Percutaneous patent foramen ovale closure is superior to medical treatment alone in preventing recurrent stroke

1. Patent foramen ovale (PFO) closure was superior to medical treatment alone in preventing transient ischemic attack (TIA) and recurrent stroke.

2. However, PFO closure also raised the risk of atrial fibrillation (AF) or atrial flutter (AFL) in people with PFO and cryptogenic stroke.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Individuals with a PFO have a heightened risk of cardioembolic cerebrovascular accident.  Since PFO could possibly be a location for formation of a thrombus or a path for paradoxical embolism, percutaneous closure may be used to prevent recurrent stroke in people at high-risk.  Current guidelines do not recommend PFO closure on a routine basis, but data from two new randomized trials in late 2017 were not yet factored into these guidelines.  Using information from multiple databases, this systematic review and meta-analysis reviewed new data for recurrent cerebrovascular events in individuals with PFO and cryptogenic stroke who were treated with PFO closure compared to those who were treated using only medical therapy.  The authors found that PFO closure was superior to medical treatment alone in preventing TIA and recurrent stroke.  However, PFO closure also raised the risk of AF or AFL in people with PFO and cryptogenic stroke.  Therefore, the authors suggest that cardiac imaging should be used to assist in the careful selection of candidates for PFO closure.

A strength of the study is that it includes the latest data from two recently concluded randomized trials.  Limitations of the study include heterogeneous inclusion criteria and the lack of double-blind trials.

Click to read the study in Annals of Internal Medicine

Relevant Reading: Closure of patent foramen ovale versus medical therapy after cryptogenic stroke

In-Depth [systematic review and meta-analysis]: The authors used PubMed, Scopus, Google Scholar, reference lists, abstracts from relevant scientific sessions, and cardiology web sites to search for randomized controlled trials that evaluated PFO closure (using a device that is currently available) in comparison to medical treatment alone and that included results for rates of stroke, TIA, AF, or AFL.  Four trials met this criteria: PC, RESPECT, REDUCE, and CLOSE.  These trials involved a total of 2 531 patients.  The trials showed that PFO closure decreased the risk for stroke or TIA (risk difference [RD] -0.029) but raised the risk of AF or AFL (RD 0.033).  The advantage of PFO closure was linked to the use of larger interatrial shunts (p = 0.034).

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