Is closure recommended for patent foramen ovale and cryptogenic stroke?Patent Foramen Ovale in Cryptogenic Stroke Not to Close

摘要

A quick PubMed search reveals an abundance of editorials, reviews, and opinion pieces on the subject of patent foramen ovale (PFO) management, and this is now the fourth published article on this topic that has adapted William Shakespeare's classic words from Hamlet to describe the conundrum that faces neurologists, cardiologists, and their patients. The degree to which this title has been overused reflects the tremendous uncertainty that clinicians feel about patients who have had a stroke and are found to have a PFO. The reason for this confusion is that high-level, unbiased data do not yet exist to guide our clinical decisions with these challenging patients. The Food and Drug Administration rescinded the prior Humanitarian Device Exemption for percutaneous PFO closure devices to spur research into this clinical question. Unfortunately, although the National Inpatient Sample demonstrated a 50-fold increase in the number of percutaneous PFO/atrial septal defect closure procedures over a 6-year periodending in 2004, enrollment in clinical trials has continued to be slow, suggesting that many patients are receiving percutaneous PFO closure with the use of off-label atrial septal defect devices. The rampant off-label closure of PFOs is both hindering the progress of randomized controlled trials and undermining their validity. So, to answer the titular question: do NOT close the PFO, EXCEPT in the setting of a randomized trial