Transcription:

The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of .25 AMA PRA category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.

Melanie Cole (Host):  Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I’m Melanie Cole and today, we’re discussing high sensitivity troponin assays in the Emergency Department. Joining me is Dr. Brandon Allen. He’s the Medical Director of UF Health Shands Emergency Room and an Associate Professor in the Department of Emergency Medicine at the University of Florida College of Medicine. Dr. Allen, it’s really a pleasure to have you with us today. This is such an interesting topic. And as the management of Emergency Department patients with chest pain continues to evolve and even many low risk patients are admitted whether it’s for observation or inpatient bed for noninvasive cardiac testing, that others might get testing within 24 to 72 hours; do you feel that this approach was and remains inefficient, possibly costly and has it been shown to definitively improve patient oriented outcomes? Explain the problem a little bit to us and tell us some of the risks of admitting patients to the hospital as well as the risks of overdiagnosis.

Brandon Allen, MD (Guest):  Well thank you for having me. The risks are real. And the process really lies in the Emergency physician or Emergency provider doing an assessment to see if someone has a risk for acute coronary syndrome. And I usually use the history and physical exam as well as maybe a clinical decision rule but also really rely on the EKG to see if anyone’s having an acute heart attack that requires the cath lab immediately or blood tests called troponin to assess if there’s been any myocardial injury to the heart muscle. And that is a really great tool for us when we don’t have any EKG findings that are concerning for emergent cath lab activation. And the evolution of troponin has been so wide in the last ten years and Europe was the starter of this when they have had high sensitivity troponin for about ten years now. And the first FDA approval for this in the United States was about in 2018. So, we are pretty big laggers when it came to FDA approval of a test that has higher precision and higher accuracy at a lower level to identify someone to have a potential myocardial injury or infarction.

And the other value of it is gender specificity. So, a female and a male can have different cut points with the performance of the assay that can recognize injury to the heart at different levels. And this was a part that really drove me to push our institution to utilize this when I think about my family members or even my mother and what I would want for her in comparison to the contemporary assays that we had in the past. And thankfully, here at UF, we actually are the first site to have the Beckman high sensitivity troponin I in the country. So, we have some experience with bringing this online and really helping with a lot of the anxiety that can be with changing something so drastically that was embedded in a culture.

When you referenced risks in regards to this in comparison to – the culture has been that if someone is “high risk”, with their chest pain story or their risk for acute coronary syndrome; they were coming into the hospital. And that led to sometimes excessive testing, maybe unnecessary testing and then there’s other risks within the hospital whether it be infection risk, or other things that a hospital can pose to a patient that may be unnecessary. A lot of places have moved towards clinical decision units or observation status units to get some information. But there’s been some recent data as well that has shown that that data may not change the person’s event rate in the next 30 to 90 days when it comes to if you are going to have a heart attack. So, that’s where this troponin assay is so important.

Host:  So, then identify for us some of the key considerations for implementation. For which patients are you finding this most beneficial? Does it surround ruling in or out an MI as the primary issue? Tell us a little bit about where you’re finding it most effective.

Dr. Allen:  What a wonderful question. And when we talk about the previous culture, that culture led to a lot of admissions into the hospital. And where this has been found to be the most valuable is as a rule out technique and usage. Because of the sensitivity of it, you can send a lot more people home and home safely which is the biggest driver of this. And when we started to go down this road and I’m going to talk about our key stakeholders that are important for anyone planning this implementation. The biggest thing was safety and efficacy for this assay. And we did some validations and things like that behind the scenes before we rolled it out and those were to two key things. And when we talk about what’s the driver of it from an outcome standpoint; it’s something called major adverse cardiac event or MACE. And if you have a low MACE rate, and usually the magic number in cardiac literature and in acute coronary syndrome and high sensitivity troponin literature is you have to a negative predictive value of 99% or greater to consider this a safe assay to send people home with a MACE rate of less than 1%.

And nothing is 100% in medicine. Especially in Emergency Medicine. But if you can get close to that 1%, there’s a lot of people who feel safe with that and being able to have that shared decision making discussion with their patients. When we started this whole venture, one of the keys was I went into the literature and looked to see if there was any implementation guidance. And there wasn’t that much. Dr. Judd Hollander who is at Jefferson and is an Emergency physician wrote something in the annuls of Emergency Medicine of basically six steps to do this well. And he’s one of my mentors and a really great cardiac biomarkers researcher.

And what we did is we tried to follow those steps to a T. And the biggest things were about getting the right people involved in the beginning, those key stakeholders and you’ve got to get the lab, you’ve got to get IT which was one that we didn’t realize until the end how important that was to actually setting a Go Live date, cardiology of course. One thing that you’ll see is there’s going to be a significant amount of anxiety in regards to changing this from the norms because everyone’s afraid of more consults from the cardiology end and more Type 2 myocardial infarctions. Which has been shown in the literature that your Type 2 MI’s or evidence of end organ damage that may not be secondary to acute coronary occlusion will go up by about 30%. And we actually saw that. But what we didn’t see was our admission rate go up or our consult rate go up after the first ramp up period of about the first three months.

But the key to all of it was outreach and education. After we got those key stakeholders around, we said okay, we’re going to do this right and we’re going to take our time. And we basically went on a tour with myself and my colleague Dr. Massoomi from Cardiology and we did grand rounds, we did a chest pain day for five to six hours with key stakeholders from around the health system and then we had to build in some specific things in our health record to set someone up for success as the end user. And I think that’s the part that outside of all of those things that require attendance and people to buy in; is that end user can you set them up for success when they have a number in front of them and what to do. And we actually had to change our whole algorithm of how we assess these patients as well.

Host:  Well then one of the things that I find so interesting Dr. Allen, I’d like you to speak about the diagnosis of acute myocardial infarction and the pattern of cardiac troponin for other providers. What’s interesting to note in these patterns that you’re discussing?

Dr. Allen:  This is a great question because in the last year or two, there’s been the new fourth universal definition of myocardial infarction that’s come out. And it’s basically a consensus statement by multiple experts around the world about what this is and what do you use to identify this diagnosis. And one of the big drivers of this is the EKG and the high sensitivity troponin. And one of the things that changed with the fourth universal definition that was really important is this description of myocardial injury versus infarction. And that’s all based off of the high sensitivity troponin cut points. So, if you raise above the 99^th percentile, so you have an elevated troponin, the one key thing that needs to happen next is you need to have another one. Something called the delta. And when you have a delta, you can see the rise and fall of change with your assay that could identify someone to have acute myocardial injury versus just having chronic injury if they don’t have a delta that rises above whatever cut point you and your health system decides.

So, with that, you’ve got a pocket of people who are in myocardial injury. But then, when you have a significant rise in troponin, and then you have a delta that’s significant; you get into infarction range where you truly have that rise and fall on a slope that can be determined to say you have a true infarct pattern in comparison to injury. One thing we all know though is that any elevation in troponin raises all cause mortality. And it’s all important. Now the other distinction to note is that not all of these need a cardiologist to say this person needs to go to the cath lab and needs an ischemic evaluation. Because there’s a ton of reasons why someone can have an elevated troponin. It could be sepsis, it could be pulmonary embolism, but it could also be acute coronary syndrome secondary to plaque rupture. And identifying those from the ones that are secondary to another etiology that’s just showing end organ damage is really important.

And that’s where the clinical acumen, the history and physical exam, the EKG, all have distinct parts in making that distinction.

Host:  So, then based on what you just said, in your view, is the precision of the assays adequate enough to make these small distinctions that you were just discussing accurately? Do you advocate some are saying the algorithms are at one hour? Do you advocate at two hour approach? Does this allow for larger differences? Tell us about the majority of patients and triage and this algorithm. Is this able to make those small distinctions accurately?

Dr. Allen:  Yes, so I think it does. And the reason I say that is because the comparison of what we had before, this is so much more precise at a lower level to identify evidence of injury that it’s better for patients. And it’s going to get them into have better risk factor modification and or an ischemic evaluation, whether that be with a stress test or a coronary CTA or even a cardiac catheterization. But the key to this too though is that your institution can either go by the FDA package insert or whatever they have in their own validation to set those cut points that are agreeable by your key stakeholders. And when you get to those numbers, you can’t be an alarmist with these numbers either because then you’re going to have a lot of fatigue from saying oh that’s an elevation, what do we do now?

Well we do the same thing we did when it was negative. And then, you’re not going to have as much taction as you hope. The goal of this is that it’s to increase your rule out group but you can still identify people with injury and infarction patterns. The algorithms are all over the place, frankly. And that’s because of the different assays but we do have a framework from this. And it’s from the European Society of Cardiology and they’ve had guidelines for NSTEMI care since 2012 that have included high sensitivity troponin. And one of the things that they have an abundance of research on is this zero and one strategy versus you just need one troponin that is so low that it’s not detectable which means that you don’t need any more because the outcomes for this patient is really good.

And they actually just published the 2020 NSTEMI guidelines and it includes a zero and one strategy because if you have a first one, you need a second one for a delta unless you have one that’s so low to start with that the data is showing that your next one is unlikely to change your strategy or your care. And right now here at UF Health, we are looking at that. So, when we started this, we went with the conservative approach because before, we were doing zero and three hours with our contemporary assay. Some places do even zero, three and six which is a really long time in ED length of stay for a patient. We’re looking at now to see if we’re safe at zero and one and we can get rid of the three hour test. Because that would be really impactful on a lot of levels. And we’re also looking at to see if our numbers – so our cut point that the lowest that they can report is 6. So, if we have a less than 6, and what do those patients look like afterwards? Are these patients returning with MACE? Are they returning with a myocardial injury or MI within a certain time period? We’re looking at all of that now because we’re a little over a year out since implementation here at UF Health and we’re gathering that data.

The preliminary data from the first four months or so that we were able to obtain, just won an award at a local abstract for the Florida College of Emergency Physicians. Because it showed that it was abundantly safe with that strategy for a zero and one hour strategy following and mirroring the ESC guidelines.

Host:  What interesting points that you brought up. As we wrap up, Dr. Allen, how can you recognize future changes to rule out strategies and observation based on implementation of troponin of this high sensitivity assays? Do you feel they’ll help triage patients more accurately and rapidly than prior assays? Let other providers know what you would like them to know if they are implementing this process and what you’ve seen as your outcomes.

Dr. Allen:  Yes. So, this is such an evolving field. I think that what we’re going to see in the future is we’re going to see combinations and potential clinical decision rules added to these to say with this nonischemic EKG, with this clinical decision rule, you are even more safe when you add that troponin to it. So, this patient is really safe to go home. And you can tell that to your patient with reasonable certainty. I think all of that is coming and it’s really evolving now. And the other big piece is that people really want to have a way to identify someone as having a Type 1 MI versus a Type 2 is one that you ve a supply demand mismatch and it’s unlikely to be from an acute coronary occlusion. Well there’s some literature out there now and I have a large research project that we’re doing a side analysis on to see if the brain natriuretic peptide, the BNP, in conjunction with the high sensitivity troponin in some type of ratio can give you that answer with pretty good specificity. So, that’s being looked at now and there’s been some literature that’s shown that it has promise.

So, I think that’s something that’s really going to be on the horizon but if I were to talk to anyone about this, in regards to okay, we were just notified that our health system is sunsetting our contemporary troponin assay and we’re going to high sensitivity, what do I do? I would say gather as many people who you think are going to be your key stakeholders and decision makers early, make sure you are all aligned on the plan. There’s actually right after we finished our implementation strategy, there’s an article in JACC by Dr. Januzzi where it actually comes up with a check list and it’s in the beautiful JACC image, that they do with their illustrations, their central illustration and if you follow that checklist; you will be set up for success and thankfully, we didn’t have that checklist but we actually check boxed every single thing on there and that’s why I think we had so many champions after implementation is because we did it right. But it’s not quick. To do it right, may take some time. Because there’s a lot of elements here that you may not be in contact with pretty readily that are going to want to have a stake in this. And it is important for everyone to be aligned. And that alignment is how you’re going to be successful.

Host:  Nicely done Dr. Allen. What great information for other providers. Thank you so much for coming on and sharing how you developed this within your own Emergency Department and thank you again. That concludes today’s episode of UF Health MedEd Cast with UF Health Shands Hospital. To learn more about this and other healthcare topics at UF Health Shands Hospital, please visit www.ufhealth.org/medmatters to get connected with one of our providers. Please also remember to subscribe, rate and review this podcast and all the other UF Health Shands Hospital podcasts. I’m Melanie Cole.