Dr. Ajay V. Srivastava reviews options for device therapy in treating heart failure, including remote monitoring, as well as additional virtual care options now available to clinicians and patients.
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and I now have the opportunity to induce our next speaker, which is Doctor Shrivastava. So my partner now for the five years that I've been here um he is uh you know, trained initially on the East Coast at uh well initially michigan and then at Yale and then subsequently did his um heart failure and transplant fellowship at Stanford and joined the faculty here at scripts after he completed his training. There has been an incredible asset to our program. Uh and you know, an incredible partner working together to help grow our heart failure program. He's particularly interested and involved in uh population based health. And so has taken on a new role within the script system um as a leader for the heart failure approach across the script system, which is exciting for all of us. Um And additionally has a particular interest in um temporary and acute cardiogenic shock and acute mechanical circulatory support. So as the director of our ECMO and in temporary circulatory support program. Um and it's really kind of revamped our program here at scripts um and help consolidate our team. So we now have a very great sort of code ECMO team, particularly over the course of this last year with with Covid. And the amount of ECMO that we were utilizing here, um that type of structure in the program was vital to really make sure the hospital stayed up and running for the sickest of the sick patients. So Um to that end, he will be talking about device therapy and selection for heart failure in 20-21. Thanks raj and thanks everyone. Thanks again for taking time this weekend to be with us and uh Exchange ideas on care of heart failure and diseases surrounding heart failure care. What I'd like to do probably the next 20 minutes or so. It's just give you an overview on the different devices we have in our toolbox for our patients with heart failure and maybe touched a little bit upon where we see sort of remote monitoring or virtual care for the care of the heart failure patients. Um um Both in this year as well as in the immediate future, here is my disclosure. And so you know I think one of the problems with heart failure and getting patients to therapies and programs uh in terms of the right time of referral is it's not as clear cut as cardiac electrophysiology or coronary artery disease. Whether patient clearly has chest pain or they have troponin, they have an M. I. And then on the ep said you have an arrhythmia that's obviously an E. K. G. Or picked up on a monitor monitor heart failure. I mean yes we have ejection fraction but that is only a small piece of this puzzle. Um um and irrespective of ejection fraction, the symptom that's really what guides um When these patients get referred or should be referred up front. I think waiting looking for a certain metric um such as only if the ejection fractions under 35 or significant RV failure or admitted to the hospital in shock. I mean those are very end stage sort of um late in the disease process I think best more than terms of quality for patients as well as overall outcomes and costs. It's better to identify and refer these patients upstream or even get therapies on board, not just about reference and the symptoms are vague. I mean this slide shows you broadly as we all know right patients with heart failure at times that you know something Vegas okay I have some difficulty breathing. What is more obvious is when they have clear evidence of volume overload and then um as dr Rasmussen mentioned in her talk, the delivery of care for the heart failure patients is extremely diverse across the system and region we're in. Um patients could be followed by general internists, family medicine programs, um general cardiology programs. So it's sort of like Having our radar up and you know, teasing out, okay, this is a 65 75 year old patient with three other medical problems and they have these vague symptoms. Is it heart failure related or not? And at times it's hard to tease out from a lab or an echocardiogram. And we as heart failure specialists or heart failure clinics, not just specialist in sort of somebody didn't need an L. VAD or a heart transplant, but we can do some of this triaging and assessment work. You know, whether it be at the right heart catheterization being an exercise test and figuring out is this heart failure related, what percentage of the symptoms the heart failure related and how best we can help? Um um and this slide shows really, you know, the five year outcomes in patients with heart failure is pretty much the same EF preserved. No F. Or reduce CF. So it kind of goes to the same point of ejection fraction is one metric. It's an easy measure we can get with a bedside echocardiogram but truly in terms of outcomes, it's just overall substrate of the patient with heart failure that concomitant diseases that we have to sort of treat for better outcomes and not just be focused on ejection fraction. The graph on the left shows, you know, the dark red or pink bar shows the overall life expectancy in the United States and Any demographic and age group over 65. Once you factor in heart failure, whether it's reduced ef, mid range E. F, preserved ef, you can see the dramatic decrease in expectancy compared to the average life expectancy. And no matter what the F is, it's not that different across groups once a patient gets labeled with heart failure. Um And I really our goal is to keep these patients out of the hospital, there's something bad about hospital admissions. I mean, each admission adds to their mortality, uh and maybe admissions itself as a marker of a sicker patient, but also, you know, picking up infections, uh, frailty weakness for each day spent in the hospital carries bad measure. So ultimately, our goals with all these devices or therapies or medications, we want to keep the patient out of the hospital. We like to prolong their life and get patients a better quality of life. Um This is a broad algorithm for the heart failure with reduced ejection fraction. I thought I'd show this quick overview slide before I actually get into some of these devices. So I think we're all familiar With dividing management of heart failure patients based on their ejection fraction. If under 35 we get them on medications, It used to be uh S individuals, A R. Bs and beta blockers and things have changed. I mean, we are fortunate. Um the last 3 to 5 years we've had additional therapies that really make a huge difference to a patient's life in keeping them out of the hospital and translating into mortality as well. And your attention naturally seen receptor inhibition is one. Um Thank you, betrayal, val Certain has made a huge difference. And then we have um uh if Aberdeen which has been shown in patients with reduced CF, by lowering their heart rate, were able to achieve keep them out of the hospital. Um that's for evaporating. And then now we have sgmd to our sodium glucose transport inhibitors have also been shown irrespective of their diabetic status to make a huge difference for patients uh in achieving you bulimia. Um keeping them out of the hospital for heart failure and then overall mortality. So it's it's it's a great time to be in heart failure, not just on devices and transplants, but just what seems simple medications. But we have so much work to do again. You know, as mentioned that heart failure registry, we still, you know, we're getting patients on therapies. Uh we could do a lot better and maximizing their doses. We could do a lot better in the use of security drill, val satin. With the last analysis. Only about 14% of patients who qualify for it up front are getting it. Um I think copays are getting better. Insurance coverage is getting better so we should keep trying to get this um therapies as a baseline for all our patients with reduced LV function. The way I look at preserved ejection fraction for clinical management I start with usually volume because that's the biggest driver of symptoms, morbidity and mortality in this cohort. Its volume volume volume and then hama assessing volume. Okay physical exam is good but not perfect. Um Start their BNP is useful and then using we've trained our eco lab and a stenographers to get limited echo protocol focused on him. Oh dynamics. Which involves assessing right sided filling pressures. By looking at um ari systolic pressure p. A pressure size of the I. V. C. And left sided filling pressures. By looking at the left atrial filling pressures by looking at the mitral inflow. We start there. If it's still unclear then we proceed to a swan Ganz catheterization. And in some cases the echocardiogram is good but it's obviously not as granular as a right heart cat. And if we'd like to know what the true wedges um from the venus hypertension opening arterial hypertension then we're going to proceed with the swan Ganz catheterization. All focused on getting to the bottom of their volume status and thermodynamics. And broadly. Excuse me in terms of how I look at these patients then in terms of clinical management. Okay so I've done the echo or how the right heart cat. I figured out what they're loading conditions are. Can I direct them to you bulimia and if I'm having trouble or this is a tenuous patient or a patient's little far away, who can't make it every other week for me to check on their volume status. Then it's basically I think about cardio memes or pulmonary artery sensor technology and implantable little chip that I'm going to share a few slides on. Um to manage these patients into atrial shunt. Doctor Mahan just talked about for unloading the left atrium and then the myocardial itself. Is this a mid range pf patient reduced G. F. Or preserved CF patient? Any reason I need to suspect cardiac amyloid increasing prevalence. We don't need tissue diagnosis anymore. We can do it non invasively uh by getting a technician para phosphate scan to look for the white Type amyloid. If we suspect L. Type amyloid, the one where the LV function is reduced. They usually need light change plus an end of myocardial biopsy and then arrhythmias and valve disease. The structural heart space has changed a lot just like our medications and heart failure and is changing. So there's a lot of opportunity for our patients to benefit without having to undergo open heart surgery. And then while we're all focused on these individual sort of therapies, at times we need this heart failure disease management clinic for a lot of these patients like this, a program where um someone takes ownership and sort of quarterbacks this entire operation in terms of taking care of these patients. So here's a slide and and some devices I'm going to touch on a given time constraints. I want to limit to these four devices which and that's based on their technology, their utility, their clinical relevance and need across the heart failure population. Let me first start with the primary artery center center. And as of now there's one, there's one made by Abbott called cardio Memes. There are other technologies in the pipeline and other companies as well. So this should be a space with more innovation. What this entails is a chip that's about the size of a quarter that's placed in the distal primary artery with night, no loops that hold on the chip in place, there is no battery required, No anti coagulation required beyond the 1st 30 days and this chip or the device lasts forever. What it does, it has an impedance transmitter that can capture the Parliament artery wave forms and the patients at home laying on a pillow and sending a transmission. And we can see exactly what the P. A diastolic ps systolic pressures are And use the p. a diastolic as a surrogate for the wedge. And we do that calibration during the time of the right heart catheterization and implanting this trip takes about 20 minutes more um uh to a standard right heart cat. And from patient viewpoint, it works great because it's way more objective than a weighing scale. They're at home, it's a one time procedure. They lay on a pillow, they're able to transmit. They need to come into clinic lists. And more importantly, it also drives not just a diuretic therapy, but overall overall heart failure, medical therapy. This is the original Champion trial published in 2016, showing compared to standard of care, a significant reduction in heart failure, hospitalizations. And this was achieved by reduction in their mean ph pressures over time. And you can see timing is crucial. It takes a few months to start making that difference. He more dynamically. So not waiting for the patient to be too thick um is key for getting the most benefit out of a device like this in keeping them out of the hospital and just day to day improvement in quality of care and symptoms. This was a post approval study looking at heart failure related hospitalizations and all cause hospitalizations which was surprising to many because essentially this is a chip that drives down ph pressures and diuretics by use of diuretics but it shows that just having eyes on the patient and driving therapy overall you do achieve an overall impact on their hospital um admissions. Um cardiac re synchronization therapy. Most are familiar with this data comes from the championship and um I'm sorry from the companion and carry HF trial uh way back in early 2000 and across the boat in a patient with white left bundle branch block um and reduced ejection fraction getting by ventricular pacing really helps these patients out. But what I really want to focus on is once the patients get a CRT, The job is only half done following these patients over time. Especially in that 6-9-month period. Put implantation, seeing where is this patient going? Is this somebody who's responding? Social responding, not responding or declining further? And and we took this graph and created a clinic called uh with the BP and heart failure Multidisciplinary CRJ clinic. We bring the patient back about 4 to 6 months after implant. Get an echocardiogram. Get very focused dimensions to the CRT. Do what it was supposed are intended to do. Reduction in LV size reduction, michael renegotiation, better filling pressures from an echocardiogram viewpoint. And then we look at their E. P. Diagnostics and then clinically as a patient feeling better or not. We get a six minute walk test. Get some basic labs, get a quality of life questionnaire and then if we feel that there is room for optimization, medications or devices then we proceed to do that and sort of lay out this graph for every patient. We do this clinic about once in three months. We had to cut back because of covid but should be restarting this um next month again. Yeah. Um perky genius valve therapies. I wanted to touch on the micro clip or trans catheter mitral valve repair. What the sentences basically. Um This clip which is a little clasping device that brings the leaflets together both in degenerative primary valve disease as well as uh functional M. R. Patients. Um And what this graph shows you once patients have more than moderate mitral regurgitation and it's not just severe. M. Are even a little up three moderate M. Are these patients have both effects on their negative effects on their outcomes. And ultimately what we're trying to do is break this vicious cycle and once they have him oh dynamically significant mar it increases left atrial filling pressures. Probably venus hypertension, atrium is stretched, this a fib and then they're going multiple abrasions without fixing the cause of high L. A pressures. And and this is where something like this is extremely useful in the heart failure patient with significant mitral valve radio station. This is data from the co op trial showing both uh in terms of mortality as well as heart failure hospitalizations. The graph on the right is super impressive how early the curves separate right away. You're reducing heart failure related hospitalizations. But you see the graph graph on the left, it takes about six months for the mortality curve to separate. So if you think the patient has less than six months of life, they probably need a vat or a transplant, advanced heart failure therapies. But if this patient's been identified more upstream, then they could benefit from something such as a micro clip allowing that L. V. And L. A. To remodel. And this graph shows you once you click the mitral valve, what you get a significant reduction in L. A. Pressure has shown pre and post procedure. Um And my last device, I want to touch one as the left ventricular assist device. And this basically involves in a severely reduced LV function. Despite medical therapy, the patient is failing clinically and manifesting signs of now. Primary hypertension, right sided weakness and usually by the time they have RV failure, that patient is too far gone. We want to identify this patient before we want to identify before their kidneys are failing before the liver is failing. So E. F usually around 25 ish percent and why it's a three symptoms um continues to have volume issues are very narrow therapeutic window. You do a little diuretic change the kidney created and bumps up they go out and eat, you know, just a good restaurant meal for one meal and then they're off balance. So those are patients that probably it's time to think about a bad or a transplant. Um, given how genuine and how narrow their window is The the pump or technology used most commonly in the United States and across the globe. Now the hot made three um, l've at uh and this was, you know, a new England journal paper in 2018 showing compared to the prior generation of pumps. The blue is the current generation where we can see a significant improvement, both the freedom from stroke as well as um, event free survival compared to the prior generation of pumps. And we have seen this in our program as well where patients have had excellent outcomes compared to the prior generation of left ventricular assist devices. You know, this is a busy slide from the national inter max registry which puts together data from all patients who have undergone L VAD implantation. And just to focus on a couple of points over here, the use of L babs has continued to increase year over year. Uh were able to identify patients who otherwise did not benefit from heart failure therapies such as certain races, Hispanics, african americans. So we're making progress over there and increasing awareness and getting patients with therapies. Um And and you know on the left bottom you see increasing destination therapy. So with the change in Eunice listing a lot of patients are able to go directly to transplant with temporary mechanical support. But even if they're not candidates for heart transplantation, L've abs are a mainstay in the treatment of heart failure. Giving patients 5 to 10 years of life When it used to be 6-12 months with the first generation of L. VADs One year and two year survival have come along very nicely. Um the two year survival is almost 85 um across um Most patients right now and the freedom from stroke and stroke incident has come down as well. Um this is the data showing overtime period 22 2010-2014. And in the last five years at every uh your post implantation outcomes are better than what they used to be. And we're continuing to make progress in the care of these patients as well as selection as well as special device technology. My last slide is really on this. Where are we going with what you will care and what do we think, what will care for the heart failure patient will look like? You know I mean some of this is pre and post covid but I also think about it is just time and space where we are currently, you know the traditional model of heart failure delivery used to be primarily you know doing a lot of stuff inpatient, some established heart failure programs as inter mountain and you know scrape stand for the larger programs and um but 70 of heart failure care is delivered in the community and that was just like a very standard clinic. What we see is evolving to this model and the right where we're going to have inpatient are really our goal is to keep patients at home. So having the right tools and technology and not just one such What you such as Chile medicine or remote patient monitoring. I think this whole virtual care space is really going to evolve in the next 5 to 10 years and there's going to be different technologies that go just beyond sort of weight and blood pressure in keeping patients at home and improving their experience and and making it um not like um um just in patients day and a clinic stay, I think it's gonna be very different and I think as much as we talk about it, we fully don't understand where this is going to end up in a few years. But I certainly do think we're gonna have a very different model and a very at home. Virtual multidisciplinary model, multipronged approach, model devices, technology, all of it will be very different but an exciting time to be in heart failure Nevertheless, to be part of how we translate care going forward for this population, um I am going to stop here and thank you so much for your time. And this was you know Dr Rasmussen share this slide earlier. We really truly believe that there's a lot of work we can do for the launch general care of these patients. And this is really what we want to focus on, keep the patient in the center and and really do what's right for the patient. Thank you.
