Watch members of the Sentara Heart Valve team close a small hole called a foramen ovale between the upper two heart chambers. The procedure uses fluoroscopy to guide a small occluder device through a long catheter. Using echocardiography we gather images from within the heart to help verify the position and function of the device during the procedure. This technique is known as transcatheter closure of the PFO. A patent foramen ovale usually doesn't cause complications but some patients may have heart defects and complications of low blood oxygen and possibly a stroke.
Sentara is the largest heart program in the Southern Virginia Hampton Roads region of the state and participates in many clinical research trials.
Good morning, everyone. Uh My name is Matt Summers and I'm one of the structural heart interventional cardiologists. Uh I'm joined by Doctor Deepak Tara and Doctor Dave Adler uh as part of our case series for the Heart and Vascular Service Line Masters series uh where we're gonna be demonstrating a live PFO closure. Um I'm calling from Norfolk General but I have Doctor Deepak Tara and Dave Adler uh in the Cath lab at Virginia Beach who are going to introduce the rest of the team, but also uh talk to you a little bit about the, the case that they're performing today. Deepak Matt. Thank you for the introduction. And in the Kath up here at Virginia Beach, we have a pretty large crew. We have Doctor Adler and I and Jordan at the table. We have Megan Manning the echo machine and helping get these pretty images from Abbott. We have Caitlin Katie is circulating and, and making sure everything stays stable and good with the patient anesthesia. And in the back, we've got our broadcast team which is Amy and Matthew and Amy and, and team. Thank you guys for making this possible and displaying everything. We've got Daphne running the computer in the background. We've got our A PP Chelsea over here who's helped get everything set for today. We've got Susie and Karen Roker here in the back who helped make sure everything runs smoothly in the calf lab. There's many more people whose names it's uh I'll spare you further introductions of, but every case obviously depends on a lot of people. So, Matt, thanks for the introduction. Of course. Do you want to uh talk through the case here? I uh if you can see the screen, I'm sharing the case background here. Yes. So JH is a pleasant 55 year old female referred after a cryptogenic stroke for consideration of PFO closure. She was admitted earlier with a right MC AC VA causing an expressive aphasia and left hand weakness was evaluated by internal medicine, neurology, and cardiology. Um She uh since the time of that event has been on aspirin and cholesterol. And more recently on Plavix plus aspirin had a recent diagnosis of sleep apnea and is still waiting on sleep apnea machine. During that index hospitalization at the request of all those services above, she had a two D echo that doctor Summers will show you shortly which was positive for bubble study uh uh transit across the atrial septum. She was seen by neurology and initially started on aspirin and statin. She had a telemetry work up while in hospital as well as a hypercoagulable work up that was negative and she wore a 30 day event monitor since discharge, that did not show any arrhythmia. Specifically, a FB we were worried about since discharge, she's continued to improve very dramatically. She's a teacher, very dedicated to the community and she still has some residual left hand weakness and tingling. That's now only intermittent was seen by neurology and cardiology with the agreement to proceed with PFO closure. On the next slide, you see some of her problem list. CT of the head. August 5th showed um well suspicion at that initial time for a right temporal, frontal and parietal, acute and subacute infarcts in multiple locations. CT A at the same time showed an inclusion of the M two segment of the inferior right middle cerebral artery just past its uh its uh origin and then repeat CT A showed no significant change. This is three days later to confirm the diagnosis and also to rule out a hemorrhagic event because of some progression of neurologic symptoms. She has a borderline elevation of A one CG er D and as mentioned before, sleep apnea. Next slide, please. Dr summers ill turn over to you. Sure. So uh while they're busy getting access, it looks like they're, they're already set up to start. I'll walk you through this uh transthoracic echo. So, on the screen on the left, that's a standard paternal long axis view. Um what we're looking for there, at least in a PFO evaluation is to make sure there's no concomitant valve disease, normal LV function. If the uh EF was reduced, it might implicate an uh uh an LV thrombus on the right. This is a apical looks like an apical four chamber or five chamber. Uh That's a bubble study. And what we're doing is injecting saline micro cavitation, so agitated, saline through A IV. And we're looking for the transit across the right ventricle into the left ventricle. So really either implicating a shunt at the cardiac level or a shunt at the extra cardiac, almost always uh pomona level. And uh Deepak, as he mentioned, is a significantly positive uh bubble study. You can see some impression down here of an atrial septal aneurysm or an A S A which we consider a higher risk feature uh for PF OS as far as their uh associations with PFO associated strokes. Deepak, do you have anything else to comment on the, on those pictures? You nailed it, you nailed it and what, what generally comes next? And this is often uh one of the things that we get consulted for, we'll get a referral just for a positive bubble study to consider PFO closure and a positive bubble study. As most will note, uh does not necessarily implicate a PFO though it's far more common to be from a PFO, but you can have multilevel shunting. Uh And the tee is important to demonstrate that you do have shunting at the at the atrial level, but also to confirm the anatomy of the PFO um or I'll open it up to Dave or, or DAK, are there certain characteristics of this that, that you find anatomically challenging or what, how would you interpret this te with regards to the PFO closure itself? Sure, Dave is actually replicating this image and what we'll see in a second from ice. When you look at this, you see the top of the screen is the uh left atrial side, right next to the imaging probe. The bottom that fills in fully with bubbles is the right atrial side. And the aortic valve in this case looking so nice as in the sense. And as you pointed, as you were alluding to matt, this is a very aneurysm atrial septum, it bulges out with respiratory variation. And right after the bulge, you see what I think again, as you said earlier is an a significant shunt here which again makes us suspicious of this as a potential cause for that CD A. What else would you add? I think that's exactly it. I mean, we've confirmed that there's atrial shunting. It's a beautiful picture that shows with respiratory variation how that PFO opens up. Um I think technically be classified as a longer tunnel PFO although it's right borderline and with the a uh aneurysmal intra atrial septum, certainly uh all the factors uh with ruling out other causes of CB A, this this seems to be a PFO associated stroke. Nice. I'll tell you what we have ice up. Maybe Doctor Adler can talk through the ice on the screen and we can do a bubble study right now to confirm and, and again, elucidate its morphology, as you said. Sure, we've already got our uh our, what we commonly refer to as ice, which stands for intracardiac echocardiography. It's ultrasound technology uh on a catheter that we've advanced from the right femoral vein up to the right atrium. And if you look at our fluoroscopy screen, there's a live picture of what it looks like. We can confirm the position of our catheter in the right atrium. On the right hand side of the screen are the echo images that we obtain. And, and you can see we've uh got a nice view of the inter atrial septum there at 12 o'clock. It is the thicker part of the septum just below that, that very thin uh fossa that you see moving with uh respiratory variation is the uh fossil oval. And you can see the uh sepal ays that we've been discussing. And if you'll note with respiratory variation, you see it, that sort of jump rope action of that thin portion of the, of the septum is the atrial septal aneurysm. And so we'll proceed with a bubble study. Now, what do you want to se aneurysm? Say that again, dear. I was asking, what do you think of that atrial septal aneurysm area, I think it, it probably uh at least technically usually means for me that we may have to size up a little bit on the device to capture both of the, you know, all that tissue. Um What do you think? Agreed. Agreed and Dave, you're gonna say something. Oh, well, if we look, there's the bubbles. So at the top of the screen in the right aprons, um we could do it again in case folks. So I missed it happened pretty quickly. But uh that, that right atrium filled with saline bubbles as we've injected, agitated, saline uh through a femoral vein. And if you watch, we'll see bubbles in the bottom half of the screen. That's the left atrium. Here's something the recent bubble study. So markedly positive bubble study, there's a lot of bubbles in the left atrium uh which suggests a significant shot and, and just uh I think the screen wasn't pulled up when you were describing the anatomy. So, well, David uh to the left of the screen is inferior to the right is superior R A is on top and L A is below that you can see the septum and the aneurysmal components of it. Um uh Is it possible to get a short access view because we typically will do uh two views inferior and superior to look at those rims and then anterior and posterior uh to look at it in relation to the aortic valve and the retro aortic rim and the, the posterior rim. Uh I'm sure you'll get, get to that point, but I think we've described the anatomy sufficiently. Um Do you have any comments deepak anything else to add? I love what you got. You guys have pointed out and we're set up now. So what we're gonna do now is we're going up with a multi purpose diagnostic catheter and a uh glide wire with just a little angle on it and let me zoom up a little bit. So you can see better in the hand. Maybe Matt, you can talk through the steps here of getting across and what's next. So they, they typically have standard uh femoral Venus access. The ice catheter uh goes through uh an eight or nine French, some use 10 French uh left femoral vein. Uh and the uh a PFO devices will go through anywhere between an eight and 11 French um catheter in the right femoral vein. So we have Biemer Venus access. Uh You can see the ice catheter pointed up for a, a long axis view of the um the septum and we have a multi-purpose guide coming in from the right with, it looks like a glide wire. Is that what you guys are using? Yes, sir. So lots of different ways to cross these. I think most people will do a glide wire like that and multi-purpose some people cross without a wire because there's lots of fenestrations that it can, can exist alongside the uh the PFO and you can fall into those and it can constrain your device. Um but it looks like we're, we're working hard to get through that PFO and it looks like you just got it. There is in the left upper pulmonary vein um by the, the X ray appearance of your wire. If you look on the, the ice images as well, you can see the catheter crossing. You go with the fluoroscopic and echocardiograph and confirmation of our catheter position TED. And uh let's see if we're gonna gently advance our catheter up into the left upper pulmonary vein. And then we're gonna switch this wire out for a stiffer wire that we use for balloon sizing and device. And then Matt. Meanwhile, we're preparing a 24 millimeter sizing balloon. This is where the implants are sizing balloons to just characterize the um septum and to measure the size. So we can together choose an appropriate device size, all of us. What percentage of your uh Ko Deepak and then Dave, do you, do you balloon size? Yeah. And I know there's a, a large spectrum for me. I like to balloon size, almost all of them as much as anything else to measure it. To know ahead of time how the device will see. Um What about you? I agree with you. Yeah, go ahead, Dave. Uh I, I routinely balloon size. Uh sometimes we're surprised by the size of the, the defect and sometimes difficult to estimate with uh noninvasive imaging. So I I routinely balloon size. These uh guys I do as well. It's I think it serves two purposes. As you mentioned, the uh appropriate sizing can be difficult. You can see how the PFO anatomy conforms to a device. But it also in a lot of cases will, will help de tunnel the, the PF OS to allow more adequate expansion of the device. And so I think there's a lot of people don't, but I think it's a, a good practice to balloon size. Uh for days beforehand, I have uh in your powerpoint Duck. I have a animation of the device that you're gonna use. There's, there's two devices that are commercially used and, and you guys use the uh uh Amplatzer Talisman device. Is that correct? That's what you're planning to use here. That was our plan is to use that today. Maybe if we can cut back to the powerpoint slide, I will uh show that video while you guys get your stiff wire in and prepare, prepare for the phone. Yes. Hey, this is the animation. So I, I tell folks and you guys can chime in when, when you want a Apfo is basically a remnant of uh fetal circulation uh when you're in the womb, uh you're not breathing air using m lung, mom's lungs for, for oxygenated blood. And so you have to have a purpose built detour around the lungs such as shunts aren't created. And that is the framing of Valley, as Doctor Adler mentioned, uh and two thirds of people in the world that closes when you take your first breaths and the umbilical cord is cut and blood starts flowing to the the lungs. Uh But in a third of people in the world, the PFO remains open in some sort of fashion And really, it's a potential route for a clot in the venous system transiting and producing a systemic em embolic event. So we typically see it in young patients like this really without any other risk factors for stroke or evidence of other more common causes of stroke. Um but this device uh that they're about to implant is effectively and both devices really are a soft night and all based clam shell that, that situates and has discs on both sides of the septum and will prevent the transit of any Venus. Uh thrombo thrombotic uh material from the, the right side to the left side and thereby uh significantly reducing the risk of subsequent stroke. Anything to add for the, from that guys. That's well said that's what we are, we are across with the balloon. Do you want to cut over this way or do you have another image to show there? That's what I got for now. Um I think it's, it's probably nice to see the, the way the balloon conforms right now, if you can go back to Deepak and Dave, OK. And maybe we'll show you on the upper right screen, which is the echo you can see from the left side of the screen down to the right our wire going across the atrial septum. And in a second, when we know you can see us, we'll put on some color and you can see the flow across the atrial septum that matt alluded to are we, are we laugh at these pictures. So, just to orient folks that are watching uh in the audience on the left hand side, the fluoroscopy screen, a wire is going from the left side of the screen to the right side of the screen across the PFO. And then on the right side here, you see our, our echo image and can we throw some color on that real quick and just show folks, um you see a little bit of color flow across there. We, we've tinted the PFO open a little bit with our wire and we're about to advance a balloon cross and Megan, you were measuring the size of that I saw earlier. What'd you get is 0.9 pretty good size with just the balloon or not even the balloon but the wire. So now you can see the balloon across the PFO and we're gonna change our floo angle just a little bit optimize our view and they're gonna gently inflate this balloon. The idea here is just a nice, gentle inflation enough to create a waste on the balloon that we can use to measure the size of the PFO. And so that inner to inner marker, there's, you see a two big black markers, one is a double on the far side and one is a single between those two is 15 millimeters. So right off the bat, you can see this is smaller than 15. It's less than the inner to inner segment, but it's more than half of that. Let me think. Yeah, about 10 is, so that fits with Megan's nine size measurement. We're thinking this is 9 to 10 millimeters in diameter, which is pretty big for a PFO what do you think? Matt? Yeah, it is. Uh I, I typically use the, you guys have much more experience with the MPL device with the, the Gore device. I think anything under 17 is doable with a 30 millimeter device and, and then 11 or 12 is the demarcation for a 25 device. So this is one of the bigger devices 25 or 30 from from my end. Um What size device or do you, do you think you're gonna use with this information uh for the talisman, like you said, for Talisman, our choices are 25 and 30. Caitlyn. What do you do bigger? Yeah, David, what do you think? I agree. I think that the two reasons for upsizing, I'll, I'll, I'll back up and say we're using 25 probably in 90% of patients. But in this situation, because of the aneurysm or septum and the larger size that we've measured on the balloon, I wouldn't upsize to 30. So I hear Doctor Adler avoiding 30 of the 30 doctor summers. Yeah, exactly. As Dave said, I think if you have any other, an atomic features like an aneurysm and intra septum or lipos hypertrophy or thick uh prem, all those things tend to, to upsize your device. So I would, I would use a 30 gore or 30,000. All right, we're all on the same page. So 30 delivers through this sheet that we're getting no front sheet. And then Amy, is there a way for us to switch to showing the table now? So the camera on the table like, OK, I'll give it to go here deepak this patient went through neurology. Do you feel like that's a requirement for PFO associated strokes, foreclosure? What's, what's your work flow? Yeah. What? That's a great question. I think it's nice when neurology has a chance to see the patient and help us adjudicate that it's clearly a stroke. I would say, I think in this day and age with the great I uh CT and MRI imaging and frankly with uh with the fact that our neurologists are so busy, there are certainly patients. We see where the the diagnosis is not in question. And so if if as cardiology, we've done a rule out for other causes. Look, look for a FB, then I think it's not a requirement but it's a luxury when we can have it because the neurologist is so good about also helping with patient recovery issues and, and so forth. What, what would you add to that? Yeah, that's really well, well, well stated, I, I think uh for the exact reasons you, you said it, it can be hard to get into neurology, but a lot of these patients are coming to us being referred from the hospital after their stroke. So you've seen neurology in some capacity in the in the hospital. Um And we have pretty clear guidelines since the data in 2017 by sky that I can go through. Uh once you guys are, are uh further into the procedure. I I think it really leaves open the door for a very specific criteria that, that we can use to adjudicate these events uh and use the evidence that we have for the big clinical trials to justify uh secondary prevention of stroke in younger folks. Nice. All right. I was gonna show the device here. This is the device. I don't know if you guys can see it on your screen right now, but it's a as, as doctor Summers pointed out, it has these two clamshells that go together with this device, we always unscrew it first it comes self mounted and then rere it and then we tighten all our connections just in trans if they can be loose. Doctor Adler is hooking up a flush to this and then we always make sure it's free from any bubbles and regardless of what device or other technologies like Watchman or Tabler and, and we're always careful about these, making sure these bubbles are gone when we prep any device. So under this tub of uh heparinized saline, we're injecting Heper nice Saline to make sure everything is nice and free from bubbles. And then that device you saw earlier, which was the clams shall go in and out one more time. Deepak uh uh I don't want to speak for you or David, but we, we get a lot of referrals for patients with stroke like symptoms or tias without imaging evidence of, of stroke. Um We, we obviously the, the, the bar is much, much higher in those because it includes complex migraines, complex partial seizures and a bunch of other reasons that there can be neurologic deficits besides a VT event uh through a PFO. Um What what percentage of patients do you think they get referred? Um Do you, do you actually think have a true indication for PFO closure in your experience? Yeah. What a great question in my experience. It's, it's less than 50% there's a lot of patients that have a PFO but like you said, truly, I like that one time. Uh But truly didn't have uh that and then, especially in era's past. And even sometimes now I think like you said, we get patients sent to us with migraines that have heard. Maybe there's something there. I don't know if, if you're gonna address that in your slides. But what, what do you, what, what do you say when a patient comes to you more with migraine than stroke or with uncertainty and is excited about thinking about something like this. Yeah, it's a good question. I I think we have clarity since 2017 before. Then. We didn't really have much clarity. Uh There is association with stroke and some, some data that suggested uh point estimate improvements in uh recurrent stroke. But there was this big mix of migraines ti a sort of different syndromes that uh we were studying the migraine trials all turned out negative. Um And the the guideline still leaves the door open for really high risk ti a presenting symptoms or people that had early revascularization. Um If a neurologist feels it's, it's likely I kind of use anything but the PFO associated stroke at the age of under 60 with imaging evidence of C VA and no other sort of indications of other ideologies as the the point to to do the PFO closure. But if there's any of these other uh setups, ti a you know, hypercoagulability decompression illness, variety of different things, I generally rely on uh neurology to, to help uh adjudicate the PFO as something that proposed. That makes sense. Dave, is that your problem? Same, same exact. And so it's, it was disappointing the mistrial and other trials didn't show any benefit there. But since they didn't, I, I'm so, I'm 100% with you. That really, this is for true ti A or stroke. All right. We're coming out with the balloon and we're gonna go up with the delivery system. Let's see, it's 1226 while we get the delivery system in place. Do you wanna go through some of the didactic information you have? Sure. Sure. All right. So this is what we've been talking about in the background. Deepak alluded to this uh with the patient presentation in the work up, we typically have the criteria of PFO closure for secondary prevention of stroke and very select patients patients that are equal to or less than the age of 60 if you have true uh embolic topography, meaning you have imaging evidence of an embolic event, meaning meeting a vascular distribution that's consistent with an embolic event. So, usually cortical infarct. Um no other evidence uh of a source of the CB A. Besides that atrial fibrillation is the most common. We typically have patients do 2 to 4 week monitors which captures a minority of the A FB. And we acknowledge that uh but is uh was included in the trials and we make sure there's no other concurrent indications for atrial uh for inte coagulation. There's other uh indications like systemic embolic events with PFO that weren't a stroke without identifiable causes, something that comes up commonly uh but often uh does not need closed platina orthopnea syndrome. Questions about whether patients over the age of 60 scuba divers with prior decompression illness, migraines as we talked about tias or other high risk anatomy has been the question for the past several years and really with the most recent guidelines based on data or lack of data, rather, a lot of these have fallen out of favor. Um In 2022 sky released these guidelines. And as you, as you see, uh they, they leave remarks that say patients particularly those with debilitating migraines who have failed to benefit from conventional medical therapy, who place a high value on the uncertain benefits of having their PFO closed in a lower value on the uncertain arms may reasonably choose PFO. So getting it reimbursed is a different question, but it leaves open specific scenarios where patients that have debilitating uh issues. It can be a discussion between the physician uh and the interventional cardiologists if they value the lack of clinical trial data, but uh have significant symptoms in general. Patients under the age of 60 should be closed regardless of their anatomy, high risk features or not, or their clinical risk scores. Patients over the age of of 60 are the ones that require a little bit more thought as the ideologies of stroke become uh more confounded with the more typical causes like atrial fibrillation. Um And so we typically would do something like a rope or pascal score to estimate the likelihood that the stroke was from a PFO. And as you see, as the age gets older, you lose points uh as your cardiac risk factors and vascular risk factors uh uh change. So does your risk score and generally a score over seven means that you're, it was highly likely that it was from a PFO the two trials that we've all been hinting at are the reduced and closed trials. You can see that these were with uh Amplatzer or Gore and then Amplatzer devices respectively. Uh I tell patients it's between a 70 80% risk reduction of subsequent stroke on top of DAPT. Um And that's why we're, that's why we're exposing them to the risks of a device based therapy. Um for something that's preventative. Do you all have anything to add to that? No, that, that's a great summary. Can I add, we're, we're loaded with the device and maybe we can come back to the case and then go back to the slides afterwards if that's ok. So on the screen, now, what you see is you see a catheter we've placed in place. This is the delivery system that distal marker is in the left atrium and then simultaneously on the right side of the screen we have our ice images and sometimes getting everything in plane can be a little tricky, but we see the catheter headed across and then we do a push pull test on the device here, push pull, we're making sure it's attached nicely. You see the edge of the device has that black dot It's a matter, we'll position that and then maybe you can talk through as we, as we pull back what everyone's seeing on the uh on the imaging. So you talked about it in grand rounds this morning, the uh the unfolding of an Amplatzer device or the cobra heading, it looks like that left atrial disc deployed perfectly. So we see we see ourselves there now slowly scooting back to the septum. So you're using, you're using fluoroscopy ice and uh tactile feel to, to deploy this right atrial disc. Is that right? Right. And so now I've deployed both disks and we'll take some picture imaging, gonna get some nice images for sure. So on the right hand side of the screen, the ice images, we're just gonna gonna look around and uh confirm capture. We saw Doctor Tara's excellent work there though. No question, the device is in good position. Um One thing, sometimes we'll back our delivery sheet away a little bit from the device because it can bias the position. Once we let go of this, it'll settle down into a natural position on the septum. We'll try to replicate that nat most natural position before we let it go. So if you look on our ice images, we see a sandwich with uh the two discs of the device on either side of the atrial septum. And we're just looking around to confirm uh that we have a good capture of the septum. Sometimes this can be a little tricky as that delivery system pushes our ice calendar a little bit out of the original position that we had there. But um looking pretty good, we can see. And this is certainly one of the larger devices you can tell it's a 30 by uh just its appearance, especially that right atrial disc. But I, I like those. I like our choice of it given the atrial septum and see the relation to the, the aorta there. And uh we see the thin and big parts of the septum captured inside the device. So Dave, you're just confirming that you, you captured all the rims of the, of the set. Is that right? What we're doing right now is a little push pull just to make sure that it's in a stable position. And as I do that, you can actually see you see it. But as I pull all those apart, you can see the accept them in between the two discs. So we're, we've looked around, I'm uh I'm basically just turning the ice catheter rotating through the device uh to see as you as you exactly as you described it, see all the rims of the, the device and make sure that uh it's in good position and we have the gap with se did you do a push pull already? We did that and it looks good. Fantastic. I get seated beautifully. Matt, what do you think? You happy with that? Yeah, I think you, you deployed. It perfectly looks like you've captured everything about to release. OK. Vote to release my vote is with you Jordan Caitlin, everyone else, Katie. Yeah, definitely back there, Elsie Karen. All right. The whole team here says release. So we're on the same page. Thumbs up all around the rooms. So we're gonna unscrew the me, of course. Right? And you can see how it's sort of fallen into a more natural position as we deployed it. So on the on the fluoroscopy screen, you can see the device and now we'll take another look around with ice. Oh, it's gorgeous. Maybe we can put a little color better now. Yeah. Uh Megan. Do you want to put some color if you uh if you saw color here, uh Dave or Bubbles after the fact, do you get worried? That's a good question. Um We, we think about that uh from time to time when we see color. Um Usually if I feel good about the device position and uh and uh you see that we've got good capture of the septum as this endothelial iss that, that seals up and the colors not gonna be there when we repeat an echo in 30 days. So that usually doesn't bother me. And usually we've been very thorough. I agree. We usually, we've been very thorough making sure there are no other sources of shunt um, ahead of time when we did our initial work up. So it really should be just through the device. But as you point out, it's nice to have that final imaging here. I don't see any across and it's, it's encouraging to see. What about you, Matt? What are thoughts do you have? Yeah, I, I mean, I, I think II I typically do a bubble at the end but I tell folks that uh if there's bubble transit or there's flow just like Dave said, it needs to end of the eye and heal and as long as the position is appropriate and all the rims are captured, um people will have them seal up. Um This, this was excellent imaging with the ice catheter and in one dimension really, um it takes quite a bit to navigate. Uh You made it look easy, Dave um navigate from long axis to short axis. Uh And I'll open this up to Deepak and Dave. Do you think that 3D ice would have been helpful in this situation? Absolutely. Um You know, we, we've been doing PFO closures for a long time with the, this two D ice. But as you can see, it takes some manipulation of the catheter to obtain the fuse. And uh there is newer technology that uh doctor Summers is referring to that actually gives us the ability to have uh 3D imaging um which is extremely helpful if there's any question about the position of the device or if there's anything unusual about the patient's anatomy, having uh that additional uh you know, imaging technology is helpful. It's also helpful for a lot of other cases that we do. But other types of uh procedures that we do, I was just gonna say that that you guys have built. So, so Sana is now the second largest mili program in the in the country. Thanks to you guys, hard work and you guys are doing these tri flips as well. But those technologies as well, it really does seem like it's absolutely essential to evolve in that direction and have that technology. So I think that's a no brainer of our next progression. What would you say? What other thoughts you have on that map? I think you, like I said, you made it look easy, Dave, but to uh switch from a long axis to short axis uh to look at the rims, it, it actually takes quite a bit of manipulation uh to, to view the aortic valve uh and you showed it perfectly. But, but 11 benefit would be that you can do X plane, you can do biplane, you can set, set the image up in the superior, inferior and then just uh triangulate a short axis image and get 3D. So a lot of structural heart procedures I think would benefit. And I think uh the three of us will be using it uh quite commonly going forward. Great, we're looking. So we're basically done. We've released the device. All we have to do is close the uh the uh anatomy sites we have per closes in, in there. Um rather than making them watch that given that we have about 20 minutes left. Do you wanna go back to Didactic? And then we can address any comments, questions, thoughts between us all. Yeah, that, that sounds great. You guys got a perfect result in this. Um And it, it, it made it look easier than it actually is capturing the septum when it's that aneurysmal that that can typically be a, a more complex thing to do and require recapture and redeployment on a few occasions. Uh But you got it on the first try. It looks perfectly seated, perfectly sized uh perfectly in the, the PFO uh such that it was de tunneled appropriately. I think all this stuff looks uh looks fantastic. So, congrats on, on a successful procedure. Nice. So I I think the most common referral we get is is high risk neurologic symptoms. So tias and um high risk PFO anatomy and they, they take a different level of threshold for confirmation before we can estimate any clinical benefit for patients only because they weren't included in the trials. The trial, the two successful trials really, there's been three but the two most recent uh really narrowed down the patient population uh where there's less of this heterogeneity and you know, complex migraines and complex partial seizures and and a lot of that come comes out when you have tias. So I think the first bar is uh age under 60 imaging evidence of ac va and then you get into a little bit more of the, the finer points. Is it a subcortical infarct? Uh Is it an old infarct? Is there, you know, uh subclinical carotid disease? Is there transient A FB all these things kind of work their ways in um the minority of patients have uh such a robust uh indication. Is this patient young no other risk patches. A lot of patients end up getting some atrial fibrillation afterwards and it can be hard to elucidate whether this was a FB all along and un captured on the 30 or 60 day or I'm sorry, the 14 or 30 day monitor. Uh or rather this is just healing and irritation on the left atrial side from the device deployment that would go away. So it's a common thing that we deal with the other, the other scenarios as we pointed out um decompression illness, that's not a general recommendation, more migraines. There were two clinical trials that uh doctor uh Tara was talking about that, that uh sorted out those issues. Uh Ti A and high risk anatomy have all really fallen by the wayside. But the guidelines leave open very specific instructions so that, that there is a patient preference and patient uh values involved in the decision. We don't typically use the rope quil all that much at least quantifying it. But uh from a referring standpoint estimating the likelihood that a stroke was from a PFO I think is helpful. Um When you calculate this out, you can actually correlate with the percentage likelihood of, of the stroke being from the, the PFO. And then just to highlight again, these, these clinical trials, this is very, very impactful on top of aspirin and Plavix. That procedure that you all just did on a 55 year old reduced the hazard ratio to 0.23 and 0.03 for these two trials. And I estimate, you know, I tell folks that it's between a 70 80% risk reduction and their and their subsequent stroke risk, which is very, very impactful when someone is young in their twenties, thirties, forties, fifties and have many decades left of, of, of life. Um But the these trials, it was very solid data. Um It's changed our practice and, and uh how frequently we get asked to close these PF OS um but being able to offer a patient a stroke reduction benefit after they've already had usually a pretty significant cortical stroke uh is, is uh very appealing and, and and helpful for folks. Do, do you have anything else to add guys? So you nailed it? Nice to have a technology like this that can so efficiently take care of these patients and, and my numbers are just like yours uh based on respect and so forth that 75% reduction is really impressive on, on top of the fact too that, that a lot of people will, will get a diagnosis of PFO and then wonder why we don't close it. Um And I, I tell folks that even though PF OS uh are very, very common, um you know, if you take the numbers can be up to 2 billion people. PFO associated strokes are still very, very uncommon. If you have a PFO, the risk of stroke is still very, very, very small. And sometimes that's hard for patients to understand why we don't just close them uh to prevent risk and, and while we wait for a first stroke to happen, but it's because those numbers are still very, very small and we can't affect any clinical impact with pre emptive closure. Um anything to add on that. Deepak or Dave. Now your points so well taken. And those are the hardest consults, right where someone's really worried and they come to you, they come to you and the best medical knowledge is not to do anything. But that is the right answer. So like you, I, I as hard as it is to convey that that is the right answer. Do we have any questions from the audience or can we invite questions from the audience? I'm pulling up the uh question list here. See if we have any, I have 11 comment or question for you guys. Meanwhile, I I'd ask you guys the other un less usual indication but when we see is Platia orthodoxy, when patients deat in certain positions, can you guys talk about that? And how often you see that? Yeah, we, we get consulted for it not infrequently. Um It's generally associated with other things, liver disease, uh pulmonary disease. Um And so the index of suspicion is, is generally already high in folks. We get uh tasked with looking at shunting and people with lung disease as well. Um There's, there's a variety of uh other consults that we'll get for Platia orthopnea or if the PFO is acting functionally like an A SD and, and creating left to right shunting or right to left shunting hypoxemia. Um I, I've can count on one hand the number of times I've, I've seen true Platy Ortho uh orthodoxy. What about you, Dave or Deepak? Yeah, I was gonna say it's the true uh the true uh syndrome is, is pretty rare. Yeah. Um I have not closed very many PF OS for that, but it, it is, it's a real thing. Yeah, we're always on the lookout for it. Mayo's big series was like five cases. So you're right. It's, and then one more question, uh maybe more related to a sds than PF OS. But since the technology and procedural parts of closure are so similar, matt, I, I know I've watched you do this a bunch patients with significant pulmonary hypertension and A sds. What do you, what's your guys' approach to those folks? Yeah, I, I think it's a step wise approach. The concern um is that you can have shunt reversal. And if you close the A SD, if people are too far into the natural history of a secundum A SD, you may be taking away a pop off valve if they have concomitant, pulmonary arterial hypertension. And so typically, what I'll do is something called a balloon occlusion test. Uh where we take just like that sizing balloon that you had. Um and I'll measure right atrial pressures and pulmonary pressures after, before and after 10 minutes of occlusion. Um and confirm that the pulmonary pressures don't increase or the, the uh right side filling pressures don't increase. Um And then I'll close it uh with the backup plan for introducing pulmonary vasodilators if the pulmonary pressures do rise. And so we still have the option to close it. And then a rare example, but one that has come up is you can fest the A SDS if there is uh uh increase in pulmonary pressures, just on the back table, just like you guys did when you were prepping the device by uh putting smaller uh defects holes in the, in the device or using a multi-tenant device, anything from your end? What uh what is your thoughts? It's like you said. So A SD is unlike PF OS, you almost always close when you see a Secundum A SD. But that's the one group that I think is, is tough to manage. And your approach, I think is spot on David. Yeah. No, I agree. I think uh the challenge in those folks with a SDS and pulmonary hypertension is determining the chronicity of that and uh whether they have reversible pulmonary hypertension. And so the, the real answer is to diagnose those folks early and, and you know, and close the A SD before they develop pulmonary hypertension. But, but I do exactly like you did that uh balloon preclude it. And uh I think that's the best way. Uh just, just try a real world challenge and see what their pulmonary pressure do. One more quick question for both of you. So she came in loaded with Plavix already as far as for the for the clinician managing a patient with a PFO closure in the post operative period. And you guys talk about anticoagulation, SB prophylaxis, those kinds of things. I'll let Dave go first because it's controversial. OK. Well, um so a any platelet therapy, I put everyone on dual antiplatelet therapy for some amount of time. Um theoretically by 30 days, the device should be endothelial and, and they should be able to come off of any plate of therapy. But I generally do six months uh because we know that not everyone is completely endothelial and, and as long as they're tolerating the, the dual therapy without any problems, I tend to, to keep that on longer. Uh S pe prophylaxis is another controversial uh topic by the book. The guidelines say six months of S pe prophylaxis. I tend to go longer than that for my patients because again, if the device isn't endothelial, they're at risk. And uh the the consequences of uh endocarditis on the device are, are so high that uh I don't like to roll the dice. So the guidelines say six months, but we generally any differences in your, no, he said that much better than I would have said it if I started. But I think we use what we know from ST and end for a variety of device therapies. We historically have done this for Mili and tavern. We deescalated as new data comes out um to single antiplatelet for post post have. But with these devices, we've kind of done the same thing. If you talk to adult congenital folks, they'll just use a, a full aspirin so that, you know, I typically do what Dave uh outlined, which is at least a few months of gap. Uh And then a baby aspirin um just while endothelialization is occurring. Uh But the, the, the trials used that regimen too. So we replicate that. Um I think there's probably benefit in medical therapy alone, obviously. And that includes DT in most, most uh patients. Um But I, I follow the same regimen as far as SB prophylaxis, think we're uh our glasses are tinted, so to speak because we see folks come back and have that selection bias. As far as um seeing people with endocarditis related to device therapies. It's actually very, very, very rare, but I tend to extend out uh SPP uh prophylaxis for a year or more. What about you? Deepak same. I'm I'm right with you guys. It's funny you mentioned SB prophylaxis. The lo the longest one out I've seen was one patient in the respect trial. This was years and years ago, developed an infection, 18 months out that we ended up having to do a surgical extraction and replacement. And that was a very unusual situation. A patient with significant dental issues, but we did a full year of SD prophylaxis and, and like you both mentioned, it, it tends to make me probably a little conservative and go a year or two with most patients for SD. How, how do you guys handle nickel allergies? That's something that comes up with these two. So, so this one too, how about you? I'm not trying to put you on the spot. I would, I would say it comes up uh where, where it actually happens in Real World. Um There's, there's been some studies that show that you really don't elude much for the, for those in the audience. It's uh night. Naw. Is, is the primary material that's used in these devices, the nickel titanium alloy. Um And, and so there can be people with really uh significant hypersensitivities to nickel that develop uh symptoms as a consequence. Um, I, I screen everyone. I asked them about allergies and then I'm reluctant if they have a nickel allergy. Um I'll send them to an allergist, um, because you can't take the device out unless it's surgically. And, uh, a lot of folks, if they have that allergy after the device is implanted every little s, uh, symptom, um, you know, you, you wonder whether it's related to the device or not. What, what do you guys do? Yeah, exactly the same. I think, uh, a, as you mentioned, the, there's very little, um, risk but I think if, if you're gonna implant something that patient's gonna have lifelong, having them, see an allergist and just confirm that, that, uh, they don't have a significant, uh, reaction to the nickel. Just give some peace of mind for, for us and for them. And so I've got a pretty low threshold to send folks for allergy testing. And, uh, I'll say it's pretty rare that someone comes back with allergies. A lot of times they are, they've been told they have a n allergy, but once they, they get uh formal testing, reassured that it's ok and we'll proceed. This is great. This is the latest and greatest and most up to date you can hear, I'm getting the signal from Amy that uh that we've hit our, our time. Can I say a couple of thank yous Matt. Thank you for moderating and taking the time to put together the latest data, Dave. Thanks for, for coming and scrubbing Amy Matthew. Thank you for making the broadcast work. The structural heart team in general takes care of so many of these patients. I'd say a thank you to all of them and to the team here at beach today that participated in this patient's case and to the patient herself who was kind enough, she's a teacher and uh was willing to, to allow others to learn from her experience, Matt. I'll send it back to you. Yeah, congratulations guys. And you made it, made it look easy and uh uh we're all thankful the patient got a, a good results and, and can benefit from this therapy. Um It doesn't look like there's any other questions in the chat. So I think uh if if not at any other points or, or questions we can can uh stop here. Thanks so much. Thanks that
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