Transcript Video What Happens When TTM Becomes Standard of Care?Dr. Gabriel Variane < Back to Boundaries of Temperature Session 2: The Patient What Happens When TTM Becomes Standard of Care? Presented by Dr. Gabriel Variane as the next speaker I announced dr Gabriel Mariana, his medical director of the neonatal new york critical care program in santa casa, Sao Paulo brazil. And I think important to mention is that he started a national wide project and the organization called protecting brains and saving futures. An organization who was successful to start telemedicine and 90 technology project in brazil covering 45 different hospital around the entire country. And he work at this organization has been nominated and awarded several national international prizes and recognitions. And the topic of his presentation is what happens when T TM becomes standards of care. So we are in heaven now please dr Mariani. Well good afternoon everyone. So in first place I would like to say it's a it's a great pleasure to be here today. I think we just wait for my slides. But yeah they're coming. Uh but actually I may say uh as a disclaimer as today all my background actually comes from an anthology and today actually I'm gonna try to explain to you of course how did you implement it cooling for our babies? But on a large scale in a middle income country as brazil. And by the end of this presentation I think. Let me see. Yeah. And by the end of this presentation I think that I will you know deliver the message about the importance of promoting homogeneity of care among centers even if they have different amounts of resources. So let's start. Uh and I would like to start this presentation actually you know telling a history of a family and this is the highest result. Her mother called iris and her son Bento iris was pregnant for the first time and bent would be you know her first son and she was really you know a great expectation we know that when a baby, you know it's born is like like this this quote is like a piece of heaven actually arriving on earth. Actually there is lots of good explanation about bentos birth. But what actually happened to Bento right, so Bento actually did not breathe at birth. So he needed research station. He required you know maneuvers, he was intubated in the delivery room and he was diagnosed with birth asphyxia and hypoxic ischemic encephalopathy. So when this family actually comes to the nickel and the nickel this very very busy place. You know a lot of equipment. And the very first time these parents comes to the nicu the first news are you know your baby had difficult oxygenation during birth. This is a serious disease that can lead to that first if you're not a logical in babies and you know bento this is for the first time they hear this kind of thing like this is the third main cause of neonatal death. And even if bento survives who have a high risk for cerebral policy cognitive blindness and deafness. And of course he requires specialized treatment. So on let's talk today about hypoxic ischemic encephalopathy in neon AIDS. So we know this is a life threatening condition, high risk for seizures, high number of these infants survive with high risk for neurological impairment. And the incidence is quite high in high income countries. It's 1 to 2 per 1000 live births. And in lower middle income countries it's much much higher, even 20 times higher than in high income countries. So this is a big issue. Looking to epidemiological studies. We know that we have over a million babies with HIV every year and from those actually over 200,000 babies will develop important neurological impairment. This is an issue of World Wild but every single time, one year ago this is numbers, you know around the globe. This is actually a representative number in marinades and you know I'm Brazilian. So I like soccer. So I like to Look at this picture and if you think that's around 100,000 people in the stadium multiply this number by two or three times and they're actually the babies will develop important neurological impairment. This is a big issue world wild. So our current scenario in an anthology actually we have strategies to reduce neurological impairment and basically now we really really are in brain folks that need to care. So we have increased use of clinical practice of this multiple methodologies for brain assessments in order to improve the neurological development outcomes. And this led to the concept of neuron issues. So basically when we implement a neuron and actually we collaborate a lot with people from University of stanford in the US who teach that these pillars were talking you know, about a comprehensive approach that includes your assessment, neuro imaging, neuro monitoring and neuro protection. And talking today about one of those pillars which is neural protection then becomes the therapeutic hypothermia is being applied the standard of care for infants moderate severe on a large scale by various organizations around the world. And 2015 I was doing an observer ship in England in UK and actually I got to meet you know, this project was bebop or baby brain protection. Basically all babies in the east of England uh were diagnosed with H. I would need to receive calling. Uh and this is, you know, there's a large literature since 2012 we have meta analysis concluding that hypothermic improves survival on the development of in newborns with moderate severe H. A. So we know that cooling in babies for babies with moderate severe HIV in high income countries actually it works very well. So but actually it's this feasible to apply these methodologies on a large scale, even in a low middle income country. You know. So here comes the question, how can we reach, you know that over a million babies that are worldwide suffering of birth asphyxia. So I truly invite you to look at this under the lens of a new perspective and today we're gonna talk about PBS. F. Project in brazil. I'm gonna explain very briefly about collaboration, international studies and kindly invite you to think outside the box. So let's start talking about PBS F protecting brains and saving future is the project that we started in brazil. But first of all, I would like you know to walk through from Brazilian scenario with you. So we know brazil alright said this, you know, we love soccer, you know, But brazil World Cup talking in Germany must be cautious about this. But yeah, uh we have the rainforest. Uh we have the largest carnival in the world and many, many beautiful places to visit. If so, if you have never come to brazil, I truly invite you to come. This is a very, very nice country. But let's talk about neonatology. Right? So brazil has actually three million live births in year and from those who have estimated 20,000 babies with HIV every year. So this comes like two babies with AJ per hour. The numbers are gigantic. Uh as another view, Brazil's quite an interesting country. We have over 8000 neonatal care beds, lack of resources on the variety scale and a huge and huge variability in clinical practices when we talk about the virginity of care, we have level three units, you know, with centers with a large amount of resources, equipment, specialized multidisciplinary team, fetal surgery, advanced imaging. But we have a Level three centers that actually has a lack of resources, equipment, lack of this multidisciplinary approach or any kind of advanced image. So it's a big issue and we don't have a robust neonatal transport network. So it basically depends where the baby is born uh moving forward. And what about the cooling practice in brazil nowadays? And we have published a survey in 2018 actually looking related to the assessment of babies with A. J. In therapeutic hypothermia practice in brazil. And this actually included over 1000 participants from basically all over the country. And what did we found by that time? So results, we ask how they're doing with their babies with in their centers. And actually 62% of professionals reported using therapeutic hypothermia treatment for babies with prenatal and A. J. The main reasons for not providing would be lack of adequate equipment knowledge training with this intervention. And the big issue is that from those professionals, 94% couldn't you know, transfer this baby to referral center or you know, transfer again this baby within the six hour uh therapeutic window that we have that we know for therapeutic hypothermia in babies. So uh even now about current practices and about monitoring. So the time to therapy initiation. This is quite a concern because many people like 27% were starting doing cooling even in the delivery rooms or they're just, you know, turning off the heat from the baby, which is not a very good practice. And even from the centers that were providing cooling here comes the problems, only 26% would have any kind of server control system. So the vast majority would do passive cooling argues of Opec's talking about brain monitoring. 12% of respondents who provided therapeutic hypothermia had, you know, a G r E G readily available and only forehead access to neurophysiology services and continue e G. So it was quite a mess. So in the end of the day, results from this large survey demonstrated therapeutic hypothermia was implemented in brazil, but you know, it's virginity, most aspects of its management and by understanding the scenario and what people were doing actually by that time, you know, when I came back from my observer ship in U K and I got that project that bebop got to know I for I got this brilliant idea in my time. So, you know, why should we not start a large project to implement adequate care for infants at high risk? And I came directly to the Ministry of Health and sing about the project and so on. And do you know what happened? They left me, you know, Are you crazy? Do you think you're in case you're not in UK? It's impossible. We don't have resources. That was the answer. And you know, no money. No, honey. So sorry. And that was certainly very, very frustrated at that time. But I was figuring out, you know, so let's connect the dots, we have these big projects implementing this standard of care, brazil's continental country don't have much resources. And again, technology might help. So at this time point we started thinking about the project that we called protecting brains and saving futures. What is P B S F is actually a low cost, self sustainable project that united a group of specialists tending to teach, enable implement protocols of neural protection and early diagnosis in babies at high risk for brain injury. Own a large scale, we are a private organization, wants to make a united effort with hostile physicians, industry, healthcare influences and the Ministry of Health itself. And we have this mission that, you know, couldn't be more ambitious, but we will significantly reduce the number of Children with disabilities in the world. That's the mission of PBS F. So how the big question is All right. So how do we work actually, we truly believe about the importance of teaching, implementation of methodologies and protocols. So, we have initial ends from PBS. F that includes promoting longitudinal training, use of standard, internationally validated protocols. We work to implement across a large number of centers and together with hypothermia of the brain monitoring and again, of the management of these babies. And this would lead to promote homogeneity of care across the entire country. Again, how could we achieve this? And since 2016 now it's very, very common. But we always believe about the importance, you know, of using telemedicine system and the developer called central surveillance intelligence or C. S. I. But basically a monitoring center that can connect to any across the entire country. And of course there are many advantages from this approach including centralized data from different distant populations, highly specialized live assistance, high level of teaching launched regional training intensive support to clinical staff does facilitate the implementation methodology protocols in different centers in a lower cost model, which is interesting and again a lot of homogeneity of care between centers even if they have different amount of resources. So this is a pick from a baby near the amazon in the north of brazil in this city called Bell Indo para. And this baby is receiving calling and bring monitoring. Our information comes to a monitoring center in san paolo like over 2000 kilometers from that. And then everything started in the cloud and we have remote access by C. S. I. 24 by seven. Uh and our information started in a central security database, Talking about a little bit about our experience. So when we started in 2016 PBSF was actually implemented, you know this telehealth approach in three hospitals in the city of San Paolo. But right now actually and this keeps improving very fast. We are 51 different hospitals in Brazil for hospitals internationally basically in research projects. But we have now over 6000 monitored babies and over 1000 babies treated with hypothermia with over 400 hours of eg monitoring always historian cloud servers and many, many live interactions with from the remote team and local staff. Again, to promote homogeneity of care, basic standard protocols that we use will have the cool indication we follow the N. S. A. D. Criterion management and all the brain monitor indications not only for babies with HIV but all the babies at risk. And again, this kind of thing will region standardization of care and clinical practice guidelines between different centers through the use of telemedicine. And again, I know this is quite repetitive but this is important. The idea is to promote homogeneity of care. And when we talk about the bone genital care. Again, we have implemented similar protocols of brain folks assistance from large Nikki groups in brazil. About 200 nika bed's too small in distant places. So it's it's really, really interesting to understand how this works. So why don't we talk about PBS. F in brazil had this kind of results And again, this telehealth approach actually helped a lot very briefly. I'm just comment about some collaboration that we have with international studies truly like this one in India which is called the prevent study or prevention of epilepsy by reducing neonatal encephalopathy. The chief investigators DR and the sponsors Imperial College London. But I like the rationale, let's see in the world you have, for instance, 50 to 70 million people with epilepsy, 12 million lived in India. The incidence of collapsing low mid income countries is, you know, much higher than in high income countries. And the perinatal bringing accounted for the largest fraction of both pediatric and adult epilepsy in this country. So programs to improve perinatal care, low middle income countries may prevent a substantial proportion of epilepsy. And we're also helping with this telehealth approach In this study, which has been actually quite well, you know, recruiting has recorded over 20,000 models back there in three from three different sites in India. And very, very interesting. But again, this is telehealth and tele health collaboration for international research and uh also very important, we collaborate here with University of stanford at the US with I think for over six years now with many, many educational projects but we have to try is running now which is the multi center trial in 12 centers in brazil to improve the pilot of carrying babies with HIV and the pilot using uh multimodal monitoring approach aI tools and so on. But this is a topic for another talk in the end of the day. I kind of invite you, you know, to quite fast think outside the box. So basically so we're doing this, we're doing health approach assistance, some homogeneity of care. And we have now a big, big database from this baby. So of course this brings a brilliant opportunity, you know, for applying ai and machine learning algorithms to this structure. So what do you actually want with this? We want to you know to create accurate alarm systems, analysis of correlation of all monetary data. Again, opportunity for machine machine learning creation of new risk scores for brain injury. But the idea, you know, is using all that source to promote earlier and more accurate diagnostic of brain injury. And I will just briefly walk you through a case that actually made all the difference. And if you remember this case it was the kind of bento you remember we're here, the parents were in the ICU and you know, they got the terrible news and they knew benton needs needed specialized treatment. So what happened Bento required actually had this neuron eQ plus telehealth approach uh and also was monitoring some ai to us here, I kindly explain to you this, you know, for a baby to term infant with 24 hours of life. This was the E. G. Of bento, which was really, really good. The prognosis here probably would be you know over 95% of having no important neurological impairment. So actually everything was doing really, really well here with Bento but the Nikko is a dynamic place. And at 4 52. So around five a.m. In the morning a new pattern was diagnosed automatically by the system which is high, highs electric. So this turns into you know alert to our team. So I called the physician, the attending physician the bedside say, look, someone, something really, really bad happening to this baby. Go and check that. Is this a new seizure? No, this baby is not having a seizure. There is no brain activity. Go check. So he went, you know, and said, oh, Gabriel, the heart rate's good, the blood pressure is good, pulse oximetry is good and he's not moving. But you know, this should be because of a J. And said, no, something really, really bad is happening to this baby. Topless, the attention keep investigating. And he did an echo and this baby was having a pericardial effusion cardiac tamponade. A diagnosis that being a nanny Atallah gist, I might say that I think is quite hard to do if you're not thinking about this. You know, many times we only do after a prolonged cardiac arrest or even after death. Uh, so this baby of course received the treatment. So the more phone puncture and what is really nice. Again, this baby never had a cardiac arrest. And I may say that in less than one hour actually, this baby had the depression and the recovery of the brain activity. And what was the outcome? You know, this alarm that triggered, you know, for just maybe some minutes before the cardiac arrest. What does this discharge for this baby? He was charged with 10 days of life. He got a normal woman right here when he arrived at home seven months, nine months here. He's already walking, you know, and also helping the country's economy, which is also very, very important. Uh so again, how an alert system at five a.m. might have made a big difference in the outcome of this baby and this family. So to finish this presentation, I like to think that preventing neurological impairment can bring lots of benefits. Right? We know this is starting with the economic benefit by reducing the number of patients with neurological impairment. And this comes in more important in babies. There will also be a significant reduce in the directing the the costs of this population for the hospital designs, technology, intelligence and the remote into weight in the treatment of these babies at high risk. And the big thing here of course is the social impact that I truly believe about the importance of changing life histories, allowing more infants to fulfill their physical and cognitive potential. So in conclusion, strategies to reduce the chance of brain injury, implying reduction of mortality morbidity and cost. And from our point of view, this should be, you know, implementing a large scale not only in brazil but actually worldwide. So this is just uh success cases. I just would briefly tell you about this baby. Uh that was the very first baby that received cooling and bring monitoring in a region called Bashardost ista, in which I'm sorry, this is in Portuguese. But this is the news in 2016 basada Zanchetta had the highest infant mortality rate of the sample state. We started PBS. F project there in three centers in 2017. This was the first baby and actually centers which the largest city had the lowest in 2020 had the lowest infant mortality rate ever registered. And so again, this homogeneity of care is really, really important also on reduction of mortality rates. And it's quite nice because now in san paolo, our largest city in brazil, it became actual law. We have this brain protection program for prevention of neurological impairment babies, something like the B ball project that we saw in UK several years ago. This is a big victory for the project itself. This is our reasons why of course this is why we worked so hard and in the end of the day I we went with this this quote from Anton lake, former executive director from UNICEF, where he says, you know all this is a big challenge. We are here today because we face a huge challenge. But his line is just perfect. He says somewhere a child has been told he cannot play because he cannot walk or another. She cannot learn because she cannot see well that boy deserves a chance to play and how we always, that's the most true, how we benefit when that grow and our Children can read learn and contribute the path forward will be challenged. But you know what? Children do not accept our limits. There should be thanks so much for your attention. Created by