Transcript Video Temperature Control in ECMOProf. Bruno Levy < Back to Boundaries of Temperature Session 5: Control Temperature Control in ECMO Presented by Professor Bruno Levy Ladies and gentlemen welcome to the next session. It's a pleasure to announce Professor Bruno Levy. He's the head of the cardio medical surgical division and head of the intensive medicine resuscitation department at the institute uh to and he's the P. I. For the hyper ECMO study and is presenting now for the first time. The results we are reluctant. Please thank you very much. So good morning. During the next 20 minutes. I will discuss the place of moderate hypothermia during via ECMO my disclosure and as you know moderate hypothermia as many cardiovascular effects. The first one is a decrease in art right which is proportional to the decrease in temperature, decrease in cardiac output. Which is also proportional to the decrease in our trade. Generally not change or moderate increase in arterial pressure at least in animal models in an improvement in cardiac contracted itty and decrease in myocardial oxygen consumption which is higher than the decrease in cardiac output. So why use why propose during V. I. For this many reasons. The first one is that in civil cardiogenic shock shock is a society did with injuries And the patients treated with a more likely as the most civil ischemia injury. And as you know a proxima. Typically 50% of the patients with Catholic shocks at the cardiac arrest. The properties of hypothermia are well known and the right part of the slide. You can see this was for the brain but this was also may apply for all organs. First of course brain protection. Second the prevention of the mitigation of organ injuries and first we hypothesized that hypothermia may improve cardiac and vascular function. And we also have to take into account the potential side effects of to many and increased risk of bleeding and increased risk of infection. What we know about hypothermia during catatonic shock patients not treated with V. A. ECMO is presented in this slide. It was a study published by older teams teams and it was published in circulation. They investigated the place of moderate moderate hypothermia versus Normal Tamia in 40 patients with cardiogenic shock after myocardial injury. The main endpoint was cardiac power index. And as you can uh sorry. As you can observe on the slide there was no differences for cardiac index and no differences for those norepinephrine doses. But they used during the registration but this study of course was not powerful mortality and the study investigating only the cardiac properties of but not the potential properties on profusion. So the ECMO ECMO is not a cardiac assistant. ECMO is a secretary assistant. And as you know during the ECMO the blood is rain through the vina vina cava goes to with a pump to amount brain blood is oxygenated. The cashbox elated and written to the body through the common iliac artery and the effects of via eight more are in increasing blood flow to the organs via Aston Organist Kamiya and decrease chuck stated information as you can observe here chuck is associated with ischemia information production of inflammatory mediators at least two ways the pressure, the use of and organ failure and death and is elbow in the most favorable cases to decrease all this vicious cycle. So there is also many pathway in which hypothermia may improve the productivity of the patients during cardiac resuscitation during cardiac picture during cardiac arrest during cardiac arrest. And of course also after uh cardiopulmonary bypass. We also perform model animal an animal models of catatonic shock that was treated with ECMO in pigs. It was a skeptic model and we compare moderate hypothermia to normal Tamia and we found that for the same global pressure the same form blood flow but was associated with less read less norepinephrine, faster elected clearance, better cardiac function and better vascular function which is expressed here in this slide here is we use incremental doses of norepinephrine and we measured the mean arterial pressure and we found that pigs treated with hypothermia as better answer to one compared to the pigs treated with normal. So we perform randomized controlled trial which was published in the february issue of the Jamaat. Was called for hypothermia during V. A. ECMO. The design was very simple patient were included the six hours after initialization and we designed two groups. The first one was moderate hypothermia group, moderate hypothermia was defined by the temperature between 33 and 34°. We used the exchange of the ECMO device to decrease or To increase the temperature. After that the patients were re Rome they will point to the hour during a period of for 48 hours. And after that normal Tamia was maintained for a total period of 96 days for the normal group. The temperature was maintained between 36 6 to 46 for patients with cardiac R. S. And 36 30 between 70 37 degrees for the over patient. And the normal Tamia was also maintained during 96 hours. And as you know also which is an attentional society for more recommendation is currently to maintain normal Tamia in these patients. The primary endpoint was 30 days mortality and we also use many secondary endpoints. The first one was a composite endpoints which we may call the major cardiovascular events which Is was composed of death, Cardiac Transportation struck or escalation to level two side device and we measure these events are 3060 and 180° and a lot of secondary endpoint. The statistical analysis was classical. Please have a look at this part. This part was after a look of the statistician run out of the jam. It was post hoc analysis and he asked to calculate the risks difference and we also performed a analysis. So it was a multi center randomized control trial National wine Study. We included all the french University ECMO Catholics truck center. The including very simple, we included patients. We've intubated of course with chuck treated with a more or less than for less than six hour. We also have some non inclusion criteria. The first one was out of hospital hospital revelatory, Kadak. Our rights. We need some cpr for example. ECMO for L. V. A. D. Or our transportation and controlled breeding despite medical authority. Ical treatment acute poisoning with toxic drugs such as beta blockers and cardiopulmonary resuscitation, low flow area than 45 minutes. You can see on this part of the charter. And the reason for the non exclusion. And the majority was one and more than 100 patients that were non incubated. And some patients after our transportation uh and categorization other than 45 minutes. And we included 168 patients in a proxima tiddly. In each group. The ideologies of catatonic shock were very classical are for the patient and the ischemic cardiomyopathy. So myocardial infection in a proximity re 35% of patients. And then My party some important part of Rick Nicholls Party. And please note that we also included approximately 15% of the patient immediately after open chest surgery. The characteristic of the patient depicted here, of course 11 regular ejection fraction was very low patients were in the state of lactic acidosis with I see control organ fairy score and many were treated with Some of the patients were not treated with the pressure here because they were win from the pressure after more insulation. But before all the patients were treated with this operation and I know Trump drugs and please not that and this is classical. But 47% of our patients in both groups experimented cardiac arrest before Marina. So the first important result is here is very very easy to maintain or to decrease the temperature in using the the heat exchanger or the enigma device. We never use of a device to maintain the temperature. So the decrease was very very fast. And uh we maintain the temperature. The temperature re roaming was classical and throw and we are able to maintain the temperature at 46 47 degrees during the less 48 hours. This is I think an important result. You can see on this slide visual abstract of gemma. And as you can observe if we consider the main endpoint, we found that 42% of patients of our patients died in the moderate hypothermia group and 51% of the patients in the normal Tamera group. So this is a true difference of 9% which was not statistically significant If we consider the uh critical analysis that we publish. But if we use the risk difference that was asked by the you can see that the difference is important but means 16 2 minutes 0.3. So this is a result. But the official result is this one and the P is 0.7 as you can observe in the premier here with I think a very important difference between the patients we also found that the use of hypothermia was associated with decreased incidence of the composite endpoint. As you can see at least during the first month. And the second important result for me and especially in this meeting is that in this situation hypothermia seems very safe. First we did not find any differences in the number of the patients that need transition and you have to remain invite. Approximately 50% of the patients were treated immediately after open surgery, which is a high risk bleeding situation in the patients who receive transfusion patient with received more blood than the patient. But uh but uh that were treated with uh normal and eight versus five. And we did not find any differences at least in the higher risk of infection in the model at hypothermia. On the contrary we found and this is a little bit surprising. Less bacteria mia in the group of the patients that were treated with hypothermia you can see on the slides uh results of the buyers and analysis. This is a little bit complex but if we consider for example, but We you don't have any informative probability was rather than 90% 4% which is elevated and in all scenarios probability of mortality benefit with hypothermia was higher than 85%. So this is also I think an important result might might be discussed and of course our study has some limitation due to the inclusion criteria for example. So we included only intubated and sedated patients. So this limits the applicability of fighting to stay seriously ventilated vocalization patients. We included all sorts of catatonic shock at least to a form of patients virginity. But as you know is not so it is not so common and as you know, 48% of patients at rest but all the survival of cardiac arrest in the study are in C. B C 12, which is not surprising And at least despite the fact that is the largest conduct today, we were likely slightly under power to statistically detect the 9% difference in mortality that we found. So the conclusion to part, the first one comes from the paper and was suggested by the Jama editor. The application of hypothermia for 24 hours did not significantly increased survival when compared to normal. But however the 90 50 person confident confidence interval was wide very wide and included. Important surely important effect size and these findings should be considered and conclusive And moderate hypothermia was a society with a lower risk of the composite input at 30 days and was associated with more days alive and without organ dysfunction. Original replacement therapy and the race of hemorrhagic and infections even were similar in the two groups. So since it's the largest city on ECMO via performed to date and this is important because ECMO used during caloric chuck is still increasing what right it is now very urgent to determine the best approach to optimize such promising therapy and comparatively to new drugs or to device regions. When we use hypothermia with the more it's inexpensive because the device is included in the device is very simple to implement in real life. Not but the temperature management. And so the cost for society in the situation is a core when compared to via normal we did not find any major safety concerns and the poster by that analysis is in father of hypothermia use. So for me, it's a negative study with very, very positive end point. So my personal conclusion is that inactivated extract patients, an early use of moderate hypothermia appears to be safe and is likely associated with a clinical benefit. Of course, the TTN protocol and the non inclusion criteria that we use in the student should be respect and of course this is a general recommendation station should be the lightest as short as possible. We have to avoid political agency as possible and the neural identification remains essential and should not be delayed. Thank you very much for your attention Created by
