CardioNerds at SCAI SHOCK 2022: The VANQUISH Shock Registry

Despite advances in treatment, cardiogenic shock (CS) outcomes remain dire. As such, researchers initiated the Multicenter Collaborative to Enhance Biological Understanding, Quality and Outcomes in Cardiogenic Shock registry (VANQUISH Shock), which aims to assess unrestricted adult patients with CS at several North American centers.

In this interview, Drs. Norhan Mohammed and Dinu Balanescu of the CardioNerds spoke with Drs. Phyllis Billia and Behnam N. Tehrani about the details and significance of this prospective observational registry.

This interview was conducted as part of a collaboration between CardioNerds and SCAI SHOCK 2022, led by Dr. Julie Power, Dr. Dan Ambinder, and Dr. Amit Goyal with mentorship from Dr. Alex Truesdell.

Dr. Norhan Mohammed:
Hello, everyone. My name is Norhan Mohammed, cardiology fellow, PGY-5 at New York Presbyterian Queens, and a CardioNerds fit trialist.

Dr. Dinu Balanescu:
Hi Norhan. Hi everyone. My name is Dinu Balanescu. I’m an internal medicine chief resident at Beaumont Hospital in Royal Oak, Michigan and CardioNerds Academy faculty for House Jones. I’m very excited to be here with Norhan on this exciting interview.

Dr. Norhan Mohammed:
That’s right Dinu. We’re expecting quite a shocking interview as we address the Vanquish Shock registry as part of a CardioNerds and SCAI Shock 2022 collaboration. The multicenter collaborative to enhance biologic understanding quality and outcomes in cardiogenic shock or the Vanquish shock registry for short is a perspective observational registry that will study unrestricted adult patients with a primary diagnosis of cardiogenic shock at four North American centers with multidisciplinary shock programs.

Dr. Dinu Balanescu:
A unique concept, as far as shock registries go, Vanquish which will address as primary endpoint survival at 30 days after hospital discharge. Secondary outcomes will include in-hospital adverse events and survival to six and 12 months. We’re privileged to be joined today by leaders of the registry, Dr. Phyllis Billia, who’s an associate professor at the University of Toronto, Director of Research at the Peter Munk Cardiac Center, and Medical Director of the mechanical circulatory support program at the Peter Munk Cardiac Center Biobank. A Toronto General Hospital research institute scientist, Dr. Billia specializes in heart failure and leads a team that studies the molecular mechanisms involved in heart failure. After completing her medical and research training at the University of Toronto, Dr. Billia finished the postdoc fellowship with the world-renowned Dr. Tak Mak at the Campbell Family Institute for cancer research in Toronto.

Dr. Norhan Mohammed:
And joining Dr. Billia is Dr. Tehrani. Dr. Tehrani is a member of Inova’s cardiogenic shock, coronary chronic total occlusion, pulmonary embolism, and chronic thromboembolic pulmonary hypertension programs. He also serves on national committees with the American College of Cardiology and the Society of Cardiovascular Angiography and Intervention. Additionally, he has been an investigator in numerous clinical trials for coronary artery disease, cardiogenic shock, and pulmonary embolism management.

Dr. Dinu Balanescu:
Dr. Billia, Dr. Tehrani. Thank you so much for demonstrating true CardioNerd spirit and joining us today. I’d like to start with a question for Dr. Billia. What really are the biggest barriers to delivering care for cardiogenic shock patients and how can registries improve this care?

Dr. Phyllis Billia:
That’s a very loaded question because there’s many aspects to delivering proper care of a cardiogenic shock patient. I think, depending on the kind of practice that you may have, it really is about identification of the patient early enough to have an intervention. That’s the first step, identifying the patients and then determining what is the kind of care that they can or that they need and where do they need to go? Because you can imagine, any emerge in any site in the world would have patients that are coming in, but is that the right place for that patient? And how do they quickly get to a place where they need potentially a cath lab, some sort of circulatory support or other things? So, it’s really identifying patients up front or as early as possible, and then providing them with the kind of support and treatment strategies that would benefit that patient.

Dr. Phyllis Billia:
The problem that we’re left with, is decades have gone by, and we’re still stuck with a mortality as high as 40, 50%. So even though we’ve come up with fancy new devices, we’re really stuck with this very high mortality. What the registries can do by having a real-world registry like Vanquish, it’s really… In the past what’s happened is most registries have really focused on patients, have gone onto devices. And so, what we’ve tried to do is to take a completely different approach and have all comers. Anyone with cardiogenic shock showing up would potentially get registered in our registry, and then we can follow what happens over their care. And we’re not restricted or not biased by a particular treatment algorithm. The other good thing is, the centers that are involved, we all have shock teams, in essence. And that approach is probably one of the few things that have been shown to really change the trajectory and of how patients do.

Dr. Phyllis Billia:
So we have at least that as a common ground, but we’re going to be a little bit different in… And it will be the case across the world. It’s not just North American centers as to what kind of support we can provide patients. What devices do we have on our shelf? What are we funded for? So, it’s really a real-world evaluation to that, as well as things that Vanquish is doing, that’s different, which is looking at quality of lifelong term for our survivors. Doing biomarker discovery work, which not many registries are collecting samples. In fact, very few are. I think we’re one of two that I’m aware of that is collecting early, early samples and sequential samples. And then that’s really what makes Vanquish very unique.

Dr. Norhan Mohammed:
Thank you, Dr. Billia. So, I agree. I think part of the hardest part of my training, thus far, is early identification of these patients. Whether they’re coming in with a STEMI or they’re already in the hospital with heart failure. I think that’s really the toughest part so far. And so, I really am looking forward to the Vanquish results. And so really Vanquish will create a long-awaited cardiogenic registry to help study the clinical course and outcomes of patients presenting with cardiogenic shock. And clinical sites included in this trial have a robust access to resources, including intensivists, cardiologists, and level one CICUs. So, my question for you, Dr. Tehrani is how will the Vanquish trial results affect centers without these multidisciplinary shock programs or capability for mechanical circulatory support? And do you, this is sort of a loaded question, do you anticipate maybe a network formation or cardiogenic shock hotline that maybe hospitals without these resources can contact to help expedite care for their suspected patients in cardiogenic shock?

Dr. Behnam Tehrani:
That’s a great question Norhan. So, I think one of the things that we need to wrap our minds around and understand better, is how hospitals within a community, whether they’re a hospital with full spectrum services, cardiac surgery, LVAD transplant destination therapies. And as they’ve been called level one hospitals, or essentially hubs, how they can work and coordinate the care of these patients with those in the community that are level two or level three sites. Level two sites are those with a cath lab, a balloon pump, maybe an Impella. And then the level three sites are the standalone hospitals that have an ICU, but don’t have cath lab capabilities or MCS capabilities. And how these three levels of hospital systems can work in a coordinated fashion.

Dr. Behnam Tehrani:
Now it’s going to be tricky because many of them belong to different health systems. And so you’re going to have to have coordination of care between hospital system X and hospital system Y with a common understanding in the common goal to improve the care of these patients through early recognition, inner hospital collaboration and communication, and getting them to the destination center where they need to be get the full level of care.

Dr. Behnam Tehrani:
So what we think that this study will do, and you have four sites that each of them are level one sites within the respective regions, they’re going to get about half of the patients that come into the registry from these level two or level three sites. Where they’re going to come into the level one site, and they’ll get follow on care and management. And I think you’ll be able to get a better understanding that how these essentially destination centers have been able to develop networks, integrated networks, if you will, in which they get patients not only from their own emergency room but those from in the community and how they use these protocols and the presence of 24 7 shock teams to potentially improve the care of these patients. So by looking at the biomarkers, by looking at quality of life, by looking at early presentation, their clinical features, and a whole host of other factors, how this can change the arc or the trajectory of this illness.

Dr. Behnam Tehrani:
And we think that in complimentary fashion to the other registries, that Dr. Billia alluded to, this will be unique, because it will capture all patients, not just those with an Impella, not just those that are AMI, but all of them, the whole gambit. Heart failure, RV failure, LV failure, STEMI, and it will serve as a blueprint based on the data that we are able to gather and collect to really harness the impetus, if you will, for centers to develop networks for care in these patients. We think that shock networks and a regionalized system of care is really the next step in the [inaudible 00:09:54] of cardiogenic shock. So, we really are right now where AMI and stroke care was about 20, 25 years ago. And we’re hopeful that this high quality, very granular registry that we are privileged to work together on, will serve as one of the major steps in that direction.

Dr. Dinu Balanescu:
That’s a very meaningful answer, and it proves the ambition behind how impactful Vanquish can be and will be and how it sets the stage for true shock networks. Now, the information from registries seems like it can be used to coordinate care, improve inter-institutional collaboration and hopefully ultimately improve patient outcomes. And speaking about patient outcomes, we noted in our introduction, that the primary outcome of the registry is survival 30 days post discharge. And the secondary outcomes include six month and 12-month survival post discharge. Now outcomes of cardiogenic shock are naturally related to center expertise. Dr. Billia do you anticipate any geographical or center-based differences in outcomes of the Vanquish registry?

Dr. Phyllis Billia:
You kind of already answered my question. So, the thing is, what the expectation is, depending on the level of the center, whether it’s level one, two or three, if you are not in a coordinated environment in a hub and spoke, and you don’t participate in that, or don’t have the connections, that the outcomes theoretically will be worse. And I think they have been shown to be worse. That’s pretty clear. So, the geographical, there’s two layers to the geography piece or center specific piece. One is what can each site offer? And how can we build those relationships with those sites from an educational perspective, so that they feel that they can call a level one site at any time? And this is not just something that Vanquish is doing, but it’s something that is actually focused at the International Society of Heart Lung Transplant, which now also has a cardiogenic shock task force, which we’re trying to put a document together.

Dr. Phyllis Billia:
And this is one of those key things that we’re looking at. Sometimes people get offended by being, versus a hub versus a spoke, so we’re trying to change that language and make it a collaboration between sites, so that we can help all patients. So, the geography is related more to what each center can offer and how quickly they can identify patients to transfer them where they can get their care. And then the geography can be also country related and what is actually covered and what is actually… You can actually put in patients and support them. Because just as Dr Tehrani just had said, some sites may not even have a balloon pump. Some sites may not even put in a PA catheter, and we feel… And there’s data to show this now that the PA catheter can really be informative and actually help dictate the kind of support a patient should get.

Dr. Phyllis Billia:
So it’s a very complicated look at things and will, hopefully, I think we’ll be able to really look at the data in a way that we can actually even provide quality improvement measures. Because I think that’s a really important part of this, especially for centers that feed in into our key areas. So, each center, we can even do center level analysis to see. But it also then allows us to educate the centers that we collaborate with to get them, to bring, identify patients sooner and how to do this. And I can tell you from our own experience in Toronto, one of my colleagues, Adriana Luk, who’s working on the registry with us, is actually to develop this city-wide shock protocol. And why that’s important is that we have algorithms that will feed into our center. So, when a patient arrives at a community hospital, and they’re trying to figure out what to do, we’ve clearly outlined with education to know when to transfer a patient, how to do the assessment, how to get us involved.

Dr. Phyllis Billia:
And really the key is as early as possible. That’s the key in all of this because… And the other thing is to recognize that there’s heterogeneity in these patients. The early data was on acute MI. Well, that’s completely changing. The population of cardiogenic shock patients is no longer acute MI. Almost half of them are heart failure and it’s really changing. So, your strategies are different. They don’t all have to go to a cath lab. It’s just getting as much information as possible to then look at those kinds of questions that you alluded to, Dinu.

Dr. Norhan Mohammed:
Thank you, Dr. Billia. Yeah, I completely agree. I think that the patient population is changing. The technology that we’re offering patients is changing and just even our knowledge of cardiogenic shock now is changing. And I think Vanquish will really add a lot to that. And so oftentimes when we’re pursuing mechanical support, since we were talking about the center dependent support that they can offer, we think of an end goal or what bridge to therapy there will be in the future. And so, what was interesting to me is that this registry takes all comers. So, whether you are 35 or 85, you will basically be a candidate for the same therapies. So, Dr. Tehrani, how do you think that will affect the results of the trial and how will the risk stratification be adjusted for when analyzing endpoints?

Dr. Behnam Tehrani:
Yeah, so great question. I think risk stratification is a really important aspect of shock management. As much as the SCAI Shock classification system has really expanded our knowledge base in terms of how to risk stratify them. And it did it based on three parameters. Based on the physical exam, based on the labs, and based on the PA catheter. That’s crucial because up until about three or four years ago, the PA catheter was out the window. They had discussed what was called the obituary to the PA catheter. So, I think having a validated and having a consistent risk stratification mechanism is crucial. So, I think the SCAI Shock classification system was a seminal one in 2019 and the subsequent update in 2022, when they looked at some of these modifiable and non-modifiable risk factors like cardiac arrest and others. But I think there’s going to be other aspects of risk stratification, which Vanquish is going to be able to harness and leverage the volume and expertise at these four sites and potentially change how we do that.

Dr. Behnam Tehrani:
So the biomarker component will be key. So inflammatory biomarkers, other biomarkers as it pertains to cardiovascular function, other potential areas, that’s going to be very crucial to it. I think one of the other areas where we will be able to provide a little more, hopefully, data around how to risk stratify these patients is based on understanding that the phenotypes of shock is not just the hemodynamic phenotypes, but the end organ insult phenotypes. So those that develop end organ insults to the liver, the kidney, those that develop persistent respiratory failure. And in terms of how they ultimately leave the hospital in terms of disposition of needing long term end organ support.

Dr. Behnam Tehrani:
And I think the last area where I think that we will be able to provide some more risk stratification, not as much early on, but downstream, and I think that’s very crucial cause we don’t have answers to that right now, is with regards to the quality of life aspect of it and neurologic function. Up to 50% of patients with cardiogenic shock will develop cardiac arrests. We have some data with regard to cerebral performance category scores, Ranson scores, and other mechanisms to understand how these patients will leave, but we don’t have much data as it pertains to how that influences outcomes a year out. So, I think risk stratification using what we already have developed with SCAI Shock and what we think Vanquish will then further supplement that with, will give us a better understanding in terms of how to risk stratify these patients. Because the key component here is that not every patient unfortunately is going to survive.

Dr. Behnam Tehrani:
There’s about 50% of, sorry, there’s about 30% of patients that will survive no matter what you do, they will differentiate themselves into that. Or from the pre shock into the more healthy patient population. There’s about 30% of patients that will need multidisciplinary coordinated care to literally drag them essentially from the cemetery to get them to where they need to be to leave the hospital. But there’s about 20, 25% of patients, unfortunately, whether it’s because of age, because of late presentation, because of goals-of-care, and because of health values, that will unfortunately not make it. And that’s fine, but we need to understand how these risk stratification mechanisms can inform those discussions that a physician, an APP, any healthcare provider, has with a family member or a surrogate regarding the care of the patient. Because the goal is not only to advance a science, to do good work in the care of these patients, but also to use this data, to have informed decision making, and provide compassionate care that’s in line with healthcare values and goals-of-care.

Dr. Dinu Balanescu:
Dr. Tehrani, thank you for that comprehensive answer and you’re showing us that it truly takes an army to treat cardiogenic shock patients. Now, by definition, these patients are very sick and Vanquish is a unique registry and a much needed one given the ethical and logistical difficulties of designing trials, addressing patients that’s sick. Now, Dr. Billia, how do you see the Vanquish trial impacting future studies of cardio shock?

Dr. Phyllis Billia:
It’s a great question. I think the world becomes our oyster with the data that we’re going to get actually from the Vanquish registry. Because it will… We have specific questions that we want to address within the first year. But really what we’re also trying to do is push the fringes of science a little bit and look at some novel biomarkers, as well as the quality of life, which has not really been addressed before. Because from the biomarker approaches that we’re looking at, this will then potentially help us to further risk stratify patients that present acutely. Because if we can identify bedside tests that it can be done with a drop of blood next to the patient with a point of care device, then we can actually… And predicting mortality or outcomes, it can really push the kind of approaches that you can take. So it’s not just the run of the mill registry, but it’s also really going to impact the need for biomarkers and biospecimens being collected and future registries.

Dr. Phyllis Billia:
I think the fact that we’ve broken that ground through a North American registry, I think, is critical and really will push other registries to do this. Otherwise, they just won’t match us. And that’s important. And the other part of it is that quality of life that I alluded to, because that is something that… From the surgical ICUs, there’s some essence of work that’s being done. There are some key intensivists that have been looking at quality of life, but not in this population of patients. And it’s interesting when you look at quality of life of medical surgical ICU patients, that those that survive even to a year or two years are greatly impacted by their ICU, stay, let alone anything else that happens to them. So, there may be something very unique to our cardiogenic shock patients that we will be able to tease out. So, there is so much that we can do with this, and it actually will hopefully be able to be a vanguard kind of registry that then other registries will be benchmarked against. And that’s what we’re really hoping for with the vision and the creation of this registry.

Dr. Norhan Mohammed:
Thank you, Dr. Billia. Yeah, I think that this registry’s going to open so many doors for future studies, as well as maybe reeducate us about cardiogenic shock and supplement the knowledge that we’ve already had. Bring back some of the older methods of the PA catheter and bring back maybe the physical exam and see how maybe those early signs could help us identify these patients. Dr. Billia, Dr. Tehrani, thank you so much for sharing your wisdom with us. CardioNerds everywhere are grateful for you taking your time to go over the Vanquish registry with us. We’re excited to see what the future of cardiogenic shock holds. Dinu and I thank you for joining us. This interview is part of the CardioNerds and SCAI Shock 2022 collaboration with mentorship from Dr. Alex Truesdell, please make sure to follow the CardioNerds coverage of SCAI Shock 2022.