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Clinical Confirmation of Profound Improvements in ...
Clinical Confirmation of Profound Improvements in Neuro-Intact Survival Using the Head-Up CPR Bundle
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to neuro and tax survival using the HeadUp CPR bundle. First of all, I just want to thank you all for listening to this and more importantly, thank you for what you do on a day-to-day basis, especially the last two years. I also want to thank these incredible team of international investigators and who really carry the workload on a day-to-day basis. And then we're going to mention later these three statistician, this is an international group. This guy's from France, we got Australia and U.S. involved and they independently gave us some really good advice that put us in the right direction here. This may be deja vu all over again. Many of you know about the principles of this, but it's just in case I'll go through it. But for everybody, we're really going to have some compelling new outcome data. This is our first look-see and it's really, it's a good signal here, you'll see. All right, so first of all, I'm going to be talking about a lot of devices and I have no conflict of interest with any of them. And the only disclosure I have is that I'm not a morning person. So I'm really glad that I was able to do this and record it in the evening here. All right, here we go, let's get going. And fasten your seatbelts. So as an introduction, CPR as we've known it for the last six decades, clearly saved lives and AEDs also add something to that, particularly in some public settings. But the problem is that most cardiac arrests are not shockable rhythms, 80% are not. And asystole, those remaining cases in PEA have very poor prognosis. And overall now, even in some of the best systems, survival odds with good recovery remain less than 10% in most US 911 systems. So then, people say, why? Well, some have pointed out that, well, things that work together in the laboratory, we were able to prove them, they didn't turn out right in clinical trials. But then again, one of the things we said about that was that there were a lot of confounding variables. One of the things about cardiac arrest studies is that there's so many things that affect modifiers, quality of CPR or results, ventilation, timing of various interventions, and just really lack of control. I think the term randomized clinical trial is kind of a misnomer. It's really randomized uncontrolled trials out there for the most part we've learned over the years. And that was always their biggest proponent to do clinical trials. But perhaps I think relevant to today and more aptly are the physiological limitations of conventional CPR itself in the supine position. So no one is a bigger proponent of CPR and I've recommended it for everyone to know how to do. But the problem is even if it's performed optimally, there's limitations physiologically. A supine chest compression not only increase our chill and venous pressures at the same time, but they create sort of an increased intracranial pressure when that happens. So as a result, cerebral performance is not as good. So it's more difficult to get blood in, arterial blood up into the brain and more difficult to get venous blood out of the brain, et cetera. So there's that physiological limitation. Well, to get around that, the first step we have taken or not the first step, but one of the first steps was the use of something called the impedance threshold device, the ITD. I'm not gonna get into how it works, specifically just know it's an airway device and that during the recoil phase of CPR, as chest wall expands and air rushes in, this basically impedes the airflow. So it delays the negative intrathoracic pressure of the vacuum that helps pull more blood in. So it helps pull blood out of the brain and therefore you have a little bit better circulation going out as well. And it's interesting because there was actually a study done 15 years ago where they went out in the field, they went out and took patients and actually put arterial lines in and they measured blood pressure during conventional CPR. And what we have known is that conventional CPR, even in an optimal situation, usually only gives you a 15, 20, maybe 25% of normal flows. And what they found here with the ITD and the comparison is interesting because they used a ITD that were activated and half of them were inactivated. And it was nicely blinded, very elegant study. So you had sham valves and you can see the differences in blood pressure when they did this right 14 minutes of ITD use. Well, when you put the ITD together with this, which is like a toilet plunger and it works like this, is active compression decompression device, not only pumps blood out, but then of course you see on the recoil, it enhances the recoil and you pull more blood in. So now you've got two devices that are actually helping to pull blood out of the brain and back into the chest and therefore get better outflows as you go ahead and do this. So in the supine position using this approach, combination of the active decompression and ITD, Lancet clinical trial, 50% improvement one year later in terms of neurologically good outcomes. Well, what's the next step? Well, we took a lesson from you folks, these smarties in the ICU that knew, especially in neurocritical care that draining blood out of the brain is a good thing to lower intracranial pressure. Well, since that's part of our issue, we actually made sure that you looked at the combination that's important of the ITD and the active compression decompression here using a lupus device to do that mechanically. And by the way, we've shown that putting a head up itself right away like that is actually can be harmful. So having this bundled together, it really is actually what it's all about. And this is maybe one of the most important slides I'll show. This here is showing the group of animals that before cardiac arrest, they're put into cardiac arrest and then standard CPR here shown and that eventually the cerebral perfusion pressure is obviously a lot lower, but it kind of falls off as vasodilation takes place, you're losing arterial tone. Head up CPR goes a little bit better, but still falls off. But we already know that active compression decompression device, ITD supine, actually saves lives clinically, let alone here in the laboratory looking better. The most important part is that when you put them all three together, the ITD, the ACD and the head up, it's not additive, it's synergistic. You have three different mechanisms that get blood out of the brain and into the chest and therefore you have much better flow. And this is so impressive and I think that's the key that this bundle is synergistic and you need them all and you have to do it in a sort of precise manner as well. So the next phase in our research address that, we were looking at fine tuning this, like how soon do you raise that? How do you raise the head? And one of the things we found is if you gradually raise the head over about two minutes, after two minutes of performing ACD, ITD CPR, you got the better performance here. So this is a prototype device we used in a laboratory, automated head up torso up position device. It's now FDA approved. I'm not sure what the brand name is, but I have no conflicts with them. But all these things are actually FDA approved at this point in time. But going back to the laboratory, what we are doing now is not only getting better cerebral perfusion, but we were actually getting normalized, and these animals were doing really well, all coming back, neurologically intact. So it was really robust. And one of my messages is we really follow, and if you're in the laboratory watching this, it's really cool. So the gradual elevation of the head was the next step in all of this. That begs the question, what's the purpose of this study? Well, the study here was to see if such robust outcomes found in the laboratory could be translated to the clinical setting. And particularly with in terms of neural intact survival when you use this head up torso up bundle. And also if this translation could be accomplished without the need for an RCT. So here's the methods we used. An IRP approved registry was in place for all agencies using the head up bundle, and all the data were collected prospectively, routine outcome tracking, and so on. The protocol called for immediate application of the devices, but the question was when, and we did it after we applied the device, but then we did not elevate the head for a couple of minutes after we did priming with the ACD and ITD, and then the AHEP device gradually elevated the head over another two minutes with the oxygen rising to about 22 centimeters and the mid thorax about 13. That's actually important because you get better blood flow through the chest because of the mechanics that way. Again, all our statisticians warned us to get doing a clinical trial here. They said, we're going to give you a more, you know, a more stringent way of doing this. We're going to give you a more rigorous comparisons by looking at a comparison with three large-scale NIH published clinical trials that involved over 5,000 patients that were treated in high-performing EMS systems. And that was the key to get into the studies you had to be. And these studies, these systems, these sites monitored, reported, and reported the quality of CPR. In fact, a priori, you had to have documentation of quality performance in your study site. It usually was NIH required. And one study site that we compared to only had shockable cases, et cetera. And so, you know, there's all these disadvantages in a sense that we put upon ourselves to see if this really going to make a difference. All right. So both traditional multivariate analysis of the 5,000 patient, the usual propensity scoring of four to one ratio was employed to account for the imbalances. We know the outcomes work really well with these various factors here. And so for propensity scoring, you know, again, each head up bundle was specifically imagined for conventional. The neuro-attack survival is defined as a modified Rankin less than equal to three or the CPC one or two scores. And by the way, again, all devices were FDA approved and the agencies though were quite heterogeneous geographically, sociologically, and also how they did their responses. So nice mix. And so what were the results? Well, regardless of the presenting EKG, early administration of this thing was associated with profoundly higher likelihood of neurologically intact survival. And the application, you know, was earlier you did it, the better the outcome, even among non-shockable patients. For example, the odds ratio for all patients, shockable or not, was threefold higher if you got there within 13 minutes of the time of the, not time on scene, but the time of the 911 call, the first receipt of that. And that's kind of typical. Usually this would happen around, you start CPR right around 10, 11, 12 minutes, but it was fivefold higher if you got it on board within less than eight minutes. And that's actually one of the more important findings here. Also the propensity scoring techniques and the multivariate analyses both provide the same corresponding results. So as you see here, when you're looking at our percent with good neurological outcomes, you hear all patients were hitting like plus 30% here. And then compared to the conventional groups, it just was really striking here. These are statistically significant. These are probably, eventually it'll be statistically significant, but we just didn't have enough numbers out in the group. They're, most of the responses are in this arena. The most important thing I think here is that we found out that if you, in these areas, usually these involve where supervisors or paramedic ambulances were taking the people to the scene. This is where the neighborhood fire truck was delivering it in those cases. And I think the important thing was it wasn't just that they got there faster, but they packaged them well in many of these places. And they also had like a pit crew approach. So when you opened up these backpacks that they were taking to get it there faster, they also, when they open it up, you've got everything done faster. And that was the whole point, not just get to the scene fast, but getting the application going really quickly. Same thing with shockable rhythms, but the most important thing I wanted to show you was non-shockable rhythms. And compared to our propensity match, you know, conventional CPR code, you can see statistics all the way around. And again, the earlier the intervention, the better results here, you know, approaching eight, nine, 10% here, neurologically intact, even though these are asystole PEA patients, et cetera. And what really hits me, I always say, what we found here is just like AEDs, this is the AED for non-shockable rhythms. And in fact, you have a wider range of efficacy here as well than you do with AEDs. Well, limitations are clear, small sample size, not a gold standard RCT, comparison data were several years old, et cetera. But we were worried about not doing gold standard RCTs. And despite the small sample sizes, the statistics are already very compelling. And we purposely compared against high performance systems that say we're getting, they closely monitor the quality of CPR. And these are systems that had comparable, if not overall better outcomes when compared to current national databases with respect to outcomes. Again, keep in mind, we were restoring normal values and we got some surrogate variables out there as well. It's not just these data. We're seeing end-tidal CO2s in the fifties, even with, you know, these asystole patients. And I think more compelling was that we had patients now that were reporting, they were remembering everything. We had to set up a sedation protocol. And so they, it really is creating a better effect In fact, one of the patients who was during his persistent ventricular fibrillation was remembering what was going on, could actually tell us. And he said, you know, you should call this neuroprotective CPR. And so internally, we actually do that. So in conclusion on the Lord to the 2030s, I'm just going to say that we may be getting back people we never got back before. And keep in mind, these are basic functions. It's not going to require invasive procedures. Yeah, a lifeguard could do it. Police officer and firefighter can do it. And the earlier the intervention, the better results. And with that, I thank you all for your attention here. And I'm Paul Pippi and I approve this message. Thank you all again.
Video Summary
The speaker discusses the use of the Head Up CPR bundle to improve survival rates in cardiac arrest patients. They highlight the limitations of conventional CPR and introduce devices such as the impedance threshold device (ITD) and the active compression decompression device (ACD) that help improve blood flow and reduce intracranial pressure. The speaker presents the results of a clinical study using the head-up torso-up position device, which showed a significant improvement in neurologically intact survival rates. They emphasize the importance of early application of the devices and the potential for widespread implementation by various emergency responders. The study provides promising evidence for improving survival outcomes in cardiac arrest patients.
Asset Subtitle
Resuscitation, Neuroscience, 2022
Asset Caption
INTRODUCTION: The modified physiological approach to CPR using head-up/torso-up (HTup) positions and adjuncts to lower ICP (and enhance venous return) clearly facilitates neuro-intact survival pre-clinically and markedly improves resuscitation rates in pilot clinical studies of out-of-hospital cardiac arrest (OHCA). The purpose here was to confirm improved neuro-intact patient survival (SNI) using this method. METHODS: Prospectively-collected data were obtained from a national AHUP registry in which 6 participating EMS agencies routinely tracked SNI for OHCA as well as T911-CPR, the elapsed time from 9-1-1 call to initiation of an automated HTup CPR device (AHUP) combined with manual (or automated) active compression-decompression and impedance threshold devices (all FDA-cleared). AHUP steadily elevates the head/torso over several minutes (occiput reaching 22 cm). For rigorous comparisons, conventional CPR (C-CPR) controls were derived from 3 large-scale published OHCA trials involving 5,330 patients from high-performance EMS systems including those that closely monitored, recorded and reported quality of CPR. Multivariate and propensity score analyses accounted for imbalances in characteristics (age; sex; bystander-witnessed; bystander CPR; shockable rhythm; T911-CPR (C-CPR or AHUP initiation). Each AHUP patient (n=227) was matched with up to 4 C-CPR patients (n=930) in propensity analysis. SNI was defined as achieving mRS3 (or CPC 1 or 2 in one study). RESULTS: Regardless of presenting cardiac rhythm, early initiation (T911-CPR < 20min) of the AHUP bundle was associated with profoundly higher rates of SNI vs. current published findings. Even compared to high-performance/highly-monitored EMS systems and stratified by T911-CPR, SNI differences with the AHUP resuscitation bundle became increasingly more significant than C-CPR with shorter T911-CPR (eg, SNI was nearly 3-fold higher with T911-CPR < 13 mins [OR 2.68; 95%CI=1.17-6.13] and nearly 5-fold higher [OR 4.74; 95%CI=1.40-16.01] if < 8 mins). CONCLUSIONS: The HTup CPR resuscitation bundle was associated with markedly improved odds of neurologically-favorable OHCA survival versus C-CPR even when comparing well-matched controls with closely-monitored CPR performance. Moreover, shorter times to bundle initiation further augment the odds of neuro-intact survival.
Meta Tag
Content Type
Presentation
Knowledge Area
Resuscitation
Knowledge Area
Neuroscience
Knowledge Level
Intermediate
Knowledge Level
Advanced
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Select
Tag
Cardiopulmonary Resuscitation CPR
Tag
Cerebral Blood Flow
Year
2022
Keywords
Head Up CPR bundle
cardiac arrest patients
impedance threshold device
active compression decompression device
neurologically intact survival rates
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