Penn Presbyterian Medical Center’s Grand Rounds program welcomed Stephen Chrzanowski, MD, the Medical Director of the Ventricular Assist Device Program and Co-Director of the Dyspnea Program at Penn Presbyterian Medical Center. Dr. Chrzanowski discussed the impact of heart failure on society, treatments for heart failure patients, and which of those patients are eligible for a ventricular assist device.
All right, good morning, everyone will give everyone another minute or two to log in before we get started. But for those of you online already, the CMI code is 78125 Again. And we'll make sure it's in the chat box. And as always, if there are any any problems claiming CMI credit, uh you can let myself for linda lafferty know and we can we can help sort it out. Alright. It looks like we've got a pretty good group of folks online now. Welcome and good morning to cardiology. Grand rounds, very excited to have one of our very own faculty members present and speak today. Many of you know dr steve Karnowski who is one of our heart failure doctors here. Steve received his undergrad training in journalism from N. Y. U. And went on to do post graduate studies before in in journalism before moving on to medical school at Jefferson steve Dented his internship residency of Christiana health system in Newark. His cardiology training at university of Connecticut and then ultimately his advanced heart failure l bad training here at the University of pennsylvania steve has been with us for a number of years and I've really gotten to know him over the last what eight years now that I've been here and has really done an amazing job helping to build the heart failure group as well as really taking the lead in my mechanical support steve now serves as the medical director here at penn presbyterian Medical center for the ventricular assist device program and co director for the penn Presbyterian Center for dysthymia. So with that introduction steve, I want to make sure I give you enough time. If folks have any questions, comments, please feel free to leave them in the chat box or in the Q and a box. And and at the end we'll leave hopefully about 10 to 15 minutes um for a Q. And a session with steve. So steve, I'm gonna bow out here and let you take control. Great, thank you. Sameer. Can everybody hear me? Okay? Hear me fine. Samir Yeah. Perfect. So this is the information for the C. M. A. Hopefully you've got all that. So let me let me get started. So um again uh Stevie Janowski, I'm medical director for the valid program and I want to talk to you a little bit about the impact of heart failure on our practice as physicians, cardiologists as well as the impact on society in general um as well as what we can do to help treat that for our sickest patients. And also I'm going to do a couple of case presentations to kind of illustrate um what what elves are all about. Just a couple of things up front. I have no conflicts of interest and also there are a couple of patients I used in the in the presentations uh those patients, I've gotten permission to use their images and their names. They wholeheartedly supported that effort. So let's get started. So the impact of heart feeling the United States is pretty significant. As any of us knows who's rounded in the hospital. There are about 7.8 million adults in the United States with the diagnosis of heart failure. With nearly a million new cases every year. As patients get older, The frequency of heart failure increases so that at the age of 60, about 10% of men and 8% of women have been, have been given that diagnosis In 2018, heart failure accounted for nearly 380,000 as a contributing factor on nearly 380,000 death certificates. In the United States, It accounts for about 8.5% of all heart disease deaths and contributes to about 36% of cardiovascular deaths. Um, the impact financially is significant as well. We spend here in the United States somewhere in the ballpark of $31 billion. That's with a B billion dollars a year. And that's as of 2012, the latest data for which I had, I had a value. And as you can imagine, uh that number has probably increased. Since then, that cost isn't just the cost of hospitalization, but it's also the cost of doctor's visits medications as well as days work, days of work missed. Um, and it's also significant because one out of every 4 to 1 out of every five of those patients whom we see ends up back in the hospital within 30 days here in philadelphia. The impact is significant to, with 100 and 50 deaths per 100,000 citizens being secondary to heart failure And 24 hospitalizations, out of every 1000 hospitalizations being secondary to heart failure. So the impact isn't just in dollars and cents citizen lives, especially for our older patients. So as we see here in this graft from Jack from a few years ago with each hospitalization, you're the likelihood that you're going to live a longer life significantly decreases. To the point where if you have somebody who's an older patient who has been hospitalized three or more times for heart failure, their life expectancy is less than a year. So when we talk about treating heart failure. Um First we start with the basics for patients lifestyle modification. Um as I explained, all my patients lifestyle is the foundation on which the rest of their care is built and you can't build a strong anything on a weak foundation. So all of my patients, when I see them, the first thing we talk about are things like sodium restriction, no more than 2000 mg limiting fluid intake. If there are issues with volume retention, checking daily weights and getting exercises, medications that we're all familiar with using these days, beta blockers which have been around for a long time. Aces and arms which had been cornerstones in treating heart failure until and presto, which is an Arnie, which combination of an angiotensin receptor blocker and never listen inhibitor came along. That's one of the most important medications we're using these days for our younger excuse me for our patients with depressed ejection fractions And the latest tool in our armamentarium SGL- T2 inhibitors which have been proven to help reduce morbidity and mortality in patients with systolic heart failure. For patients with left bundle branch blocks we always consider C. R. T. To help re synchronize but in spite of all the best medications and all the best intentions of the patients and all of our care. So many of these patients do dwindle over time and eventually they end up being new york Heart association Class three Beer Class four heart failure. Um And that's where ventricular assist devices should be should be discussed. So LVads initially were developed over 50 years ago as a short term way of getting patients off of bypass. Um Over time and improvements in technology they have subsequently been used to provide support to patients who are clinically declining and awaiting transplant. So a little bit of L VAD history. The first ad was developed back in 1966 by DR DeBakey. He was able to support a 37 year old woman who had trouble coming off of bypass, she required support for 10 days but eventually it was successfully explain it. That's the even that's the debate. The ventricular assist device there on the right It's an extracorporeal device. Yes for for 22 years and dr bernard implanted the first bad for long term use. This was something that was used to support a patient for a few weeks before transplant. Few years later 1990 for HeartMate uh developed the l vast system of the heart mate X. Ve. Which was used and approved by the FDA for bridge to transplant. And in 2001 um the game the field really changed. That's when the rematch trial concluded that elves were an acceptable alternative for patients who were not considered to be cardiac transplant candidates. Then move forward. Just 21 years later there are over 27,000 VADs implanted with overall two year survival approaching 80%. So as VADs have improved over time they've gotten smaller, stronger and smarter. So all the way on the left there is um is the heart made X. Ve. That's the granddaddy of them all. Um That was a pulse, it'll pump. And basically the way that worked was that metal can. There was um was the actual pump. It was a pneumatic pump. And what would happen is blood would flow passively into that um pump, there was a bladder inside of it, that bladder would fill once it was full. Um The drive line um would basically send a pneumatic charge or a pump air into the can squeeze that bladder inside the can and push blood out up into the ascending aorta and out to the body. Um It provided hope to a lot of patients who really had no hope anymore but it was also big and clunky. It had to sit in a pocket in the abdomen and moved around a lot and um Quite often after a year to 18 months um all those moving parts started to break down and often they needed to be replaced if the patient either didn't pass away or move on to transplant. Um The next generation they're in the middle is the heart made to that was the first continuous flow pump used for for advanced heart failure patients, essentially what that is, is that bell shaped thing in the middle um has basically like a turbine er and uh an ex uh an actual rotor that spins on to ruby ball bearings. What it does is it pulls blood continuously from the left ventricle and pumps it up into into the ascending aorta. And there are plenty of patients around, even from the days when the initial studies were done, um who who are actually still alive with this pump again um sitting on the two ruby ball bearings, it helped decrease blood trauma, in other words, Hamal icis and also sharing of platelets. Um and the batteries were worn on the outside and the controller. That white device there around the patient's waist was worn usually on the belt or tucked in a pocket um Go all the way on the right there and that's the latest iteration that we most commonly use. That's the HeartMate three. The HeartMate three is a centrifugal pump. Um It's implanted in the pericardium. So unlike the other devices, the surgeon doesn't have to make a pocket in the abdomen. Um The device is sewn into the apex of the left ventricle and it has a centrifuge essentially that that spins and pulls blood from the ventricle and pumps it out to the body. Um This is just a closer look at a centrifugal pump. The small device which like I said, is about the size of a golf ball was able to pump about 10 liters of blood per minute. Um It's small and it goes right into the pericardium. And um it has a flexible drive line that can tolerate a lot of wear and tear. The big difference between this device and its predecessors is there's no if you look on the bottom there there is no mechanical contact contact. So that gold disk in the middle is your um centrifuge or the pump. It's uh it's magnetically levitated between uh and spun with those magnets and there are no there are no moving parts that touch, thus reducing blood trauma and and Hamal icis also with this device it varies speed a few times a minute, which helps prevent thrombosis formation in the device. So with improved technologies over the years, we've also seen an improvement in survival. If you look at the bottom there bottom right. The rematch study in 2000 and one optimal medical therapy had a two year survival of 8% and that includes even patients on no or no. Uh As I'll discuss a little bit later, Miller known is something we commonly use for patients but it helps patients, it does not help patients live longer. Just helps them feel better At that time it was considered a big breakthrough because survival at two years was 24%. With the HeartMate pulse it'll that moving forward even just a few years Um with the HeartMate two we see survival improved to more than 50%, in 2009 and further improving up to 68% by 2017. And then just fast forward to the most recent studies looking at the heart made three where survival is 79% and Compare that to just 82% for transplants. So this is certainly something that's coming close to certainly rivaling transplant as far as survival. We expect that to continue to improve as we improve the technology. So the momentum three study, which looked at compared compared the HeartMate to uh To the HeartMate three showed that a lot of categories the HeartMate three, the Centrifugal pump was significantly better. Um There was significantly less pump thrombosis, strokes of any kind and Gi bleeds. So when we talk about who gets a bad not everybody gets a bad, so um it's not quite that simple unfortunately. And there are a lot of patients who we evaluate here at presbyterian who are sent to us for vat who unfortunately don't qualify. But at the same time there are a lot of patients out there a lot of patients who potentially could benefit from this technology who I have not gotten the opportunity. So this slide kind of depicts um where we are with heart failure in the United States today. So overall there close to eight million people with either systolic or diastolic heart failure in the United States adults that is. And of those, About 114,000 have class three B. Or Class four heart failure with an ef of less than 25%. And just again, class three or class, class three B. Or class four. These are patients who are getting short of breath with simple activities like trying to take a shower or brush your teeth or even just short of breath just sitting still Of that group. There are about 62,000 who are considered to be good candidates for Elvis. But of that there is a significant gap in treatment because if you look at it, there are only about 4000 to 5000 patients in plant of the year with Elvis and transplanting might say well what about transplant Transplant is maybe at best about 2000 people a year. So there's a large gap in the treatment. So when we talk about who gets a bed, there are clear indications and contraindications. Um Class three beer class for heart failure in spite of optimal medical therapy is certainly the big one and ef of less than 25% is is another patients who come to us who are in a trope dependent on things such as mill renown or other into tropes bloom pump ECMO or we should probably add to impel a dependent Patients who undergo testing who have a vo two max of less than 14 or an index of 2.2 or less. Also a significant candidates. Also patients who don't qualify for transplants should certainly be considered. And um transplant standards vary somewhat from institution to institution but generally patients older than 65 are generally not considered for transplant if it had cancer within the last five years, uh, immuno therapies to help prevent rejection. Um uh is a is a risk and patients who are heavier with A. B. M. I of greater than 37 also are not considered contraindications. Some of the things that you can probably imagine, but probably one of the most significant ones why that's why I have it highlighted is RV dysfunction. There is no permanent right ventricular assist device. Once the right ventricle goes, there's not a whole lot we can do. So the important thing is to get patients before they get to that point. Um extensive organ dysfunction, particularly the liver kidneys. If patients have developed renal failure that's irreversible or cirrhosis. There's nothing we can do. Same thing with bad peripheral vascular disease, irreparable valvular disease also has a significant limitation. Older patients patients over than 80 although that may change as time goes on. Um And of course there are patients who just don't get it. They don't quite understand what they're getting themselves into or we you know, we think they may not be able to commit to uh the kind of care that their vet needs in order to stay alive. And also of course Conditions that impact two year survival such as advanced cancers or other diseases. So when it comes to selecting patients there are a number of different criteria. I won't go through these all. But um I just highlighted uh in each of them some of the things that we look at. Um and then some of the more common denominators. There, things like low systolic blood pressure, advanced age, uh elevated creatine and elevated B. U. N. Uh These and low sodium. These are all indicators of of poor prognosis and decreased success. So here at uh presby we used the pen Colombia risk score. This basically is a numerical score that helps give us an idea what one year survival will be. Um And uh it's pretty straightforward. It's essentially you you add up the different variables depending depending on on what you see there on the left and a score of less than six uh is a low risk or favorable patients, 6 to 6.7 intermediate risk and over 6.7 our patients, we should have second thoughts about, I don't know. So when it comes to getting event, um it's not a simple process. The patients who come to us are usually discussed. Uh First in our bad meetings that we hold every week, it's a multidisciplinary meeting between physicians, um surgeons as well as physical therapists, social workers, nursing. And we discuss a lot of different things. So, you know, we get input from a lot of different folks. Once we determine, determine that a patient should be evaluated. You know, we get PT and OT involved. They do frailty scoring with our patients to help us determine if the patient is going to be strong enough to take care of their device, social work and palliative care get involved to make sure that they have the proper social support at home. Everybody is involved in the process to help determine if the patient gets it. Do they understand what they're getting themselves into administration helps to help determine if the patient has the proper financial wherewithal to do this and if they don't or if their insurance isn't gonna cover a lot of the costs. We help make sure they get the necessary insurance to do so because it's not just the hospitalization, it's the cost of supplies, the cost of doctor's visits. The costs of medications. Again to psychiatry when needed. We get involved as well as palliative care to see if there are any psychosocial barriers. Given the fact that we're putting a big piece of metal in these patients. Um Oh mFS is always involved to make sure that we have clearance these patients. And of course there are lots of different diagnostic studies, different imaging studies, E. G. D. Colonoscopy to rollout malignancies and also to make sure there aren't any potential bleeding sources. So and again the big question here for us is always does the patient get it. Is it the right thing for the patient? Um Quite often these are patient that that this is often a big stumbling block for us because often these patients can come to us and not quite understand what they're getting themselves into because it hasn't really been discussed with them prior to this. Um But you know we do certainly see hard stops. Um If if they're at the point where there is significant and organ dysfunction or they're unable to commit if there are financial constraints that we just can't get around. Um And often with patients if they're stable enough to go home on mildred own we often will do that to make sure they can handle it. We kind of consider training wheels. If they can go home and handle their mill renown and their medications without difficulty then they probably should be able to handle it that and if we see any hard stops along the way that that usually prompt referral to palliative care and hospice. So let's discuss a case. First cases a patient CF. CF. was a 60 year old man, 69 year old man, excuse me with a history of neuroendocrine tumor and ischemic cardiomyopathy. He had been cared for by one of our cardiologists for some time and Had been noted to Dwindle. Then he came into the hospital back in March 2021 in Cardiogenic shock In the Cath Lab, he was seen to have a cardiac index of 1.1. Um He required Milano therapy as well as further optimization of his medications which got him up to an index at 2.5. Um part of that optimization included as they said, starting him on mill renown and he felt great with that and throughout his hospitalization, as I mentioned also prior to his hospitalization as cardiologists had noted to him that you know, he was dwindling and should think about advanced therapy. But in spite of that the patient deferred work up to the outpatient setting and once he got to the outpatient setting, he continued to defer the work up in spite of the close follow up by his cardiologist as well as our nurse practitioner and heart failure our ends um in spite of those best efforts. Um as we know that the patient continue to delay his work up until he ended up back in the hospital on christmas day last year. At that time he was found again to be in cardiogenic shock. After he suffered a single episode we attempted to go up on the patient's miller known but he started having shocks for VT. So um we had to back down on the mill renown. Um During this time he also we saw by echo that he developed torrential tr moderate ai and severe M. R. Um as well as during his hospitalization, secondary to his heart failure. He started to develop all your renal failure. Um At this point during the hospitalization the patient decided today he and his wife were now all in to move forward with the L. VAD work up. But unfortunately at this point the window of opportunity had closed. He was no longer a candidate due to valvular disease as well as liver and kidney failure as well as I'm sorry. Yes liver and kidney failure. So he eventually was discharged to home on hospice and died two weeks later. So one thing that's important is timing for all that um this is a scoring system um made by inter max inter max is the database that's part of sts that keeps data on all patients who have been implanted since 2000 and five. Um As we can see here it's a scale of one through seven with one being the worst and seven being the best best being class three B heart failure and as you can see with with worsening with worsening class um at the time of presentation the worse the prognosis. So you know our goal is to get patients before they get down to inter max one or two because those are the patients who are going to have the hardest time. Um And again to you know if we can get those patients while they're sick but not too sick. Um The results usually turn out the best and this graph this capital Maya graph showing inter max data exempt exemplifies that. As we can see those patients who were inter max one uh in the bold red line did poorly not just in the beginning when you would expect to have higher mortality but also if you look even extending out it's out past three years before the lines really start to merge between them and the other inter max classes. So there is a significant benefit to getting these patients before they're so sick that that they require um that they require mechanical support who are crashing and burning. So our Montreal and our program is you can certainly never be too early but you can definitely be too late. Unfortunately often we have patients referred to us in the clinic um for consideration for mechanical support when it's a last ditch effort. Um In other words it hasn't really been discussed with the patient prior to this and they're sent to us because the the the referring cardiologists or other referring physician just doesn't know what to do with them anymore. And then when these patients come to see us, sometimes left ventricular assist device have never been discussed in detail. So these patients are shell shocked when you start talking to them about what you're what you're proposing to do, they just shut down. So that's why I think that our practice among our physicians here is that we make sure that we discussed this with patients from early on. Um I try to make sure that I discuss it as part of the continuum of care that may be necessary. But to make sure that it's not a surprise if and when the patient gets to that point. And again, also many of these patients by the time they're sent to us and there's very little else to offer. They've already suffered right ventricular failure or irreversible renal insufficiency or cardiac cirrhosis. So as this article from updates in advanced heart failure from a couple of years states it's quite true. Early referral prior to the onset of end organ dysfunction in human dynamic instability is critical to achieving good outcomes for vat or transplant. It's imperative it really truly is imperative that clinicians collaborate within and between different health systems to make sure that patients with severe heart failure are given all the appropriate options. So let's discuss another case. This is a case of DS, he's a gentleman who ah It was a 68 year old gentleman with a history of longstanding ischemic cardiomyopathy. Uh he had had an ejection fraction is somewhere in the ballpark at 10-20% for some time but actually cooked with it very well until August of 2020. When he presented to us with worsening heart failure symptoms, he underwent a left heart catheterization that revealed no lesions that were intervene herbal and a right heart cath at that time revealed severely elevated pulmonary pressures and um cardiac index. At 1.3 at that time he was started on mill renown Repeat right heart showed that his index, it increased to 2.35 and his pulmonary pressure is also significantly improved. He was discharged home on military known to get stronger but he felt so good on Melbourne on again. He was in that honeymoon period as we called on Milano and then he started to have second thoughts about his getting event. Um He also got received, he also received mixed messages from some of his physicians outside of the health system. He told me he was asked questions like, well why do you want to live an electrical cord coming out of your stomach or if you get this thing you're just going to be a cardiac cripple. Why don't you just wait till you get sicker and this medication doesn't work anymore thankfully. His daughter who is a cardiac nurse here in the health system and his wife were more persuasive He underwent implant in April of last year and discharged 13 days later. Um He's had no readmissions, knock wood and he's spending his time now with his family and friends, going to the shore, hanging out by the pool at his apartment complex and planning his daughter's wedding. So this is that patient with his daughter, her engagement party. And as you can see, um he certainly doesn't look like a cardiac cripple. Uh and he's very happy for what he's done. And he's also been one of our greatest ambassadors in in this last year since he was implanted. So all the best to him. So what we do know is Vans do improve functional status. Um, So patients who are implanted within six months have gone from, on average, going from Class three Beer Class four to Class one or Class two heart failure, meaning no symptoms with activity or very little symptoms only with moderate to significant activity objectively. We've also seen that play out with six minute walk test where patients have significantly improved values and those values have continued throughout greater than two years. Um, and this data is from 10 years ago. So we we see in our patients that that data extends even further now. So also, most importantly, VADs improved quality of life when surveyed about the differences that VADs made in their lives patients who have been surveyed say the difference is that they're able to get back to a normal life, they're able to go to work or go to school, get involved in hobbies have sex, be able to just live as much of a normal life as they could prior to getting sick. So just to show you a little bit of our data here with our program, uh this shows uh satisfaction scores for our patients um during the five year period after implant. And our scores are there in the blue, with the inter max total population in red. And as you can see, there are scores pretty much follow along with those of the inter max patients were hoping to try to further improve those scores by getting patients before they get to inter max one um and thus helping them to transition to a better quality of life sooner. Um A little bit more data from our program. This is our survival curve Since we rebooted the program and restarted it with our current coordinators back in 2020. Um And as you see here are numbers again, also mirror. Inter max is pretty well um to the point where 12 year survival with inter max, excuse me, 12 month survival at inter max during this timeframe, it's about 84% ours is about 86. Um So uh we've we've done a pretty good job, I'd say so far in keeping our patients going And the cases where we've had significant mortality have been in those patients who are inter max one sent to us. Um But again, to the goal is to get those patients before they get that sick. And just a little more data, this is more extensive survival data comparing again our patients uh in the red dash line to sts. And as you see again here, falling pretty close in line and uh five year survival for inter max overall is about 42% for us, It's about 48%. So I think we're doing a fairly decent job. So it's not all roses, there are complications with that. Um and close follow up with these patients uh is one of the best ways to prevent it. That specific complications that we sometimes see are what are called suction events sometimes over time with remodeling the vat can actually change its position a little bit in the ventricle, and it can actually abut the septum uh sometimes when that happens. Um And if the vat draws too much blood from the left ventricle and actually kind of can suck suck onto the septum and uh that you'll have a little bit of a speed drop or an alarm. So usually in those cases we try to make sure that we make any adjustments on medications or make sure the patient has enough volume on board, make sure they're drinking enough when they get a band, they're so used to having advanced heart failure and being told not to drink that it's often a shock for these patients after they get a bed that we tell them no you gotta drink more, you got to drink more, pump thrombosis sometimes can occur in with these devices. These devices are machines and machines can fail. There have been pump failures to um and also drive line damage over time. With wear and tear on the device, Especially with our more active patients, we can see some damage to the drive line that connects the actual pump to the pumps brain which is called controller. That associated complications that we see bleeding stroke. And we're going to talk about these a little bit more shortly, infection which can occur in these patients. Um also right ventricular failure arrhythmias and also aortic insufficiency. So let's talk a little bit about pump pump thrombosis force first. So thrombosis formation. In spite of the fact that patients were on both Coumadin and aspirin, they can still sometimes develop clots. Uh this can result in pump dysfunction, Humala, Asus stroke and even death. This can occur because the patient's iron or maybe some therapeutic. Sometimes other factors such as infection which can affect coagulation, you can do it hyper co global states such as malignancies or inflammation can do it and also atrial fibrillation we've all seen. You know, patients in spite of anti coagulation can sometimes still form clots in a fib Sometimes these patients can present completely asymptomatic lee and we pick it up when we interrogate their devices. Sometimes they have more symptoms of heart failure and in the worst cases they have complete pump dysfunction and even shut down. This is a medical emergency of course. Uh Sometimes this requires Trumbull isis or in the cases of complete shutdown. This often requires uh pump exchange. So this is just a picture, thankfully not of one of our patients but of HeartMate two with clot in it. Um This is in that actual pump, that rotor device you see plenty of clots stuck in there. Top left is in the outflow part of the pump itself. You can see that that the the orifice significantly decreased due to clot that's propagated. And obviously from these pictures this was a pump that was either exchanged or the patient passed bleeding, another big complication that can be seen again as we said, patients are on um two forms of anti coagulation with both aspirin and Coumadin. Um but bleeding can happen a lot of different places along the pump itself As well as mucosal surfaces. Um G gi bleeds according to interfax data affect 15-30% of all bad patients. There are a couple of factors that go into causing this one is the fact that patients develop a qualitative platelet deficiency because often with these pumps. Um the von will brand factor which sits on the outside of the platelet can be sheared off uh thus making the platelets less effective. Along with that the lack of pulse pressure seen with a continuous flow device can cause the formation of arterial arterial venous malformations especially in the gut. So um bleeding of events are usually most severe and older patients in this case. Often if we do see bleeding in the earlier phase, that's usually secondary to um hepatic congestion, often secondary to write part failure. But that's usually something that we can be unmasked with. You know once the right ventricle which has maybe been used to seeing just three or four liters of blood per minute is suddenly seeing 10 liters per minute. So again that's why it's important to make sure that right ventricle is healthy when patients come to us a lot of different ways to treat bleeding when we see it. We can give packed red blood cells F. F. P. But that can sometimes be a lot of volume. Um We can also give pro throbbing complex concentrates altria type can sometimes also be given as well as von will a brand concentrates where desmond crescent. Sometimes we often uh sometimes we can also give vitamin K. But we use that pretty sparingly because that can also cause a complete reversal of anti coagulation and pump thrombosis. So these are a couple of pictures of places where bleeding can occur on the right, that's a hemorrhagic stroke um that occurred in a patient on the left there this is clips in one of our patients who had had a G. I bleed. When patients come in with anemia or evidence of Melania. Um Usually the first thing we do when we have G. I see them is uh we we will do an E. G. D. First because most bleeds occur in the upper G. I. Tract If we don't see anything on E. G. D. Um colonoscopy is the next step. And if colonoscopy doesn't show anything we'll do a capsule study. Um And of course when it comes to these patients anybody who presents with a new neurologic symptom or a really bad headache they get a head C. T. Right away infection. As we said infection also can be significant in these patients, rates of infection have approached 42% according to inter max and first year post implant. And with most of these events happening within the first few months it's the third most common cause of death and bad patients especially within the first year. Um Dr line of pump pocket are the most common places for these infections to occur With about 80% of driveline infections occurring within the 1st 30 days according to interfax. Um Remember the exit site the drive line exit site is an entry site for bacteria. So that's why we stress the patients that it's crucial to make sure that that site is well cared for uh and kept clean. Um these infections if they're allowed to track back and track back from just a simple cellulitis around the drive line site back to a catastrophic, catastrophic event. If it gets back to the pump pocket or the parent guardian and bad patients, especially in the early phase during their hospitalization can also get other infections such as pneumonias C. Diff U. T. I. S. Those are not uncommon with the most common causes later on being secondary to the drive line. So this is what a drive line should look like. So the drive line, as I said, is an electrical cord that um connects the vat to the VADs brain called the controller as well as its power supply. Um The vat, the drive line site where it goes in is covered by an antibiotic impregnated disk. It's then covered up with an inclusive dressing that has two parts to it to make sure that it is completely sealed off from the outside world. And then that thing, that hourglass thing all the way on the left is an anchor that the patient puts on the abdomen. And basically what that does is that prevents any kind of tugging or pulling on the drive line site. That could cause a trauma such as if the patient drops the controller. Um But as I said, one of the big things before any of our patients goes home, our coordinators make sure that they know how and their caregivers know how to do a sterile dressing change. This is considered a sterile site. So dressing changes are done with masks on and sterile gloves um And the area is always clean well and like I said they don't go home until they prove that they can do it. So that's what a good drive line looks like. That's what a bad drive line looks like. So this is a patient. Again this is um a patient from a study, not one of our patients but from an article that shows what happens when that infection can track back along the drive line. Um Not too hard to imagine this patient did not do well. So again just to compare some of our data compared to inter max just showing adverse events since our Reboot of Our Program in April of 2020. Um we've done pretty well are bleeding events. Uh gi bleeds here have been less than that of inter max device malfunctioning pump pump thrombosis. Also significantly less re hospitalizations for any cause we're we're doing better than air max there. And the one event that we did have where we're doing a little worse is neurologic dysfunction. We did have one patient who suffered a stroke but because of the numbers that one patient was enough to uh bump us up over the inter max. Uh the inter max number with at just 14.3% for us. So um and the other thing that we're pretty proud of here is because of the work of our physicians and most importantly our heart failure nurses and our bad coordinators especially. We've been able to significantly improve our 30 day readmission rate over these last The last number of months and well yeah from 2020 on through September 2021 um inter max's readmission rate 30 day readmission rates somewhere around 24% ours now 4.9%. So that is a great credit to our team. So what does the future hold for Vans? Um As we've seen technology has significantly improved over the last few decades and um as we continue to study these devices and to see what they can do for our patients. We hope that the technology continues to improve. Um Transport a Gnaeus power supply is pretty much the one of the Holy Grails of VADs. If we can find a system where everything is internalized like it is with I. C. D. S. Or pacemakers then I think that that's really going to change the playing field for patients. I'm not an electrical engineer nor would I pretend to be. But um you know what I know is there are studies out there that are being ongoing looking to see if there are systems that can work kind of like this system that's that's being studied Um that was published in the journal of heart and lung transplant three years ago this study looked at basically uh what's called the three D. System which basically the patient is able to wear a vest that has a battery on it. It has a conductor coil which in turn uh transmits energy to the vat itself which has a receptor coil. And by that the patient is able to um able to walk around without any drive line. Again, technology is not perfect with this. Again, from what I understand the amount of power that's really truly needed to supply of AD which is about seven watts uh is more that can be transmitted through the skin. The issue with that being that there's damage to the skin trying to transmit that much energy across. Uh And also if you try to have a battery inside an internal battery it would generate. It would either have to be so big or generate so much heat that would also cause um trauma. Other research that's going on is looking at smaller vans and even perk you attain hisley implanted van. This is a study also that's been done in vitro and also has been done in a pig model. Looking at this perky attain hisley implanted device. Um This is a device that as you can see there is smaller than a triple A battery and also as per Catania slee powered. If I remember correctly, I think the studies showed that this device was uh it was work, it was able to work and patients were supported for the matter for a matter of um a few hours I think up to three hours in the pig model. Um So but research here is ongoing. But again um they're these articles from a couple of years ago. There haven't been much in my lit search in the in the very recent future and the very recent literature other devices. So for patients who are awaiting transplant um there's there's the seine cardia total artificial heart. Um This device has been approved for patients um inter max one or two and staged a heart failure who are awaiting transplants. Um This is this pump basically mimics the human heart with four chambers and four valves. Um There's uh like as I said these are for patients awaiting transplant but the one advantage to this pump is it's also been able to uh give life to patients with conditions such as hypertrophic cardiomyopathy, or infiltrated cardiomyopathy such as amyloidosis or hemochromatosis. Or even in patients awaiting transplants who had right ventricular failure with a bad. So You know, we talked about rematch in 2001. You know, we wonder if if 2001 is coming all over again with Sinn Cardia at this point. Um Their their device is just for a bridge to transplant but there is research right now or the there's a clinical trial looking at this as destination therapy for patients who do not qualify for transplant. So who knows we might be talking about a total artificial heart. But again the technology here we're going back to the XV. Technology with this thing is again a pneumatic pump. So one more case study uh This is our patients see D. Um C. D. is a gentleman who at the time when I met him was 28 years old. Um He was referred to me by his uncle who was also a patient of mine and he said that his his nephew had been treated a number of times for pneumonia and just hadn't been getting better. Um And he had gone into the hospital one time for one of these pneumonia flares and An Echo showed that his ejection fraction was about 10% with a severely dilated LV. Um Unfortunately his insurance didn't cover transplant covered pretty much everything else but so he was sent to us. He was in cardiogenic shock at the time and was placed on an impeller. Um After about a week or so on in Pella we eventually were able to um excuse me not an impeller. He was on ECMO I apologize after about a week or so we were finally able to get him to the O. R. And as you can see from the other pictures that's him pre op and the left and all the other pictures is him post op along with his fiancee. And as you can see he's not just living he's thriving and as you can see from the pictures all the way on the right. His family is also growing and uh this is him along with his fiancee and their one year old daughter Logan at the time coming to visit us. Um don't worry, we just had the masks off for a second. Um but um The patient is he's a wonderful guy. As you see, this is a post from his instagram page and he goes under the tag life with a device he has about 1000 followers around the world right now. And the the amazing thing about this young guy who is now 31 is that he has given back so much to folks. He uh constantly posts uh different things about just inspirational stuff. Plus he's in contact with bad patients around the world, helping to helping give them advice on on different things about life with a bad not to mention just practical things like drive line changes and things along those lines. So he has given back significantly to the population and him and his family are why we do this. So the takeaway That's in general have significantly improved survival and end stage heart failure patients with now over 27,000 patients having been implanted patients who had just Months or days to live now have years, the longest living patient out there right now is 18 years post op and doing well very well um from another institution Here at Penn Presby. We have patients who are approaching the 10 year mark with their vets. Now keep in mind The mean transplant survival is 10 years. So it's it's a it's a pretty strong rival to transplant. Short and long term success depends on early referral. I cannot say that, I cannot emphasize that enough. Short and long term success depends on early referral for these patients crashing and burning patients do not do well. Um either in the short term or quite often. Unfortunately in the long term. Uh and L VADs are not without their complications, bleeding infection clotting are are seen. They're comin in some patients but they're not inevitable, especially with close care. And again, arrhythmias and right ventricular failure also can be complications, but not as much if we get these patients early and get them treated before they start to decline. So if you've got a patient who you're thinking about or you want to see if there's somebody who we should be talking, you know, bad with. This is our team. Um part of the team. Not everybody, as I said, we are a multidisciplinary team but there's myself, our other four heart failure surgeons are wonderful coordinators, Melissa Mcginn and Dottie thomas. We have our bad hotline for our patients and of course our surgeon who came on board with us a couple of months ago. Mike Ibrahim who has been a wonderful addition to our team. So with that I will say thank you and open it up to questions. Thanks. What a great talk and a great summary from mechanical assist devices. I really really appreciate it. Um He's done a great job building the program and presbyterian, the quality it speaks for itself that's for sure. Um Somebody asked a question about bleeding and the question was someone's got a bat in have an interest liberal hemorrhage, how do you handle that? Mhm. Um um Well of course so it's a stat consult to neurology and neurosurgery um in those cases often we will go ahead and reverse any coagulation if needed. Um But you know the most important thing is you know I'm certainly not a neurologist or neurosurgeon but the most important thing is to get those patients over to those folks as soon as possible thankfully I could say that we have not had um we have not had a a significant bleed like that. We have had one patient who had a fall and had an intracranial hemorrhage um subdural hematoma and was treated by neurosurgery. Um uh and and has done well but yeah the most important thing is getting that patient triage and and seen by the proper proper specialists as quickly as possible. Thanks steve. Um It's one question here is can you deal with a suction event by turning down um turning around the company at least temporarily. Yeah well you know usually so you know seeing suction events. Yeah I mean what what we'll do is if a patient is having recurrent suction events will decrease the speed. If if in spite of doing all the other things uh to help take care of that things like making sure the patient is is getting enough volume on board. Like I said, one of the big things that we see with our patients is they are so used to being fluid deprived with heart failure that once they get a bad and we tell them they need to drink more, they they're they're so hard wired to not drink that we really have to push them to do it. But yeah, sometimes dropping the bad speed a little bit. We'll do it often. What we do with these patients in such cases. If it's recurrent is we'll do an echo for to optimize them basically. You know, we'll make adjustments on the speed and look at things like whether or not there's any aortic insufficiency. Any mitral insufficiency with the, with the size of the LVs with either a speed drop or speed increase. And that will help us determine to, you know, get them get them set at the optimal speed. Thanks steve the question. Very important question is how do we prevent unconscious discrimination with social, we have social selection. I mean with social selection criteria, et cetera. And I know that probably big issue just in terms of disparities and insurance in different populations. A complex question but important, any thoughts steve it really, truly is. Um, and it is something that we, we do concern ourselves with. Um, it's it's a challenge, I mean, and that's why one of the things that um, uh, we've, we've tried to do and has been um, one of the big efforts with our administrator. I'm sorry, I didn't mention in our, our folks that's our clinical team, that one of the other extremely important additions to our team is Jane slater Beck, who's our administrator and jane has made a phenomenal effort over this time helping make sure that we have folks who do a thorough job in our financial vetting of these patients. Um, and making sure that if patients don't have the proper support, that we've helped figure out how to get them that, I mean, there is a, you're absolutely right. There is a challenge in that in some communities getting the proper care or having the proper support is difficult and um, but we, we try to do our best to, to, to, to get around that to try to scale that. And again, that's where our social work program and our palliative care folks also come in another couple questions here. What do we do to educate and help improve inside of the patients? And the other part of that question is the same person, what's the oldest age criteria? Is the oldest patient we have or what's the, is there any age cut off. Yeah. Right now we kind of have an age cut off of 80, but um you know, if you came to us with an 80 year old patient who you know, had been a marathon runner, but you know, just recently had a big m I you know, we might still consider it, but we have We've had patients as young as I think our youngest was 23 or 24. Um and our oldest was 79. So you know, we kind of span that range. Um you know, we we pretty much are what we consider destination therapy center. So we see the majority of patients whom we see our patients who are not transplant candidates. Um The other part was just educating what what kind of stuff can we do to help educate patients? I see a patient in the office and I think they're readable bad candidate, but they're hesitant. I'm not sure they want to talk to you about it. We have some literature and we have some person to person connection they can talk about it with. Well, yes, we do a few different things. We we try to, you know, we we we talk to our patients about it, like I said introducing it as early in the conversation as possible and folks with bad systolic heart failure is key. Um you know, making sure that they understand what we're talking about. We don't sugarcoat any of it when it comes to you know exactly what that is like. Um you know, but we also tell them that you know, this is going to make the difference between you feeling the way you do now and you being able to do the things you used to do. Um What we we have a number of patients who are wonderful ambassadors for us who we put patients in touch here, put potential candidates in touch with to talk to them to ask them, you know, what's life like with the device. Um and um you know, we we we try to make sure, like I said, we we make sure that they buy the kind of questions they asked by the support that they bring with them to their visits. You know, that kind of helps us get a feel for how well they understand. Um And our coordinators dottie and Melissa play a really significant role in this. Um you know, they are you know, they they along along with the physicians in some ways they probably have more contact well especially with the existing patients. They have more contact than than we the physicians do. But you know, they're very much involved in the evaluation process as well, steve another question here. Many heart failure patients struggle with depression. Does the depression improve after an L VOD do we have psych support after the implant for these patients? Um Yeah, if if they need psychiatric support, we do our best to help get them get them hooked up with the right folks, we do have a couple of patients who are battling with anxiety and depression and we do help them. Uh, and um, it's it's something that we do see uh, improved along with quality of life. Um, you know, once patients start to see that they're able to do more, but I mean, they're they're, you know, VADs are, you know, it still brings, you know, a degree of anxiety and, you know, we have resources for our patients if they need them or we can direct them to the proper resources. Thanks steve. I just we're almost out of time, but I have one question. I just curious for your thoughts. You know, it sounds like as you brought up that sometimes there's a choice between transplant and vat and it really is a choice for the patient. Mm hmm. Given transplant is not the easiest to achieve number one. Number two. It's also got life altering changes in terms of immunosuppressive therapy, etcetera, etcetera. I just wonder how often does that kind of a discussion come up with transplant versus vat? And how do you handle that? Um, with the patients in that discussion? Oh, sure. You know, Well, transplant is still considered the gold standard and whenever possible, we do refer patients to transplant. Uh, that is the option for either, like I said, patients who don't qualify for transplant or for those who don't want transplant. Um, you know when it comes to that discussion with patients um You know one of the things that that I do I tell them that you know I said you know transplant is not like dropping a new engine in your car. It comes you know both of these both of these solutions come with a lot of issues you know with with transplant you know it comes you know at first weekly doctor's visits and biopsies and immune suppression and being worried about infection. Um and other complications can come along with the medications and you know explain to them with the complications or that that the you know the want to see chores but the responsibilities of owning a that are too. So I kind of you know I just in those patients who you know are are trying to decide. I just you know I try to present the facts but I make sure that they understand that you know neither way is going to be a better roses but you know it's gonna it's gonna provide you know a new life. Well our time is up here steve what what a wonderful talk in summary and exciting new developments, impressive outcomes with bads and long survival and certainly good quality of life. Thanks for all your hard work in the program and thanks for a great grand rounds and thank everybody for coming and attending look forward to seeing in future grand rounds and have a have a wonderful day. Everybody thanks a lot. Everybody get them to us early. Thank you linda for helping to organize all this. Hi everybody.
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