All posts by TheTraumaPro

REBOA: A Comparison Of The Hardware From Two Companies

I started off the week describing a study using a new version of the REBOA catheter (Resuscitative Endovascular Balloon Occlusion of the Aorta) that was smaller than the more commonly used one. Today I’ll put both side by side and describe the similarities and differences.

First, let’s start with the current market leader, the ER-REBOA catheter by Prytime Medical in Boerne, TX. Here’s a picture provided by the company:

And here’s a photo of the Frontline Medical Technologies COBRA-OS, based in London, Ontario, Canada. This acronym stands for Control of Bleeding, Resuscitation, Arterial Occlusion System. Now, REBOA is used by surgeons as a general descriptor for this type of technology. I assume that Frontline does not include REBOA in the name of this product since Prytime has incorporated it into theirs.

There are a number of similarities, as well as some key differences. Let’s start at the tip and make our way back to the syringe.

Catheter tip: Prytime has a trademarked “P-tip” which has a little extra curl compared to the Frontline’s flexible j-tip. The Prytime version is designed to “help reduce catheter migration and aid in positioning. Although a guidewire can be inserted into either to assist in repositioning, it does not enter the P-tip. And note, neither device requires a wire for insertion.

Arterial line port: This is only found on the Prytime device. This is located just distal to the balloon so arterial pressures can be measured above the catheter after inflation. This port extends through the catheter, terminating in a hub that can be connected to standard pressure transducer equipment. The Frontline device is too small to incorporate this feature.

Balloon: The Prytime balloon is a more standard ovoid shape. The company provides guidelines of 8cc inflation for Zone I and 2cc for Zone III. This can be adjusted based on confirmation of occlusion provided by the arterial pressure wave form. The Frontline device has an “ice cream cone shaped” balloon with the taper proximally and a “safety shoulder” to protect the balloon. The company claims that this design helps reduce the likelihood of rupture. The balloon will accept 13cc at maximum inflation. Since there is no arterial line, alternate means (palpation, ultrasound, or a transducer in the insertion port) must be used to determine degree of occlusion.

Markers: The Prytime device has radio-opaque markers at either end of the balloon, as well as length markers on the proximal portion of the catheter. The Frontline catheter has the same markers around the balloon, but only two large visible marks on the proximal catheter. These are marked for placement in Zone I (48cm) and Zone III (28cm) in average size patients.

Sheath: The Prytime product has a peel-away sheath that is used to cover the P-tip to straighten it. This unit is then inserted into the previously placed access port. Once inserted the sheath is peeled away after the balloon has passed the end of the port. The Frontline device does not have a sheath, but includes a reusable j-tip straightener on the catheter. This straightens the tip as it passes through the port.

Access port: These are included with both products and are inserted using typical Seldinger technique. Both have a side port for fluid infusion. The side port of the Frontline product can be used as an arterial pressure monitor. The port is 7Fr in the Prytime product and 4Fr for Frontline. This smaller size may decrease the incidence of vascular thrombosis or vessel injury requiring repair after removal.

Bottom line: I’ve described two different products that allow trauma professionals to use the REBOA concept. This evolution demonstrates the usual cycle of new product and feature refinement that we have come to expect in medical devices.

Is one “better” than the other? That’s probably not the right question. More likely, it will boil down to which one is right for a particular patient or situation. Only time, and lots of additional research, will tell.

References: 

  • Prytime Medical – www.prytimemedical.com
  • Frontline Medical Technologies, Inc. – www.frontlinemedtech.com

I have no financial interest in either of these companies

REBOA Size: Where Did The French System For Catheter Size Come From?

Medicine sure has some weird measurement systems. Besides the more standardized units like microliters, milligrams, and International Units, we’ve got some odd stuff like French (tubes) and gauge (needles). When dealing with tubes and catheters, the size is usually specified in French units.

Since I’m posting several articles on the size of REBOA (resuscitative endovascular balloon occlusion of the aorta) this week, I figured I would re-post this article on where the French sizing system came from.

Where did this crazy French system come from? It was introduced by a Swiss-born gentleman named Joseph-Frédéric-Benoît Charrière. He moved to Paris and was apprenticed to a knife maker. At the age of 17, he founded a  company that manufactured surgical instruments. His company developed and improved a number of surgical instruments, including hypodermic needles and various catheters.

Charrière introduced the system for describing catheters based on their outer diameter (OD).  It was actually named after him, and in France one will occasionally see catheters described in Ch units. Unfortunately, we Americans had a hard time pronouncing his name, and changed it to the French system (Fr).

So what’s the translation? The Ch or Fr number is the outer diameter of a catheter in millimeters multiplied by 3. It is not the outer circumference in millimeters, and the use of pi is not involved. So a big chest tube (36 Fr) has an OD of 12 mm, and a bigger chest tube (40 Fr) has an OD of 13.33 mm.

The Shrinking REBOA Catheter

REBOA (resuscitative endovascular balloon occlusion of the aorta) is one of the relatively new toys in our trauma toy chest. Although it’s been used for decades by vascular surgeons, believe it or not it only made the jump into the trauma world less than 10 years ago.

The original catheters used during the early days, and primarily in swine models, required a 15 French sheath for insertion. As might be expected, insertion of these huge sheaths into the common femoral artery can cause significant vascular injury. Equipment manufacturers have been steadily reducing the size of the REBOA catheter, first to 12 Fr and then to the 7 Fr size commonly used today.

The surgery group at the London Health Sciences Center in London, Ontario, Canada performed a pilot study of a new and much smaller sheath and REBOA catheter. It is made by Front Line Medical Technologies, also located in London. This was a proof of concept for the device and was performed in seven neurological death organ donors prior to their donation.

The kit consists of a 4 Fr sheath introducer with a 21 gauge needle and a guidewire, plus the REBOA catheter itself. Here is an image of the catheter:

This catheter includes several innovations not found in current catheters used in the US. I will do a side by side review of these later this week.

Here are the factoids:

  • Seven organ donors were studied after appropriate consent from the hospital IRB, organ procurement agency, organ donor procurement team, and family
  • A single general/vascular surgeon performed all insertions
  • A left sided arterial line using the 4 Fr sheath was inserted for monitoring before the procurement began
  • A right sided 4 Fr sheath was inserted for catheter insertion after the procurement incision was made
  • Average sheath insertion time was 48 seconds, and deployment time for the catheter was an average of 70 seconds (max time was 105 seconds)
  • Occlusion was confirmed by the left femoral arterial pressure monitor and by palpating the aorta below the baloon

Bottom line: This was a very simple study of the feasibility of using a smaller REBOA catheter. It measured both ease of insertion and presence of full occlusion. This is an exciting study, because there is the potential for easier insertion and fewer vascular complications at the insertion site. Obviously, these factors are not yet known, and only further work will make this clear. 

Nonetheless, easier and safer insertion has the potential to increase the use of REBOA. This will allow us to get quicker answers to the nagging questions about whether it is actually a valuable resuscitation tool and help us figure out how and in whom it is best used.

Reference: Size matters: first-in-human study of a novel 4 French REBOA device. Trauma Surgery & Acute Care Open 2021;6:e000617. doi: 10.1136/tsaco-2020-000617

Best of EAST #8: Reversing Antithrombotic Drugs After Severe TBI

Falls are the most common mechanism of injury at a majority of trauma centers these days. And due to the escalating number of comorbidities in our older population, more and more are taking some kind of anticoagulant or antiplatelet medication. And as all trauma professionals know, falling down and failure to clot do not mix well.

A variety of reversal regimens have been developed, including Vitamin K, plasma or platelet infusion, prothrombin complex concentrate, andexxanet, or idarucizumab depending on the agent. But when it comes to evaluating the efficacy of these agents, there are two important questions that need to be answered:

  1. Does the regimen reverse or neutralize the offending agent?
    and more importantly
  2. Does the regimen have a positive effect, i.e. reduce mortality and/or complications?

This last question has been problematic, especially for the direct oral anticoagulant drugs (DOACs). They are very expensive, but there has been little, if any, evidence that they improve mortality.

A study from the University of Florida at Jacksonville, and sponsored by EAST was performed last year. It was a multi-center, prospective, observational study of data provided by 15 US trauma centers. They collected data on the agents used, reversal attempts, and comorbidities in injured patients taking these drugs, and analyzed for head injury severity and mortality.

Here are the factoids:

  • There were a total of 2913 patients in the study, 46% on aspirin (ASA), 13% taking ASA and a P2Y12 inhibitor (one of the -grels), 11% on warfarin, 4% on ASA + warfarin, 13.5% on a Factor Xa inhibitor, and 6% on a Xa inhibitor + ASA
  • Patients on platelet blockers (P2Y12 inhibitor) had the highest mean ISS at 9
  • Warfarin was associated with a higher abbreviated injury score (AIS) for head, 1.2
  • Controlling for ISS, comorbidities, ISS, and initial SBP, warfarin + ASA had the highest head ISS with an odds ratio of 2.1 (with the lower confidence interval value of 1.19)
  • Reversal of antiplatelet therapy with DDAVP was not successful, with no change in mortality (87% with reversal and 93% without)
  • Reversal of Xa inhibitors with plasma or PCC was also unsuccessful with a mortality of 100% with reversal and 95% without

The authors concluded that reversal attempts for antiplatelet therapy or Factor Xa inhibitors did not decrease mortality, and shared the observation that combination therapies posed the most risk for severity of head injury.

My comments: Remember, the first thing to do is look at the study group. The authors did not share the inclusion or exclusion criteria for the study in the abstract, so we are a little in the dark here.

The next item that makes this study difficult to interpret (and perform) is the fact that nearly a quarter are on combination therapy for their anticoagulation. So even though nearly 3,000 patients were studied, many of the medication subgroups had only a few hundred subjects. The aspirin group was the largest, with 1,338. This makes me wonder if the overall study had the statistical power to find subtle differences in their outcome measures and support the conclusions.

Now have a look at one of the results tables:

In reviewing the demographic data, the concept of statistical significance vs clinical significance quickly comes to mind. Somehow, age, ISS, head AIS, mortality, and SBP are significantly different between some of the groups. Yet if you examine the specific values across most of the rows, there is little difference (e.g SBP ranges from 137 to 147, ISS from 7-9, mortality from 2-7%). These are all clinically identical. The only row that means much to me is the top one telling how many patients are in a group.

Here are my questions for the authors and presenter:

  1. Tell us about the study design, especially the inclusion and exclusion criteria. Were there any? How might this have influenced the study group?
  2. Please comment on your perception of the statistical power of the study, especially with seven groups of patients, each with relatively small numbers.
  3. Do you have information on the variety of reversal agents used? Were there any standards? Could this have contributed to the mortality in some of the groups?
  4. Do you have any clinical recommendations based on your findings? If not, what is the next step in examining this group of patients?

My bottom line is that I’m not sure that this study has the power to show us any significant differences. And looking at the information table and logistic regression results (odds ratio confidence intervals close to 1), I’m not really able to learn anything new from it. I’m hoping to learn a lot from the live presentation!

Reference: EAST MCT: comparison of pre-injury antithrombotic use and reversal strategies among severe TBI patients. EAST 2021, Paper 19.

Best of EAST #7: Whole Blood Plus 4-Factor Prothrombin Complex Concentrate

In my last post, I went through some of the basics of whole blood transfusion. However, the focus was more on compatibility than function. Today, I’ll review an abstract that explored functionality of that blood transfused.

In theory, whole blood contains the usual array of clotting factors. It has been shown that high factor levels persist in whole blood, even when stored at room temperature. So in theory, additional clotting factor infusion should not be necessary.

The group at the University of Arizona explored adding 4-factor prothrombin complex concentrate (4-PCC) to whole blood transfusion. The scanned three years of data in the TQIP database. They identified two groups of patients, those who received whole blood alone and those who received 4-PCC in addition to it. They were interested in the impact on total product transfused and the usual crude outcomes of hospital / ICU length of stay and mortality.

Here are the factoids:

  • Only 252 patients in this entire database (tens of thousands of records in three years) received whole blood, and 84 of them also received 4-PCC
  • The patients tended to be young (average age 47), 63% male, with moderate (median ISS 27), and blunt injury in 85%
  • Administration of 4-PCC was associated with a significantly decreased transfusion requirement of both blood (5 vs 8 units) and plasma (3 vs 6 units), but not platelets
  • ICU LOS was significantly lower in the 4-PCC group (5 vs 8 days), but there was no difference in hospital stay or in-hospital mortality

The authors concluded that 4-PCC given with whole blood was associated with a decrease in transfusion requirements and ICU length of stay, and that further studies were needed.

My comments: Well, this is certainly interesting and unexpected.  Why would a clinician even think of giving 4-PCC when giving whole blood? It looks like a very rare occurrence in the dataset. Unfortunately, we can never find out. We can’t just go back and look in the charts. Perhaps these centers were using TEG or ROTEM during the resuscitation?

As always in these big databank analyses, the researchers can only control for the variables they can think of that are already present in the database. Although they were able to match the patient groups for the usual demographics, vital signs, injury patterns, comorbidities, and trauma center level, it is entirely possible that there were other factors in play.

Here are some questions for the authors and presenter:

  • Why did you choose to do this study? Was there some clinical question that arose that triggered it? Something you found in the literature that suggested it?
  • How do you explain the results, given that the factors in 4-PCC have been shown to persist at functional levels in whole blood? Why do you think less blood and plasma were needed?
  • What needs to happen next? I agree that more research is needed to see if this association is real. How would you go about doing it?

Thanks for a very intriguing paper! Details will follow, I’m sure.

Reference: Four factor prothrombin complex concentrate in adjunct to whole blood in trauma-related hemorrhage: does whole blood replace the need of factors? EAST 2021, Paper 18.