The point is that ESO never had done a guideline about PFO. There was a Karolinska consensus written about the indication of closing or not closing the PFO and it was not done by this rigorous grade system, so we needed a really updated meta-analysis as we have a lot more knowledge and we needed a really rigorous approach to this. It’s a rare disease but when it happens, a clinician needs clear guidance on when and how to treat the PFO...
The point is that ESO never had done a guideline about PFO. There was a Karolinska consensus written about the indication of closing or not closing the PFO and it was not done by this rigorous grade system, so we needed a really updated meta-analysis as we have a lot more knowledge and we needed a really rigorous approach to this. It’s a rare disease but when it happens, a clinician needs clear guidance on when and how to treat the PFO.
We divided the guidelines in three parts: one was diagnosis, second was treatment, and long-term management. Regarding diagnosis, we found that based on the rigorous grade system approach we could not give a definite indication of which diagnostic tool has to be used. There are some observational studies about transcranial doppler, transesophageal and transthoracic echocardiography, but there’s no gold standard. Even if we all think that transesophageal echocardiography is the gold standard, it’s not like this because there has never been a study to validate transesophageal echocardiography as gold standard. We compared all the methodologies, but in the end there was no clear indication. So we did a very pragmatic approach on which is the best way to diagnose PFO and we gave the indication that based on the facilities and the skills of the centers, they should use what they can use better. For example, if they are very skilled in transcranial doppler, do it, wonderful. If they have good cardiologist, do transthoracic doppler. But if they are able, use on top of the transesophageal echocardiogram because the cardiologist they have to put the hand, it’s not about us neurologists. In the end, the cardiologists want this examination because they have to see how to put and how to use them, so in the end this will be the tool that makes everything more definite.
Regarding treatment, we gave a clear indication that patients between 18 and 60 needs to be closed. So if there is a PFO and a stroke, the patient needs to be closed. We also use, based on a patient individual analysis, the PASCAL score which is a morphological score on top of a clinical score. When there’s a high suspicion of a PFO-related stroke and the PASCAL shows you that it’s possible or probable, then you have to close the PFO. There are also some cases where you can think, when you don’t have such a strong relationship but when there was a clinical event… like a long distance flight for example, a patient had a stroke after a long distance flight and you find a PFO with not all the characteristics of the PASCAL but there is a clear temporal relationship then you should think about closing it.
Regarding the long-term management, one of the complication that we have after PFO closure is AF. Often we do not really know how we can interpret these AF episodes and we do not know how much they are related to the stroke. Now we have more and more evidence that positioning a loop recorder after PFO closure does not really add any diagnostic value. So even if there’s a short atrial fibrillation after closure, these patients tend not to have other episode of AF. So what we can do, especially in the higher age 59-60 year old patient, maybe there you can put it, but put it in when there is a randomized trial. The other point is also what we saw based on our data: the higher the PASCAL score and the younger the patient, the less we have the risk of atrial fibrillation. Another question that we asked during the guideline is how long these patient should be treated with antiplatelets. Again, small evidence. Only observational studies. So we stated as an evidence-based recommendation that DAPT (double antiplatelets) should be done for 1-6 months, followed by at least 5 years of single antiplatelet therapy.
This guidelines was done by me as a chair, but my co-chair was Christian Pristipino, a cardiologist. Inside our group we had another cardiologist who was the one of the main authors of one of the main random randomized trials. It’s very important and we’re always making fun about us: they say that cardiologists always want to close the PFO and neurologists never want to so this is why we’re trying to find a good agreement and I think we found it because we looked very deeply to the morphology of the PFO, adding this as an additional argument for closure. We had very hot discussion in our group and I think this is a good way to put guidance scientifically but in a very pragmatic way.