Thanks for the opportunity to present at this conference. My name is Santiago Garcia, I'm an interventional cardiologist with the Minneapolis Heart Institute in Minneapolis, Minnesota, and the title of my talk today is the Midwest Stemming Consortium. I would like to begin this presentation by highlighting some of the limitations of current stemming registries. We have known for quite some time that national stemming registries exhibit remarkable variability regarding the processes for identification and selection of patients, which oftentimes exclude important subsets of stemming patients, such as those presented with cardiac arrest and cardiogenic shock. Consequently, information gathered from these registries may not be consistent with real world experience. And therefore has limited external validity. To address these shortcomings, the Midwest Stemming Consortium was created. The Midwest Stemming Consortium, or MSC, is a collaboration of four regional stemming programs. The Midwest Stemming Consortium is composed of four different sites in the Upper Midwest. Those sites are listed here and include the Iowa Heart Center in Des Moines, Iowa, Minneapolis Heart Institute Foundation in Minneapolis, Minnesota, Prairie Heart Institute in Springfield, Illinois, and the Christ Hospital in Cincinnati, Ohio. Collectively, these institutions include six PCI-capable hospitals and a network of over 100 non-PCI-capable centers that have established relationships with these PCI-capable hospitals. This is a map of the Midwest Stemming Consortium sites. As shown here, the primary PCI hospital, which for the case of Minneapolis Heart Institute is located in Minneapolis, has established a relationship with hospitals in two areas. The one denoted in blue are hospitals within 60 miles of the primary PCI center, and the ones within the red circle are those hospitals within 60 to 200 miles from the primary PCI center. The dedicated transfer protocols are part of the Midwest Stemming Consortium. The common elements of the standardized systemic protocol are listed here and include enrollment of patients who present within 24 hours of the onset of symptoms, usually chest pain, shortness of breath, or other equivalents. We have included all patients with ST-segment elevation of at least one millimeter to continue with LITS or new onset left bundle branch block. And importantly, we have no exclusion criteria. The CAD lab is activated by a single phone call, and we have predetermined transfer routes for all hospitals affiliated with the primary PCI center. For those patients presented to hospitals without access to primary PCI with anticipated transfer times of more than 120 minutes, half of those thrombolytics are part of our protocol, and all patients receive the standardized doses of antiplatelet and anticoagulant medications consistent with contemporary guidelines. Part of the protocol is also to bypass the emergency department and proceed directly to the cardiac CAD lab for primary PCI. This slide shows some of the unique characteristics of the Midwest Stemming Consortium. We have an ongoing database, which is prospectively collected data on all patients. And this database has a broad geographic representation. And a person has approximately 20,000 patients with STEMI presented to one of these four sites. It's inclusive, as it contains detailed information regarding high-risk STEMI subsets, including cardiac arrest and cardiogenic shock. It also allows for collaboration with other ongoing registries, such as the ACC, Chest Pain MI, and Cat PCI registry. It is also a great educational tool that has allowed research projects to our summer internship program for college students that are interested in pursuing medical careers in the future. And it's comprehensive, as it contains detailed clinical and geographic and follow-up information up to 10 years. The structure of the MSC is presented here. The Christ Hospital in Cincinnati is the coordinator center. Minneapolis Heart Institute is the data coordinating center. And then every site has a primary investigator, a co-primary investigator, and a research coordinator allocated to this project. We have meetings every month, every Tuesday. We have conference calls where we discuss ongoing research projects and opportunities for collaboration and quality improvement. The MSC board meets monthly via conference call, as previously described. We also have committee members that oversee implementation of the protocol in each center. The STEMI coordinators prospectively update the database with summer interns assisting the process of unifying data fields and extracting missing data whenever necessary. Data coordinator center has plenty of statistical support to provide the PIs with data necessary for manuscripts and other presentations. These are the elements that we capture in our database. They include demographic data as well as cardiovascular risk factors. For patients presented with cardiac arrest and cardiogenic shock, we have dedicated forms to capture arrest variables and also use of mechanical circulatory support for patients with cardiogenic shock. We systematically collect time to reperfusion and causes of delay. And geographic characteristics are also included in our database. Importantly, we follow these patients longitudinally after discharge to capture rates of myocardial infarction, stroke, and mortality up to five years after they are discharged from the hospital. This is a summary slide that captures the patients included in the Midwest STEMI consortium up to July of 2021. We have approximately 17,000 patients. The mean age is 62. Approximately 20% of these patients are elderly patients over the age of 75, and 30% are women. With regards to baseline characteristics, about a third of these patients have a history of coronary artery disease. The risk factors are listed here with approximately 60% have a history of tobacco use, and 22% are diabetics. The LAD is the culprit in approximately a third of the cases, and about 16% of patients present with significant left ventricular dysfunction at the time of the heart attacks. High-risk pre-PCI conditions, such as cardiac arrest and or cardiogenic shock, are present in 13% of patients. This slide contains a brief summary of some of the publications that have come out of this dataset. We have published our design and rationale for everyone to see how we treat these patients and our different protocols for transferring in different states. We have also used this very important and contemporary dataset to compare the treatment of acute myocardial infarction during the COVID-19 pandemic. We have also dedicated resources to investigate some subsets of importance, such as those patients with previous CABG, diabetics, and we also reported the largest experience with regards to the incidence of stroke during primary PCI. These are some of the most notable publications, including the initial findings from the NACMI registry, which I will be expanding on later, and the characteristics of patients with high-risk pre-PCI conditions, such as cardiogenic shock and cardiac arrest. We also have used this important tool to assess the effect of the COVID-19 pandemic on STEMI outcomes. Our group was the first to report a significant 38% decline in cardiac cath lab activation for primary PCI during the early phase of the pandemic. This was a very important observation that helped us understand some of the collateral damage of the lockdowns and other restrictions to healthcare during the COVID-19 pandemic. Various subtracts have also been published from the Midwest STEMI Consortium, and this has allowed us to expand these opportunities to our summer interns, who spend two months every summer helping us with data collection, and that gives them an opportunity to write abstracts and manuscripts on topics of their interest. We have mentors at each site that provide guidance and statistical support during the writing of manuscripts and abstracts. I would like to spend some time highlighting two recent projects in which the Midwest STEMI Consortium provided key data that made a meaningful impact. The first one relates to the effect of the COVID-19 pandemic on access to the cath lab for patients with heart attacks. We noted early on, in March of 2020, there was a significant drop in cath lab volumes everyone was talking about in social media, but there was no real data to support that claim until we got an opportunity to congregate all the Midwest STEMI Consortium and also other sites in the East Coast and West Coast to try to understand this phenomenon. As shown here, we were able to quantify this significant decline in cath lab activations in the early phase of the pandemic, approximately 38% reduction in cath lab activations. As we learned later on, this was not an isolated phenomenon. It happened with multiple cardiovascular emergencies, including a stroke, acute aortic dissection, abdominal aortic aneurysms, etc. So this powerful data set allowed us to make an early observation that had meaningful implications for patient care. We expanded our initial observation by including 17 STEMI programs in four different U.S. regions. This analysis was expanded to the month of April, and we were able to confirm that in every single region in the U.S. there was a significant decline in STEMI activation during the early phase of the pandemic in relationship to the pre-pandemic levels. This was present in all areas, but it was most notable in the Northeast region of the United States that was the most affected during the early phase of the pandemic. In addition to reduction in activations for primary PCI, we also observed a significant increase in door-to-balloon times of approximately 20 minutes, which is consistent with our changing of the protocols during the pandemic to accommodate rapid COVID testing and other modifications that were introduced during the COVID-19 pandemic that affected the care of STEMI patients. And then, perhaps more importantly, is what we did with the data. So this is a slide that shows all the centers that participated in this survey in March 2020 and in April 2020. The data is presented as a change expressed in standard deviations from baseline. So zero is the baseline prior to the pandemic, and then in purple is March 2020, and in green is April 2020. So when we first noted this precipitous decline in STEMI activations in March, many programs began an educational campaign to reach out to patients in the community with chest pain and try to get the message out that even during the lockdown, patients with chest pain should come to the emergency department and be evaluated. And as shown here, there are many centers, such as Christ Hospital, Northwell in New York, et cetera, that made significant improvements. And by the end of April, they were back to baseline in terms of number of STEMI patients presented to the ED, but that was not universally applied across the spectrum, and for many programs, it took longer to recover from the early effects of the lockdown. In trying to understand what are the drivers of this drop in STEMI activations, we conducted an analysis using MSC data and also with some external collaboration of the monthly STEMI volumes according to the number of COVID cases in that particular region. And we found that one of the main drivers was the incidence of COVID in that particular area. So for those sites, particularly in the Northeast, that were hit really, really hard with COVID early on, those are the sites that saw the most significant drop in STEMI volumes. And this is shown on the left of the slide, almost a 50% reduction in the number of monthly activations. Similarly, we explored the notion that perhaps the stay-at-home or lockdown orders had an effect on the decline in STEMI activations, and as shown here, those areas of the country that adopted stay-at-home orders early on suffered the most in terms of STEMI activations with declines up to 50% in STEMI volumes. So the point here that I'm trying to make is that perhaps the message should have been more calibrated with regards to stay-at-home orders, in particular as it relates to patients with chest pain. Many of them did stay at home, and unfortunately, the consequences were not good. And I say they were not good because we noticed a significant increase in the number of cardiac arrests. And this is data from Europe, but the same has been observed in the United States. In Paris, France, they have a very sophisticated system where they track all the 911 calls and our hospital cardiac arrest calls as well. And as shown here, during the lockdown in 2020, there was a significant increase in the number of cardiac arrests at home. This is shown on the left. On the right, which is also disturbing, is the proportion of patients that presented alive after a cardiac arrest in Paris, and that proportion significantly declined during the pandemic. So these patients were dying at home, and many of them were dying alone. By the time they were being resuscitated, there was decreased survival. Similar observations were made in the United States. This is data from New York City showing a significant 800% increase in the number of 911 calls during the early phase of the pandemic, a significant increase in the number of cardiac arrest deaths at home, which paralleled the number of confirmed COVID-19 deaths. Now this is likely multifactorial. We don't think that all these cardiac arrests are related to COVID. We suspect that a large proportion of these patients had cardiovascular emergencies, including heart attacks, and they did not seek medical care during the early phase of the pandemic. As mentioned, this affected the whole spectrum of cardiovascular emergencies, not just heart attacks. This is data for acute stroke care, showing a significant reduction in the number of patients undergoing a stroke imaging during the early phase of the pandemic. For those patients who were presented to the hospital, we noticed a significant proportion of them presented very late. In fact, in our own hospital, we had two mechanical complications within the same week, which we typically see once or twice a year. This is one example of a 67-year-old patient who presented to the emergency department 14 hours later. She had expressed concerns about coming to the emergency department due to fear of contracted COVID-19, had an occluded right coronary artery, Q waves in the inferior lids, and failed rapier fusion. Subsequently, she developed a mechanical complication, as shown here in the slide, a BSD that required surgical correction, and unfortunately had a fatal outcome after the operation. So COVID-19 can affect multiple aspects of heart attack care. One of them is when COVID-19 and heart attacks coexist in the same patient. We know that patients with cardiovascular disease have increased risk of mortality with COVID-19, and approximately a third of these patients admitted to the hospital have elevated troponins, consisting with myocardial damage. Some, in particular our Chinese colleagues, have advocated for a shift to pharmacological reperfusion during the pandemic to try to mitigate the risk of exposure to health care providers and allocate resources that are strained during a pandemic. Prior to the NACME registry, which I will discuss in the next slide, there was remarkable variability in the reported data with regards to treatment and outcomes of patients with STEMI and COVID-19 infection. The early experience in New York City reported a mortality of 72%, and the international experience also reported high mortality, significant use of thrombolytic agents, and a shift away from mechanical reperfusion. There were also reports in social media highlighting the significant variability in angiographic outcomes of these patients. Many of them had typical ST-segment elevation with non-obstructive coronary artery disease, which to many suggested that taking these patients to the cath lab was not a good idea. In order to better understand the significant variability in clinical presentation, treatments, and outcomes, we began a collaboration with the American College of Cardiology and its Canadian equivalent to try to understand what are the treatment characteristics for patients who have COVID-19 and STEMI, and we used the Midwest STEMI Consortium as our control group for this ongoing prospective registry. The NACMI registry enrolled patients with both suspected COVID-19 infection and confirmed COVID-19 infection, and we wanted to be broad with regards to different treatment options. So this is not an angiographic or primary PCR registry. We allow in the registry patients who were treated medically, patients who received pharmacological reperfusion, and obviously patients who were taken to the cath lab for primary or facilitated PCI. The initial results of NACMI were presented this year in the Journal of American College of Cardiology and are highlighted here. We initially did our first data analysis with 230 patients with confirmed COVID-19 infection and 495 patients with suspected COVID-19 infection who later on ruled out for it. We call this group the PUI or Persons Under Investigation. The main findings are shown here. This registry was unique in that 50% of patients with STEMI and COVID-19 infection were from ethnic minorities. The other important finding to highlight is that approximately 20% of patients presented with cardiogenic shock, and many patients, instead of having chest pain, presented with dyspnea, and approximately 50% of these patients had an abnormal chest X-ray or chest CT. This is consistent with the known preference of COVID-19 for the lungs. Perhaps more importantly is the very high in-hospital mortality of 33% for COVID-19 positive patients. In contrast, patients in the Midwest STEMI consortium have a 4% hospital mortality. The PUI group had also increased mortality approximately 11%, and this is something that needs to be better understood with regards to how our treatment protocols changed during the pandemic and what the final effect was on the care of these patients. NACMI continues and has a goal of enrolling 500 patients with STEMI and COVID-19 positive status. We hope to finish enrollment at the end of 2021. We have already exceeded our goal of 500 patients. We presented the initial results at TCT last year and a secondary analysis at SCAI. At that time, we had 331 COVID patients in the registry. These patients are going to be followed. Those who survive the index admission are going to be followed for up to one year, which is another important characteristic of this unique registry. In summary, the Midwest STEMI consortium, which was supported by an ACC accreditation grant, has provided important information during the COVID-19 pandemic, both with regards to the indirect effects of COVID on STEMI activations, which has prompted us to change our approach to these patients, and also the direct effects of COVID-19 in patients with STEMI, which, as previously shown, has very high in-hospital mortality. We appreciate the support of the American College of Cardiology, and once again, I want to thank you for the opportunity to present our data today, and I wish you a very good conference.

Midwest Stemming Consortium

stemming registries

patient subsets

COVID-19 pandemic

NACMI registry

mortality rate