debate 2 audio-esv2-50p-bg-10p-music-10p
===

Speaker: [00:00:00] All right. This is the second ACS debate. It is also scheduled for one fall, and I expect this to be a good one. Resolved: Roboa is life-saving. Now, introducing first and fighting out of the pro position, a relentless advocate for innovation, hemorrhage control, expensive bourbon, and good barbecue, coming out of Houston, Texas, Dr.

Brian Cotton. And, uh, hold on. And across the aisle and fighting out of the con position, calculated, composed, ready to counter, a military hero and a legend, Dr. Marty Schreiber out of Portland, Oregon. Same, same rules apply. Same rules apply. Fifteen minutes each at most, and then we'll have a little rebuttal [00:01:00] period.

And like they say in this great town, let's get ready to rumble

Speaker 2: All right, good morning

So again, we are all at our essence, at our core, blood doctors. We get blood and we stop bleeding. And again, hemorrhage is the problem that ROBOA addresses. Uncontrolled hemorrhage is the leading cause of preventable death and trauma. We all know that. And you can get better control with the right tools.

You can see one of my sons here is gonna live with the tourniquet. One of my sons is gonna die with the Elmo doll tied around his leg. And in case anyone has any doubt, I am the tourniquet and Marty is Elmo

So it's absolutely not a definitive treatment, but it is a great bridge to hemostasis. Reducing r- uh, he-hemorrhage, it's gonna restore coronary and cerebral perfusion pressure. It's gonna buy you time to get to the right place, which is either IR or OR, depending [00:02:00] on where you're dealing with it. Bottom line, it treats what we need, and it takes a physiologic insult away.

It's immediately and predictable on its ability to take care of per-perfo- uh, perfusion centrally as well as coronary and cerebral blood flow, and it can be the difference between a salvageable and unsalvageable patient. It can take you a patient that is dying en route to the OR versus someone that is at best alive and at worst in extremis.

It's less invasive, m-more than an ED thoracotomy and a cross clamp, and it's performed percutaneously with reduced exposure to body fluids and minimizing procedure morbidity, which should not be discounted. Lots of body fluids going around when Marty's doing an ED thoracotomy. Re- da-da-shh. RBOA offers similar proximal control as well with less anatomic insult, and again, we don't want to be debriefing with Schreiber in the corner after a failed ED thoracotomy.

Again, the current versions are much, much safer, a lot less obnoxious than the ones that were, like, as long as this table back when they initially came [00:03:00] out, the giant wires. Now it's a small little sheath, four to seven French profiles, a lot easier to do ultrasound, guided access, partial and intermittent RBOA strategies.

Hell, we even let ER and, and OB place these things, so it's really, really low profile and easy to get into Non-compressible torso hemorrhage. Again, profound hemorrhage, refractory to initial insults and in imminent arrest. However, these catheters should only be used in settings where definitive control is available and not for transferring patients as the UK Roboa study.

Then that's where it failed. It was used selectively, though Roboa can overcome these things in otherwise fatal trajectory into a survival trajectory. Again, aortic zone three is what I'm talking about here. I'm not talking about getting silly and going to zone one. God bless Deb Stein, love her like a sister.

However, that's stupid. Zone three is where you need to be. Zone two, you never wanna be in. Life-threatening OB gyn hemorrhage. This is where we've seen it person-- personally seen it at [00:04:00] our hospital, saving women's lives and turning that obstetrical disaster into a controlled situation. You got a lot of high-end in real estate down there, a lot of blood vessels down there, and this can take care of a, of a lot of that bleeding until we can get some actual hands in there and get control of the blood loss.

With the Accretas, it has changed the game at our h- place from a crashing multi, multi cooler transfusion into our ICU to one where we put a Roboa sheath in after the, after the, uh, epidural's placed, and then when they call us, if they get into bleeding, we just slip the Roboa catheter right in there.

Does take seconds, and it's truly, truly helped with a, with these Accretas in our settings. Again, very dense, rich blood vessels down there, whether it's from OB hands, OB hemorrhage, or whether it's from a pelvic fracture and things like that, this is a game changer. Again, you can have all these things, and you can look like Marty over here, like Edward Scissorhands, and be going after and trying to get control and flailing, or you can put something nice [00:05:00] and simple in and get r- uh, control of it with a Roboa catheter.

You could have all this blood loss or again, get control when you have the opportunity. Rapid, uh, common femoral artery cannulation, deploy it really quickly. Femoral access can be achieved again and Roboa deployed very rapidly. It's something we, again, we do quite a bit on the, on the OB side of things, not as much on the trauma side, but man, our OB, it has been a massive, massive game changer And then again, let's get into the ROBOA, uh, study from the UK.

Absolute disaster. Absolute disaster. Glad my name's not on it, but a pragmatic Bayesian design randomized controlled trial, sixteen different UK trauma centers. Um, and again, if Brohe was here, I'd put trauma centers in quotes, but Brohe's not here, so I'm not gonna talk shit out him behind his back. Um, a total of ninety, whopping ninety patients, which is I think what some of us see in a weekend, uh, coming through in hemorrhagic shock for randomized standard of care with or without the addition of a ROBOA.

[00:06:00] The study spanned almost five years during which significant changes occurred in resuscitation of these patients, and it likely impact that in addition to an evolution of the ROBOA catheters available. So all-cause mortality in both groups was actually higher than most reported studies evaluating similar bleeding patients.

Uh, and again, you'll see that with TOWER and SWIFT and these other studies that are coming out of bleeding patients. This fifty-four percent in the ROBOA arm, forty-two percent in the standard of care arm, both of which are extremely high and kinda outliers Again, sixteen different trauma centers, whopping ninety patients, almost five years.

So there's a lot of stuff going on to unpack as well. Forty percent of the ROBOAs were simply just had an arterial line placed. So of course, you're not gonna get much of a difference there. Unfortunately, a lot of those needed the catheter deployed, but they only got the sheath placed. And then among those with catheters placed, only forty percent, uh, had, uh, or over forty percent only had partial inflation of it.

And the authors argued again that clinicians likely determine the balloon would no longer be ava-- [00:07:00] uh, intervened. But again, if you're gonna buy an intervention on a randomized control trial, you gotta follow through with it. And again, so it wasn't truly tested in this study. Another concern, again, which can be addressed as well, larger cohort.

Despite randomization, there appeared to be more severe head injuries. We noticed that in one of our st- randomized trials we did, where we had a, weirdly enough, because it wasn't a powered large enough, it was only about a hundred patients in our study, that the head injuries were disproportionately in our intervention arm.

So it can and does occur without a large enough size trial. But again, at the end of the day, just like Cryostat-2, if you're familiar with that, the enemy was time. Time from injury to hospital exceeded ninety minutes in both groups. Ninety minutes. Once randomized, it took another thirty-two minutes. This should take five at most if you've got a hemorrhagic shock patient, and that's if the resident's doing it who hasn't done one before.

Finally, time from randomization into definitive control was an eighty-three minutes, and the ROBOA arm was [00:08:00] sixty-four, uh, uh, versus sixty-four in the standard of care. So there was a lot of flailing going on. This is what happens when trauma surgeons are not, for the most part, running the trauma resuscitations.

It's run by, uh, the EM specialist over there and not us, so I don't know what kind of shenanigans were going on there. The study also suffered from, again, delays in delivery of care and in interventions, and the negative results come as absolutely no surprise, and I'm sure Marty will attack it as well he should.

Uh, minutes count, and again, in the minutes in that pre-hospital setting were absolutely huge and likely limited any potential benefit for ROBOA. Again, in, uh, looking at earlier time to hemostasis from Ryan Chen-- from Chang, who d- uh, worked with us at, at, uh, Houston, looking again that every fifteen-minute delay in getting hemorrhage control is associated with increased mortality of three percent, every fifteen-minute delay.

So again, applying this and ignoring, again, all the crazy pre-hospital time, you could easily see the potential benefit [00:09:00] of randomized product being completely erased by how much time they spent messing around, uh, down in the ER on the r- on, on the ROBO, ROBOA trial. And again, in trauma, as in life, i- its time is life and death.

So again, should we stop the bleeding or should we start letting Marty just keep flailing around? Well, let's dissect this out and let's look at it. And if you're a visual learner, hopefully this is one way you can understand this. We're gonna figure out exactly how we need to take care of bleeding in this.

And I'm not gonna get my video. This sucks. I had Edward Scissorhands going to town, bleeding loss, and me with a little balloon and no blood loss. But I'll leave you with this with some minutes to spare. This is, you know... I mean, I, I won the debate before I started, but this last slide, again

Speaker: There's a, there's a lot of material on that last [00:10:00] slide. I've got to be honest. We're coming back to that in just a few minutes. Uh, fighting out of the Khan position, Dr. Marty Shriver

Speaker 3: All right, Whiskey Tango Foxtrot, Cotton Not only is roboa associated with more death, more morbidity, but it's also associated with chi chi, and I think many of you in the audience know exactly what chi chi is. So as Dr. Cotton just showed you very, very nicely, no good data support its benefit. He did show one paper that, that shows that there's a survival benefit with roboa.

He, he attacked it, but showed no paper that showed any benefit of roboa. M- most data shows increased death and morbidity. The papers written-- Or there's, there are papers written on roboa that sho- solely talk about complications. When you start having papers about-- that are just about the complications of a procedure, that is a big [00:11:00] problem.

Use is not increasing. People aren't getting better outcomes with roboa despite the technologies that was just, uh, stated. Maybe in the future it'll get there. It is not there now, and I'm gonna show you why. Now let's talk about, a little bit about Brian Cotton. Brian Cotton is a professor. He's been a mainstay at the University of T- of Texas.

He is a research expert. He is a scholar He's a philosopher, and his philosophy gets better after a few beers as he's talking to the young residents and fellows. He's a political savant. He tells us the purpose of government is to build roads and to protect us from our enemies. That's it. Now, I work at an Army hospital.

I'm next to the Joint Base Lewis-McChord that has the Seventh Infantry Division and the First Special Forces Group. But if that China, if that balloon goes up and China attacks us, [00:12:00] I'm going to Cotton's house, because he has more armor and weapons than that entire army in Joint Base Lewis-McChord. Believe it or not, it's true.

All right. What do our organizations tell us? American College of Surgeons, American College of Emergency Physicians, they came up with a consensus statement. Look at the first thing it says, "No current high grade evidence clearly demonstrates roboa improves any outcome." They go on to say some other very interesting things.

"Roboa will be uncommon in most settings," because no one wants to put it in because of all the complications it cause. "After initial training, there should be ongoing competency program. There should be simulation and cadaver labs. There should be BEST courses and asset courses. There should be a strong quality management program at each institution because of all the complications."

What other procedure do we do that the American College of Surgeons recommends all of this regulatory stuff? [00:13:00] None that I'm aware of, Dr. Cotton. Now, let's get into the data because Dr. Cotton failed to show any data positive. I'm gonna show you all the negative data. A lot of it comes from our good and reliable and extremely brilliant colleague, uh, uh, Bilal Joseph.

This is the first paper, TQIP analysis. Looked at roboas placed within one hour of admission. The roboa was matched one to two to no roboa, and they used propensity score matching to ensure the patients were equally matched What does it show? Patients who got ROBOA increased renal failure, increased amputations, increased death.

That makes me really wanna put it in, Dr. Cotton. How about this pelvic fracture group? Dr. Cotton referred to, to the zone three patients. You're gonna put up a zone three ROBOA, patient's massively bleeding from a pelvic fracture. It's gonna save their lives, right? Well, let's look at those data. We looked at- this paper looked at another TQIP analysis, looked at pelvic fractures [00:14:00] receiving more than four units of blood in the first four hours.

They looked at the available interventions, pelvic packing, angioembolization, or ROBOA, and did a stepwise regression analysis to control for severity of injury and match the patients. What does this show? Angioembolization patients did the best, pelvic packing patients d- did second best, and for all indications, the patients who got ROBOA did the worst.

They were the most likely to die. Tough to argue, tough to argue. What about our Chinese colleagues? What do they think? Well, our Chinese colleagues, turns out, are pretty smart. They did a meta-analysis and looked at all the papers that have been written on ROBOA used for hemodynamically unstable patients.

What does this show? Angioembolization. You see everything over here to the left on the odds ratio less than one, angioembolization associated with improved survival. ROBOA, every single [00:15:00] paper associated with increased mortality. Every single paper on ROBOA associated with increased mortality. Okay, here is a paper from the experts on ROBOA.

These are the people who developed it, who, who, uh, naturalized it. Laura Moore is one of Dr. Cotton's, uh, uh, very genius, uh, partners. Todd Rasmussen, Charles Fox, Joe DeBoa, all these guys, Megan Brenner, all of them. Here's a whole paper on the horrible things that can happen with ROBOA written by the experts themselves.

Now, A and B, look at those because, uh, these are the only ones where the ROBOA's in the right place, a zone one and a zone three Now how about some of the others? Here's C. This one's covering up the renal arteries. That's why the patients get more, more, uh, renal failure. Here's D. This one's bouncing off the aortic valve.

Oh my God, Houston, we have a problem. How about E? This one's going down the internal [00:16:00] iliac. That's not gonna help anybody. How about F? This patient has a torn aorta, now we're putting an aorta, blowing up the balloon, and we're gonna blow up the torn aorta. Oh my God. And how are we gonna know if the patient has a torn aorta when we put this in?

Very dangerous in blunt trauma patients. Let's look at some more. Here's a, here, here A, this patient has a gunshot wound, the REBOA goes out through the hole in the gunshot wound. These are the experts. How about, how about B? This one's going in the carotid artery. How about C? This one goes in the subclavian artery.

How about D? This one's going in the aortic arch. These are the experts doing REBOA, and look what they're doing to people. I'm surprised they even wanna go up there and say we should do it. Here's another paper, Megan Brenner, foremost person that wants to do REBOA. This is a very nice paper that shows exactly all the horrible things that happen when you go into REBOA, and it does it very systematically.

Number one, what are the physical, the physical problems of placing the REBOA into the, to the [00:17:00] femoral artery? Pseudoaneurysms, thrombosis of the femoral artery, compartment syndrome, amputation. All in this paper. How about the complications of the placement? I just showed you all of those. And then it goes on to talk about ischemia reperfusion complications, which are severe and develop into multiple organ failure.

Written by the experts. That's what it shows. Remember, you didn't see a single piece of data from, from Dr. Cotton, let me just point out Now, the argument is we're gonna get better at this, it's- the use is gonna spread, and survival's gonna get better. So this study looked at that. Do we do that? Is that what happened?

Well, REBOA utilization went up starting from 2017, but then tapered off 2021, 2022. That's what it shows. Now, how about the outcomes? Have they gotten better? No. In fact, you can, uh, you can see slight decreases in survival over time. We're not getting better at this. The technology has not improved. We are not getting better [00:18:00] outcomes, so throw that argument right out the door.

Here's the UK REBOA. You saw it presented in a very biased way. I'm gonna present it to you in, in an entirely unbiased fashion, okay? Randomized trial, multiple centers, highly intelligent U- UK individuals. These people, uh, you know, we all came from, from, uh, from the UK. Now, it's pragmatic and randomized, exsanguinating torso trauma.

They did standard of care versus standard of care plus REBOA. That's probably the best way to do this study. Primary outcome, 90-day mortality, Bayesian statistics. The patients were well-matched for injury severity, types of injury, mechanisms of injury, uh, and essentially everything that's important. What does this show?

It shows that if you put a REBOA in people, you are more likely to kill them than to save them. Here's the survival with REBOA, and, you know, and so Dr. Khan said all those things. Does all of that really matter? [00:19:00] In this study, if you put a REBOA in a patient, they were more likely to die. This is a randomized trial, okay?

Yes, it has limitations, but if REBOA was such a magical, beautiful thing, shouldn't the REBOA patients have done better? Really, just ask yourself that question for a second. So in conclusion, REBOA, high complication rates, high mortality, high morbidity. Other options, angioembolization, pelvic packing, have better outcomes.

Those are also demonstrated to be better than REBOA. It is clearly not ready for prime time. The future of REBOA is unclear, and yes, maybe someday it'll get better, but not today, on this day when we have our debate. Thank you.

Speaker: I have to be honest with you, after expecting a debate from two of my heroes and watching neither of them take one real punch at [00:20:00] each other, I'm kind of disappointed in that. I mean, I was trying to figure out how to commandeer the monitors and put video of Marty dancing and some other incriminating shit about Brian up on the screen, but I couldn't do it.

All right. Um, Brian, just by way of rebuttal, uh, just in a minute or less, uh, anything that you want to add to the conversation at this point?

Speaker 2: Yeah. So again, you, you saw three T-QUIP studies. Again, T-QUIP is garbage. Uh, it's a very... I mean, it's overused, it's abused. It's supposed to compare centers, not patients, and people like, uh, Bilal and others, again, friend of mine, but still, uh, the T-QUIP stuff is garbage.

And you had three surveys of the same damn patient population looking at Raboa different ways, and obviously you're gonna have the same results. I would also say that the T-QUIP studies that are done were done off the old catheters. The newer catheters are much easier to get in and much less morbid, a lot less complications.

We absolutely had a ton of complications with the [00:21:00] older ones, so I think that's all the old data. And then finally, at the end of the day, it's kinda like Marty's paper he was talking about earlier in the week about PROMPT and FAST exams, how FAST exam sucks. Well, maybe it's you. Maybe you suck at doing FAST exams.

And so Raboa, if you suck at it, it's gonna suck. If I did a robot- robotic gallbladder, I'd probably kill the patient. I've never touched a robot before. I suck at robots, so I ain't gonna worry about it. So that's, that's... Yeah. Do better, so...

Speaker: It--

If you suck, it might be you. That's, uh, another quote from this great debate Marty, question for you. I think one of the points that is, is, is really vital that you made is that grownups vote with their feet. Trauma surgeons vote with their, and institutions vote with their dollars in development and tech- you know, in, in new technology.

Five years ago, I was like, "Man, we, we need to drop some money in this company [00:22:00] and invest in this," and that would've been a mistake at this point. I don't think that would've come back in, in, in what, what we want. So, so wh- I mean, why don't you think we're further along in the development platform?

Speaker 3: Well, I mean, I think, I think the issue is that...

Okay, let me, let me tell you a little story. So Brian says I suck at Roboa. So the truth of the matter is that I was very excited about Roboa. I thought it was gonna be great. I really liked the idea. Um, so we got Roboas at OHSU. We all had the training from the Pride Time people came, showed us how all to put it in.

I was revved up. I'm like, "I'm gonna get this pelvic fracture patient. The IR guys aren't gonna be ready. I'm gonna put this Roboa in. I'm gonna... Instead of doing ER thoracotomy, I'm gonna put..." Well, we had them for three years, and not a single one of them went in. And, you know, it's me and all of my partners, you know, we didn't put it-- we-- Actually, one person tried to put one in and it didn't go in properly, just like, you know, all those misplaced Roboas I showed you.

[00:23:00] And then Pride Time said, "We're gonna increase the price." And we said, "No, we're not gonna buy more catheters that are gonna be more expensive. We're not putting any of these in. We're gonna sell them and, and buy an exercise bike to put in the call room." And that's exactly what we did. We took our catheters.

Now they became useful because we got an exercise bike out of it. So that was the only use that we got at our institution. So, so do I suck at Roboa? Probably, 'cause I've never tried to put one in because I never had a patient that meet, that met the criteria. Now, f- I think what happens is people get really excited about the technology and they wanna put it in, and they're gonna start putting it into patients that don't really need it.

But, I mean, bottom line on this debate Dr. Cotton has not shown you a single piece of data supporting the use of Raboa. Yes, he, he states T-quip's no good. He says randomized trial's no good. Um, Dr. Cotton, why don't you write a paper so that you could come here next year and show us how great Raboa is? You write a lot of papers.

[00:24:00] Why have you not written a paper showing how great Raboa is? That's my question to you,

Speaker: doctor. Now, now we're, now we're talking. I can tell you this. That, that's what I was looking for earlier, okay? I'm glad we're awake now. One, uh, note from the moderator's podium. I can tell you this, uh, and I'm not gonna jump in on this debate, but the first one that got put in at Parkland when I was the TMD, uh, proved, uh, without a shadow of a doubt that a Raboa catheter in the vena cava does not improve your outcome.

All right. Again, this is an audience participation- You suck at the vlog. Uh, yeah. Yeah, it's definitive. Uh, for sure. Uh, all right. If you are voting for the pro position, Dr. Brian Cotton, please raise your hand

No, no. No, no, I said if you are voting for Brian Cotton, go on ahead and raise your hand. Hey, listen man, I'm gonna be honest with [00:25:00] you. You would've got- Hold on, hold on, hold on ... you would've gotten

Speaker 2: those

Speaker: results- Hold on ...

Speaker 2: before I presented.

Speaker: Hold on. I'm running shit here, okay? But I'm gonna tell you this, I- we've been doing this a long time, okay?

We, we s- this is a trendsetting meeting. It teaches people how to do things, and what happens here changes the world. But I'm gonna be honest with you, I don't think I've ever seen anybody get blanked- ... here yet. So just to make it official, if you're voting for the con position and Marty Shriver, please raise your hand.

Speaker 3: So, so let me just say one other thing. Uh, obviously you know Dr. Cotton and I are good friends, and, uh, Dr. Cotton wasn't happy to have to take this position. So-

Speaker: Hey ...

Speaker 3: just so you know, uh, he took one for the team and fell on his sword. So- So let's give Dr. Cotton a hand.

Speaker: Sometimes that's the way it-

Sometimes that's just the way the cookie [00:26:00] crumbles here. All right. Thank you very much