<v ->Quickly we're gonna talk</v> about some current practice patterns based on surveying neurologists and cardiologists, how they feel about PFO. And then we're gonna talk about the guidelines that exist. That's gonna be American focused, something I guess we do in Texas, not because I think (audience members laughing) they're better guidelines, but because we are here and we can contrast them. It'll be interesting. I don't have time. No one wants to hear about all the guidelines in the world on PFO closure. All right, so very briefly, we were interested in how neurologists and cardiologists felt about PFO closure. And we did a survey back in 2005. We managed to get almost 90 doctors to respond to the survey. We felt really good about that. It's not really that many. But what we did find, this was again before there was any evidence that PFO closure was beneficial, but it was certainly out there and there was an HDE by the FDA, a humanitarian device exemption. So they were being closed pretty regularly at that point. We asked neurologists what they usually recommend for treatment, and about half of them recommended antiplatelet agents. And for cardiologists, about half of them recommended endovascular closure. Equally, maybe 20 to 25% thought anticoagulation was a good idea. But you could clearly see there was a distinction between the way neurologists and cardiologists were managing this disease or this condition, excuse me. And then we were interested in a couple like outlier conditions. So have you ever recommended PFO closure for an asymptomatic patient, never had a stroke or a TIA? There were about 9% of the cardiologists, yes, 2% of neurologists. For scuba diving to reduce the risk of decompression illness, it was almost a quarter of cardiologists compared to 6% of neurologists, and for migraines, 14% versus none. At the time, there was some thought that it might reduce migraines and I think there still is a possibility that it might, although the trials have been negative so far. We came back to this question in 2022 now that we actually have evidence that PFO closure's beneficial and we have a better sense of who probably should be getting closed, and we got a much larger survey sent out. This was done in conjunction between some vascular neurologists and SCAI was involved, which was great. And we got responses from 300 vascular neurologists, over 300, and 190 interventional cardiologists. The general themes of the responses are that vascular neurologists are less likely to recommend closure based on a patient's age. So above 60, 65 or 70, vascular neurologists would put the brakes on that idea, whereas cardiologists, age is no number. Right? And then interventional cardiologists in general across all the different categories are more supportive of closure. These are not surprising things. And I'll show you some examples of that. And then we were interested in, what are you doing after the PFOs close? How are you managing these patients? And does anybody not provide antithrombotic medication? And for interventionalists, it was about a quarter of them told patients to stop taking aspirin, stop everything after six months of dual antiplatelet therapy. And only 6% of neurologists do that. I don't do that. Do you guys recommend stopping antiplatelets after closure? We're getting silence from the cardiologists. <v Cardiologist>I keep.</v> <v ->You do. Yeah. And we can talk</v> about that, interesting topic. All right, so this is an example of the vignettes that we would show and the kind of responses we would get. So this was a pretty classic patient you might consider for PFO closure based on the evidence that Dr. Thaler just presented. This was a 50-year-old cryptogenic, otherwise cryptogenic, embolic-appearing strokes that would be considered PFO-attributable or PFO-associated stroke. And this is a Likert scale type response. So the different colors on the bottom green is strongly supporting closure, mauve or pink somewhat support, neutral yellow, and then a blue, somewhat oppose, and a lighter blue, strongly oppose. So you can go across the spectrum of how strongly you feel about closure. And again, this was someone that I think I would've said I would be strongly in favor of closure but it was only about half of the stroke neurologists responded strongly. Another third were somewhat supportive and actually 12% were neutral or negative on recommending closure for this patient. And again, these are stroke neurologists, not general neurologists. Interventional cardiologists, they're decisive, 92% strongly supporting closure, another 6% somewhat supporting it, and only 2% were neutral. So they're pretty monolithically in favor of closure in that patient. In a different patient where you have a strong alternative explanation for a high-risk mechanism in a symptomatic severe carotid stenosis, stroke neurologists know that's like red alarm, gotta fix it. It's clearly the reason they had their stroke. In addition, then finding a PFO, would you recommend PFO closure, there were actually 4% of the stroke neurologists, 1% said strongly in favor of PFO closure, 3% somewhat supportive and everyone else was neutral or negative. It was, sorry, 22% of the interventional cardiologists would've considered closing that patient even though there was a very high-risk alternative mechanism, again, just illuminating the fact that there are some distinct differences in the way we're managing these patients still. All right. Now moving on to the guidelines, again, I apologize if I'm leaving out great guidelines from Canada or Europe but we're gonna talk about first how to do a guideline. The Institute of Medicine which is part of the US federal government actually came out with a guideline on guidelines. This was like in 2011, and I know. And then there's gonna be a guideline on how to do guidelines for guidelines. They recommend that you do a full systematic review of the literature. You have to assess every publication. You have to look at the abstracts and the gray literature and all this other stuff to get all the evidence that might inform your recommendation. You wanna form a panel of experts. That needs to be balanced with transparent and limited conflicts of interest. You need to have patient engagement which is a great recommendation, which many of these guidelines have failed on. And then when you're formulating the recommendations you want to consider all of these things equally, strength of evidence which is only informed by the systematic review, but then also benefit relative to harms, importance of outcomes, variations in patient preferences, cost and availability. All of those things are important when you're recommending to clinicians and patients what they should be doing. So starting first with American Heart Association Secondary Prevention guidelines. So this is not a PFO-dedicated guideline. It's a huge, comprehensive guideline on secondary prevention. And it's a huge undertaking when this gets published every time and updated. This was from 2021. And the first recommendation is first of all that there should be shared decision-making, which is a great recommendation, between neurology, cardiology, and the patient. So having a brain-heart team involved is a good idea. AHA supports that as do I. The second recommendation says that if you're under 60 years of age and you have an embolic-appearing, otherwise undetermined cause of stroke with a PFO with high-risk features, as Dr. Thaler articulated what that might be, it's reasonable to choose closure with antiplatelet therapy over antiplatelet therapy alone. The third block down there says if you don't have high-risk features, don't close the PFO, which is interesting. So that doesn't jive with what we just heard about also with Pascal, suggesting if you have a high RoPE score but none of the high risk PFO features you still would probably benefit from closure. And then lastly, if you require anticoagulation long term, it's not clear that PFO closure is beneficial or not, which is reasonable. Alright, the AAN, which I was involved in this one, updated their guidelines in 2020. We adhered to the IOM methodology pretty seriously as much as we possibly could. The recommendations, and I'm gonna really do this as a high-level thing, I'm not gonna touch on everything 'cause it's really boring, but you wanna consult with both neurology and cardiology. Again, the brain-heart team is critically important, that both views are discussed together. You wanna make sure you do the appropriate workup for stroke to make sure that the PFO, which is generally a very low risk for stroke occurrence, is the only thing left. And there's not a high-risk mechanism like a severe carotid stenosis there that might explain the stroke. And then importantly for neurology, and I think that cardiologists were happy we got here finally, in patients who are under 60 years of age with an embolic appearing stroke, no other mechanism, you may recommend closure. So that's great. I think what's also great about these guidelines is we do look at some of these edge cases. So even patients over 60, I think if you have a clearly embolic appearing stroke, low vascular risk factors, you could consider closure. If it's a small deep stroke in a young person who doesn't have small vessel disease, it's probably embolic, you could consider closure. And then in patients who opt to receive medical therapy alone, it's not clear whether antiplatelet therapy or, anticoagulation is better. And again, like the AHA, we also said that in patients who do require long-term anticoagulation, we don't know if PFO closure is additionally beneficial or not. So now the SCAI guidelines are the ones that were published most recently, very strongly adhere to the IOM methodology. They worked very hard to do that. And they did much more of the edge cases. So for sure they supported with a strong recommendation closing PFO rather than antiplatelet therapy alone in patients with PFO associated stroke. And these conditional recommendations, which mean that the majority I think of patients would be willing or want to do this, but not the vast majority, they said do not routinely offer closure for scuba divers trying to reduce decompression illness. Do not routinely offer closure patients with Afib, a high-risk alternative mechanism. Do not routinely offer closure to patients with TIA because transient neurologic spells aren't always vascular. But do offer closure to patients over 60, which is similar to the AAN, although we say up to 65. And then do offer closure to patients who require lifelong anticoagulation. So that is different from the other two guidelines. And I think I just wanna make the point again that there's different recommendations out there. There's different perspectives depending on who's giving these recommendations. So just to look at the methodology comparison, I think the most important thing, the SCAI guidelines I think did a great job of trying to get everybody on board. They had patient representation which the other guidelines did not. The one thing that none of these had was really the most recent patient level meta-analysis that Dr. Thaler did and presented to you showing that Pascal actually is important for whether patient benefit or not. So to conclude, despite much greater agreement overall if you look at those surveys, there remains meaningful variability in management, both within each specialty as well as certainly between specialties. And there's lots of guidelines out there. They have different methodologies and panel constituents leading to different recommendations. Most of them are supportive of PFO closure in select patients. If you're eligible for the trial, for example, you probably get closed. Most advocate engagement of cardiologists and neurologists working together in heart-brain teams, incredibly important. And the shared decision making with the patient is also critically important. But there remain many unanswered questions, and therefore we really need more research. We need better clinician and patient education. We need more collaborations between neurology and cardiology, and then of course, more shared decision making. Thanks. (audience members clapping)

PFO closure

stroke management

neurologists

cardiologists

guidelines