two systematic reviews [1], [12], 57 non-randomised studies, 349 studies (editorials, reviews, case reports). The abstracts were reviewed and after applying the inclusion and exclusion criteria, articles were selected for full-text evaluation. Of the articles selected, only three studies (2303 patients) met full criteria for analysis and are summarised in Table 1A, Table 1B. The
Discussion
Our meta-analysis seeks to understand the available evidence from randomised trials for transcatheter closure in prevention of recurrent neurological events in patients with cryptogenic stroke or TIA, compared with medical management.
Agarwal et al. [11] performed a meta-analysis of 48 observational studies to compare the rate of recurrent neurological events (RNE) between transcatheter closure and medical management of patients with cryptogenic stroke/transient ischaemic attack and concomitant
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Reduced Stroke After Transcatheter Patent Foramen Ovale Closure: A Systematic Review and Meta-analysis
2018, American Journal of the Medical SciencesPatent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated meta-analysis
2018, Journal of the Neurological SciencesCitation Excerpt :However, the superior was not confirmed in subsequent three randomized controlled trials (RCTs) [12–14]. Furthermore, the meta-analysis results based on the three RCTs did not support a policy of routine PFO closure for secondary stroke prevention [15–25]. At present, the American Academy of Neurology and the American Heart/Stroke Associations do not recommend performing PFO closure to patients with cryptogenic ischemic stroke outside of a research setting [26,27].
Meta-Analysis Comparing Patent Foramen Ovale Closure Versus Medical Therapy to Prevent Recurrent Cryptogenic Stroke
2018, American Journal of CardiologyPatent foramen ovale closure to prevent secondary neurologic events
2017, European Journal of Internal MedicineRisk of stroke in patients with right-sided congenital heart disease and interatrial communication
2017, Progress in Pediatric CardiologyCitation Excerpt :Despite the fact that the association between interatrial communication and stroke has been controversial [22], one could argue that patients with right-sided congenital heart disease and interatrial communication may benefit from more aggressive prophylactic treatment for stroke prevention. Whether or not transcatheter closure of interatrial communication is preferable to medical treatment at preventing paradoxical stroke still remains controversial [23–28]. In the least, prophylactic closure of PFO in these patients at the time of their initial reparative surgery would seem reasonable.