Cardiac Surgeon, Dr. Marisa Cevasco, describes the use of the Impella(R) Axial Flow Pump for ECMO treatments and reviews available evidence through recent cases. Specific to ECMO, she talks about the unchanged limitations and overview when navigating. “I had to present on ECMO this morning and pulled out a presentation from 2019. That should tell you things have not changed. ECMO is still the quickest way to rescue someone out of shock.” - Dr. Marisa Cevasco on the topic of ECMO.
@PennMDForum This is uh congratulations. This is a really impressive program that you guys put together. Thank you for having me. Um I do speak for a and I am on their advisory board and I'm in, in one of their uh clinical trials. So that is a disclosure. But um what do you this one? So I'm just gonna briefly talk today. I know we're running behind, so I'll try and move things along and get us back on track. I'm gonna talk about impella as an option in cardiogenic shock and uh talk about some of the evidence available and like I said, I gave this ECMO talk this morning and ECMO really hasn't changed. We talk about pressure, volume loops. We know different can strategies we can debate what's better peripheral or, or central. Everyone knows what's safest in their own hands. Um There are limitations um But um you know, I've been thinking a lot about echo and impella. I put an impella in last night, I took someone off ECMO this morning that really needed an impella, but the limitation of the device is it can't be put through a mechanical valve. So we, we, we have no perfect mechanical support strategy yet. And that's why we have to pay very close attention to them. Um It requires meticulous management and, and a true team approach. So this is my final. So when I went through the echo talk, I had three cases and, and 50 slides and the only I would, I would have changed one slide, um sorry, one slide only. And it was about this last case. And this is your pretty much your classic uh cardiogenic shock patient. Uh seems like it's going the wrong way and you guys Gonna try and rewind here. OK. Here we go. So this was your classic patient who comes in in cardiogenic shock. A 70 year old man with no medical care. He came in through the emergency room in cardiogenic shock, decompensated heart failure. He was new to the hospital. He was initially sent to the C C U on two inotropes. They put a balloon in, it helps him for a little bit, but he continued to progress into shock. His urine output, dropped his lactic, climbed his creatine and L F T started to go up. I mean, we've all seen these patients. He had refractory arrhythmia and then he arrested and then that's when we got involved. So we put him on ECMO at the bedside and this is his G T E. Uh it won't play, but that's OK. It's just your classic biventricular function. It, thank you. Thanks. So much. So, just your classic biventricular dysfunction. Just a, not a great looking ventricle here. Not really doing much so he's on and he has a balloon and this is kind of what I had done up until a few years ago. Just left him on ECMO, left him on the balloon. We had the five, we had the five oh, we didn't have the 555 oh, wasn't that easy to place. Uh, didn't have great complication profile compared to the 55. So I would keep balloon to vent. I do a partial flow strategy to avoid pulmonary edema. Keep him ejecting. Keep the uh heart um uh not distended. I would pause the balloon to check to see for recovery. I would use a swan. I do believe you need a swan for ECMO to wedge every day if possible, get an x-ray to monitor for pulmonary edema. A conservative use. He and um you know, we try to optimize and tune him up, diarrhea, him, pause. The balloon is the patient volume optimized. What is this E V P? Is it less than 15? Does the systolic drop by greater than 10? What does the echo look like? I, I believe hemos are hemos trump the echo. But could this patient come off at? No. So he was cleared for a device. And before the 55 came out, I would just go from ECMO. He's inter max one to buy that strategy with a heart made three and a cent R bed. And uh, you could do different types of art beds, pros or centro mags, homemade ones or not. But now, and so this is why I brought this up because now I think the P 55 really changed the paradigm of how we transition patients both on ECMO and, and off ECMO. And um, I would try and bridge with the 55 1st. And why is that important? So what does the P 55 give you? Well, it goes in through your axillary. A lot of the time prefer. We've done around 70 something here. I was at S T S with Chris. We were on similar panels with Cleveland Clinic has uh the probably the biggest experience around 200 patients with the 55. There's really no multi center studies, there's one multi center study um that we, we have so far. But The 55 is good because it allows patients to emulate, they can get their nutrition up, you get them excavated, you have less hematologic complications when you take the oxygenator out of the system. And so it's overall less physiologically insulting to the patient than ECMO. Now, ECMO re rescues people out of shock. It is biventricular uh support. The 55 is mostly L V unloading and it can replace the L V and, and there is some anecdotal evidence, especially from Devine Kapo writes about this in some of his papers, how we see some improvement in R V function as well. But again, we're still learning about this device. And I do think, you know, Doctor Bermuda has pointed out some important limitations of the device. Does it really correct the degree of micro regurgitation? What do we see it doing with the L V and diastolic dimension? And the end diastolic volume are are are is the wedge pressure dropping with this device is the cardiac output that it's putting on the screen. Is that really accurate? It's a fiber optic cardiac output uh calculation. And is it with the A I, is that something that's truly accurate? So anyways, I just again, you know, we know that temporary support in cardiogenic shock, it's increasing over time. Why is that? Because more and more studies show that um a high invasive active inotrope score um means higher mortality. So getting patients off the meds off these toxic meds onto devices that have better and better hemo compatibility profiles. It does reduce mortality. So early rescue with device helps. Uh there's just a plethora of guidelines from this side of the Atlantic and across overseas. A CAA H A European Society of Cardiology Sky. Uh A H A again, we know that early bridging with mechanical support helps get patients out of shock rapidly. And so, you know, I was outside and they didn't want me to put impella on the screen because it's it's a brand name. But I said I can't do the talk but you know, it really is the only player uh in, in, in, in town right now. Um I did have to give a talk at just about future devices and a lot of the future devices are focused on implantable vds. Um So right now there, there is another device out there, but for right now what we have the 55 is a predominant device that we use from a surgical perspective. There is AC P, you could see the entire family of the of the of the impala devices here up on the screen, they're actually flow catheters. Um they have a R P device too. I'm gonna focus mainly on the L V here and you know, your flows are really dependent and again, how accurate are these flows? You know, that's something that we can discuss. So what does the impeller do? So the left sided device, it directly unloads the L V and it augments L V function and it has um this is different, right? ECMO is an afterload producing machine. This, on the, on the contrary, like Dan Burkhart was at Columbia, I trained at Columbia. We looked at pressure volume loops a lot. I'd be happy to see them being used in clinical uh setting more and more. I think it would be great, especially, you know, we can put them right on the screen, it helps us take care of the patients. The 55 increases cardiac output. It increases the map, it decreases the end diastolic pressure and the end diastolic volume. And now there's this concept of door to unload instead of door to balloon. Right? So what does this do by putting in? Uh uh now this is the five oh, right, with the pigtail still on it. But if you put in a, if you put in AAA pretty cutaneous LVAT or, or a um a transaxillary L V D, if you can decrease the an diastolic pressure and the end diastolic volume that the L V sees, you decrease the wall tension, you decrease the mechanical work that the L B has to do, you're decreasing your left atrial pressure. They look at the stuff under the microscopes, the the researchers, the guys in, in the lab and you can see that um the the myocyte recover more quickly, you have increased myocardial perfusion, um also decreased pulmonary congestion from from the pulmonary side. And this can all mitigate this reperfusion injury, which really seems to be um barring patients from recovery. And that's actually something that some of the players in this field are looking at. Um you know, how do we get these patients to recover? And, and the one of the future impella devices, the impella BT R or bridge to recovery, it's a purge list system. I'll talk about that if I have time. Um It just is trying to get patients to recover uh And um what are we using it predominantly here? We're using it as, as um I try and get my patients off ECMO to impella again, like I mentioned, or we're using it as bridge to transplant or bridge to durable device. And we're not really seeing the same rates of R V failure like implantable. Doctor Ramu has had a great um case where a patient was being bridged for a long time with a 55. And I've, I've seen this too, eventually, they kind of slide into this biventricular failure after being in the hospital for 2 to 4 weeks, waiting for a heart given. Uh how, how long our patients are waiting a status to in this region? Um We're having to support them for a while. Um But again, this is not like when you put a heart ma three and, and you're coming out on, did you go on an R V or are you on dual moderate to high dose inotropes? So there is something different about this device. So, but overall just taking a step back uh and very briefly, like does the literature support this use of these devices? And it's really hard to show these. So a lot of the randomized control trials have not really shown significantly improved outcomes over balloon, for instance, uh in stemi shock. Uh So, so far, you know, the literature is kind of equivocal, we have an absence of superiority of percutaneous baths to balloon puffs. But on the other hand, um these trials were small, they were underpowered to detect uh some of the differences. Uh They were conducted with uh less powerful devices. But I think a higher complication profile personally, if I get a patient coming in on AC P I like to transition them to a 55. um and uh mostly for hemolysis reasons. Um And the thought of that, why, why these have not, why haven't we seen a benefit with some of the new devices is because uh they just are not able to provide the level of cardiac output required um to help prevent multisystem organ failure in some of these patients. Now, we did have a pilot trial. Uh the stem EDT U the door to unload pilot trial did help to show that impella can help diminish reperfusion injury. So this is a trial that came out, I think it was 2019 and it's going on to a pivotal trial. So there's further studies that are necessary and this is ongoing. Um there's more stuff to come in this space. But again, like a lot of the literature, if you do a search, what I'm trying to justify to the hospital administration that I need to put in a $41,000 pump to get this patient to transplant. Um you know, I have to just say this is our clinical experience and this is what we're talking about at a lot of the um uh uh a lot of the uh conferences. Um yet here, another one, uh here's a meta analysis, um a little bit dated, but again, Perk Elva ads do work uh in, in supporting patients compared to balloons and the, the bleeding risk were worse with LVAD. Now, does that make sense? Yes, I think LVAD we know have interaction with one will burn factor, its impact on platelets, its potential for hemolysis. So, well, I really ran out of time. So I'm being told I have one minute left, so I am and I have to go to the operating room. So I'm just gonna flip ahead. I'm sorry. It's probably OK. So, so just some really briefly, some of the data, some single set of results, the impala 55 there are 55 patients, you know, this is they, they kept these patients on the device for a while and that's what we're doing clinically now. That's technically off label, but we are using, we have patients on 55 up to two months now. And um I think our complication rates, I don't have our, our results up here. Um It's in publication, but we know that we've had one or two thromboembolic complications. We've had one axillary site infection. Um And uh but overall the, the, the safety and complication profile of this device is, is very good. It's much easier to put in. There's only been I think two people we have not been able to get the device into. I'm not quite convinced it's based on the arterial size alone. I think it might have something to do with Thoracic Inlet. Um And of course, you can always go to the uh direct through the um to the AORTA. Uh Here is Danny Ramsey and Mark Anderson out of uh Hackensack and Ed Soltes. This was their uh initial results of the 1st 200 patients. The survival to explant was around 74%. Again, this is what we're seeing at what we're seeing. Survival to uh destination around, right around 70% with our, with our uh cohort here of around correct me, 77 patients or so that we, we have again, complication issues, access site issues, hematoma bleeding. But the authors conclude that survival outcomes are generally improved uh compared to historic rates that have been seen with patients in cardiogenic shock. So, like I mentioned before, I talked about the bridge to recovery impella. It's available in three sites and I hope that we'll see it live. I think one of the sites had a problem with the Perla system shutting down. But hopefully in the future, this is something that's on people's minds, getting these patients recovered, decreasing the myocardial oxygen demand. Um and, and, and having ventricular remodeling in a way that you're not having to put like this like a big heart mate too, like we're used to through the apex, which is, you know, pretty morbid. Um And I think I've run out of time but Dr Bermuda has already talked a lot about this already. So, again, my favorite pressure volume loops from uh uh and you could see what happens when you don't take care of ECMO. You end up with this. I have a power point of, of, of things that have gone wrong with ECMO. This was after the prior one was just a regular shock patient and this was just L V Thrombus. It's almost hard to believe, but I'm gonna, I'm gonna end here and thank you. Thank everyone for their attention.