Thank you for the introduction, Ndidi. It's great to be here. As she mentioned, I'm a pediatric cardiac intensivist and a bioethicist, which I find go very well hand in hand. So we're gonna be talking about the ethical considerations of destination therapy VADs. I have no disclosures. Our learning objectives are to briefly review the history of current destination therapy VADs, explore ethical considerations of the use of these destination VADs in kids, and consider future directions. We've heard some great talks this morning on medical management of heart failure pediatric VADs as bridge to recovery or transplant and in unconventional circulations. And now we're gonna discuss what happens when kids fail medical management of heart failure and are not candidates for heart transplant and we consider a destination VAD. So the definition of destination VAD therapy is the implantation of a VAD to provide cardiac support for individuals with advanced end stage heart failure who are unlikely to recover from their disease and are not candidates for cardiac transplantation with the intention of permanent support until death with the goal of prolonging and improving quality of life. Not to pick on our surgeon who said we shouldn't use the word, I've been thinking about this, we shouldn't use destination or bridge to transplant, but as an ethicist, I'm gonna have to ponder that one because the implications are really significant for these kids and their families. So I'm gonna have to think about that one, even though you asked us not to pick on you. So why would we even consider this? And the pictures in the slides are, most of the kids in these slides are from Seattle Children's there are patients and they all have VADs. So why would we even consider this? So to state what others have said and everyone listening in this lecture already knows there are more individuals with end stage heart failure in need of cardiac transplant than there are organs available and significant numbers of individuals die waiting on the transplant list. And for this reason, transplant centers must determine which individuals are most likely to benefit from the organs and which individuals do not qualify for transplant. So the question becomes, how can we best support individuals who do not qualify for transplant? So investigations into the use of destination VADs in adults began before the turn of the century. In 1999, there was a rematch trial, published its results comparing LVAD to medical management for adults with advanced heart failure who were not candidates for transplant. And VAD was shown to significantly improve survival and quality of life. The Intrepid trial in 2007 and the HeartMate 2 trial in 2009 demonstrated similar findings. And in 2010, the FDA approved the first VAD for destination therapy. Common indications for adult destination VAD include age greater than 70, recurrent or recent malignancy, diabetes mellitus with end organ damage, chronic renal failure, drug use, severe obesity, fixed pulmonary hypertension, for some examples. Despite relatively wide use of this therapy in adults, use of destination VADs in kids remains relatively limited. A recent study in PDMAX, which we've already referenced here before, looked at data from 2012 to 2017 and found that of 423 devices implanted in patients less than 19 years of age, only 2% or less than 10 patients were placed as destination therapy. The use of VAD as destination therapy is growing since 2017, but it still remains quite limited in scope and by institution. One limitation of destination VAD therapy for kids is that currently only pediatric VADs, the current only, let's see, currently the only pediatric VAD suitable for discharge and long-term use is the HeartMate 3. And unfortunately, this VAD is only suitable for kids greater than 20 kilos or the average size of a six-year-old with 20 to 30 kilogram kids considered high risk. More safely, this VAD can support a child of greater than 30 kilos, which is the average size of a nine to 10-year-old. So no dischargeable VADs currently exist for smaller patients, such as this patient of ours in the picture who is being supported by Berlin. One of the challenges to the use of destination VAD in kids is the limited data. What we know is extrapolated from adults based on anecdotes, case reports, or derived from children supported for long periods of time with a VAD not intended as destination therapy. When we do consider destination VAD for kids, our goals include prolonging life, minimizing adverse events, and improving quality of life when transplant is not an option. The most basic criteria include the likelihood of discharge home in a way that improves the quality of life of the child. Examples of current indications include kids who are not candidates for transplant based on life-limiting non-cardiac systemic conditions, severe pulmonary hypertension, severe obesity, malignancy, patient and family preference. And the most current common use for destination therapy is for children with muscular dystrophies. Morbidities include all the variations of thrombosis, bleeding, infection, and relative contraindications to destination VAD include significant morbidities that would preclude discharge home or significantly limit the likelihood that the VAD would improve quality of life, such as end-stage renal disease requiring dialysis, dependence on hospital-provided mechanical ventilation, contradications to anticoagulation, and potentially severe cognitive impairment. Decision-making is complex, and extensive assessment by a multidisciplinary team is similar to decision for transplant. Kids who do receive destination VADs live their lives with limitations set by the portable battery life, which currently is about 12 hours. They need to be in close proximity to a multidisciplinary support team and limitations to the types of activities they can do, although the goal with destination therapy is to be more liberal than bridge to transplant, given the goals. Teams need to recognize and support the growing and maturing child that is marching through developmental milestones. And although we focus on the quality of life of the child, it's important to acknowledge the significant impact this technology dependence can have on the family unit. Finally, we must remember that we are using this device to prolong life and that life expectancy is limited. Now we jump to the ethical consideration of pediatric destination VAD use. This is one of my favorite quotes. Almost every action within the medical setting, either explicitly or implicitly, contains two judgments, one ethical and one scientific. And there's a constant interplay between what is technically possible and what is morally desirable. When we are considering destination VAD, there is a strong moral desire to avoid death and relieve suffering on the part of the patient, the family, and the medical team in a situation that has few other options. Even if a destination VAD can do this temporarily, are the trade-offs or the burdens for the child worth it? Under circumstances of strong emotions and high stress and little research to guide us, how can we make the best decision possible for the child when the alternative is death? The best we can do is to enter into collaborative decision-making process with the family and the child as appropriate. We must take the time to elicit patient and family values, goals, and perspectives. Our hopes of improving quality of life must match the individual patient and family's definition of quality of life. We must be clear that simply increasing cardiac output does not necessarily improve quality of life, and we must be transparent and honest with what we anticipate for their experience. We need to meet the highest goals of informed consent possible. Another ethics consideration is common to many areas of medicine, especially complex medical interventions. How do we ensure that innovative interventions are offered equitably to all patients? History shows us that there are health inequities in access to care and risks for selection bias on the base of race, ethnicity, socioeconomic status, family language, citizen status, medical savvy, family advocacy, et cetera. And there are risks for exclusion on the basis of value-laden assessments of cognitive ability, disability, and social supports. We must also protect vulnerable patients and families from coercion, experimentation, and becoming victims of insufficient processes of informed consent. I think we must also be aware of a risk of increasing bias in transplant candidacy, selection, if destination VAD is a more viable option. In other words, some children who risk bias against transplant listing on the basis of factors such as social support, cognitive delays, obesity, may be more likely to be declined for transplant if destination VAD is an option. As a collective, we need to acknowledge that value-laden decisions are still a significant part of our medical decision-making processes, and we have to commit to continuing work to understand our biases to provide equitable care. Another area ripe for ethical challenges, the patient for whom the VAD is used as a bridge to decision, which according to PDMAX 2012-2017 data was about 34% of the implanted VADs. Undoubtedly, most of these VADs were bridges to decision between recovery and explantation or transplant. However, some of bridge is decision to transplant versus destination therapy. And this opens the door to very complex medical decision-making, which is incredibly difficult for those involved to truly consider and understand the benefits and burdens of destination VAD when the hope is for transplant. How do we best support families making this decision? And how do we best support children and families who receive a bridge to decision VAD, but ultimately don't qualify for transplant and are now living a life dependent on the VAD with all of its limitations? In my assessment, this is a far more challenging circumstance than considering destination VAD outright. A common ethical consideration in complex medical care is how do we best include the child? This is particularly poignant in destination VAD decision. While there are generalized ethical recommendations about how and when to include children of different ages in medical decision-making, in this particular case, it is critical to involve even young children in this decision to the extent that they are capable. Because this is a palliative therapy, consideration for destination therapy VAD is different than decision-making for curative or life-saving therapies in which children may have more limitations to refuse. Children of all ages should be supported to their level of maturity to participate in the decision. And as mentioned previously, children of all ages should receive psychosocial support as they mature through childhood with VAD. As we know from other chronic illnesses, adolescents may need particularly support with desire for independence, compliance, and life decisions. The experience of changing maturity and natural childhood development with destination VAD is unique and cannot be extrapolated from adult data. Finally, when considering destination VAD, we must acknowledge that this is a palliative intervention. The VAD may prolong life, but it does not reverse the life-limiting conditions of the child. And to this end, palliative care should be integrated into decision-making processes and ongoing care of the child and family. Decisions at the end of life with mechanical heart support may be very complicated since most disease processes proceed to cardiac death. Decisions and discussions ahead of time can help families through the transition of living with a VAD to dying with a VAD. Ethical disagreements at the end of life between medical teams and families are undoubtedly inevitable given our pluralistic society. An example could include a child who has severe neurologic injury and progresses to brain death, but the family refuses to deactivate the VAD. Hopefully these circumstances are rare and most can be prevented with antecedent preparation. And when they do arise, expert bioethics consultation can be helpful. Given our current rate of exponential technology growth, it is reasonable to expect that this field will continue to expand rapidly. For us to move into the future, much more research is needed to understand the complexities of the experience of children and families living with destination VADs. Technological advancements that could significantly change the equation for pediatric destination VAD include dischargeable VADs for smaller patients, longer battery life, fully implantable devices, and reductions in morbidities. In our most imaginative state, it is possible that technological advancements in VAD make destination VAD superior to transplant, but that's for another talk. Thank you very much. Here's citations and we'll move on to questions. Thank you.

ethical considerations

destination therapy VADs

children

advanced end stage heart failure

heart transplant