 On behalf of the McLean Center for Clinical Medical Ethics, I'm delighted to welcome you to today's lecture in our year-long series on ethical issues and end-of-life care. Today's talk, as you know, is the first talk of the spring quarter. Next Wednesday, on April 8th, Dr. Diane Meyer from New York will speak on improving quality reduces costs, ethical aspects of care for the seriously ill. Today it's my pleasure to introduce our speaker, Dr. Savitri Fetsen. Dr. Fetsen is an associate professor of medicine. She's a cardiologist who specializes in heart failure and heart transplantation. Savi is part of a team of medical and surgical specialists who provide a full range of treatment options, including LVADs, to improve heart pumping ability in patients with heart failure. If transplantation is required, Dr. Fetsen cares for such patients before and after the transplant to ensure the best outcome. Dr. Fetsen is actively researching comparisons between invasive and non-invasive hemodynamic measurements and heart failure prevention. Dr. Fetsen received her MD from the University of Virginia before completing residencies here at the University of Chicago and at Cook County Hospital and a cardiology fellowship at the University of Chicago. Dr. Fetsen also completed an ethics fellowship at the McLean Center in 2008 and 2009. Today Dr. Fetsen will speak to us on the topic ethical issues in discontinuing LVADs. Please join me in giving a warm welcome to Savitri Fetsen. Thank you, Mark. Thank you all for coming. It's a pleasure to be here as part of this symposium this year and end of life care. I hope to to enlighten you a little bit not only on how to perhaps die with mechanical circulatory support but also the indications for MCS as it may be something not all of you are familiar with. I do not have any disclosures. I will be discussing one of my cases off-label use of ventricular assist devices and as Mark has mentioned I am a transplant and that cardiologist so I guess that is fundamentally at least an influence not a conflict but an influence what I'm going to talk about. So as MCS is really not something which is discussed really much outside the realm of advanced heart failure I'm going to bring people up to speed just to permit me a little bit of history for MCS and indications for MCS to put things in a proper frame of reference. This is just a brief slide of the history of circulatory support, mechanical circulatory support is now about 60 years old. If you go back to the original cardiopulmonary bypass in 1953 I think many people of course are familiar with Louis Wachinowski who was the first transplant recipient in 1967. What people are less familiar with was that was also the same year MCS was used as a bridge to transplant. So even though it's something that really has only come to the fore and come to be part of mainstream medicine perhaps the last 10 years again 40 plus years ago it was it was first used and tried. The biggest thing in which really has influenced the development of mechanical circulatory support so MCS was really in 1964 when the NIH really started its artificial heart program. Now when we think about MCS these are all of the durable LVAD so I'm going to use MCS and LVAD. MCS is mechanical circulatory support LVAD is left ventricular assist device I will use them somewhat interchangeably although they are not. What we are really talking about or what I'm going to be talking about today is durable LVAD. So LVADs are designed to last for a long period of time to go home with the patient and these are really the devices sort of on the bottom half of the slides. So these are devices which really have only been in play about 20 years which is why the field of discussion about how to approach patients with LVADs how to talk about turning things off or on is really in its infancy comparative to other fields certainly in medical ethics and surgical ethics. Now who needs an LVAD so it's a big question probably a billion dollar question to put things in perspective there about four five to six billion people in the U.S. with heart failure. Heart failure of all types whether it's reduced ejection fraction or preserved ejection fraction I count for about 40 billion dollars of health care expenditure a year. Heart failure is a leading DRG for the Medicare population as far as hospitalizations. If you take all of those people with heart failure those who have reduced of ejection heart failure is about 50% of those and about 400,000 of those so a relatively small percentage are people who are going to be stage DRG failure. So those people in whom we would think about advanced options such as mechanical circulatory support transplant or also equally as acceptable palliative care and other means or hospice care. So it's about 400,000 people a year who would be eligible for us to consider these types of therapies. Why is this important I'm sorry that's a little bit blurry this is a cartoon which has been published in a variety of forms looking at the trajectory of heart failure and unlike other conditions which are terminal conditions as advanced heart failure what you have is a clinical course which could be steady and then you start having these undulations and decrease in care. So what we try and do for advanced heart failure is intervene at some point there and break the sort of downward cycle and the repetitive ebbs and flows of symptoms and we could either think about transplant where we restore some degree of normalcy. Mechanical support here continuous inotropes or other forms of strict palliation or MCS with complications. So of course I'm talking here about mechanical circulatory support and MCS with complications. Those are the people in whom of course we're talking about today. What are the indications for now that just to put things in perspective so you know what the type of people we're talking about when we're talking about stopping a therapy who could have actually been able to get a therapy. These are class four heart failure patients who have been unresponsive to optimal medical therapy for at least this is the CMS I should say this is the CMS definition of what they'll pay for. These are the guidelines we use clinically. So unresponsive to medical therapy for at least two out of the last three months people who have decreased ejection fraction less than 25 percent. Functional limitation lesson. This is based on a cardiopulmonary stress test of less than 12 mils per kilo per minute or who are inotrop dependent. So chronic to butamine or miller known therapy and have an appropriate body size. These devices are big. So a very small person is not suitable for many of these devices that have been out there newer ones are coming just strictly because we can't wedge it all in the same thoracic space. They could be implanted either as destination therapy meaning that this is the one option we have for them. Their LVAD will be their therapy. We have no plans to change it out for transplant down the road. We have no plans for other therapy. This is this is the ultimate the end of the road for them as far as what we could offer them aggressively. So that's DT. There is bridge to transplantation BTT where our ultimate goal would be to support someone long enough with these devices to ultimately give them an organ when an organ became available. There is in later gray bridge to consideration which is not a clear indication but which is something we practice all the time where we aren't quite sure what's going to happen to the patient. So we're going to bridge them to something and we may bridge them to transplant or they may end up being a destination therapy candidate if things change or if things don't pan out as we hope and then in much much less frequently about 1% of the time, 2% of the time, we could put these in as a bridge to recovery where someone's heart function will recover after an acute illness, acute stunning and we're able to explant these patients. I'm not including these in this group of patients because that happens so infrequently and it's not really the bulk of what MCS care is about. So the terminology I'll use are DT or BTT. Again, I'm really talking about DT destination therapy patients here. And then there are the types of alvads that we have to think about. And I'm specifying alvads because alvads are really where most of the research has been, most of the implants are really to support the left ventricle. We can infrequently support the right ventricle in an isolated form but it really is the alvad world that all of this has grown up in. And there are durable alvads. So these are alvads that we expect a great deal of longevity. We expect years of life, years of normal functioning with them. People, we expect them to be ambulatory. We expect them to be at home. The other type would be a temporary alvad. People can be ambulatory with these. They tend to be in hospital and they're meant for short term periods of support. So there are two types of MCS or alvads that we have to keep into consideration. Just to give you a visual of what these are because many of you may not be familiar with what they are. On the left side of the slide are the two examples of some temporary alvads I could be. And the top one is the tandem heart. This is put in in the cath lab with this because of the way in which it's positioned. Patients are obligatorily bed bound for this. So clearly this would be a non-ambulatory support. The bottom one even though it's a very large platform is Centromag which can be put in in the cath lab or surgically. People can ambulate with these. I mean you're ambulating with a huge console but people can walk with these devices. They're designed to be short term. Weeks to maybe a few months at most if you push the envelope. On the right side of the slide are conventional vads that we think about. This is the heart mate too. And this is the heart wear HVAD. They're two different types of devices. These are the most common ones that are now implanted. They're newer ones certainly down the pipeline and in trials. And they are smaller compared to the older LVADs. And that becomes important when we talk about some of the sparse data out there about beliefs and opinions about turning off all that. The year of life support can be lengthy. The longest person with a heart mate to LVAD right now is going on nine years of supportive therapy at home. So a very good duration of longevity of good quality of life. Longer battery lives. Batteries can keep people out of the house for up to 12 hours. So it does really restore good quality of life. Such is a little bit briefly to bring everyone up to at least some level of speed about LVADs when we talk about turning them off or how to die with an LVAD in place. The other thing to realize is when we talk about putting in LVADs there's something called the InterMax score. The InterMax is a registry, interagency registry for mechanical assisted circulatory support. It is in some ways a voluntary registry but most centers that implant LVADs participate in it. And it's a way that we as a VAD community are tracking the appropriate time to put in VADs with patients. And so you will see when we talk about patients what level of shock they are. Realizing that the best of these patients which is an InterMax seven are the New York Heart Association 3B. These are people who get breathless with fairly minimal exertion. So if you take that as the best of the possibilities in this InterMax score, we go there to progressively worse. Where if you look at let's say InterMax four, their frequent firemaning route current readmissions and we expect their survival to be weeks to months. So that we expect their survival of unless we intervened to be in the order of months. They would certainly we would expect them to be dead by a year and if you go back to the original rematch data which I'm not which I'm not showing you looking at the difference between the first generation of durable LVADs and optimal medical therapy at one year you had 25% survival in the medical management arm at two years you had 8% survival at two years. So medical therapy in these groups of patients 8% survival at two years worse than most solid tumors. So this is the group of people we're talking about. If we look at the people who are InterMax 3, 2 and 1 progressively we expect them to live days weeks or even hours before we intervene. So generally speaking talking about a very sick population that we're trying to support. Now with an LVAD you get the good. And LVADs have have an opportunity unlike many aggressive therapies which are instituted when people are critically ill and I don't really want to use the word end of life because if we did not do something for these heart failure patients it would be the end of life. However because of an LVAD and what we're able to do we could actually restore life in a manner of speaking so that we can give people a longevity without addressing their underlying heart disease. But we could give them longevity and restore and perhaps sort of blind ourselves to the fact that underlying still do have severe heart failure. So LVADs do give a good quality of life. These are data that were published looking at the real world data of LVAD implants. So taking away the trials and the perfect clinical situation of someone calling you to make sure everything's following up. But if you look at the the real-life data of LVAD implants this is quality of life data that were published in 2010. And if you look at it on the top you have green is good. So progressively as you have longer implantation you have more people going to a New York Heart Association class one. Essentially asymptomatic with normal exertion where previously they had all been near a Heart Association class four. So we can improve their functional quality of life. Over here you have six minute walk distance. So people can actually walk the equivalent increase of three lengths of a football field with all that therapy. So it's a meaningful quality and restoration of life. And I just want to have the caveat that these are all implants so people are implanted as a bridge to transplant as as destination. Fewer than or roughly 50% of those who are implanted as a bridge are actually ultimately transplanted. So while it is it is certainly our intent there are many people who we implant as bridge you become by default or become a sort of by criteria destination candidates. So this is the good. You have the bad. So with bad that with LVADs there can be anticipated complications. We absolutely know that there are anticipated complications that will happen with an LVAD. Those are bleeding very commonly they could be and it could be fairly debilitating. You can imagine an intracranial bleed is fairly debilitating. GI bleeding can be profound can be repetitive can be exhaustive for the patients and for our GI colleagues who have to help us manage them. Epistaxis people can have profound epistaxis which is difficult to call NGU bleeding. So bleeding we know can happen. You could have thrombosis of an LVAD. You could have homolysis of an LVAD. You could get infections you could get driveline infections all of these devices have some component where you cross the skin. There's a barrier across the skin so that you have some portal of entry into the patient's body from the external world and then you could have a current heart failure symptoms. So we know that these will happen. How frequently will they happen? If you look at the on the top with the line plot here these are months after discharge and reasons for hospitalizations. And you could and this is the scale is a little off. It's readmissions per patient. So if you add it all up together there are a number of missions per patients but people are readmitted for psychosocial reasons for cardiac diseases for infections and for non-cardiac comorbidities the greatest of those is GI bleeding. If you look at the bar plot on the bottom it shows you the 30% of the readmissions are for this is cardiac 30% are for bleeding. This is not a benign treatment we're giving people. Follow by 20% for infection. So we know that these these complications are going to happen and it's more more than on the order of 1 to 2 percent. This is you know a third of patients will have these complications upfront we know them. So when we talk about MCS we have to talk about who's going to get them. So how do we think about it? First of all not everyone has accessibility to VAD centers. There's a huge part in the West if you take Montana, Idaho those those regions where you don't have VAD centers. It's hard to get an LVAD if you live in those. You talk about some places in the south their pockets where it's hard to get an LVAD. So not everyone of the 400,000 patients has equal accessibility to an LVAD center. Absolutely. That goes the same with transplant centers. So people who are going to be implanted as an LVAD perhaps is it because they just don't have access to a transplant center perhaps if we had equal access to all transplant centers that might be a more appropriate therapy. So certainly in the selection process of who gets an LVAD there is some inequity. What about age? How old is too old to get an LVAD? How young is too young to get an LVAD? Because interestingly some complications such as infection are greater in the younger population than the older population. So if you look at who might benefit more it's sort of a toss up. So what is the right age? There is a certain amount actually a great deal of patient VAD interaction that has to take place. Unlike many other devices and many other therapies that we offer to patients the patient has to be directly involved with care of their VAD on a day-to-day basis. You cannot forget that you have an LVAD. I think it probably would be easy to forget that you have a pacemaker. It may be less easy to forget that you have an ICD if you've ever had a shock. But if you've never had a shock you could probably forget that you have an ICD. You can't forget you have an LVAD. So there's a lot of interaction that you have to have. There's a lot of cognitive awareness that you have to have in order to take care and do self-care in your LVAD therapy. So mental age, developmental delay become important. How about comorbidities? Cancer? What type of cancer? Chronic infections, HIV, hep C, now curable, hep B? Renal failure. Renal failure is interesting because there are many centers who will not consider a destination VAD in someone who is on dialysis. So in and of itself that's an exclusion of many centers. So again, we exclude people upfront saying that they don't meet the criteria for appropriate therapies within all that. And then you talk about who can best use a pump? Who best tolerates a pump? Men tolerate it differently than women. Women tend to have more intercranial beliefs than men do. Is this something we need to go when we talk about who should have a pump? And so ultimately we're really allowing patients to survive from their cardiac disease which otherwise would have killed them to then start experiencing our other disabilities. We are setting them up to not feel good in some ways while restoring their life because they could get arthritis, they could have progression of their cancer. All of these things have to be taken in consideration. But how much do we need to have it in there when we talk about implantation of VAD? So I could overwhelm a patient and scare a patient to death, no pun intended, talking about an LVAD and how bad I could make them and not focus on how good I could make them. Now if we look at survival, again what I mentioned earlier was the rematch trial here and this is the 8% to your survival. LVADs really let people live a long time and if you take the modern day era of VADs and in a real life population you now have, you've taken mortality from 92% mortality to a 30% mortality at two years, meaning 70% survival of two years after LVAD implant. We are giving these patients a good chance at a good quality of life. What makes MCS unique though when we talk about advanced and aggressive end of life care or options for terminal heart failure? We talk about consent, you know, autonomy of personhood and agency is really the underpinning of consent when we try and get informed consent. Heart failure is fraught with difficulty right off the bat because heart failure imposes on people a certain amount of cognitive impairment. Cognitive impairment predominantly based on work done by one of our nurse practitioners here in the executive functioning and visual spatial domains. So the ability to sort of executively track things make decisions. Awareness of one's own limitation is impaired in heart failure and also visual spatial. So you could imagine connecting a battery to a drive line. That type of that type of coordination is impaired more preferentially in heart failure than other types of executive functioning. So how can we accurately inform our patients up front of the rest they're going to have later? I mean, all procedures are have some inherent flaw in this, but I think heart failure does have a little bit different. And we're trying to set them up to exchange one set of medical problems that of breathlessness, that of fatigue, that of orthopnea, VT for another set of problems. A patient did describe it as life with a toaster. How do you tell someone what life with a toaster is going to be like? It's amazing how many people you discover really love swimming when you start talking about vats because it's the one thing that they can't really do. And there are a number of people out there who that's the only exercise they ever like to do and now you're telling them they can't do it once they get a durable LVAD. Now the implantation of vats is often urgent and life saving. Someone comes in and intermax one where they have days, two weeks to live. They're crashing and burning. We're going to have to put in an LVAD to save their life. You don't have time to have all these discussions. And normally when we think about intervening in the setting of acute medical illness like that, we're talking about intervening on things where if we decide to discontinue the ramifications are very different. So if you intubate someone for mechanical ventilation, that's fairly benign compared to the process of sending someone to the operating room for an LVAD. If you think about putting in a catheter for dialysis, again, fairly benign in the setting of putting someone either in the cath lab for a catheter-based LVAD or to an operating room. So the scale of intervention that we're proposing is very, very different. I would say though because we do have the ability to put some of the temporary MCS in the cath lab, that changes a little bit. So we can't send someone to the cath lab and put them on a center mag, put them on ECMO even in the cath lab without having to do open heart surgery. So we're able to get people to very aggressive therapies in a less aggressive way, I should say. So it may equate or equalize the balance someone, but then you're dealing with a surrogate. And most patients and family members certainly are not familiar with LVAD technology. Very few physicians talk about it unless you're an advanced heart failure physician. So there's not a lot of general understanding of what life is like with the VAD, how things work, the pros and cons of having an LVAD in that setting. And the implications of durable LVAD technology for the patient is more complex because of the direct interaction. So having primary consent in this case is crucial. I will not advocate for putting in a durable LVAD meaning a long-term LVAD and a patient unless that patient tells me they want it because I don't care what their surrogate says, that surrogate isn't going to have to live with the toaster and have to do all the manipulations themselves. So having primary consent is absolutely crucial for an LVAD and we often don't have the ability to do it upfront. And there have been a number of papers written about this. The Baylor Group actually does a lot of work in LVAD, the ethics group at Baylor does a lot of work in LVAD decision making. And there's a lot of increased awareness about the necessity of primary consent because the patients then change their mind or make up their mind having never given it in the first place months after the device has been implanted. So should we just say yes? Should we just say yes? You know, someone's crashing let's put them in. So with LVADs as DT it's non-curative. We are not changing their underlying pathology. We are masking it. We are making it unnecessary. We are taking over the heart function. We are giving them five liters of flow which is certainly enough to sustain everything. So should we just say we're going to do this? It's interesting. A lot of the studies looking at decision making at end of leg care and heart failure have really looked at the time tradeoff and looking at quality of life. And for many heart failure patients and this is work that's really been beautifully done by Eldren Lewis at the Brigham looking at decisions about quality of life. And because in LVAD necessarily changes your day-to-day life it can improve your quality of life tremendously. But for a certain period of time after you have an LVAD you can't take a shower. We encourage bathing but you can't take a shower. You can't sit in a hot tub. You can't go swimming. Aside from that you could pretty much do everything we encourage normal life. But certainly it does affect your activities of day-to-day living. The other thing which I sort of hesitate to say but truly as a when we think about it as a community of LVAD doctors we do have to think about the economic implications of it. There are countries in which destination therapy LVADs are not offered because of the economic consequences of destination therapy for LVADs. If we think about necessitating primary consent for durable LVAD therapy we're talking about putting in a temporary device letting the patient wake up clear their sensorium have a conversation then implanting them with a destination therapy the hospital get reimbursed for one LVAD and you've given them two. So it's a huge economic consideration to consider. I think it's worth it to make sure that we make the right choice for the patient. But these are all of the considerations that have to have to go into the discussion of who actually gets an LVAD. And LVADs are palliative care. They're an aggressive incredibly expensive costly burdensome form of palliative care but they are a wonderful palliative care and I love this phrase which was published out of Britain actually in 2007 which is it could improve the short wretched lives of people and it absolutely can but it also has great potential for complications. It places great stress on caregivers and support. Up to 25% of caregivers report PTSD associated with LVADs. So it's the support network that is involved is incredibly burdensome for family members and I don't think even when a surrogate is making trying to make decisions they're aware of the burden to themselves that they will incur with that. And it's I mean it's interesting it's this is a article now I guess four years ago from the New York Times looking at you know when is it appropriate to tell people to stop? You know they were doing this in the context of dialysis but when it comes to an economic burden to society and to an individual family these are very important decisions. So futility. So if we're talking about how to die with an LVAD or MCS. Futility often comes up. At what point is something futile? Advanced technologies are absolutely appropriate and justified when there's clinical benefit. But what happens when this changes? What happens when there's no longer clinical benefit? And in the setting of LVAD what criteria means that there's no clinical benefit? Remember it restores symptoms it prolongs life. It does not cure the underlying disease. They still have heart failure. They may still even have VT. They may even have VF and be walking around in VF with an LVAD. That absolutely happens. So we are not taking away their disease at all. And we all I think would agree that when care is futile we don't need to continue it. But if the futility is not related to the pump but other things else patients may not be able to die. We can keep their heart going. Heart going as long as we have an electrical power source to it. So how do you how do you navigate that pathway? And there is I think a consensus I would hope that therapies that prolong life but do not reverse the medical conditions can be withdrawn. And there's very good moral and ethical groundwork case law to support those decisions. We certainly do that with human dialysis. We do it with mechanical ventilation. We even do it with insulin and diabetics when it becomes burdensome to check their glucose. But when should we talk about it? That becomes part of the case or the discussion of this. When should we talk about these things? Jim Kirkpatrick and he was here as a cardiology fellow. We did a study together and Jim has now gone on and he works very closely with the Ethics Group at Penn and has written on deactivation of devices and cardiac patients. He's a cardiologist. He's an echocardiographer. But we did a study in patients in our own CCU here and we compared it to the oncology floor because oncology is really where we think a lot about advanced directives and there's been certainly a historic network and organization to talk about end-of-life care, palliative care, hospice care. We're behind in cardiology and so we looked at our own group of patients in the CCU and amazingly the vast majority of them in the green wanted more information about palliative care and advanced care. Very few patients said no, I don't want to hear about it and I'm sort of embarrassed to say that some of these patients were heart transplant patients who had already faced death once and apparently we had neglected to talk to them about it. People had already had VF and VT, they'd already died and they'd been brought back and we still hadn't brought up advanced care directives with them. So in cardiology at least eight years ago we'd not been doing a very good job but comparing it to the hemong floor here against same institutions, same period of time, it was interesting because it was absolutely the opposite on the hemong floor. People didn't want to know more. People didn't want to discuss the mortality. So certainly in cardiology there is this need for patients who I think are aware of this, of the aspect of the fact that, you know, heart failure is a terminal disease. They wanted more discussion about it. So how does it approach them? So this is an example of patients' experience of turning up cardiac devices and this is just, this is again a pacemaker or defibrillator. Something which you don't have to interact with every day. You don't have to change a battery, you don't have to change a dressing, it's in you. And I think the accepted practice now is if someone is getting paced and they're end of life, we will keep it on if it's sort of more for palliative, for entering comfort care or palliative care, we may keep it on because it's not burdensome. If people get shocks, that could be burdensome. We'll turn off therapies from a defibrillator, for example. But if you ask patients what they, or how they feel about it, this was, I mean, a small study, 15 outpatients. Two had had the device for greater than a year had never gotten a shock. Eight had had it for greater than a year. It had gotten a shock. And five had had it less than a year and had never gotten a shock. So you have, you know, seven patients who had never gotten a shock, eight patients who had gotten a shock. Appropriate shock, meaning it saved their life. It brought them back from sudden cardiac death. None had ever discussed the activation of the ICD as a possibility, either time of implant or anything else. And they, the vast majority felt that turning off therapies, even if they'd never gotten one, was an act of suicide. So their own experience of how to turn off a device, which is essentially there as an insurance policy, was similar to committing an act of suicide. So patients feel very, have very strong views about turning off device therapies. I mean, this is, again, a very small study, but this is, this has been replicated in other studies. But within all that, it's support, but it's restoring the quality of life. This is a quote from one of our patients who when I first met pre-Elvad, I walked into his room and he said, you are here to bring life into my happiness and I'm here to bring happiness into your life. And he has done that. And he's had, he has had an Elvad now and he's, was admitted numerous times with GI bleeding and has had complications of having to have a pump exchanged. I mean, he's not had, he's at the typical course of problems. But this is his attitude about, you know, I want to live and he is with an Elvad. They're restorative. But what do we do about it? And turning off an Elvad is different than turning off a defibrillator. It's different than turning off a pacemaker. Turning off an Elvad often results in imminent death. And there, there have been a number of papers out there talking about what it means and it really actually, the European and the American views are actually quite dissimilar in this respect and that many, many more of our European colleagues actually think of turning off an Elvad perhaps more as either euthanasia or physician assisted death as opposed to an act where the primary tension is not death but the primary tension is to stop what is now a futile therapy. So there's very discussion and there are people here who have been involved in turning off an Elvad who still have flashbacks were they trying to figure out did they kill someone by turning off an Elvad? Because when it's, it's a very direct or it can be a very direct event similar for example to withdrawing mechanical ventilation on someone who is vent-dependent. I mean we in medicine certainly do things all the time which we know the next series of actions will lead to the patient expiring of whatever their underlying disease is. That has to be remembered with an Elvad. They are dying of their underlying heart disease. They aren't dying because we turned the Elvad off. They're dying because their EF was 5% to begin with and I haven't made it better. But what do we know about it? What do we know about how patients feel? So this is a paper actually Dan Solmezzi was part of about five years ago. They're actually interestingly they've only been about three or four papers looking at the opinions about turning off an Elvad. And so this was a this was a group of patients that were implanted at the Mayo Clinic and it was a 2003 to 2009 so just be where it's both the older and the newer generations of devices. The older generations of devices were bulkier had less incidence of bleeding but were more in some ways some of them were noisier. You could actually hear them in here. So you would be aware of the sound of it and they also had a much shorter duration of time. The older devices for example might only last two years not seven to nine years routinely expect these days. And in this group of patients there were 26 who died 14 had surrogates or they themselves and those are the two highlighted requested the device be turned off. And if you look at what caused them to request this it's really not the VAD the VAD was functioning but it's hemorrhage which we know happens multi-system organ failure and it didn't specify whether it was progressive renal failure liver failure respiratory failure any combination of the above. Cardiac arrest CHFs progressive heart failure absolutely this is someone and the cardiac rest of the people who actually were able to say for themselves they wanted to have a VAD turned off cancer multi-system organ failure. So these are the things that prompted patients to say let's turn the LVAD off. In a slightly more contemporary study this is a study out of Utah there are 92 destination VADs and 69 patients. You do the math but clearly some patients had more than one VAD. And these are again patients who were actually implanted as part of the original destination trial. So the XV and the Novakor these are larger bulkier pumps these are pumps that did not have a long duration. For example the heart made XV routinely would start having mechanical failure at about 18 months. So these are devices we knew up front were not going to last a long period of time. And this is a study that asked three questions of caregivers or patients. Was there an event or a series of events that prompted the decision to discuss withdrawal? How was that discussion reached and was there sufficient support for the family? So this is really looking at the caregiver support and burden of these. Twenty of these patients actively engaged or their surrogates actively engaged in the end of life decision. Interestingly the mean age was 67 but clearly with the 23 old in there you had young people in there so maybe people who had cancers who were put in the who had a DT VAD let's say for age or mice and related cardiomyopathy. So not just an elderly population certainly a young population. They had the VAD for a period of time you know that had the VAD for over two years the mean duration of support of these 20 patients most died at home some died in the hospital 17 of them turned the device off only three of them turned the device off after they became unconscious. So they allowed if they had a CNS bleed for example they would allow the CNS bleed to progress till unconsciousness and then they would decide to deactivate. What were the events that prompted the discussion about termination of care turning off the LVAD? Again what we would expect infection sepsis driveline infection leading to bacteremia strokes cancer renal failure and impending pump failure and the decision to discontinue from the decision made to the time or discussion begun to the time of discontinuation was between one and 14 days. So it happened very quickly so these are events that happened really at the end of life and had not been done beforehand. So the question comes of when the indication changes when we put in a VAD and the indication for which we put it in changes when do we start talking about how to turn it off? So if you are implanted as a bridge to transplant and now you are no longer a transplant candidate is that sufficient to say it's appropriate now to talk about discontinuing the LVAD? If it was implanted to you as a bridge to transplant you are not a transplant candidate let's say you've had it for five years and your cancer has recurred. We typically wait five years after solid tumors before thinking about transplant. Is that sufficient to say it's appropriate to say let's withdraw care or because it's it restores life and is such a good palliative care agent is ongoing endeavor for quality of life and as long as there's quality of life we should say no, no, no let's persist and let's forge forward. It's variable in LVAD. There's not a right or wrong answer but it would certainly be you could certainly have a rational person say I'm not a transplant candidate five years of my LVAD I'm not a transplant candidate. I will never be I don't want it anymore. A rational person could make that decision and the goal of the indication has changed and it is ultimately a form of palliative care in that event. So these are decisions that have to be addressed with patients. So when is it appropriate to discontinue or to discuss discontinuation? Especially because turning off an LVAD could make you worse. Turning off an ICD therapy will not make you worse. Most people don't feel better with an ICD turning it off does not make them feel worse. Turning off an LVAD could make you worse because leaving a turned off LVAD which there is a power switch on off button you could turn it off with an accidental flip of a switch or deliberate flip of a switch but turning it off you can have regurgitation through the LVAD you can make someone's heart failure worse. You can have thrombosis and embolization of an LVAD. You could have interference with intrinsic cardiac contractility so if the ordered valve actually opens it may interfere with the ability to eject the ordered valve may not open and saying let's expand if you don't want your LVAD let's expand it. Am I going to subject someone to a huge operation to take out a device? So turning off an LVAD is not without harm. It can make you worse. So it does introduce a new pathology into the setting of the pathophysiology of chronic heart failure. So consider this this is a patient we had on our service this last year. 20 year old man with an inherited cardiomyopathy since childhood he came to us for options with VT and he was in shock. He had biventricular failure. He had pulmonary hypertension profound catechia and frailty. When I first met him he could not lift his head off the bed unless he physically picked it up with his his hand pulled his hair and looked pulled his head off the bed. His mother had died on a temporary LVAD and he was not a transplant candidate because of his frailty and his pulmonary hypertension and medical comorbidities. So after about six weeks of trying to improve nutrition and get him to a point where he was up walking around with physical therapy. He did improve his physical sort of protoplasm. He underwent an LVAD implantation as a bridge to transplant. Months later one month later still in the ICU. And he now required a temporary RVAD because of human dynamic instability went into basically incest in BT. In the interim he had had bowel surgery because he'd had a schema gut he had an x-lap. No nothing resected but an x-lap unable to close the fascia because of bowel edema. He had a tracheostomy for respiratory failure. He was on CVVH because of renal failure. Two weeks after this we put an RVAD in. So he's now got biventricular support versus supporting his heart. He's an incessant or intermittent VT. Doesn't matter the VAD doesn't care. He's in renal failure still in CVVH. Respiratory failure he's trached intermittently requiring positive pressure ventilation and he has essentially gut failure. He was intolerant of two feeds because of every time we tried to feed him he would develop an ileus because of the metabolic burden of trying to digest food by his gut. So he was on TPM. He was interactive. He was mouthing words. He was speaking when he had his passemure valve in. He was appropriate. Psyche was seeing him to help with sort of his adjustment I think also to help with everyone else's adjustment and it was difficult I think for everyone taking care of this patient to go in the room to see him. Because he was being kept he was sustaining and he was appropriate initially very very appropriate and aware of things and terrified and scared and wanting to continue with what he was doing. He was a 20 year old young man. But he had no end. There's no end to him. He's got by that support he's traked he's on continuous CVVVH. There's no place for him to go ever outside an ICU. So what do you do? And he eventually started having continued also mental status and it was clear he was you could argue it was clear a month ago that he was dying but it was clear that he was dying. So we had a discussion with his father who is his his decision maker to withdraw care and the question came up how to do it with someone who is on so much support physiologic support and the father wanted to be home when his son died. He didn't want to be there he'd spent enough time to bet that he did not want to be there when his son died. So the decision was made to turn off all possible alarms and change the the device over from sort of direct current to battery and to let the batteries run out. That would take about 10 hours. So that happened the father left the room and then shortly after that the batteries in the drive line were discontinued and he died within minutes. The father was still in the parking lot when his son died. So the question comes how do you stop and all that? What's the best pardon? I'll go into that offline. The question is the best way to stop and all that you could silence the alarms and I hope to get an audio of it that the alarms are alarms so you are not designed to sleep through. Okay. These are alarms that are designed to wake you up wake up the neighbors keep you alive right. These are alarms that are life-saving so you can't silence them forever. You could silence some of them but ultimately when you go to the low battery alarms those batteries will those alarms will keep on going so you cannot continue to silence these alarms so if you decide to silence alarms and switch to batteries at some point 10 hours down the road you're going to have alarms so they're going to be pretty loud pretty obnoxious and really not conducive to a peaceful calm passing into this you know the good silent night right or should you just turn off the power immediately disconnect disconnect battery and drive line what's the best way to do it? Patients will eventually succumb to their heart failure minutes, hours sometimes days sometimes you turn it off and people manage to live four or five days without an LVAD without power without anticoagulation with nothing there's no there's no programmatic set of I'm going to turn you off and you're going to die within minutes so what's the best way to think about it? So that's why I think we need preventative ethics I think vows are really a beautiful field where you really have to start talking about it early because of all of these the nuances that are involved in taking care of these patients and what complications and what comorbidities might prompt this whether or not it's cancer and that CDA is pain just inconvenience refer patients early now the CMS mandated in October of last year that we have palliative care involvement pre LVAD implantation which is great and Charles Rhee is now our sort of palliative care cardiologist which is lovely for us and it's really important when we think about when do we put in an LVAD? just to end up with a poem this is a Carl Sandberg you know good Chicagoan poem which I think is speaks to this in some ways I'm glad God saw death and gave death the job of taking care of all of us who are tired of living when all the wheels in a clock are worn and slow and the connections loose and the clock goes on ticking and telling the wrong time from hour to hour and people around the house joke about what a bum clock it is how glad the clock is when the big junk van drives his wagon up to the house and puts his arm around the clock and says you don't belong here you got to come along with me how glad the clock is then when it feels the arms of the junk man close around it and carry it away and this is just a our team the LVAD team and a heart failure team there's a lot of people who do this and a lot of people who are involved in trying to make thoughtful decisions about both when to put in a VAD and then importantly sometimes when to stop a VAD thank you let's play for the children similarities between hemodialysis and renal failure and here and use of LVADs Mike there's many things I could ask about but my question is related to whether there's for lack of a better way of expressing it a hierarchy of decisions and thinking about the last patient you presented you could have turned off the vent you could have stopped the CDVHD so why was turning off the LVAD the decision that was made and then the second part of my question is is deciding to use an LVAD whether it's a bridge to transplant or destination therapy is that level of commitment then commit you to other life sustaining therapies such as hemodialysis or putting someone on a ventilator so the first question it's we could have and I think on him I mean at that point he was on trach collar he didn't need mechanical support so that's would already had the trach you can't you could plug it CVVH you know and we certainly do stop CVVH the question is I think came down to one of time and the question is if you stop CVVH again people can tolerate not being on dialysis for a number of days if not longer especially with no sort of muscle mass and I think the concern at that point with him was that the VAD being on was just prolonging things and it was a question of if we stop the VAD we knew that he would die and if we didn't ultimately the problem is with CVVH you stop doing it you go into VT you get some volume overload the VT doesn't matter because of the LVAD so if he goes into a cardiac arrhythmia it doesn't matter and the volume overload it would have taken him longer from a respiratory standpoint so that by not turning off the VAD by stopping those other things we would have possibly made him worse if that makes sense I mean we certainly try and do lesser aggressive actions first if someone's on pressers and a temporary LVAD will stop the pressers first things like that now with respect to how much does it commit us for other therapies it's a great question and we tend to be a little bit more aggressive here about we will consider LVADs and people who are on renal replacement therapy if they're a bridge to transplant for example I think in some ways there are some patients we know we're going to end up on temporary dialysis and we're willing to have a discussion with patients about yes the likelihood of renal failure is this it may or may not recover are you willing to accept that risk or not I think it's also reasonable to have a discussion with patients saying you know if this happens you may end up on renal replacement therapy and there's no place that is by your house whoever it is that's going to take you with an LVAD on dialysis and we're going to be left with the decision I don't think it obligates you to do that generally in sort of the immediate period operative period we will accept a lot of risk upfront it's the question is how long you continue them and that's a tough one because I mean as you know renal failure can take six months to recover but it can recover I rely on your crystal ball to help us with that it's healthy sorry I missed the beginning but so I don't know if you covered this but it seems like there's not a lot of good outcome data on what happens to people in LVAD it's like what's what's the expected oh so did you show yeah 70% two years and probably now about 65% five year survival I mean there is associated morbidity and you know we current hospitalizations for heart failure erotic insufficiency we're still trying to figure out how best to manage people with a VAD but it can be a good quality longevity with the newer devices right and and part of the consent for getting the VAD you don't discuss turning it off that's not part of the procedure I mean at all we are so Charles is now involved in all of her patients pre-implant we have tried to address it before not formally when I discuss implant and I try especially after the date I shared with Jim's study in the CCU about how abysmal we were doing about talking about even turning off ICDs I try whenever I I talk to a patient about an implant saying we could make the decision at some point to turn it off and whether or not you tell me it's more important that you tell whoever's going to be making your decisions when to turn it off so that you know people have an intracranial bleed that's probably the easiest one to say if you have an intracranial bleed and you're going to be vegetative would you want to turn it off in that situation it's hard to come up with all the nuances of of the complications because there's people who can have 10 GI bleeds in the first year and then after the first year or something miraculously happens and they never have another GI bleed so it's tough to try and you know figure out upfront what's going to make them do it it's important to make them aware of these are complications that you're going to have and at some point if the complications become too burdensome we could talk about turning it off and just making it an open discussion I don't know if Charles wants to comment actually I did following up on that just to comment you know we're just starting up the involvement of palliative care in kind of pre-implantation evaluations and one of the issues is really dealing with preparedness planning you know the problem is question is how far do you push it like we have actually really good relationship with the entire team here but at various conferences I hear something more contentious relationships between the different groups in terms of even addressing those issues you know there's the old fear that you know that oncologists had for a long time that you know oh the palliative care physician is going to convince them not to get the procedure or something and so you know that is always been kind of an issue we have to work around and work with the various teams you want some level of preparedness planning again that's also time dependent you know when you have the intermax ones coming in crashing and burning you don't really have time to address all of these potential scenarios and you know talk about options like discontinuation that's why Savi had brought up the the you know the point about putting in a temporary device with the hope that it will improve their mental status to the point that you can actually have a more meaningful conversation of the implications of a more durable device but these are still all issues that are we're we're learning to just follow up on Shull's point what percent of new LVADs are put in at the with the decision of being made by Surrogate rather than by the primers I don't think 25% fewer I don't think we have data on that as far as durable LVADs certainly you know the ability to put in a temporary LVAD I would say 80% of those are probably made by Surrogate for the crash and burns maybe a little high I mean there's certainly case case published cases out there of a surrogate making the decision to put in a temporary device and then switch over even after two weeks to a durable device and then a patient two months later saying turn it off so there's certainly there are certainly published cases out there of patients having saying I you know you made this decision for me I don't want it anymore but I don't think that's studying I don't know Jean do you know if in the Intermax Registry they capture that I don't think so you mentioned that this had a pretty high economic cost could you explicate a little bit more about what say the initial costs and the two year cost typically would be both for insurance and out of pocket for the patients and their families so we don't we actually bet insurance before we do these pretty carefully to make sure that it will not be it'll be feasible for a family it's the upfront cost for let's say and part made to $240,000 you know insurance is approved the biggest cost for patients at once they get home is going to be the care like the drive-on care the gauze the gloves the that type of stuff because the medication really is you know we're for it and antihypertensive medicines and whatever else they have so really it's just that the the medical equipment they get batteries that are exchanged you know batteries last a year and then they'll get exchanged and that's covered by insurance but the there was a cost analysis that was done comparing transplant and alvads for example looking at the cost cost comparison and it was a flawed study because they didn't take into account readmissions so there's been nothing that looks at the cost the comparative cost of a bad versus a transplant if you assume that let's say a patient will get admitted once during their first year with the GI bleed and require an upper and lower endoscopy and they will come in and require three extra echoes and also five right-hard cast or whatever it is so there's been no cost comparison in that way but the cost of maintaining a person on a bad is probably about a hundred hundred twenty thousand dollars which if you take at the cost of dialysis now is about 80 so you know one and a half times more what is the acceptable standard cost for quality of life for one year people asked if we see it being covered by Medicare so it's I mean it is it is covered by I mean it is covered by Medicare now automatically as eligible I I don't think it'll go there in part of first of all the numbers are smaller so financially would not be as huge a burden but if you take something just like saying that someone who meets the indication for an ICD if everyone who met the indication for an ICD which simple ICD simple one lead is about twenty five thousand dollars that would bankrupt our system if you talk about taking you know the four hundred thousand people and maybe they've done estimates about the need the need are about thirty per hundred thousand people would fit criteria for an LVAD big cities are doing like two point eight per hundred thousand Chicago is a big city we do about two point five LVADs per hundred thousand who are eligible for it I don't think we're going to get to a point where we say just because you have EF less than twenty five percent you're going to get it I don't think with with the new recognition of the complications and and not only the complications but the amount of people that it takes to care for these patients that that you can't quantify it's not because of because of cost and also manpower I mean our VAD coordinators are on twenty four seven to take calls about you know different alarms different leading all these complications that the type of infrastructure you have to have when someone goes home with an LVAD we have to educate the fire department and the police department in their region so that they know what it is you know so they know what to do so they know what the alarms mean so they know if power goes out someone's going to come and want to use their generator to recharge the batteries these types of things so I don't think we're going to get there I don't think that's a bad thing that we're not going to get there it is better than that can I quote you on that dialysis increases your risk of getting heart failure by twenty three fold twenty three fold not causation but association absolutely so many decision makers have the same moral standard as primary that is the individual himself or herself and I thought I heard you say that the Baylor group and others have really questioned the standing of surrogates to make the positive call that is the call to initiate long-term right because of the ramifications of living with an LVAD because of the personal ramifications of living with an LVAD so that you was an instance when it appears that the surrogate doesn't exactly have the same claim rights or standing as the individual okay mm-hmm uh... any final questions