Thank you so much. I'm so excited to be here today. Let me get these going. This is one of my favorite topics to think about and to talk about, so I'm hoping there's gonna be great discussion afterwards, so thanks so much for inviting me. All right, I have no conflicts of interest to disclose. I want to start this presentation with the types of cases that keep me up. Were we right or wrong to cannulate? Did we make the right decision? Was it the wrong balance of harm and hope? The first case is the heroic ECMO. It was a four-year-old girl who was resuscitated at a community hospital after 90 minutes of being submerged in a cold water lake. And an adult cardiothoracic surgeon there at that community hospital had just started an ECMO program and decided to cannulate her, despite the fact that they weren't achieving ROSC, through the chest because he only has adult cannulas. She's transported to a pediatric center and over the subsequent week it becomes clear that she is not gonna have neurologic recovery and the team and the family decide to withdraw life-sustaining therapies. She's able to donate her liver and her kidney, which brings her family some meaning to the tragedy. So was the decision right or wrong? And how do we quantify the benefits and burdens? It was very unlikely that she would ever survive and many centers would not have cannulated her. Could the decision be justified simply on the benefits of hope or time for her family to come to terms with this tragedy? Or how about her organ donation? Or were the burdens of the prolonged existential suffering dignitary harms to her body, false hope, resource utilization of staff, ICU bed, ECMO pumps, blood products just too much? And what if other patients were harmed by being diverted because of lack of PICU beds? The second case is the last minute switch to late ECMO. Two month old boy has undergone cardiac surgical repair of congenital heart disease, but there are residual cardiac lesions resulting in a progressive multi-organ failure. It's the team's assessment, a big multidisciplinary team over many meetings that there are no good surgical or transplant options for the baby. And it's determined that he's not an ECMO candidate. The infant eventually progresses to cardiac arrest and the medical team and surgeon on that night make an impromptu decision to cannulate for ECPR and offer the infant a heroic surgical option. And the next day, a large intracranial hemorrhage is found and the shared family team decision is to withdraw life-sustaining therapies. In a desire to steward resources and avoid ECMO in the setting of a likely poorer prognosis, did the team miss an earlier point of cannulation that might've resulted in a better outcome? Did we have rescue bias for a patient and family we knew well and felt some responsibility for after a previous cardiac surgery? And how do we navigate earlier ECMO team decisions when we're faced in the moment with an impending death? This is the I can't believe they survived ECMO case is really conglomeration of all those cases where we all thought the prognosis was terrible but we cannulated anyway as a Hail Mary and then the child survived beyond all odds and discharged home to live a high quality of life. Were we wrong to use intensive and scarce resources in the setting of poor prognosis? Is the occasional good outcome worth all of the burdens and harms we create when we're wrong? And what about the benefit of advancing the field of ECMO by simply trying and pushing the envelope? Does that outweigh the harms to patients and families, the medical team and the healthcare system? It's all of these impossible decisions that I hope to provide some guidance for today. And spoiler alert, I don't have an answer to all these questions but as a good intensivist, we have a process in store. So whether we were right or wrong can't simply be about whether the child just lived or died. Prognostication is particularly difficult in pediatrics so we can't get the decision right 100% of the time, not with all the evidence, not the training, not the studies, not the knowledge in the world. So each of these cases I just reviewed demonstrates inherently complex ethical and moral decisions, not just the scientific decisions that they may appear to be on the surface. And when we make the most complex ECMO decisions, we are consciously or unconsciously struggling to sort through the scientific knowledge and a diversity of values to balance benefits and burdens, hopes and harms. And we are facing these kinds of complex decisions more and more each year. ECMO utilization has expanded significantly over the past decade. We have increasing accessibility to ECMO devices, improvements in ECMO management, increasing ECMO providers, more centers, and more indications for ECMO. And in addition to increasing indications and utilization, the contraindications that have been used to accept, that used to be accepted are being challenged. And as if this uncertainty about the limits of indications and contraindications wasn't hard enough, there are inherent challenges unique to ECMO decisions beyond that of the typical medical decision. There are, it's a resource intensive, it's a scarce resource, there are significant burdens, there are challenges with informed consent, it's high stakes, time constraints, challenges with prognostication, we have eternal hope in pediatrics, we have diverse opinions, and decisions are increasingly based on values and ethical principles. It really is the perfect storm that will strain even the best decision-making teams. So where is the line in the sand? Can we even draw a line in the sand about where we will or will not cannulate? What guidance do we have to make ECMO decisions in increasingly complex situations? ELSO provides guidance for categories of indications and contraindications, often in lists, but as we have already mentioned, we are constantly pushing the boundaries of these contraindications, trisomy 13 and 18, stem cell transplant and CAR T cell therapy, or earlier gestational age. So how do we use these lists to help us in moments of complex ethical decisions? There's no ELSO guideline that I can find about how to make high stakes decisions in the setting of tremendous uncertainty. In the intense, fast-paced moments of decision-making, we are trying to balance many things. On one hand, the benefit to the patient, hope, acceptable burdens, advancing the medical field, and of course our fiduciary duty to the patient right in front of us. We're balancing that with harms to the patient and family, unrealistic hope, unacceptable burdens, strains on the medical system, and stewardship of resources. And it's very easy to slip to one side of the scales or the other when what we are seeking is really that perfect, acceptable balance. So lists, which are most helpful when we have more diagnostic and prognostic certainty, are helpful, but less helpful to balance complex ethical decisions in the setting of uncertainty. And for the most complex ethical decisions that cannot be guided by data alone, we need to be guided by a decision-making process, a process that adheres to ethical principles, that eliminates disparities, that reduces variability, that attains family value concordance, advances the field, and stewards scarce resources. So I propose developing a guideline for a reproducible ECMO decision-making process that involves five major steps. The first is to develop a team, a decision-making team. The second is to establish ethical guiding principles. The third is to establish bias reduction best practices. The fourth is optimal family-shared decision-making, and the fifth is review and team support. So many teams do parts of this process and do them very well. The goal would be to have an all-encompassing, reproducible, transparent decision-making process similar to the variety of processes we have in place for ECMO management or eCPR, for example. And I know what you're all thinking right now. We don't have time for that kind of decision-making, but I really do assure you that if we can do ECMO, we can do this with the same intention, vigor, and practice, practice, practice. So I'm gonna go through these five steps really briefly. The first is the decision-making team. So the first step is to develop a decision-making team that is multidisciplinary and represents a wide variety of diverse perspectives. This doesn't mean it has to be the exact same people every single time, but ideally representation from the same groups. And decisions are ideally not made by just one or two people at the bedside in order to avoid variability and bias. But sometimes, of course, as we all know, in the middle of the night, that is unavoidable. The more ECMO experts coming together to make a decision, the better. Decisions should not be made on the fly in hallway conversations, if avoidable, but during intentional, prepared spaces where accurate data is presented and there's sufficient time for discussion. Optimal decisions require building a culture of trust and respect and psychological safety where all voices feel comfortable speaking up and being heard, not just dominated by the louder voices. And to accomplish this, often, we have to make decisions in an anticipatory manner when there's time for a considered process. One other advantage of large, reproducible decision-making teams is that the decision is most likely to be respected and supported by other ECMO team members who are not part of the decision-making process. Next is establishing ethical guiding principles. Group decisions must be made on a foundational understanding of ethical theories, and the ECMO program should work to pre-establish agreed-upon guiding principles to reduce variability between ECMO teams. Organizational ethics teams may support ECMO programs to develop these ethical guidelines. One example actually comes from recent work we did at our organization to develop ethical allocation guidelines in the setting of scarcity. And one of the most difficult aspects we had was to agree on guiding ethical principles. For example, what outcome should our decision even be measured against? Survival to discharge, survival with longevity, or an accepted quality of life, and whose quality of life? There should be regular ethical training for all ECMO team members. This can both help in team decision-making, but also build moral resilience. Finally, as we begin to use ECMO for greater indications, we may regularly bump up against institutional supply constraints. And one task for the ECMO program is the development of allocation principles in times of scarcity. It's beyond the scope of the talk today, but I will be speaking at the Harvard Organizational Ethics Consortium Conference later this week about our institutional experience developing allocation guidelines during the most recent threat of auctioneer shortage this past summer. Healthcare disparities and bias in decision-making can be incorporated under the ethics umbrella, but I'm calling it out here because it's so critical to address. Ginny Kingsley, in just a few minutes, has given an entire presentation on this, so I'm not gonna steal her thunder, and I'm gonna keep this very basic. But essentially, inequities, disparities, and bias exist at all levels of healthcare, including pediatric ECMO, and quite simply are unacceptable. And progress to dismantle this complex structure that creates these disparities has been slow, despite our best intention. Any ethical ECMO process-based decision-making guidelines have to address this issue head-on, transparently, and actively. Some basic suggestions about how to incorporate this goal into programmatic guidelines include developing principles to address healthcare disparities, recurrent bias reduction training for ECMO providers, regular review of institutional data, monitoring decisions in marginalized groups of children, and diversifying the workforce. We're gonna learn a lot more about this from Ginny in just a couple minutes. Step four, once the team has made a decision to offer ECMO, the team must then engage in a collaborative decision-making process with the family. It's our responsibility as ECMO experts to guide families in this complex decision about which they know very little. And the foundation of a collaborative decision-making process is the development of a trusting relationship. There are many challenges to family decision-making in ECMO, including high stress and emotions, complex technologies, and time pressures, just to name a few. So decision-making must be supported. Optimal and shared decision-making is supported by training and difficult communication for the providers, establishing the trusting relationship that I just mentioned. Engaging family support mechanisms, if that's social work or cultural navigation, religious support, family support, palliative care. Eliciting the family's goals and values. Transparency by the medical team of the uncertainty that we have and the risks of burdens and harms, and staying away from what we always do, which is that optimism bias. And decision-making guidance aligned with the family's values and goals, not simply presenting a menu of options. And clearly pre-established conditions of ECMO trial continuation and discontinuation. So in settings of significant uncertainty, the goal is to support the family to make a value-concordant decision so that no matter the outcome, the family can feel at peace with their decisions. We don't have much time, so I'm only gonna show this briefly, but this is a model I created years ago to think about the spectrum of collaborative decision-making with families. On one end, I think it's the left, we have the scenario where the child will clearly not benefit from ECMO. There's no choice for the family to make, and our goal is to support the family through the experience. On the other end of the spectrum are the cases where the predicted outcome is so good that we really don't offer the family the choice, and if they were to decline, we might consider compelling them. In the middle is a wide range of uncertainty about the predicted outcome that requires a supported, collaborative decision-making approach. I'm also not gonna spend much time on this slide, but just use it as an example of an ethical decision-making checklist that we can develop to ensure that our decisions to the best of our ability are ethically sound. So the final step in the guideline is to ensure that there's a process for review of all decisions and team support. This is really hard work that we do, and we know we're not gonna get it right all of the time. Children are gonna die, and at the worst, we're gonna worry that we unintentionally caused harm in some way. Many of us experience moral suffering in the decisions we make and the care we provide as the situation unfolds. To ensure that we are continuing to refine our decision-making process and to support a healthy team, we have to regularly review cases and aggregate data, report our outcomes transparently, regularly review guiding principles and decision-making processes, monitor healthy teams and work environment indicators, and support efforts to cultivate team moral resilience. So I'm just gonna leave you with a couple of questions to mull over. Maybe we'll have a chance to discuss this, but my personal opinion is that I think we can and should continue to push the boundaries of ECMO in the cases of uncertainty, but this requires new and different ethically robust decision-making processes to get it right and a way to terminate ECMO, which Eric talked about earlier. So my questions are, are we at a point where we can stop thinking of ECMO as an extraordinary measure in the setting of uncertainty? Can we begin to think of time trials of ECMO where decisional certainty is more ordinary? And how do we simultaneously protect against the historical creep of technology as obligatory? So in conclusion, ECMO indications are expanding, contraindications are being challenged, and we are in a place of making decisions in the setting of tremendous uncertainty in an increasing number of cases. Lists of contraindications are decreasingly useful as the sole tool, and established guidance for robust ethical decision-making processes are needed to ensure an optimal balance of risks, benefits, burdens, and harms with the use of ECMO. Thank you so much. Thank you.

ECMO

ethical dilemmas

pediatric cases

multidisciplinary team

decision-making process