The American Heart Association (AHA) recently created the Cardiogenic Shock Registry to enhance the quality of care and understanding of patients presenting with cardiogenic shock across the United States. According to the AHA, a few aims of the registry include:
- Provide high-quality evidence that helps inform clinicians, researchers, federal agencies, industry and other healthcare stakeholders on best practices for treating cardiogenic shock.
- Develop streamlined longitudinal research infrastructure for pragmatic clinical trials and other translational, clinical, and implementation science.
In this interview, Drs. Kayla Riggs and Gurleen Kaur of the CardioNerds spoke with Dr. Marielle Jessup, Chief Science and Medical Officer of the AHA, and Dr. David A. Morrow, director of the Cardiac Intensive Care Unit at Brigham and Women’s Hospital, Boston, MA, about the registry’s importance.
Kayla Riggs, MD: Hi everyone. My name is Kayla Riggs, and I’m a current second year cardiology fellow at UT Southwestern in Dallas, Texas. I serve as the CardioNerds ambassador for our fellowship.
Gurleen Kaur, MD: Hi everyone. My name is Gurleen. I’m a second-year internal medicine resident at Brigham and Women’s Hospital. I’ve also been a part of CardioNerds as an academy fellow and director of the CardioNerds internship. We’re so excited for this collaboration between CardioNerds and SCAI Shock 2022 with mentorship from Dr. Truesdell. I’ll turn it over to you, Kayla, to introduce Dr. Jessup.
Kayla Riggs, MD: Thank you. I have the pleasure of introducing Dr. Jessup. She is the Chief Science and Medical Officer of the American Heart Association. Her efforts resulted in heart failure and transplant cardiology becoming a certified subspecialty within cardiology. She has served in many important roles throughout her career as a physician scientist including president of the AHA.
Gurleen Kaur, MD: Welcome, Dr. Jessup.
Mariell Jessup, MD, FAHA: Thank you so much. It’s such a pleasure.
Gurleen Kaur, MD: I’ll introduce Dr. Morrow. Dr. Morrow’s the director of the Cardiac Intensive Care Unit at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. He’s a senior investigator in the TIMI Study Group where he directs the biomarker program and has research focused on cardiac critical care. I’ve had the pleasure of working with Dr. Morrow several times in the CICU during intern year and I’ve learned so much from him. He’s such an exceptional clinician, investigator, and educator. Welcome Dr. Morrow.
David A. Morrow, MD: Thanks very much. Pleasure to join you both.
Kayla Riggs, MD: I’ll start off with the first question. Get with the Guidelines has been a hospital-based quality improvement initiative by the AHA with registries for stroke, heart failure, atrial fibrillation, and coronary artery disease. Dr. Jessup, could you tell us about what led the AHA to create the Cardiogenic Shock Registry within the Get with the Guidelines program?
Mariell Jessup, MD, FAHA: Well, thank you. The AHA is very proud of the Get with the Guidelines effort. It’s been 20 years, and I think you forgot resuscitation as one of our modules. Actually, stroke was the first. Indeed, at the beginning of the pandemic, Dr. Morrow helped us stand up a registry built on the platform for Get with the Guidelines around the hospitalized patient with Covid to see really what the cardiovascular complications were. I think that model of saying, “We don’t know enough about the patient,” in that case it was the patient with COVID and subsequent cardiovascular disease, “We don’t know enough and yet we need to have a standardized way of collecting data.” The success really of the entire suite of Get with the Guidelines modules and then the strength and the utility of our Covid registry led us to say, “Maybe we can address all of the big unknowns in cardiogenic shock by setting up a Cardiogenic Shock Registry.”
Mariell Jessup, MD, FAHA: I think nobody on this call and probably most people that are subsequently listening will know that as often as we have to deal with a patient with cardiogenic shock, there’s just so many things we’re not sure. We don’t have any guidelines for cardiogenic shock. We have consensus recommendations, and we have lots and lots of papers that say, “Here’s who should be taking care of the patient with cardiogenic shock.” But we really lack sort of standardized definitions, although they’re coming along. We lack an approach to who should do what on the team, and we don’t really understand the outcomes based on etiology of shock.
Mariell Jessup, MD, FAHA: Much has been written about cardiogenic shock following a myocardial infarction. But being a heart failure doctor, my perspective is that a lot of shock comes from chronic heart failure patients who deteriorate. Shock is often in the eyes of the beholder. We decided that when there’s so much variability in what we know and understand, it’s time to really put some science behind it. That was a long answer, but it was really to say how strongly we felt at the American Heart Association to go out and find incredible collaborators like Dr. Morrow to help us stand up this registry.
Gurleen Kaur, MD: Yeah, thank you so much for explaining where the scene is in terms of cardiogenic shock, the gaps, and there’s so much that we need in terms of guidelines and evidence-based practices. The registry, I know based on the website, will capture patient demographics, clinical characteristics, interventions, and outcomes in patients hospitalized with cardiogenic shock. So, Dr. Morrow, how will this data be used to create these evidence-based metrics for cardiogenic shock?
David A. Morrow, MD: Yeah, well I think as Dr. Jessup just emphasized, unlike in MI, stroke, and heart failure where we do have sound evidence-based guidelines, which doesn’t exist for cardiogenic shock as she just described so well. Really we want to start at the ground level, at the foundation to establish a very robust foundation of epidemiology that will give us a view of the landscape of how we care for patients with shock, the phenotypes of shock and their outcomes, allow us to probe variability in practice and to then develop hypotheses from this carefully performed epidemiological work that we can then report back not only to hospitals and those who are providing care, but also to stakeholders in the healthcare community that interdigitate with the care of shock patients. Through all of those parallel efforts, which will really establish that upstream work that we need to do to work toward evidence-based guidelines for cardiogenic shock as well.
Mariell Jessup, MD, FAHA: I might just jump in here because what David said is exactly what we’ve learned from the past. For instance, our Stroke Get with the Guidelines. At the very beginning there weren’t a lot of evidence-based guidelines. I mean, we said, “Well let’s try one metric,” which is how long does it take before the patient gets in the door where they actually get definitive therapy? Initially we said, “Well gee, maybe 190 minutes is good.” Now, over the years we’ve been able to cut that time down significantly.
Mariell Jessup, MD, FAHA: In addition, because beginning to collect the data has inspired so much change and so much team effort that Get with the Guidelines – Stroke is looking at, for instance, “What do you do when the patient calls and is taken in the emergency vehicle?” That’s changed. Addressing stroke actually in the street when the emergency vehicle is there has changed all the way through to using the right definitions of stroke and through to rehab. So, you can’t change it if you don’t measure it. That’s what we’re doing. We’re starting to measure it.
David A. Morrow, MD: It’s worth picking up too that what we’ve seen from the Get with the Guidelines platforms across the spectrum of other cardiovascular disease is then it allows you to feedback and actually develop implementation at the system level. So, it’s first you collect the data, you understand where the vulnerabilities are, where the opportunities are, you feedback that data and then you actually learn in a way that you can build a system of care. That’s really what we hope to do and what we need to do we think for cardiogenic shock as well.
Kayla Riggs, MD: Thank you for sharing how we can use this data. It’s very exciting. There are currently 10 hospitals listed as participants of the registry. Dr. Jessup, is there a specific goal in terms of number of hospitals you are trying to have participate in this registry, and what efforts are being done to increase participation and streamline the process for sites?
Mariell Jessup, MD, FAHA: Well, thank you for that question. We’re trying to not be too ambitious initially. We need to learn what are the challenges that face hospitals as they’re putting this data in. We need to learn how we’re doing as far as our variables that are going into the database. So, we are purposely starting small. Again, I talk about Get with the Guidelines – Stroke, 85% of the strokes that happen in this country happen in a Get with the Guidelines hospital for stroke. So, we’re not anywhere near that.
Mariell Jessup, MD, FAHA: But we have big plans, and I think what’s really important is the sense of the entire shock community to realize that this is something we need to all do together. There are already some existing shock registries and people are saying, “Yes, we want our data to be part of the AHA registry,” and I think that that is a tremendous sign of all of the people in the shock community who recognize that they need to collaborate and work together to make some strides for the care of our patients. I think that’s particularly exciting.
Mariell Jessup, MD, FAHA: We’re also really excited because the FDA and CMS have been with us step by step. I take that to mean that they recognize that we need a coming together of the shock community to do the right thing and that they need more standardization of what we’re doing. Then I think we have volunteers from the variety of stakeholders including surgery and interventional cardiology and acute care cardiology and the heart failure community. All of these people are coming together to work together in this space.
Gurleen Kaur, MD: Thanks for sharing that because shock is just such a multidisciplinary entity that people take care of with different types of physicians participating in taking care of patients with shock. So, this registry will really allow for collaboration, as you’re saying with AHA using AHA platform to get patient insights recruited.
Gurleen Kaur, MD: So, we’ve touched on this a little bit before that critical care cardiology and cardiogenic shock are areas where there’s a lot of need for more randomized clinical trial data to allow for evidence-based practices. Both of you mentioned earlier that we need the data first and then we can start implementing and designing system-based strategies to improve quality metrics. So, Dr. Morrow, how do you anticipate that this registry will actively facilitate downstream pragmatic clinical trials and investigations based on the data that is collected?
David A. Morrow, MD: Gurleen, thank you for the question and thank you for making that point. Again, there really is a pressing need for adequately sized randomized clinical trials in cardiogenic shock management. It’s been a real challenge. It is a challenge to implement randomized trials in this space because of the acuity of the patients, I’ll say the tenuous balance of equipoise, the need for thoughtful approaches to informed consent in patients who often aren’t able to consent because of their impaired clinical status.
David A. Morrow, MD: One of the ways of potentially addressing that need and the challenges you face is through registry based clinical trials. It’s definitely been one of our aims from the very beginning to be able to nest clinical trials on the cardiogenic shock, AHA cardiogenic Shock Registry platform in order to leverage all of the data that we are collecting, the work that is already being done, the infrastructure of our case report form, the broad reach that the AHA has to hopefully someday reach that same goal of 80% of our shock patients being enrolled in registry hospitals and being reflective of clinical practice in that way to then build in pragmatic clinical trials.
David A. Morrow, MD: As Dr. Jessup pointed out from the very beginning, actually it’s been since it’s an inception of the registry and even the very first steps, part of our goal and for that reason, we’ve had clinical trialists, we’ve had industry, we’ve had the FDA and other regulators that are all been part of our planning. We hope that we’ve anticipated many if not all or close to it, of the needs that we would have within the registry in order to build clinical trials into that platform. The AHA is already starting to have experience in that area, and we can learn from our European colleagues who have done it exceedingly well already that it is possible. We think that the registry platform will give us that chance.
Kayla Riggs, MD: Thank you, Dr. Morrow. It sounds like we have a great adventure ahead for us for developing this platform for everyone to use. Since data will be available in real time to participating sites on the precision medicine platform, Dr. Jessup, could you share how soon we could expect to see updates to best practice guidelines or insights from the registry? Dr. Morrow, what insights are you looking forward to gathering first?
Mariell Jessup, MD, FAHA: Well, Kayla, it sounds like you’re about as impatient as I am. We have a little over 100 patients enrolled. As I said, I think that these are all sort of, I see them as beta patients that we’re really finding out where the challenges are. So, I’m not sure that we’re going to be able to see practice changing learnings early. But I do think that even just understanding what it takes to bring in data from multiple sites and from multiple registries, we’re going to learn a lot about that.
Mariell Jessup, MD, FAHA: As Dr. Morrow said, one of the things that’s really good about having industry collaboration is they have needs as well because we depend on them to develop new therapies, new devices and they have regulatory needs. We’ve had to balance without overburdening our investigators, we’ve had to balance saying, “We want to collect data that looks at social determinants of health. We want to look at data around insurance. We want to look at data, did the patient get transferred into the hospital or did they come directly to this hospital?”
Mariell Jessup, MD, FAHA: I mean, there’s so many things that probably go into outcomes, but we also need to look at the needs of our industry collaborators and say, “Is there some regulatory information that we wouldn’t ordinarily have thought about but it’s very important to them?” So, the input from industry as well as FDA and CMS has been invaluable. Our CMS members frequently will sort of look around and ask a question in a very different way because they’re payers, and we’ve learned so much by all of this varied input.
David A. Morrow, MD: Maybe I’ll address the second part of your question, Kayla, is where do we start as Dr. Jessup said? I mean there are so many areas in cardiogenic shock where we still have to learn. We really could fill an hour or longer talking about all the different avenues to be explored.
David A. Morrow, MD: I’d say if I had to pick two to keep it concise, I’d say that the first is really understanding our variability in practice. I think that’s something, to Dr. Jessup’s point, that we can actually learn very early from descriptive analyses of the data. Inevitably where there’s variability in practice, there’s opportunity for improvement, and it’s either that there’s a lack of data to inform practice or that we’re not responding to the available data in a way that may be able to provide optimal care. Either way, we will learn from that. I think that will be one of the areas where very early on we can glean information from the registry.
David A. Morrow, MD: Then I think the second would be that we are learning cardiogenic shock is not just cardiogenic shock. It is such a heterogeneous group of patients and being able to tease out the phenotype of cardiogenic shock as many have been doing now over the past several years, we want to build on that work in a very broad representation of sites and types of patients with shock to allow us to better characterize subgroups of patients with shock, their outcomes, their different needs. Ultimately we think that will direct us to different therapeutic approaches and strategies. But we’re still upstream of that really just being able to adequately describe and define those patient populations.
Mariell Jessup, MD, FAHA: I would just add Michelle Bowles, who is our senior vice president at the AHA in charge of all of our registries and Get with the Guideline programs, loves to quote Dr. Deming who said, “Uncontrolled variation is the enemy of quality.” If you look at cardiogenic shock, it’s the definition of uncontrolled variation right now.
Gurleen Kaur, MD: Thank you for both of you for sharing your answers to that question. To build off of what you mentioned, Dr. Morrow, about collecting, understanding the variability in practice, and then using that as an opportunity for improvement, one of the aims of the AHA registry is to promote systems of care metrics for cardiogenic shock patients that strive for health equity. Dr. Jessup, earlier I think you mentioned collecting data about social determinants of health, insurance practices and other aspects. So how will the registry help address these health inequities in care and outcomes?
Mariell Jessup, MD, FAHA: I think it’s really important to collect the data that I’ve already mentioned, especially social determinants of health. But more importantly, we want to make sure that we see diversity and inclusion in every aspect of what we’re doing in the Cardiogenic Shock Registry.
Mariell Jessup, MD, FAHA: So, for example, even our steering committee is very diverse. It represents a wide group of expertise and is diverse for gender and race and ethnicity. That’s how it begins. But then it also begins in the hospitals that we reach out to. It’s easy to go to the big academic centers, but it may be that their patient population is not as diverse or representative of a certain segment of the patients that get cardiogenic shock than hospitals in more rural areas or in areas that are traditionally under resourced. So, we’re going out of our way to make sure that not only do we have a diverse and inclusive steering committee, we have diverse and inclusive center hospitals and investigators locally.
Mariell Jessup, MD, FAHA: We’re going to keep track of the patients that are getting put into the trials. If there’s a hospital that we really want to have be part of our registry and they don’t have the resources to do it, we’re going to find the resources for that. This is a message that really resonates with people that potentially can help fund this registry that we’re really trying to look at a wide group of patients who have cardiogenic shock. So, we think that’s the first step towards addressing the inequities that are there. In fact, we don’t even know that much about how much the inequities exist in cardiogenic shock. They have to be there because they’re everywhere else. But that hasn’t been as well described as in other areas of cardiology.
David A. Morrow, MD: I guess I would add only very briefly to Dr. Jessup’s very eloquent description of the core of our principles of our effort and that is that at one level we really are looking to shed a brighter light on issues around diversity and equity in cardiogenic shock as a relatively unexplored area.
David A. Morrow, MD: Maybe to tie in one additional element that is an operational one but important, which is that the AHA team has invested extremely heavily in creating new solutions for interoperability to help our sites work to extract data from their electronic health records without as much human effort and to streamline processes for data sharing and creating a number of different ways to do that that hopefully will also enable centers that may have less resources for data extraction or for research to be able to contribute. It starts at the steering committee level, as Dr. Jessup described, and we’re really looking to build that at the level of data collection and then ultimately in the level of data analysis as well.
Gurleen Kaur, MD: Great. Thank you so much, Dr. Morrow and Dr. Jessup. It’s been so great to learn about the AHA Shock Registry and everything that there is to come in the future with evidence-based practices for cardiogenic shock.
David A. Morrow, MD: Thanks very much for inviting us.
Mariell Jessup, MD, FAHA: I want to offer my thanks as well. One of our goals is to train the next generation. You two are the next generation, and so I hope this is the beginning of your interest in the registry and all of the disciplines that will be critical to moving forward in the next few decades.
Kayla Riggs, MD: Yes. Thank you so much for your time, and we are so looking forward to this registry.