Category Archives: Complications

AAST 2019 #5: DOACs Part 1

A short while ago I wrote about the proper nomenclature of the new or novel oral anticoagulant medications that are replacing warfarin in patients with atrial fibrillation (click here for details). Cut to the chase, the consensus seems to be that they should be called direct oral anticoagulants or DOACs.

These medications strike fear into the average trauma professional, primarily because there is no easy way to reverse them as there is for warfarin. We are finally accumulating enough experience with them to start to see the bigger picture with respect to complications and mortality. Today, I’ll begin the discussion with a series of three abstracts regarding these drugs.

The AAST conducted a multicenter, prospective, observational study that collected DOAC trauma patient information from 15 centers. They reviewed four years of data, specifically examining the use of reversal agents and mortality.

Here are the factoids:

  • A total of 606 patients were enrolled. They were generally elderly with an average age of 75.
  • Most were taking one of the Factor Xa inhibitors (apixaban, rivaroxaban, edoxiban), while just 8% were taking the direct thrombin inhibitor dabigatran.
  • Only 1% of patients received a reversal agent (prothrombin complex concentrate (PCC) 87%, Praxbind (12%), and Andexxa (1%)
  • Those receiving reversal tended to be older than the average and had more severe head injuries
  • Patients who were reversed with PCC had no change in mortality using a regression model
  • Patients reversed with Praxbind or Andexxa had a 15x higher probability of mortality

The author’s conclusions merely restated their results.

This is fascinating information. Unfortunately, this study was not designed to provide a comparison with patients taking warfarin. However, my next two abstract reviews will cover this very topic. 

There are two interesting tidbits here. First, reversal was only carried out in about one in eight patients. Why is this? No protocol? No product? Too pricey? Patients not hurt badly enough? And how would that be judged anyway?

The second is that reversal with PCC seems to be benign, but use of one of the specifically designed reversal agents really jacked up mortality. These agents (Praxbind and Andexxa) are very expensive ($3.5K and $50K respectively). Furthermore, there are no studies anywhere that show their effectiveness. This one actually seems to show they might be dangerous.

The devil is in the details. Here are my questions for the presenter and authors:

  • Were there any guidelines for reversal? This is key because if not, the statistics just describe “how we do it.” Yes, you can tease out higher ISS or AIS head as potential reasons, but were there directions regarding this built into the study protocol?
  • Do you have any data on the success rates of PCC reversal? Were there provisions to demonstrate lesion stability vs progression after administration?
  • Do you have an impression of why the tailored reversal agents seemed to be so deadly? Were they used as a last resort due to cost. Did the centers have a hard time getting it or authorizing its use?

This abstract could be a gold mine!

Reference: The AAST prospective, observational, multicenter study investigating the initial experience with reversal ofnovel oral anticoagulants in trauma patients. AAST 2019, Oral Paper 58.

AAST 2019 #2: Predicting Abdominal Operation After Blunt Trauma – The RAPTOR Score

Patients with blunt abdominal injury, particularly those with seat belt signs, can be diagnostically very challenging. If the patient is stable and does not have peritonitis, CT scan is typically the first stop after the trauma resuscitation room. As many trauma professionals know, the radiographic findings can be subtle and/or not very convincing.

The trauma group at the University of Tennessee in Memphis sought to identify specific findings that might help us better identify patients that will need laparotomy. They retrospectively identified all their mesenteric injuries over a five-year period. A single blinded radiologist (is this an oxymoron or not?) reviewed all 151 patient images who underwent laparotomy, looking for predictors of bowel or mesenteric injury.  All of the predictors were then converted into a scoring system called RAPTOR (radiographic predictors of therapeutic operative intervention; kind of a stretch?). These predictors were then subjected to multivariate regression analyses to try to tease out if there were any independent predictors of injury.

Here are the factoids:

  • A total of 151 patients were identified over the 5 year period; 114 underwent laparotomy
  • Of the 114 operated patients, two thirds underwent a therapeutic laparotomy and the other third were nontherapeutic
  • There no missed injuries in the non-operated patients
  • The components of the RAPTOR score were culled from all the potential findings, and were determined to be
    • Multifocal hematoma
    • Acute arterial extravasation
    • Bowel wall hematoma
    • Bowel devascularization
    • Fecalization (of what??)
    • Free air
    • Fat pad injury (??)
  • Linear regression then showed that only three of these, extravasation, bowel devascularization, and fat pad injury to be independent predictors of injury
  • If three or more RAPTOR variables were present, then the sensitivity, specificity, and positive predictive values for injury were 67%, 85%, and 86%, and an area under the receiver operating characteristic curve (AUROC) of 0.91

The authors concluded that the RAPTOR score provided a simplified approach to detect patients who might benefit from early laparotomy and not serial abdominal exams. They go further and say it could potentially be an invaluable tool when patients don’t have clear indications for operation.

It looks like there are two things going on here at the same time. First, a new potential scoring system is being piloted. And second, a regression analysis is being used to examine the data as well. 

But first, let’s back up to the beginning. This is a retrospective study, with a relatively small size. This makes it far harder to ensure that the results will be significant, or at least meaningful. Use of a single radiologist can also be problematic, especially since many of the CT findings with this mechanism of injury are subtle. 

The reported performance of the RAPTOR score is a bit weak. The listed statistics show that it accurately identified only two thirds of those who needed an operation and 85% of those who didn’t. The AUROC for the regression is very good, though. Could a good old-fashioned serial exam scenario be better?

Bottom line: It will be interesting to hear the background on RAPTOR vs regression, and find our how the authors will use or are using these tools.

Here are my questions for the presenter and authors:

  • Why did you decide to create a scoring system that uses a set of variables that may be dependent on each other? Isn’t the regression equation better?
  • Has this information changed your practice? It seems that the two of the three regression variables are fairly obvious reasons to operate (active extravasation and devascularization). Do you really need the rest?
  • Has this study helped you decrease the non-therapeutic laparotomy rate for blunt abdominal injury?
  • And please define fecalization and fat pad injury!

I’m looking forward to hearing this presentation!

Reference: RADIOGRAPHIC PREDICTORS OF THERAPEUTIC OPERATIVE INTERVENTION AFTER BLUNT ABDOMINAL TRAUMA: THE RAPTOR SCORE. AAST 2019 Oral Paper 6.

 

Trocar Chest Tubes Or Blunt Technique? Part 2

In my last post on chest tube insertion technique, I reviewed a paper that compared chest tube insertion complications using two different trocar tips, blunt plastic and sharp metal. The sharp tip tubes caused more complications, although the study was weakened by the fact that the physicians inserting the tubes were complete newbies.

Today, I’ll discuss what the authors call a “best evidence topic” that reviewed the safety of the trocar technique. It is similar to a meta-analysis of available literature that attempts to reach a conclusion regarding this type of tube insertion. A literature search from 1946 to 2013 was conducted seeking to pull all papers on trocar chest tube insertion techniqes. A total of 258 papers were identified, but on closer inspection only 7 were identified that “provided the best evidence to answer the question.”

Here are the factoids from some of these papers:

  • Tube malposition occurred significantly more often in a series of 106 trocar tubes inserted into 75 ICU patients
  • In trocar tubes inserted for trauma, CT showed malplacement in 29% vs 19% with non-trocar tubes [This latter number seems very high to me!]
  • A retrospective study of 1249 patients resulted in the trocar technique being abandoned due to severe lung and stomach injuries
  • Use of trocar technique was associated with a significantly higher incidence of re-expansion pulmonary edema in 92 patients with spontaneous pneumothorax
  • A poorly controlled prospective study showed 23 complications with trocar technique and none with blunt dissection. The denominator could not be determined.

Bottom line: Overall, the literature is just not good enough to answer this question. But it does provide some suggestions.

  • Trocar insertion can be done well in experienced hands. Cardiac surgeons use these all the time, although sometimes they have the benefit of already being in the chest so they can visualize the point of entry and control the tip.
  • Any chest tube insertion can go awry.  It’s very important to learn proper technique, and take care to apply it faithfully, even in emergency situations.
  • If you really like trocars and want to improve insertion safety, start with the blunt dissection technique first, sweep a finger inside the chest to ensure there are no adhesions, then insert the trocar tube to guide it into position. Please note that I do not believe that we can control the tube once the instrument (trocar or clamp) are removed from the chest. And the tube will work fine just about anywhere it ends up (unless that’s the spleen).
  • Newbies should be supervised carefully and learn blunt insertion technique first. Be mindful that it is still possible to pass the insertion clamp into the same structures as a trocar if you are not careful. My practice is to place my fingers about 2 cm from the tip of the clamp as I push it through the pleura. If the pleura gives way more easily than anticipated, by fingers will keep the clamp from going too far into the chest. 
  • Always mark your insertion spot before prepping. This will generally be lateral to the nipple in men, so always prep the nipple into your field as a landmark.
  • Always be careful!

Reference: Is the trocar technique for tube thoracostomy safe in the current era? Interactive CV and thoracic surg 19:125-128, 2014.

Trocar Chest Tubes Or Blunt Technique? Part 1

This is an old question: what is the best way to insert a chest tube? There are several techniques available to us:

  • Blunt dissection and insertion
  • Trocar with a blunt tip (plastic stylet)
  • Trocar with a sharp tip (metal stylet)
  • Seldinger technique for small tubes

Typically, when there are multiple ways to do a thing, then there is no clear choice as to which is better. It then becomes a personal choice, or one driven by the financial considerations of the equipment used, and demonstrates the need for a practice guideline.

There are very few good papers out there that critically compare any of these techniques. Today, I’ll review one cadaver study and tomorrow I’ll tackle one “best evidence” paper that attempt to answer it.

A group in Vienna, Austria performed a cadaver study comparing the use of the two types of trocar tubes:

The top tube is the sharp trocar type, the bottom is the blunt trocar.

The study engaged twenty emergency medicine residents who had little, if any, experience placing chest tubes. Each placed 10 chest tubes (5 of each type) in fresh cadavers after undergoing a one-hour standardized lecture on anatomy, technique, and complications. The authors tabulated insertion times, as well as complication and success rate based on anatomic dissection.

Tube type was randomly assigned for each attempt by each resident. One blunt insertion and one sharp insertion were performed on opposite sides of a cadaver each month for the trainees. Over a period of 5 months, each resident performed 10 total insertions.

Here are the factoids:

  • Mean time to insertion for blunt vs sharp tips was the same, about 60 seconds
  • Insertion time declined by about 20 seconds by the final attempt at 5 months
  • Accurate placement occurred in 94% of blunt tip tubes vs 86% of sharp tip tubes
  • There were significantly more complications with the sharp tip (4 below diaphragm, 5 outside the thorax, 1 in the liver,  and 4 in the spleen) vs the blunt tip (2 below diaphragm, 2 extrathoracic, 2 in the liver, and 2 aborted due to damage to the tube)
  • BMI did not increase complications, but it did increase insertion time significantly

The authors concluded that there is a 6-14% complication rate that is operator related, and that the incidence of complications was increased with the use of a sharp tip tube. They warn against the use of these tubes.

Bottom line: This is certainly an interesting study. The insertion numbers are sort of reasonable, and the use of fresh cadavers is okay. They are not quite as realistic as real living people, but close. The biggest drawback was that they used chest tube newbies, most of whom had never inserted a tube. And they were placed in the unrealistic setting where they had to attend training and watch a video, then insert two tubes per month without coaching or supervision. This is not how we do it in the real world. 

I was impressed with what I consider the high number of complications. I don’t typically see that many, although I work at a blunt dissection institution. However, it does show that any trocar style tube is probably more like a weapon in inexperienced hands. So perhaps, even with supervision, both sharp and blunt trocar types should be avoided in the teaching setting. Sure, blunt dissection may take a bit longer, but the tube is also less likely to end up somewhere it shouldn’t be.

Tomorrow: Review of a “best evidence” review from New York.

Reference: Evaluation of performance of two different chest tubes with either a sharp or a blunt tip for thoracostomy in 100 human cadavers. Scand J Trauma Resus Emerg Med 20:10, 2012.

Retained Hemothorax: The Practice Guideline

Over the last few days, I’ve reviewed some data on managing hemothorax, as well as the use of lytics. Then I looked at a paper describing one institution’s experience dealing with retained hemothorax, including the use of VATS. But there really isn’t much out there on how to roll all this together.

Until now. The trauma group at Vanderbilt published a paper describing their experience with a home-grown practice guideline for managing retained hemothorax.  Here’s what it looks like:

I know it’s small, so just click it to download a pdf copy. I’ve simplified the flow a little as well.

All stable patients with hemothorax admitted to the trauma service were included over a 2.5 year period. The practice guideline was implemented midway through this study period. Before implementation, patients were treated at the discretion of the surgeon. Afterwards, the practice guideline was followed.

Here are the factoids:

  • There were an equal number of patients pre- and post-guideline implementation (326 vs 316)
  • An equal proportion of each group required an initial intervention, generally a chest tube (69% vs 65%)
  • The number of patients requiring an additional intervention (chest tube, VATS, lytics, etc) decreased significantly from 15% to 9%
  • Empyema rate was unchanged at 2.5%
  • Use of VATS decreased significantly from 8% to 3%
  • Use of catheter guided drainage increased significantly from 0.6% to 3%
  • Hospital length of stay was the same, ranging from 4 to 11 days (much shorter than the lytics studies!)

Bottom line: This is how design of practice guidelines is supposed to work. Identify a problem, typically a clinical issue with a large amount of provider care variability. Look at the literature. In general, find it of little help. Design a practical guideline that covers the major issues. Implement, monitor, and analyze. Tweak as necessary based on lessons learned. If you wait for the definitive study to guide you, you’ll be waiting for a long time.

This study did not significantly change outcomes like hospital stay or complications. But it did decrease the number of more invasive procedures and decreased variability of care, with the attendant benefits from both of these. It also dictates more selective (and intelligent) use of additional tubes, catheters, and lytics. 

I like this so much that I’ve incorporated parts of it into the chest tube guideline at my center!

Download the practice guideline here.

Related posts:

Reference: Use of an evidence-based algorithm for patients with traumatic hemothorax reduces need for additional interventions. J Trauma 82(4):728-732, 2017.