Is patent foramen ovale closure an OPTION in patients with cryptogenic stroke? An Italian multicentre registry proposal.

There is still no unanimous position among cardiologists and neurologists regarding the need to close patent foramen ovale (PFO) in patients with cryptogenic stroke. This is mainly due to the discrepancies between several nonrandomized studies, generally showing a net benefit of PFO closure over medical therapy in preventing ischemic recurrences in cryptogenic stroke, and the three recently published randomized trials (Closure, Respect and PC), which showed no outcome benefit of PFO closure, thus making each single decision difficult and uncertain. Many criticisms have been raised both to the nonrandomized (e.g. single-centre, bias selection, short follow-up and so on) and the randomized trials (e.g. study design, device selection choice, long enrolment period, event analysis and so on), again contributing to the uncertainties surrounding the management of this relatively frequent clinical problem. Furthermore, after the publication of Respect and PC-trial, several metaanalyses have been conducted and published, almost equally divided in pro or contra PFO closure. Moreover, Alushi et al. (pp. 761–768), in a large prospective, singlecentre nonrandomized study, published in the current issue of this Journal, showed no outcome benefit of PFO closure versus medical therapy, over a mean follow-up of 5.9 years, thus confirming the heterogeneity of current opinions on the role of PFO in cryptogenic stroke.