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Michelle M. Kittleson, MD, PhD: Welcome to Medscape's InDiscussion series on heart failure. I'm your host Dr Michelle Kittleson. This is the final episode in our 12-part series, and we're capping it off by talking about the heart transplant evaluation process. What are the most difficult decision points in the medical management of heart transplantation? Where should we focus our attention to have the greatest successes? And what do we need to know to best help our patients through the involved process?
For expert guidance on these questions, we've invited Dr James Fang, professor of cardiovascular medicine at the University of Utah and chief of cardiovascular medicine at the University of Utah Hospitals and Clinics in Salt Lake City.
He has led several position statements for the Heart Failure Society of America (HFSA), as well as the International Society for Heart and Lung Transplantation. He currently serves on the American College of Cardiology/American Heart Association Heart Failure Guideline Committee and is on the board of directors for the HFSA.
In fact, he's soon to be the president of the HFSA. Welcome, Jim. I'm so happy to have you.
James C. Fang, MD: Michelle, this is quite an honor for me, and it's always a pleasure to talk with you about any topic in medicine.
Kittleson: Awesome. Tell us what was it that first sparked your interest in caring for patients with advanced heart failure needing transplantation, and what still keeps you engaged today?
Fang: Great question. We were talking about how important people are in your life, and Lynne Warner Stevenson was one of those people. She invited me to the heart transplant meeting at the Brigham and Women's Hospital many years ago. And I had already pegged myself as an interventional cardiologist. I found the discussion on the patients and what treatment options were possible to be fascinating. Heart failure specialists are called the oncology of cardiology. And that for me is incredibly appealing because I like the longitudinal care of patients as much as I like other aspects of cardiovascular medicine, whether it's the cardiac catheterization lab, imaging, etc. I fundamentally enjoy becoming a part of somebody's life and seeing what I can do to help them in their journeys.
That's why I got into heart failure and still love it.
Kittleson: Amazing. It's so interesting — if you asked me why I picked heart failure and transplantation, I would also mention Lynne Warner Stevenson, and I would mention Dr James Fang as one of my mentors. Now, we won't talk about how many years ago she inspired you vs how many years ago she inspired me.
But it's really incredible — this web we have all created to allow us to care for the sickest patients in the most rewarding ways. Let's dive into this heart transplant evaluation process, arguably the end of this advanced-stage journey for many patients. And because our savvy listeners are likely to be already aware of what the heart transplant evaluation process entails, can you tell us what you see as the greatest unmet medical need in this evaluation process in the waiting list for patients needing heart transplantation?
Fang: In my opinion, it's fundamentally timing. One of the things that I have certainly experienced over the decades that Lynne taught us was that the trajectory of patients is highly unpredictable, and if we could sort that out, we could better figure out when is the best time to provide somebody this option.
When is the best time to provide circulatory support, both durable and temporary? That in my mind is the challenge, and that, of course, segues into the message to our listeners and folks who don't do what we do for a living, to let us help you figure that one out and hopefully not too late in the process.
Kittleson: I totally agree. I think about the evaluation process of heart transplantation in a way as predicting the future. We're trying to predict who's going to do poorly without a transplant and who's going to do well with a transplant, and it's that magical window: The heart is sick enough, but the rest of the body is well enough.
There has been a lot of attention paid in the past to risk scores. Do you use these risk scores in your clinical practice, or do you more use your clinical gestalt?
Fang: That's a great question. Back in the day, we used to actually calculate a Seattle Heart Failure survival score for every patient that we were working up for a transplant. And unfortunately, everybody by that score would be anticipated to survive quite well, when all of us would walk into the room to this patient and understand this patient was not going to survive that. So the quick answer to your question is no — we do not use risk scores in clinical practice on a routine basis to make decisions.
There are a number of mnemonics out there to try to trigger a referral. Perhaps the best known one is "I NEED HELP." I like to keep things simple, and for most of our listeners, there are just three things to think about. One is, of course, the patient who doesn't seem to be getting better — who doesn't feel better with therapy. That should be trigger number one. Trigger number two is patients you can't seem to keep out of the hospital despite everyone's best efforts. And then trigger number three is something that every heart failure cardiologist, and, frankly, every cardiologist and primary care physician, sees. And that's the issue with cardiorenal syndrome. Cardiorenal syndrome, which arguably is defined as congestion in the presence of renal dysfunction, in any patient should trigger a consideration of referral because those three issues — the lack of response to medical therapy, can't keep somebody out of the hospital, and persistent congestion despite renal insufficiency — should clue clinicians as to where this is going for the patient, and that is perhaps the time to refer.
Kittleson: I love that. I probably stole this from you, but I've always said that the creatinine is the canary in the coal mine. If the kidneys are not happy, you need to figure out why. And more often than not, it's because the heart is unhappy. I still remember when I was a fellow, I admitted this young patient with decompensated heart failure. He looked okay because young people often look okay, but his kidneys were not normal. So I went to my attending all blasé as a fellow will be, with that uncertainty combined with the hubris of fellowship, and I said, "This guy's fine. Just dry him out and send him home."
My attending was like, "Why are the kidneys not normal?" Lo and behold, within a week he was on inotropic support awaiting transplant. The kidneys don't lie. I think that is so important. Your patient isn't feeling well despite your best efforts, they're being repeatedly hospitalized, or their kidneys are unhappy. You heard it here, guys, Dr Jim Fang's top three. I think that's hugely important.
Fang: Well, thank you. Yes. There are a lot of other things we talk about, but just to keep it simple.
Kittleson: Exactly. That's the harder part when you're predicting the future, but sometimes the decision is made for you, and now the patient is sitting in front of you with something like a left ventricular assist device (LVAD). In fact, you were on the national news back in 2011 when Dick Cheney, our former vice president, needed a heart transplant and showed the viewers at the time what LVAD existed that he had.
Tell us what's changed in terms of LVADs in the past decade.
Fang: Yes. Thank you for that question. That change is perhaps one of the most exciting things in our field. I would tell you the number-one thing is patient selection. It's taken us a while to figure out who should have these devices. I'd be the first to tell you that is still an evolution. Number two is that the technical advances, such as moving to centrifugal pumps from axial flow pumps, have improved with something that Mandeep Mehra has coined "hemocompatibility." And so the stroke rates, the bleeding rates, etc., have decreased, but they are still consequential. And then number three is really how these devices fit into the longitudinal management of somebody with advanced heart failure. As you know from the guidelines, the only tried-and-true class I therapy indication for the long-term survival and improvement of life is heart transplantation. LVADs are now a class I indication too for highly selected patients. But when you have these two options and a patient is, for example, 70 years old, does that patient get an LVAD and live out their years that way? Or do you transplant them? Or if you have a 25- or 30-year-old patient — who you're hoping will live to 70 or 80 years of age — do you start with an LVAD, get as much mileage out of that as you can, and then move to transplant? And how we should do this is completely unclear, but those are some of the exciting advances we've made, and there are also a lot of the unmet challenges.
Kittleson: So LVADs themselves have gotten better, and our patient selection, figuring out who's sick enough yet well enough, has gotten better. Now tell us about how the 2018 change in the heart transplant allocation process has added complexity to our calculus when we think about putting an LVAD in a patient.
Fang: That's a great question. Our listeners will know that in 2018, due to federal law, the final rule that the allocation of solid organ transplants in this country — to put fairness and equity into making sure that waitlist survival and posttransplant survival are maximized — was an important impetus to change it. Since 2018, we've seen a dramatic decline in the use of durable LVADs to bridge people to transplantation. And a lot of this was because the allocation status priorities were changed to incorporate specific devices, particularly temporary assist devices, into the algorithms — for example, the intra-aortic balloon pump, which had never been part of the allocation scheme prior. Because those of us who've been doing this work for a long time believe that the end game is a transplant, why not do whatever you can to get the patient a transplant? If under duress, or if you know it's going to be a long wait, they are highly sensitized, or are competing within a common blood group like type O, then maybe suggest a few weeks of temporary support and then go to a durable LVAD. But in other patients who are young and who otherwise have no specific need to be rehabilitated on an LVAD, I think we would all forgo the LVAD to get them transplanted. This has been a big challenge, and in fact, if you want to learn more, Dr Mehra and I will be debating this issue on the last day of the HFSA annual meeting about the use of durable LVADs in the management of patients awaiting transplantation.
That's just one of many things that have changed, but I should remind the audience that the allocation scheme, which came out in 2018, has actually benefited many people. Waitlist times are down. Posttransplant survival as best we can tell is a little controversial but doesn't really appear to be affected. Waitlist survival is improved. There have been a number of very important benefits, and at the end of the day, I'm hoping we're going to broach the magic number of 4000 transplants because now we've expanded the donor pool to hepatitis C donors. The donation after circulatory death (DCD) thing is going to be revolutionary. All transplant physicians tell everybody that our field is fundamentally limited by donor organs, and that has been a static issue for many decades, but it's pretty darn exciting now — how this explosion of the donor pool are going to really change what we do.
Kittleson: I totally agree and love a good foreshadow. I like that you're bringing in expansion of the donor pool because I'm going to pick your brain all about that. But before we leave LVADs, from what you're telling us, the change in the 2018 allocation system has changed the landscape a bit, where temporary mechanical support devices are prioritized, which leads to sooner transplant with the potentially unintended or perhaps forecasted consequence of fewer LVADs used for the indication of a bridge to transplant. But we still have this large population of patients who may be older or who may be out of the realm of standard transplantation.
So do you feel that LVADs — as what was called destination therapy — are underused in patients who will not ultimately be transplant candidates?
Fang: I'm biased, so the short answer is yes. There are a lot of patients who frankly could benefit if given the option. Now, you and I both know this technology is not for everybody, but you have to let the patients and their families help you decide that for themselves. Not to say, "I don't believe you're a candidate" and not refer the patient. I do think there is a large group of patients who could benefit from this technology, particularly because of all the advances we talked about that could contribute to very high-quality extension in lifespans.
We would all like to see these patients sooner rather than later. It's a tough question, though. We've all seen frail patients who are elderly or even not that old and we wonder, Is the frailty responsive to cardiac output or not?. Larry Allen championed this idea many years ago — the LVAD-responsive nature of frailty. And that's really a tough call, but one that I think would benefit patients — at most centers that do this a lot or are allowed to address that for their patients and their families.
Kittleson: I totally agree. So if we go back to Dr James Fang's big three: Patient isn't feeling well despite your attempts to optimize, they're being hospitalized, and their kidneys are getting a little iffy. Then it's time to broach the subject with an experienced, advanced heart failure center, which offers the option of left ventricular assistance.
It's harder to say no than it is to say yes. If the answer is ultimately no, that's probably a good thing. The option has been exhausted, but it's a decision between the patients, their families, and the medical team. So let's circle back to the topic of advances to expand our donor pool.
We have so many ways to do this now. You mentioned hepatitis C organ donors. We now have these ex vivo perfusion platforms, the heart in a box. We have xenotransplantation, DCD. What do you see as the most impactful innovations in the years ahead?
Fang: DCD will have the most immediate impact. I think we're well on our way to do 400 heart transplants nationally in the DCD space. We're learning a lot. We have a DCD center at Utah, and there are a lot of logistical challenges with this, too. It's quite interesting that when you think you're removing life-sustaining support, those patients often don't immediately die. That's a logistical challenge, one that also unfortunately becomes one of cost because managing these patients at the donor's end of life can be very complicated and expensive if it doesn't end up with a transplant. Who's going to pay for that? And there are many other angles. There is the SherpaPak, for example, that does controlled transport. It's not profusion like the TransMedics device. There are a lot of exciting things going on, but I would tell you that probably the most immediate impact will come from DCD. Hepatitis C is exciting, too. Twenty years ago, less than 1% of donors were infected with hepatitis C virus (HCV). Now 20% of our donors are positive for HCV. That has clearly made an impact as well, but it fundamentally addresses one of the limitations of our discipline for many decades, and that is the donor pool. This is going to have an immediate impact.
Kittleson: If we agree, we must be right. So I agree completely. I think with HCV-viremic donors, most centers, if not all, are comfortable. That's something we can hang our hat on. We know what to do in this situation, but when it comes to DCD and donation after cardiac death, it's all about the ethics of the situation. Is the reanimation of this organ — after it stopped beating — best handled in situ or ex situ? It's about organ transport and the learning curve of when this transplant is predicted to go well and when it is predicted to have more risk. We'll have to bring you back in 10 years, Dr Fang, to do a rehash of this episode and see what's happened in the meantime.
But tell me: What's the one thing you want listeners to do differently after hearing this discussion?
Fang: Think about the trajectory of your patient, whether you are a heart failure cardiologist, general cardiologist, electrophysiologist, interventional cardiologist, or primary care provider. Think about the trajectory of the patient in front of you in the office visit, because ultimately life is all about timing, whether it's getting married, going to college, etc., and particularly in the course of a patient with heart failure, which is highly heterogeneous and unpredictable with both highs and lows. It's important to make sure that you're not missing the very important window to refer these patients for advanced therapeutic considerations. Not all patients will be candidates, but let us help you figure that one out.
Kittleson: Amazing. What else is there to say? Life is about timing and sometimes it's about having the most amazing mentors like I have had in Dr James Fang, or for you, our listeners, listening to this amazing wisdom right now. We've learned: Think about the trajectory. Is your patient doing poorly? What can you do about it?
And remember, medicine is a team sport. When you don't know the answer, it's more important to know how to ask the right question, and your friendly heart failure transplant cardiologist is always willing to help you do the right thing for your patients. Dr Fang, thank you so much. It's been a pleasure to have you here.
Fang: It has been so much fun and thank you so much for the invitation, Michelle. Looking forward to seeing you soon.
Kittleson: Thanks for joining our discussion with Dr James Fang. This concludes the series, but be sure to check out previous episodes on the Medscape app and share, save, and subscribe if you enjoyed this episode. I'm Dr Michelle Kittleson for Medscape's InDiscussion.
Resources
Lynne Warner Stevenson, MD, FHFSA
Risk Prediction Models for Survival After Heart Transplantation: A Systematic Review
Evaluation for Heart Transplantation and LVAD Implantation
Left Ventricular Assist Devices
The Burden of Haemocompatibility With Left Ventricular Assist Systems: A Complex Weave
Guidance and Policy Clarifications Addressing Adult Heart Allocation Policy
Heart Transplantation From Donation After Circulatory Determined Death
Frailty and the Selection of Patients for Destination Therapy Left Ventricular Assist Device
Heart Transplant Advances: Ex Vivo Organ-Preservation Systems
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Cite this: Think About Heart Transplant Evaluation Like This - Medscape - Nov 09, 2023.
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