Heart failure screening in people with diabetes: How labs can impact patient care

Awesome, thank you for joining us. My name is Alex Fohl. I am a pharmacist, but also the scientific partner for Cardiometabolism at Roche Diagnostics in the medical and scientific affairs area.

And I'm Kim Wood, I'm a medical laboratory scientist, but clinical specialist with Roche Diagnostics in our core laboratory.

And we are joined on stage by Professor Dr. Hashim. He is the professor of pathology, chief of clinical pathology and clinical chemistry director at UT Southwestern Medical Center in Dallas. He has over 30 years of experience as a clinical chemist with interest in appropriate test utilization and in promoting the laboratory to be at the clinical interface with impact on patient outcomes. So perfectly suited to talk to us about how Well, thank you very much for that introduction. So that immediately tells you who's the eldest person here.

Oh, and we're excited to have you here with us. So looking at the first slide, in 2022, the ACC, AHA and HFSA categorized the four stages of heart failure between stage A and stage D. Based on the progression of symptoms and clinical findings. As you can see, under stage A, patients with diabetes are specifically called out as at risk for heart failure.

So Dr. Hashim, what is the association between diabetes and heart failure and why would patients with diabetes be specifically called out? Well, thank you very much for that question. That's a very important question. Let me first begin by saying that we are really in the lab community, very happy that the ADA and the American College of Cardiology came up with those guidelines because it's an opportunity for us to get involved. And we'll talk about that a little bit more. The pathogenesis of heart failure in diabetes is a bit complex. So there is a genetic component, there is an environmental component, obesity, basically hyperglycemia leads to increasing the oxygen reactive species, advanced glycation and products. The (indistinct) leads to increased reabsorption of sodium. So that gives you volume overload. You've got stimulation of the renin-angiotensin-aldosterone system. You have an accumulation of hypertriglyceridemia. So really it's multifactorial. The pathogenesis is a bit complex, but the end product is volume overload, which leads to heart failure, structural complications, and cardiovascular disorders with kidney complications. So it's a big picture, but the pathophysiology is complex, but it involves multiple organs.

Awesome. And what have you seen at Parkland for the testing with NT-proBNP and hemoglobin A1Cs? All right, so that's a good question. So the guideline says that we have to screen patients, diabetic patients for risk of heart failure. And a biomarker for heart failure is NT-proBNP or BNP. It's basically a volume overload or a filling effect that leads to the increased release of those biomarkers. So the idea is to measure anti-BNP frequently, at least once a year on patients with diabetes to identify those who are at risk of developing heart failure. And that's pretty important. So we looked at the data and the current practice where we are at Parkland Memorial Hospital, which is a large county hospital in Dallas. And we looked at over 75,000 patient data and we found that a very small percentage of diabetics are getting screened for heart failure. And those who are getting screened or getting NT-proBNP measured, they are coming at the latest stage of heart failure. Heart failure, the American College of Cardiologists, you've got stage A, B, C, and D. D is total heart failure, C is clinical heart failure, but it's staged into various categories depending on the ejection fracture. And then you've got stage B, which is the preclinical component, but there's a bio biomarker for that. So, we've not been doing a very good job. Only about 16% of patients with diabetes were being screened for biomarkers.

And you mentioned the American Diabetes Association, in December of 2023, they actually came out with a recommendation that all adults with diabetes should be measured with a natriuretic peptide to facilitate prevention of stage C, heart failure. And you mentioned stage D and stage C. What's the difference between stage A and B and then stage C, heart failure? This is a very good question. Thank you. So stage A where everything is normal, the biomarker is normal, there's no heart damage, there's no heart failure, everything looks good. The transition from stage A to B, the biomarker of heart failure will become elevated, will be obvious. So NT-proBNP will be positive. There are no clinical signs or symptoms of heart failure. So the patient looks quite well. Stage B itself has about four different stages from biomarker being abnormal, we've agreed on that, to structural damage, maybe a little bit of dysfunction. And identifying that early, Alex, in the process is very important because it's reversible and it's not just reversible. The mode of intervention increases in intensity as you progress into that preclinical phase, you know, which is not really clinically obvious. So from lifestyle management to weight loss, to putting patients on HGL T2 to referring them to cardiology. Now once you move from stage B to stage C, that becomes clinically obvious. Everyone will be able to identify that and measuring NT-proBNP or BNP will be just a confirmation of a clinical picture or a clinical suspicion. So what we're looking for here is identifying those patients who we know, diabetes. We've already talked about pathogenesis, diabetes leads to heart failure. Identifying those individuals much earlier before it becomes clinically obvious, it's reversible. Intervention is easy and this is a fantastic opportunity. I'm a very strong proponent of moving the laboratory into that clinical interface. This is actually an outstanding opportunity for us to be out there helping clinicians, making sure that testing is being performed, you know, so giving them advice. We did a study where we looked at the role of the clinical laboratory in test utilization and the data was very, very interesting indeed. Only 70% of individuals thought that getting help and advice from the laboratory is helpful. So we decided to put together a best practice alert, some guidance to the clinical lab to do that. But I think it's a great opportunity for us to get in there into that clinical interface and be able to help clinicians and patients with that request.

All right, so just last year, the American Heart Association reaffirmed that the occurrence of diabetes is only going to increase over the next 25 years. As you can see on the graph behind us, it's going to keep growing exponentially. Looking at that and having heard the guidelines and recommendations for screening these diabetic patients for heart failure, that's a really big undertaking, right? A really big undertaking. And your perspective of the laboratory being at the forefront of that interface, providing assistance, these hospital systems to rely on to assist with education and implementation. What is your best vision or goal for how the laboratory can play in that space, and what do you think the laboratory can do to support a hospital system for implementing such a vast screening protocol?

So, brilliant, Kim. So this is actually a wonderful opportunity for the laboratory to come into that clinical interface. We have the guidelines, they're very clear, the evidence is very clear. Now is for us to help clinicians and help end users to actually apply those guidelines. So in my mind, there are maybe about four different ways of addressing this system. Number one is education. So providing an education to clinicians on the need for that testing. We could do that through leaflets, promotional activities with the test utilization activity that I talked about. Our senior primary care physicians and I actually recorded a video on test utilization. That video was uploaded into the training modules for clinicians. And they had to go through that in order to learn about that. And it benefited quite a lot.

Right, yeah. So training and education, developing and using clinical decision support systems such as best practice alerts. So we had an alert that would fire when it's been more than 12 months. And that particular patient with an A1C, with an ICD code of diabetes has not had NT-proBNP done. So that fires. So they say, oh, I have to remember to order that A1C. So that's another intervention there. We collect the data behind the scene in terms of like, how often did that clinical decision support BPA fired? And who the provider was, what action was taken, was it ignored or was an NT-proBNP ordered? And they go back and provide that data to the physicians and say, listen, we've been reviewing your practice and this is what happened, and is there any way we can help you? And some of it, it might be justifiable, maybe the patient was only due to come in the week before, you know, or so, and that would actually work. So education came using a clinical decision support system and continuous feedback to the providers and to the end users.

Awesome. Another big, big task, right? So when we're talking about developing these best practice alerts, which I'm assuming would be implemented in the electronic medical record system, that would require a cross-functional team probably within an entire hospital system composed of multiple departments, cross departmental collaboration. What have you guys done at Parkland? What's your idea for how to utilize all of the resources within that hierarchy to affect this change? So our experience has shown us that education, sustained education and involvement with the primary care physician, with the clinics, with the providers is key. So we have laboratory personnel at those primary care physician areas, at those outpatient clinics. 

They interact regularly with providers, they interact regularly with nursing staff, with advanced practitioners. So basically keeping an eye on the test ordering, keeping them abreast with the development, the availability of testing, the sample requirement, the stability things can be added, can be netted together. So all of that, these are our eyes and ears on the ground.

Right. And we communicate with them regularly. We should we're the medical directors and they also communicate with the clinics on a day-to-day basis. So they are really there on the ground and they're very critical to helping us with that process.

I must say that the data that we've had with the utilization experience is actually very telling and looking at the data on the A1C and the NT-proBNP. If you are diabetic in the ambulatory clinic, only 12% of those actually got NT-proBNP done. The majority of the NT-proBNP was measured in the emergency department and the inpatient setting. When it's too late and when it's clinically obvious.

It gets even worse. We talked about stage B and preventative measures. Now, if you're white, male, you're more likely to get NT-proBNP tested, you're more likely to get preventative measures done if you are a woman or black or Hispanic. So there is racial and gender disparity already as we see. How do you equalize that and how do you bring everyone to par?

Right. I think this is a very important role for the laboratory and it's an action that we will continue to do. And a wonderful systematic approach to implementing those best practice alerts to help eliminate some of that racial disparity potential.

Exactly, Kim. And you reminded me of one thing. So best practice alert, you probably heard the term alert fatigue, no one likes them. We did some look back as to how many of those alerts were actually acknowledged or deleted. 70% got deleted and 34%- So we know in the laboratory with our analyzers beeping at us. But a significant and important 34% got actually followed and he did that. So we don't do that on our own. We have to get the primary care physicians involved, cardiologists involved, internal medicine, the chief informatics officers, primary residents, nursing practitioners, laboratory. So really all of this is done in agreement. And when you're firing a BPA or a clinical decision support system, you are giving instruction.

Right. So we had consensus and agreement as to what the instruction is. This is a patient who's diabetic, the recommendation is to do it once a year, please do that because it's going to do this, this, and this and that. So we've agreed on that statement. So everyone is on board, everyone knows what to expect and it's not a surprise to anyone. And we will keep following on that.

Wonderful. So we've got one last question for us before we go to a Q&A scenario. We've talked about the guidelines and the guidelines to recommend testing. We've talked about patients that if we can catch them early, we can potentially prevent this disease progression. Do you see an opportunity where patients who get diagnosed with diabetes never have symptoms of heart failure? Is that a potential? Is that a realization that we could actually achieve?

I mean, yeah. I mean the data is clearly there and the important part is reversible. It's reversible and you need to identify that. I mean, the older guidelines say you measure it when you have clinical symptoms and signs. Now, this is a really excellent example of the laboratory at that clinical interface.

Right. You have the guidelines, the data is very clear. The response is very clear. The preventative measures are very clear. All you need is a biomarker, and to be able to educate and do that. Actually, I think it's possible. It's reversible, it's preventable, and it's treatable. So, yes, I do.

Awesome. Well, wonderful. Well, thank you for the conversation. And at this time I'd like to field any questions from the audience that you may have.

If you would like to raise your hand, I've got Jonathan, who will help and bring the mic to you.

Maybe I should ask the audience, do any of you do NT-proBNP on all the diabetics that they have if you look at your A1C testing and how many NT-proBNP were done, what do you think they're going to look like?

Yeah. Any thoughts or questions for our panel here?

It looks like we are clear. Any additional thoughts from you? We will kick it over to you to wrap up.

I just think this is an incredible opportunity for all of us at this conference who are laboratorians and have a great passion for representing the laboratory. Or we wouldn't be here, right? Actively learning and investigating all of the growing potential around us in our field. This is an incredible opportunity for us to be at that intersection between clinical medicine and the laboratory to offer our support to these clinicians to implement such an incredible, potentially life changing process that can prevent heart failure symptoms from ever becoming their reality. So when we talk about heart failure, the prevalence, the significance of what that diagnosis means, it's a fatal diagnosis. And I think if our cardiology community interpreted as such and took it as seriously as maybe a cancer diagnosis or something like that, I think the treatment and the response would be so much more aggressive. And the fact that the laboratory has this opportunity to bring light to that, bring education, and use our collective voices to draw attention to these guidelines is a privilege for us.

Any last thoughts from you? Well, I mean, I would agree with everything Kim said. I mean, this is an opportunity for us to be at that clinical interface. Like I said, the guidelines are there, the management is there, we can make a difference. The data that we've looked at clearly shows there is a gender disparity, there is racial disparity. Patients with diabetes, when they get assessed for heart failure ever, the majority of them happens in the emergency department and in an inpatient setting. The data shows that, it's very clear, only 12% to 16% of diabetics get their NT-proBNP done or biochemical assessment for heart failure at the primary care setting. Everyone else gets in the emergency department, in the hospital. What that means is, you've already reached the clinical stage. You could have reached it much earlier where it was preventable and the outcome could be very, very different indeed. So I really think I'm a strong supporter of the role of the clinical laboratory and shifting the lab into that clinical interface.

Right. If there's anything ever, this is actually the best market that you want to deal with. The guidelines are clear, interventions are clear. We can measure it, we can do it. It's an opportunity for us to figure out how we encourage education, use the clinical decision support system. We have the specimen in the lab. You might wanna do reflex testing, you might wanna come up with a reflex protocol. You know what? We have all these, they've done glucose, we can add NT-proBNP if there hasn't been any done for the last 12 months or so. So I hope we've given you some hopes and thoughts and ideas and maybe some energy. This is an opportunity really. Thank you very much. Absolutely. Thank you Dr. Hashim.