Thank you. I'm going to build on what Andrew was talking about. And I'm going to run through the, I'm obviously not going to review every single guideline. I'm going to try and paint some broad strokes on some of the bigger concepts. And this is the, first thing I want to stress, I want to thank all the people that worked so hard to make this document a success. National experts and PFO from across the country. We had, we felt strongly that we had to align ourselves with the neurology society stakeholders. And therefore, we had representatives from the American Academy of Neurology who have given endorsement to this manuscript. And as Dr. Coylewright said, we had patient representatives. We felt that was important. And furthermore, we had methodologists. Methodologists kept us on the straight and narrow and kept us laser focused on the important issues. And without them, this document could not have happened. And of course, this document could not have happened without the support of the SEAI staff who helped us put this thing all together. So with that, I wanted to first mention that this document tends to, acts to build on a previous document that SEAI had published in 2019. When it put forth the operator institutional guidelines, well not guidelines, recommendations, requirements for opening a PFO program and for individual operator training in order to be properly trained in the cognitive and technical skill sets required to build a safe and effective PFO program. But this document did not address the most controversial concept of patient selection. And this is where this document leaves off and the guideline document then takes over. And the purpose of this guideline was mentioned by my colleagues, many of whom are on this panel were in the writing committee. They provide guidelines for practitioners for proper patient selection in order to mitigate unnecessary procedures and to achieve alignment of cardiology and stroke neurology and to provide guidance and clarity for PFO associated events, which were not included in the large randomized clinical trials. So the clinical questions that Andy had run through in his presentation include five questions. I'm not going to go through them in detail, but the first set of questions largely addresses subsets of patients who were not included in the large randomized clinical trials, patients with migraines, patients with decompression illness, patient with platypnea orthodoxia, thrombophilia, high risk morphology, systemic embolism, not stroke, TIAs and deep vein thrombosis. So these are all patients who have not had a stroke, but may have had a PFO associated event and therefore would not have been included in the large randomized clinical trials. The second question addresses those patient populations which align themselves most closely with the published randomized clinical trials. The third question addresses, as Dr. Goldschweig mentioned, the issue is anticoagulation an acceptable alternative to PFO closure. The fourth question addresses the issue of patients who have had a PFO associated stroke and require lifelong anticoagulation for another indication. And then the last question addresses post-procedure medication. So we applied the GRADE protocol, and I'm not going to go through that in any detail, but there are two types of evaluations, the certainty of the evidence and the strength of the recommendations. And you can see them listed here in terms of certainty of evidence from high to very low. And the strength of the recommendations were either strong or conditional and geared towards patients, clinicians, researchers, and policy makers. So this is the first question, and it's very busy, but I'm going to stream it down for you. As I said, question one addressed patients who did not have a PFO associated stroke but may have had a PFO associated event of another sort. So to address what Andy was talking about and what other members on the panel were talking about, the data at the present time does not support routine closure of PFO for refractory migraines, although there are ongoing clinical trials aimed at addressing this question. Nor does the current data, as it exists, allow for routine closure of PFO in patients with decompression illness. Or patients with TIA, thrombophilia, DVT, or high-risk anatomy, such as atrial septal aneurysms. These are all patients who have not had a PFO associated stroke. However, the panel did express strong support for device closure for patients with orthodioxia platypnea, as well as for patients who have experienced a systemic embolism, not a stroke, mediated through the PFO. Oh, I'm going the wrong way here. Question two, then, was those populations of patients which aligned itself most closely with the randomized clinical trials. And this is the patient subsets where there was the strongest data. And I'm summarizing it for you on this slide. So as I said, these patients aligned themselves mostly with the randomized clinical trials. And the panel easily supported routine closure of PFO in patients with PFO associated stroke between the ages of 18 and 60, which was mostly the inclusion criteria for the randomized trials. But we went further, and we also supported PFO closure in patients who have had a PFO associated stroke who are older than 60. But we advised against, because this is a really complex issue, the issue of atrial fibrillation, and I'm not talking about periprocedural atrial fibrillation. I'm talking about antecedent atrial fibrillation. And the panel felt that routine closure of these patients with atrial fibrillation, PFO, and a stroke should not be routinely done. And there was a lot of controversy over PFO closure in patients who have had a PFO associated stroke, but the index stroke was years ago. And there's really no data to help us with this kind of decision. So we could not make a recommendation on this population of patients. So the PICO question three addresses whether anticoagulation is a suitable alternative to PFO closure in patients who have had a PFO associated stroke. And I'm summarizing the results here. The opinion of the panel is that although oral anticoagulants may be effective in preventing recurrent ischemic stroke in patients with PFO associated stroke, that PFO device closure is preferred because of the limitations of oral anticoagulant therapy, namely noncompliance and interruption of therapy for physicians, for procedures, surgery, and other indications. PICO four addresses those populations of patients who have had a PFO associated stroke and who require lifelong anticoagulation for other indications, such as deep vein recurrent DVTs, recurrent PEs, or thrombophilia. So the panel recommended that PFO device closure be carried out in addition to anticoagulation for these patient subsets, recurrent DVT, recurrent pulmonary embolism, thrombophilia. Why? Because for the same reason as PICO three, the opinion of the panel was that although anticoagulants may be effective, that because of noncompliance and interruption of therapy, the recommendation of the panel is that these patients get PFO closure in addition to anticoagulation. And then the question of post-procedure medical therapy. Well, you know, this issue has been nagging this area for over two decades, and, you know, we looked at the data, which was available, and there really isn't much data. And because of that, we really could make no meaningful recommendation concerning what is the best post-procedure management after PFO device closure. So this is an area for continued research, as it is for migraines, as it is for decompression illness. So these remain somewhat unanswered questions. So in conclusion, these guidelines are designed to help clinicians and patients make decisions about the management of patients with PFO, including transcatheter closure and its alternatives. They aim to inform policy, education, and advocacy, and to describe the knowledge gaps to be filled by future research. They help to support interventional cardiologists and neurologists in confronting a broad spectrum of questions encountered in contemporary practice, but not dealt with during, in our randomized clinical trials. And to help patients and their doctors achieve the best evidence-based care that is consistent with the patient's value and preferences. And with that, I thank you for your attention. There's a lot to cover in eight minutes, but I think I did it. Thank you. Thank you. Thank you.

patient selection

PFO closure procedures

guidelines

clinical questions

anticoagulation