The National Cardiogenic Shock Initiative (NCSI) aims to bring together centers from across the U.S. that specialize in mechanical reperfusion therapies and possess extensive experience in using mechanical circulatory support devices to optimize care in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS).
In this video interview, Drs. Kahtan Fadah and Pooja Prasad of the CardioNerds spoke with Drs. Alejandro Lemor (University of Mississippi Medical Center), and Sarah Gorgis (Cleveland Clinic) about the NCSI and what it means for patients with cardiogenic shock.
Dr. Kahtan Fadah: Hello everyone. My name is Kahtan Fadah. I’m a third-year internal medicine resident at Texas Tech Health Center of El Paso. I’m also a CardioNerds Academy fellow of House in [inaudible]. Currently I’m pursuing a general cardiology fellowship. I’m applying for this cycle, and I’m interested in critical care and heart failure. I’m so honored to be here today to talk about National Cardiogenic Shock Initiative.
Dr. Pooja Prasad: My name is Pooja Prasad, and I’m a PGY-6 general Cardiology fellow at Oregon Health and Science University. I went to med school at the University of Rochester. Completed internal medicine at UC Davis and now in Portland, Oregon for fellowship.
Dr. Pooja Prasad: I am the Cardio Nerds Fit Ambassador for OHSU, and I’m currently implying for Advanced Heart Failure and Transplant Fellowship. We have a fabulous multidisciplinary team of experts today to discuss the National Cardio Shock Initiative. As part of a collaboration between CardioNerds and SCAI SHOCK 2022, with mentorship from Dr. Alex Truesdell.
Dr. Pooja Prasad: It is our pleasure to invite our expert speaker today, Dr. Alejandro Lemor. He attended medical school at Universidad San Martin De Porres in Peru and completed residency at Icahn School Medicine at Mount Sinai Luke’s in Mount Sinai West Hospitals. He completed both general and interventional fellowship at Henry Ford and is currently an interventional cardiology attending at the University of Mississippi Medical Center’s Comprehensive Heart and Vascular Center. Welcome Dr. Lemor.
Dr. Alejandro Lemor: Thank you for having me here, actually.
Dr. Pooja Prasad: Dr. Sarah Gorgis attended medical school at Wayne State University followed by residency and cardiology fellowship at Henry Ford Hospital. She is currently pursuing a cardiac critical care fellowship at Cleveland Clinic. Welcome Dr. Gorgis.
Dr. Sarah Gorgis: Thank you for having me here.
Dr. Kahtan Fadah: So, we’ll begin with our first question. Dr. Lemor, for the past two decades survival rate in acute myocardial injury, cardiogenic shock, has remained low despite advancement in reverse revascularization and supportive care. Can you share with us the motivation behind the National Cardiogenic Shock Initiative, and how did you devise the protocol to improve outcome in this patient population?
Dr. Alejandro Lemor: Sure. So exactly that, right? So, mortality in cardiogenic shock has remained the same for so many years despite major improvements in care. So, this is back in 2016, Dr. William Neal and colleagues, back in Detroit, they started this initiative. And with the use of standard protocols and record catheterization prompted PALS support and PCI, they actually were attempting to improve outcomes in this patient population though. So, the PALS study actually showed there was increased survival from a 50%, which is a national cohort, to 76%. And this is why actually the collaboration grew so much and became the National and Cardiogenic Shock Initiative, which involved 80 hospitals in 29 states.
Dr. Kahtan Fadah: This is so inspiring and really glad to be here with you today and listening to you directly talking to us about this initiative that now is becoming something very national. A variety of outcomes were studied in this initiative, including procedure survival, survival to discharge, survival to 30 days and survival to one year. Dr. Gorgis, can you summarize the main findings of the study and what are the main takeaways?
Dr. Sarah Gorgis: Absolutely. So, we screened over 1100 patients across 80 centers nationally, and eventually enrolled 406 patients who met criteria for acute myocardial infarction and cardiogenic shock. These centers followed a very specific shock protocol, and importantly highlighting the use of early mechanical circulatory support use, guided by invasive hemodynamics, specifically right heart catheterization. One thing to note about these patients that we enrolled is it was a very sick cohort. About 25% of them actually met criteria for Skyscape stage E shock. And the reason that’s important is because these patients otherwise would not have been enrolled in studies previously and are unlikely to be enrolled in studies because of just how sick they are. What we found is that in using the NCSI protocol, the outcomes were excellent. So, there was about a 99% of procedural survival rate, survival to discharge of 71%- and 30-day survival of 68%.
Dr. Sarah Gorgis: So, in comparison, prior shock trials have shown mortality rates in similar patient populations of about 30 to 50%. So, the outcomes are very encouraging, and we believe that greater utilization of the NCSI protocol will help outcomes in the future and help improve survival rates. There are a few things that are important. The care of these patients is dynamic and requires continued monitoring as well as changes in care if needed, according to hemodynamics. Very specific outcomes in patients…
Dr. Sarah Gorgis: Patients who did the best were those that we were able to achieve a CPO greater than 0.8, a lactate of less than four, and those in which we were able to reduce the amount of vasopressor use. And then the last thing is that, very importantly, we can’t ignore the fact that the one year mortality rates continue to be high in these patients, emphasizing that there’s still a lot of work to do in this area, and we have to make sure that these patients have close follow up, put them on guideline directed medical therapy, and then, if needed and appropriate, then refer them to our heart failure colleagues for early consideration of advanced therapies.
Dr. Kahtan Fadah: Thank you Dr. Gorgis. This is an impressive data and first off its kind and definitely support in the early [inaudible] circulatory support, especially in this sick population. You guys have done amazing work. Thank you.
Dr. Pooja Prasad: So, door to support time less than 90 minutes was a primary goal of the protocol, and 71% of patients had MCs implanted prior to PCI. Right heart cath was performed in 93%. Although to my understanding this was not always… This didn’t have to be done prior to MCs. In terms of door to balloon time, it seems like the average door to balloon time was 82 minutes with the inner quartile range of 57 to 114 in your population. Dr. Lemor, I’ll ask you as the interventionalist in the group, in the STEMI population, do you think that in appropriately selected patients, this delay to stabilize shock is really worth it?
Dr. Alejandro Lemor: Yeah, that’s a great question actually. So, we prove that it is actually, so ideally right heart catheterization to just understand the hemodynamics. But if not just getting LVPN and then putting the Impella in front. We show that actually putting the Impella in front was better. Cause first you need to establish a patient before you start working on the coronaries. And yes, I mean ideally you need to open the occluded vessel, but those extra five to 10 minutes that it takes to place the Impella are actually worth it. You safely actually open the vessel. Would support… And then you can do the right heart catheterization either right there or just afterwards. So, understand the hemodynamics.
Dr. Pooja Prasad: Got it. And another question for you, Dr. Lemor. You know, unfortunately our data is limited regarding escalating support in cardiogenic shock. One thing I’m really impressed by is that each attending I work with might have a different strategy in terms of when to escalate support. And this also can also vary by field, but also within a field, whether it be heart failure, critical care, interventional. Each team member on a shock call could have different ideas on when we should escalate. So, I feel like a lot of critical care is just, I shouldn’t say just, it’s really the tough art of medicine. But what I’d love to know is what did the National Cardiogenic Shock Initiative look into this question and what did they find?
Dr. Alejandro Lemor: Oh yeah, you’re completely right. I mean the question itself remains unanswered. We don’t know what is right, what is wrong, and then I agree different members in the shock team will have different approaches when to escalate and which device to escalate with. We actually did notice that among patients that actually died of worsening cardio shock, only 20% actually had escalation of MCS. So, patients that actually remain in Skype class E for 24 hours, there was actually a paper published by Hanson, etal. Really interesting paper showing that those that remain in Sky E for 24 hours, only less than 24% survivor. And actually, those are actually… Even though they present in and C, D or E, that improve to Sky class in the first 24 hours, it’s much better. So actually, the next step for improving mortality in shock is actually early escalation. And actually Dr. Basir is leading the trial called Ceramics. So, we’re assessing patients early in the cath lab to make sure the escalation happens just before patient deteriorate, actually. Before patient are… It’s too late actually to up upsize the device.
Dr. Kahtan Fadah: Dr. Lemor, another question for you. Thank you for this insight. The covert vessel versus multi vessels PCI in shock is a favorite topic of discussion among an interventionist and shock provider alike. Did the National Cardiogenic Shock Initiative look into this question, and if so, what did you find?
Dr. Alejandro Lemor: Yeah, another great topic for discussion. And again, it’s a topic for debate. We did look into that actually. Had a publication, [inaudible] talking about this. We actually found that there was no difference in mortality or AKI between those undergoing proper vessel and multi vessel PCI. In contrast actually what proper shock that we all know the trial showed. So, we believe that actually selective multi vessel PCI in acute shock, it’s appropriate, especially if in cases where you have more than one severe occluded vessel, and you’re trying to actually improve profusion to the myocardium though. So, if you have a two large vessels supplying a large myocardium [inaudible], it’s appropriate actually to open both vessels, especially if you were actually supported with an Impella. And actually, what we saw is that in a subgroup analysis by Skype classification and based on the strategy of revascularization, those in Sky Class E had actually better outcomes when they underwent multi vessel PCI. Which makes sense, right? Cause they need as much myocardium profusion I think you can give them though to improve the state of shock.
Dr. Pooja Prasad: Yeah, I find this really fascinating. I think that… I feel like when I’m the fellow picking up a patient with a STEMI, or even NSTEMI, I find myself sometimes wondering how can we be so sure which one was the culprit lesion? And so especially in the case of shock where each territory of myocardium is so valuable, I think that these findings that you describe really had the power to maybe even change how we approach revascularization in this population. We’re going to close by discussing next steps. I’ll direct to you Dr. Gorgis. What barriers have you encountered in centers who have not adopted this protocol?
Dr. Sarah Gorgis: Yeah, so great question. I think every center and location is unique in the barriers that it faces when implementing protocols, in general. Just knowing about the protocol. And so, we can do outreach and collaboration and communication to help with communicating the benefits of certain strategies. And centers may be willing to implement the protocols.
Dr. Sarah Gorgis: However, there are further challenges. Mechanical circulatory support is expensive, and some centers may not have the resources to provide those services. Especially now sort of in a healthcare system where we’re moving to value-based care, a lot of people are displaying concerns about the costs of certain services, which is valid. We have to show that the cost is worth it. And then beyond that, we have to have specialists who know how to implant the devices. And then specialists who are able to take care of patients once they get to the ICUs. And beyond just the physician level, we need other staff, nursing, that are able to take care of Pels and ECMO and things like that. I think in general, resources as well as personnel trained in taking care of this patient population are some of the barriers that we face.
Dr. Pooja Prasad: Yeah, what a wonderful answer. I mean, I think… Sometimes we take it for granted, this whole team that we have. We have a team at the academic centers where we train, where have access to Impella-trained nurses and obviously Impella-trained interventionalists and ECMO-trained heart failure attendings and critical care intensivists. But I think that makes this initiative so important is that we really have to see how this can be applied to a variety of healthcare systems, and it might highlight the differences in our various institutions. And so, one final question here. I’ll direct this one to both of you. Do you see a randomized controlled trial as a feasible follow up to this initiative?
Dr. Sarah Gorgis: Yeah, that’s another excellent question. So, regarding randomized control trials. As you can imagine, they can be difficult to perform in critically ill patient populations. But despite that challenge, they’re very important in guiding us and providing us with the highest level of evidence for our patients. Fortunately, there actually are some trials ongoing that target this particular question. So, in Europe, the ECMO CS trial, ECLS Shock, and the Euro Shock trials are all looking at the utilization of ECMO versus standard of care in patients who come in with AMI cardiogenic shock.
Dr. Sarah Gorgis: And then Denmark and Germany are actually collaborating on a study called the Danger Trial that is looking at the use of Impella CP versus standard of care in the AMI cardiogenic shock population. And then finally, actually in the United States, the Recover4 trial has been FDA approved to also tackle this question with the goal of looking at the use of Impella CP versus standard of care in patients who come in with AMI cardiogenic shock. So, I think that there are a lot of exciting trials actually happening right now, and we’re looking forward to the results of these trials to further shed light on the management of these patients.
Dr. Pooja Prasad: Thanks so much for reviewing those ongoing trials.
Dr. Kahtan Fadah: Thank you today from the National Cardiogenic Shock Initiative. This impressive multidisciplinary effort and what the future might hold for us advancing forward. It’s very encouraging. Thank you so much, Dr. Gorgis and Dr. Lemor for taking the time to discuss the National Cardiogenic Shock Initiative with us. Again, congratulations on such a remarkable initiative and result.
Dr. Alejandro Lemor: Thank you for the invitation.
Dr. Sarah Gorgis: Yeah, thank you for having us. This was great.