Patent foramen ovale closure after cryptogenic stroke: sometimes uncertain benefit maybe, or even potential harm in the long run?

Abstract

The main published studies on patent foramen ovale (PFO) closure after cryptogenic stroke tend to consider it positively, in light of the reported both procedural risk profile and outcomes. On the other hand, many blind spots and controversial issues of the topic are still present, mainly including both early procedural complications, and mid- and long-term associated comorbidities as well. Oftentimes, several biases appear to be present, with the evident risk of modifying indications for both intervention, and decision-making process. Biases should be considered and discussed during the diagnostic approach as well, including the supposed evidence of correlation, or cause–effect relationship, between the clinical event and patent foramen ovale. Furthermore, such studies have mostly shown results based on short-term follow-up and very low event rates. Conversely, those patients will keep the device lifelong, generally with long life expectancy, and the increased possibility of recurrent stroke from any other cause over time, along with many potential device-related comorbidities (e.g. atrial fibrillation, nearby anatomical structures impairment, and thrombosis). Consequently, it is hard to demonstrate the mid-term and long-term device-related advantages, due to the possible higher incidence of stroke associated with iatrogenic or concurrent factors. Thus, larger, well designed, long-term, multicentric, and more inclusive studies are needed, aimed to demonstrate a net clinical benefit, ideally including a number-needed-to-treat calculation at short-term, mid-term, and long-term, as well as taking into account and comparing the long-term complications, related outcomes, and recurrent events in patients with and without devices.