 Next speaker is James Kirkpatrick. He's an assistant professor of medicine and medical ethics and health policy at the University of Pennsylvania. One of the few ethics-trained cardiologists in the country, and he directs Ethics and Professionalism Education for the Penn Cardiovascular Medicine Fellowship and Training Program. Does ethics consults and coordinates ethics educational outreach initiatives and serves in the Ethics Committee of the Hospital of the University of Pennsylvania? Jim? All right, thanks so much, Dan. And thank you so much to Mark and the McClain's, I really appreciate all the input that they've had into my career and the careers of everyone else that is in this room practically. Mark, I wanted to let you know that I still hand out Pasquale's major, Pasquale's wager, on rounds when I'm with cardiology fellows and residents and that sort of thing. It's a wonderful piece if you haven't read it. Here is my disclosure slides. I don't have any industry affiliations, and actually a lot of these things are old in particular out of the Greenwell Foundation grant. But my biggest disclosure is that I'm a cardiologist. And that is a disclosure because we have traditionally proven difficult in interacting with terminally ill patients. We tend to withhold information from patients. We tend to have lower awareness of poor prognosis. And we tend to initiate CPR and ventilation for patients with severe chronic diseases and marginal prognosis because, I mean, it's just a fact. Our patients do not die of cardiac disease. And this is part of the reason. Mark spoke earlier about the dramatic improvements that we've had in preserving patients' life and that sort of thing, and we have a lot to do with that. We've actually bent the curve since about the mid-1980s so that now heart disease mortality is decreasing, and we think we're pretty hot stuff. But the problem is that despite all of our wonderful technology, and here we're going to focus particularly on some of the implantable devices that we have here, and just over here we can see a left ventricular assist device in the upper left-hand side, a defibrillator in the right-hand side, pacemakers in the left lower, biventricular pacemaker in the right lower, and right in the middle is one of the newer left ventricular assist device that literally fits in the palm of your hand, and we actually have another one coming out that's going to support the circulation of a feeling heart, and it's the size of a AA battery. Amazing stuff, but even heart transplant, which is our gold standard treatment for cardiovascular disease, carries with it a five-year, 20% mortality, and 40% of patients, almost half of them are dead by 10 years out. If a loss of a young person gets transplanted, they're going to need another heart before they die, unless they die before that. And this is how heart failure patients in particular live. This is work that was developed by Sarah Goodland, who's now out at Oregon Health Sciences University, and she basically described this. It needs to be a bit updated with some of the advances in our devices, but essentially, number one, you're coming with heart failure. You get on the right medicines, you get stabilized, you enter a plateau phase. This plateau phase is very difficult to predict how long it's going to be, but eventually things start getting worse. You go into the hospital, you get better, you come out, you go back in, you go back in, in and out. At any of these points, the dashed lines there, where it says sudden death event, you could just die, even despite defibrillator therapy. And if you get bad enough and you're a candidate, you might get transplanted or you might get a ventricular assist device to actually support your failing heart. Then you go back on that plateau, but then you just do the same thing all over again. You end up down at number five, even with our new technology. And these patients suffer. We normally think of heart failure patients being short of breath and having chest pain maybe, and being volume overloaded and being really tired. But they have all of these other things too, because heart patients tend to be older. And they have a lot of psychospiritual comorbidities as well and social and functional abnormalities. And this is all well documented in the heart failure literature. There's a very interesting study a few years ago, and there have been subsequent ones that show the same sort of thing. Looking at end of life preferences in patients with advanced heart failure, and one of the interesting things is that patient preferences correlated very poorly with quality of life scores. And although it wasn't statistically significant in this study, there was a trend towards patients with the worst quality of life wanting more aggressive treatment. This doesn't make any sense in our sort of oncology dominated paradigms, which if you're feeling poorly, the last thing you want is more chemotherapy that's going to make you feel even worse. But it doesn't work that way in heart failure patients. And our devices are also different than giving chemotherapy. Our pacemakers improve quality of life, they improve symptoms, and they can also prolong your life, depending on what your underlying rhythm disturbance is. Implantable cardioverted defibrillators can improve your long length of life when they're appropriately put in, but they actually may make your life worse if you get shocked all the time. And it's difficult to predict where the benefit in the burden is going to lie on this. And this is a very powerful and poignant article that was in The New York Times magazine a few years ago. This academic was talking about the suffering that her family went through when essentially a pacemaker was forced on her demented father. She writes, the pacemaker bought my parents two years of limbo, two of purgatory, and two of hell. If we did nothing as pacemaker would not stop for years like the tireless, charmed brooms in Disney's Fantasia would prompt my father's heart to beat after he became too demented to speak, sit up, or eat. And in fact, that actually happened. ICDs are implanted about 100,000 a year in the United States. And as you know, they are basically put in in order to terminate lethal arrhythmias. And sometimes they do it by delivering a shock. Sometimes they can just pace the heart out of a bad rhythm. That's generally not an uncomfortable procedure. And they're put in for both primary and secondary prevention. Primary prevention, you have not had a cardiac arrest. Secondary prevention, you've had one already. And this is essentially what happens, if you think about it. But there's a downside. Defibrillator shock has been described as feeling like you're getting kicked in the chest by a horse. And this obviously can lead to anxiety, depression, post traumatic stress disorder, and obviously raises emergency department resource utilization when those things happen. So we actually are in the process of writing up a study we did. We surveyed electrophysiology practitioners. These are the people who put in the devices and maintain them from an email database from the Heart Rhythm Society. And we said, in your opinion, how would we think about a pacemaker in a pacemaker dependent patient? And these are basically the answers that we got. But about 50% of them said, well, it's kind of like constitutive therapy. It's something that just keeps you alive, like, say, dialysis. Well, contrast that when we asked the same question about implantable cardioverted defibrillators, nearly half of them said, it's not like anything else. And it's certainly not like constitutive therapy. So the nature of these devices is complicated and complex, especially among those who put them in a no best. Well, let's move on briefly to ventricular assist devices. These devices are essentially heart bypass machines that get implanted inside the patient. They were initially developed for a number of indications of the heart failing acutely and suddenly, like after cardiac surgery. It happens sometimes. If you get a heart infection, the heart muscle itself gets either infected or inflamed, and the heart fails, or a massive heart attack. And then they begin to be used increasingly to stabilize patients until they can get transplanted. And now we have this concept called bridges. We have a bridge to transplant. We have a bridge to recovery if the heart's going to get better. But we also have this bridge to the rest of someone's life, which we call destination therapy. If it comes out, you die. That's the problem with. So this is what they look like. They generally consist of a cannula that's stuck into the apex of the left ventricle, and it sucks blood out. And it goes into the pump, and that puts it out into the aorta, and it's implanted. So it has a driveline that comes out through the skin. And that goes to a controller that's kind of worn on the belt area, and that is connected up to at least two batteries. And this is basically what it looks like on the inside. This particular ventricular cyst device is basically a propeller inside a tube, and it just spins around and sucks the blood. And they actually work. They make people not only live longer, but actually feel much better. All of these things are standard measurements of how patients do and how they feel, and they were much better when the ventricular cyst device patients than those who didn't have. And they actually improved over time from baseline to six months out in this particular study. So it's led some people to conclude that there are no mathematical dilemmas in regards to these things. The technology has proved these patients have short, wretched lives. Why would we not implant them in everyone? Well, I would disagree with that. And in part, due to a study that we're in the middle of doing right now, we're interviewing caregivers and patients who have ventricular cyst devices. And this is one of the more poignant quotes that we got out of that study. This caregiver said for her husband who had a ventricular cyst device, he's verbalized many times he wished he'd never had it done. He said that if he knew that this is what was going to happen, he would never have had it done, because he's basically an invalid now. And he's really tried hard to make it back. So in essence, a lot of these cardiac devices put us into a classic principle of double effect. As you remember, a principle of double effect describes an action that causes serious harm. But because this harm is unintended, may even be foreseen, but it's unintended. It's a side effect, essentially. If it is performed in order to do something good, then it's OK. And so this is kind of a depiction of what happens. Your action can lead to good effect and evil effect together. And I think when we talk about implantable cardiac therapies, we intend to prolong a good quality of life, but we may end up prolonging suffering in some cases. This is a great quote. This was actually talking about treating coronary artery disease, but it applies even more to cardiac devices. We rescue people from a relatively sudden death from myocardial infarction, only to inflict on them a more prolonged death from progressive heart failure. And I worry that's what we do a lot. Vices like this, particularly ICDs, have been described in a number of different ways. Bio fixtures is one way to think about it. So it becomes part of the body. You can't really deactivate it, because now it's like an organ. Dr. Somasi has, I think, given us a much more helpful way of looking at this in describing therapies either substitutive therapy or replacement therapy. A substitutive therapy does some of the same things that the normal organ would do, but it's not the same thing as completely replacing it. So a ventricular assist device is not the same thing as a heart transplant. And we found in our study of these caregivers and patients that they looked at these devices, these ventricular assist devices, very interestingly. The anthropomorphize the device. They gave names to the device, like Vadi. And one person even called his Timothy. And we're not sure why that happened, but it's interesting. And essentially, they had to kind of figure out how to live with this device to come up with basically a new normal and what it meant to be someone, whether you think of yourself as a bionic person or whether you're just thinking of yourself as an invalid or somebody who has a new lease on life. There are identity issues that are all wrapped up in this. There are some inherent problems with caregiver, conflict here. If you think about it, there is a lot of stress in having a patient who has this device and it requires constant monitoring. You can't really leave them alone. You've got to make sure that the batteries don't run out. And this can lead to a lot of stress on the part of the caregiver, which may be even worse than the stress that the patient is experiencing. And because caregivers are also usually the designated surrogate decision makers and they're experiencing all this stress, perhaps there's some ambivalence that they're also experiencing. Perhaps there's a conflict of interest. And perhaps there's even moral distress that they're having to face. And there are very few programs that have caregiver support networks for ventricular assist device patients. Well, let's move on and talk briefly about advanced directives and cardiac patients. I think a lot of us would agree with this one. My advanced directives for you not to show up. When we, a few years ago, when I was at the University of Chicago, we actually, Savi Fedsen and I did a study looking at patients in the cardiac care unit. And we just wanted to find out what was their rate of advanced directives for the most part. And we found out that consistent with other studies, it was pretty low. So the light blue lines here are the number of subjects and the number with advanced directives, either living will and dark blue or durable power of attorney for healthcare and the teal are showed there. And these are across different types of heart disease, congestive heart failure, arrhythmic disease like ventricular tachycardia, coronary artery disease, heart transplant, stroke, cardiac arrest or pulmonary arterial hypertension across the board. It was pretty low. And when we asked them, the patients who said they did not have an advanced directive, did they want more information? We were surprised. A lot of them did. A great number actually wanted to. And interestingly, one third of them had been hospitalized before that and presumably had been asked about advanced directives because that's a requirement from the federal government, didn't even remember that they'd ever been asked about it. So clearly we weren't doing very good in addressing this with them. After going to Penn, we instituted a study looking at end of life issues related to deactivation of a plantable cardiac defibrillator. So we called up all the patients in our database who had defibrillators and talked to them on the phone. And of 278 patients we had had in this study, they'd had their devices for about five years. One third said they had received shocks, which is actually quite a large percentage. And they'd have an average of five shocks per patient, which is a little hard to believe. Half of them had actually had advanced directives, which was great, but only three had actually talked about their ICD in their advanced directive. And we asked them a number of questions. One of them was what should be done with an ICD in an end of life situation? Have you thought about this? Most of them had not, and even fewer had actually discussed it with their medical provider. Who should be the one responsible for discussing these advanced directives with you? And I thought they were pretty good about this. They said the primary care physician may not know a whole lot about it. So we should have the cardiologists and electrophysiologists do it. But guess what other research has said about this? Who doesn't want to talk about this? What should be done with an ICU if you are an end of life DNR? A lot of them said deactivate it, but look at the percentage that said keep it on. Doesn't make a whole lot of sense. How about hospice? If you go to hospice, what should be done with it? Again, a large percentage said keep it going. And this I think gets to their relationship with the device, which is not always so clear. Another study actually said, well, would you want your device turned off if you had cancer? Only 30%. Would you want it if you were gonna die within a month? Only 40%. If you were getting daily shocks, only half of them would want it turned off. And between 10 and 40% would never want it turned off. This is a complicated issue. Interestingly, when they actually looked at patients who had the pacemaker function deactivated along with their ICD versus not deactivated, there was no difference in when these people died. In other words, it didn't seem to matter if you kept the backup pacemaker function going or if you deactivated a pacemaker, if you also deactivated the ICD in it. It raises this question about these two devices. Deactivating them is not the same thing. Are you gonna deactivate the shocking or just the backup pacing? Are you gonna, does it matter? And whether you have a DNR, should that be an automatic sort of thing? If you're gonna deactivate the pacemaker, does it depend on your symptom relief? Are you gonna deactivate it if you have a biventricator pacemaker? You practically need electrophysiology consult just to make this decision. It's very, very complicated. Now, I'm gonna skip ahead for a sake of time here, but when we talk about, you know, a lot of patients have never wanna be on a machine, wanna be dependent on a machine, and that's essentially their advanced directive. All of these patients have ventricular assist devices in. They're all dependent on a machine. I'm not sure that if they would've thought about it, they would've said the same thing. So it raises the question, if along with the pulse forms we're thinking about this, do we need a device-specific advanced directive? Now, I don't particularly wanna be ordering off a menu with what you do and what you don't do. That doesn't seem to be the way to go. But we do need to talk about the different options that are available, depending on the different types of devices that patients have. This is being done actually at the Mayo Clinic. They developed this thing called the Preparedness Plan. You expect some bad things that could happen and you go from there. And I'll skip this issue of cardiac patients and hospice, but there are a lot of questions that are still to be left with that. So hopefully I left you with more questions than answers in talking about these different things. And I thank you for your attention.