So good morning, everyone. So as the title say, I'm going to present the case of high-risk PE and highlight the management and open it for discussion. So I have a 43-year-old male who presented with acute onset of dyspnea for two days, getting worse, no chest pain, had recent surgery of his foot two months ago. He worked as a barber, but since the surgery, he's unable to stand. He sat on the chair the whole time. No other history of any problems, any medical problem, no history of DVT or PE before, negative social history, no home medication. Very well otherwise healthy person, a dad of four kids, came with a shortness of breath. In his initial presentation to the hospital, his blood pressure was 93 over 81. His heart rate was 130. His respiratory rate was 36. His auto-saturation was 83% on room air. He's in moderate distress. The rest of the exam outside, his right leg swollen was normal. He was immediately put on BiPAP, 12 over 6, and 40% of FiO2, which took his oxygen saturation to 100%. His lab work is EBG showing auto-saturation of 85%. His blood work otherwise is good except having acute renal failure. His cardiac troponin was elevated. His pro-BMP was 978 elevated, and his lactate was 4 elevated. COVID test was negative. So his imaging, his chest X-ray, as you can see, very much normal. His EKG, so far you can see the sinus tachycardia, also which is very non-sensitive sign. He had the S1Q3D3 in his EKG. His echocardiogram, as you can see, and the parasternal long axis view. I'm sorry, just one second, I'm going to play it more. Here you can see the dilated right ventricle and the flattening septal motion. Again another echo view showing the same changes in his right ventricle and the septal motion. And as you can see here, the McConnell sign and the dilated right ventricle and the septal motion and the hypokinetic of the septal segment of the right ventricle free wall. So he had all the echo findings of right ventricle strain. His CT, as you can see here, showing massive saddle pulmonary embolism, obstructing the right side and the left side. From the CT, as you can see, the RV to LV ratio is almost 2.5, the saddle pulmonary embolism obstructing the right lung and the left lung. So we have imaging. We have EKG, echo CT. We have ultrasound of the right lower extremity showing right popliteal DVT. So what we have so far, we have acute saddle pulmonary embolism with acute right heart strain, acute hypoxemic respiratory distress. I think everybody agrees so far. So what do we do here? Do we give TPA? Do we do a surgical embolectomy? Do we do percutaneous embolectomy? Do we do anticoagulation alone or anything else? So I think this is one of the major areas, and one of the main reasons why I'm presenting this case is because this is where interventional cardiologists could be differentiated than any other specialty who do treatment for PE, where we are, I think, very well educated and mastered of the hemodynamics, which can make a difference in this case. So do we have hemodynamically stable PE or hemodynamically unstable PE? So we know that so far the definition of massive PE or hemodynamically unstable PE is only based in one number, which is systolic blood pressure below 90. But what about somebody who had all these abnormal findings and the right ventricle changes and the blood pressure is borderline above 90? Do we call it massive? We don't call it massive? Do we treat it as high-risk PE? And I think what we have here, it's not by definition massive PE, but also we have a lot of signs of cardiogenic shock. We have low pulse pressure, 12 millimeters mercury indicating low cardiac index. We have evidence of end-organ malperfusion, AKI lactate of four. We have borderline hypotension with marked compensatory sinus tachycardia. So we have a lot of signs that tell us that this patient is in a shock. If you call it normotensive shock, I don't think I will call it normotensive shock because his blood pressure is in the 90 to his borderline where the massive PE definition is. And this spiral was already presented in the previous slides and previous talk. And as we know, massive PE or submassive height, moderate to high-risk PE is a right ventricle problem more than anything else. And the obstruction cause decrease in right ventricle output, and that's affect the preload in the left ventricle and decrease the cardiac output and decrease systemic blood pressure. So keep in your mind when you have massive or high-risk submassive PE, it's a right ventricle problem, it's a hemodynamic game, and you have to be very well educated about it. And this is why I think we are special to treat this patient as interventional cardiologists. We have some predictors of adverse outcome that we have in this case, including right heart dysfunction, large clot burden, central clot location, concomitant DVT, and we'll see also the RPVO or the obstruction in the pulmonary vascular, as we mentioned before. So what happened here, the PERT team is activated, the right heart cath was performed in order to determine the need for mechanical support, and then versus just proceed with the catheter-based pulmonary embolectomy without mechanical support. The right heart catheterization, as you can see in the numbers in front of you, indicate cardiogenic shock with a cardiac index of 1.42. And given the presence of cardiogenic shock and the patient being borderline about to collapse, we decided to proceed with VA ECMO placement before performing the large port aspiration thrombectomy and see how things goes with the case. So VA ECMO was inserted, placed, and performed, and without doing any thrombectomy on the first day, the ECMO was done after, with the ECMO showing ejection on the first day, showing ejection fraction 35-40% in the left ventricle. The right ventricle, as we saw in the ECMO, was moderately increased in size and moderately reduced function. And then 24 hours after inserting the ECMO, we did another CAT scan. The purpose of doing CAT scan, because there is some data, not very large data, about the ECMO being able to help to decrease the clot burden and help, you know, help in the situation of management of pulmonary embolism. However, in our CAT scan, maybe because within 24 hours, the data was within 48 hours, showed no significant changes in the large-striped pulmonary embolism extending throughout the bilateral, lower, and segmental branches and persistent right heart strain. At that point, we did the mechanical pulmonary thrombectomy using the float reaver, 24, with the ECMO being clapped during the thrombectomy procedure. So we don't introduce any air. We repeated the right heart CAT. We found the numbers, as I'm going to show in the next slide, was much better, so we decannulated the ECMO. This is a picture showing that IVC having the float reaver and the VENUS, the 29 French, for the ECMO. And this is the float reaver, 24, for the left and the right lungs. This is how much lung clots was able to be extracted. And as you can see from hemodynamics here, pre-ECMO with PERT plus or post-ECMO with PERT, as you can see, major improvement in all the numbers, including the cardiac index improving from 1.4 to 2, the right atrium pressure going from 8 to 1, the right ventricle systolic pressure going from 44 to 19, and the right ventricle endosylic pressure going from 14 to 1, and the PA pressure main drop from 30 to 50. So this is echo after the thrombectomy and the ECMO decannulation. As we can see, the septal or the basic segment of the right ventricle now is improving, and the septal motion is improved. Definitely the size of the right ventricle to the left ventricle might take a little bit longer time to improve. So, Mom, just to keep the discussion going… Yeah, let's keep the discussion going, because I think we all see cases like this. If you don't mind, I'll just ask one question to the crowd that's a little bit more controversial, just so we understand. We know what's happening here. This is a patient who technically was an intermediate to high-risk patient, super low flow, positive lactate, low cardiac output, obviously, and the blood pressures were over 90, but clearly borderline. So, Tomas was making the argument that, is the patient compensated or not? Certainly very, very borderline, if you're going to call this compensated. Most would call it decompensated, but meeting the intermediate to high-risk criteria. They managed it quite aggressively with ECMO up front, followed by large-bore embolectomy. The big question I have for everybody in this room who's very interested in PE is, would you feel comfortable randomizing this patient into an intermediate-risk trial? Raise your hands if you'll randomize the patient. Yeah. So, how many people—I want you to honestly answer. So, I only see five. One, two, three, four—I'm raising mine, so one, two, three, four, five, six, seven, eight. Eight, nine— So, the follow-up question, what is the randomized trial? What are the two arms of randomization? Yeah, sorry. It's a randomized trial of anticoagulation versus an interventional therapy—in this case, it's called embolectomy—for intermediate-risk PE or intermediate-high-risk PE. So, those are the trials that are going to be happening, or actively happening, and will be happening more over the next couple of years. So, there's a lot more than eight people in here, and we've got a big problem if we're not randomizing this patient, is what I'm going to put out there. Go ahead. Great. So, the question is, do you randomize to anticoagulation and observation or some kind of catheter-based intervention? So, who's comfortable randomizing? The randomization is anticoagulation versus, in this case, embolectomy. This particular patient? This patient. No clot in transit. Does have a lactate. Blood pressure is over 90. So, obviously, you know, PE, shock, all of this is a spectrum. It's a continuum. Who here would feel comfortable saying this is a massive PE? Who here would truly believe that this is an intermediate-risk, whether you call it high-risk, higher-risk, or lower-risk, but who here would feel comfortable saying this is an intermediate-PE? It's obviously at the highest end, in my view, but it's a spectrum, whether you call it low, massive, or high-intermediate. It's so subtle, but, yeah. The reason I brought that up is because, right now, if this field is going to go where it needs to go, this next three years are critical. There's going to be several, obviously, there are two randomized trials enrolling now, but only one of them is against anticoagulation, and there will be a couple other trials that come out with interventional therapies versus anticoagulation for intermediate-risk patients, but it's supposed to encompass the entire range of what's currently classified as intermediate-risk, which technically, and I know this is tough for us, this falls into that. The problem is, if you don't randomize the patients on the high end of that risk, think about what you're going to do to what your results look like. If you think your devices work, you're going to lose your efficacy, your evidence of efficacy, if you're not randomizing patients towards the higher end of that spectrum. And, you know, to that point, I would add one thing. We are all cardiologists here, and we all remember what happened to PCI with the COURAGE trial. And, you know, we all know, you know, I still remember going to the ACC meeting that year, and a poll like this was conducted of the crowd, where people said, you have a 90% Sprox LAD, would you feel comfortable randomizing that patient to medical therapy arm in the COURAGE study? And only two people said yes. And we all know what the study showed. So if we don't randomize these people, we are not going to show these things work in these patients. And then eventually, patients like this will be treated with anticoagulation only in the real world because of that study. Yeah, absolutely. In fact, just one last point on that, Vikas, is that right now, keep in mind, you know, there's over 5,000 acute care hospitals in the country. Over 90% of them, if this patient showed up in, they'd be treated with anticoagulation alone. So that is the standard of care for this patient. It's certainly not the standard of care in this room. There's probably not a person on this panel who would have treated it that way, and maybe not even a person in the room. But it's important to recognize that, that that's what…if you want to change the standards of care, you've got to randomize the patient. In randomized trials of intermediate to high-risk PE, randomized trials, and they probably are excluding some of these patients, might be part of the problem, that in eight randomized trials, which are mostly against systemic thrombolytics, that short-term mortality is actually under 3%. I know we say it's kind of a 3% to 15% span. My guess is if you've got 100 of these patients, it's going to be a little higher than that. But it's not 30%. This patient doesn't have a 30% mortality of population like that. That has to include a bunch of catastrophic patients. Yeah, I know we think this, but we haven't proven any of it. I'm just trying to make sure that the message is sent to this crowd. If this crowd is going to change the field, it's not the other 5,000 hospitals out there are going to continue to treat this with anticoagulation forever if we don't change it. Don't you think that… I guess, Eun, do you want to make a question or comment, and then we'll move on? Yeah, I'd like to play devil's advocate. So, this type of patient is being excluded for the exact same reason why patients were excluded from CORAL and why patients were excluded from BEST-CLI. And I think at the heart of it, there are going to be patients that are excluded. I would say if I were doing this case, I probably wouldn't have included the patient in HyPytho. I just… Consciously, I just don't… I can't feel that I can randomize this patient. And I think we have to know that that is the crux of randomized controlled trials is that it may not necessarily be applicable for a patient like this, right? We have to rely on registries, we have to rely on what we know as historical controls and what we're doing now, and that's why the per consortium is important, so that we have that data.

pulmonary embolism

high-risk PE

dyspnea

thrombolytic therapy

mechanical embolectomy