Category Archives: Complications

Abstracts, Complications

Best Of AAST 2021: Comparing Two Different Doses Of Enoxaparin

Leave a comment

Oh, look, my favorite topic! Prevention of venous thromboembolism (VTE) and complications. We’ve grown accustomed to using enoxaparin at the standard 30mg bid dose for a long time.  The orthopedic surgeons like to use 40mg qd, and there is some literature that shows this is reasonable for fracture patients.

The group at OHSU in Portland wanted to show that the single dose regimen is just as safe and effective as the bid dose. They performed a seven year, prospective, randomized trial of the two dose regimens. Weekly screening duplex exams were performed. The outcome measured was the occurrence of deep venous thrombosis (DVT) in the legs. They also examined missed doses, bleeding complications, and hospital length of stay.

Here are the factoids:

  • There were 267 total patients, 139 on the single dose regimen and 128 in the bid group
  • Average age was 49 and BMI was 28 in both groups
  • DVT occurred in 15 (11%) qd patients and 12 (9%) bid patients
  • Bleeding occurred in 19% of qd patients vs 14% of bid patients
  • There were fewer missed doses in the qd patients
  • None of the differences were statistically significant

The authors concluded that the qd dose was similar to the bid dose and is equally efficacious.

Bottom line: Hold on, now. First, this is a non-inferiority study. Daily dosing is presumed to be as good as twice daily dosing since there was no statistical difference seen between groups. This assumes that you have the statistical power (enough patients) to detect a difference. Is this the case here?

I pulled out my Sample Size calculator to check this over. I work things backwards to see the magnitude of difference that would have to be present for the given number of subjects. It looks like a sample size this small would only be able to detect a difference of 2x in the DVT occurrence result!

Lets look at this in simple terms. The absolute number of DVTs was actually higher in the qd group (11% vs 9%). So let’s say it is actually inferior to bid, meaning that the higher occurrence of DVT is real. Using the number of subjects here, the incidence could rise to 20% in the qd group and still not reach significance. 

The other major issue is the potential for selection bias. This study took place over 7 years. Yet only 267 were enrolled, or 38 patients per year. But this trauma center admits several thousand patients annually. If the enrollment criteria were so strict, the subjects probably don’t represent the general population. And if they weren’t, where did all the patients go? This is most likely a skewed study group.

I have lots of questions for the presenter and authors on this one!

  • Please show us your power calculations. Are you sure you have the statistical oomph to show non-inferiority?
  • Why did it take so long to accumulate 267 subjects? Show us the statistics for your overall trauma population to make sure they look the same.
  • Were you able to detect any other complications like pulmonary embolism?

Lots of questions here! Hopefully there’s much more information in the presentation!

Reference: A PROSPECTIVE RANDOMIZED TRIAL COMPARING TWO
STANDARD DOSES OF ENOXAPARIN FOR PREVENTION OF
THROMBOEMBOLISM IN TRAUMA. AAST 2021, Oral abstract 40.

Print Friendly, PDF & Email
Abstracts, Complications

Best Of AAST: Delayed Treatment Of Blunt Carotid And Vertebral Injury

Leave a comment

I recently published a series on blunt carotid and vertebral artery injury (BCVI). Today, I’ll review an AAST abstract that details the results of a multicenter study on the timing of medical treatment of this condition. This typically takes the form of anti-platelet agents, usually aspirin.

The trial collected prospective, observational data from 16 trauma centers. Patients had to receive medical therapy at some time after their injury or they were excluded. The stroke consequences of early vs late medical therapy were evaluated, where late was defined at > 24 hours.

Here are the factoids:

  • There were 636 BCVI included in the study
  • Median time to first medical therapy was 11 hours in the early group and 62 hours in the late group
  • ISS was higher in the delayed group (26 vs 22); although this was “statistically significant”, it is probably not a clinically significant difference
  • There was no increase in stroke rate with later administration of medical treatment

Bottom line: This is a very interesting study. We always worry about missing BCVI (see my previous post here), and now we know a little more about what happens if we do. The authors suggest that the stroke rate does not go up if medical management is delayed, say for some other potential bleeding issue.

This is a reasonably large data set, but the key thing to consider is the time frame observed. The median delay to medical management was only about 2.5 days. Were there any strokes involved in the patients with much longer delays? That is the real question. And were there any strokes that occurred despite early/immediate medical management?

The descriptive statistics and simple analyses presented do not provide all of the information we need. A stoke is a very significant adverse event for the patient. Statistical means are fine, but information on the specific patients who suffered one is necessary to truly understand this issue.

Here is my question for the presenter and authors:

  • Please break down the details on all patients who suffered a stroke. It will be very interesting to see if there were any in the early group and if there was a trend toward stroke in the very late tail data.

Reference: DOES TREATMENT DELAY FOR BLUNT CEREBROVASCULAR INJURY AFFECT STROKE RATE?: AN EAST MULTICENTERTRIAL. AAST 2021, Oral abstract #23.

Print Friendly, PDF & Email
Complications

Treatment Of BCVI

Leave a comment

In my last post, I reviewed the grading system for blunt carotid and vertebral artery injury (BCVI). Today, we’ll wrap up and discuss treatment.

There are basically three modalities at our disposal for managing BCVI: antithrombotic medication (heparin and/or antiplatelet agents), surgery, and endovascular procedures. The choice of therapy is usually based on surgical accessibility and patient safety for anticoagulation. We do know that a number of studies have shown a decrease in stroke events in patients who are heparinized. Unfortunately, this is not always possible due to associated injuries. Antiplatelet agents are usually tolerated after acute trauma, especially low-dose aspirin. Several studies have shown little difference in outcomes in patients receiving heparin vs aspirin/clopidogrel for BCVI.

So what to do? Here are some broad guidelines:

  • Grade I (intimal flap). Heparin or antiplatelet agents should be given. If heparin can be safely administered, it may be preferable in patients who will need other surgical procedures since it can be rapidly reversed just by stopping the infusion. These lesions generally heal completely on their own, so a followup CT angiogram should be scheduled in 1-2 weeks. Medication can be stopped when the lesion heals.
  • Grade II (flap/dissection/hematoma). These injuries are more likely to progress, so heparin is preferred if it can be safely given. Stenting should be considered, especially if the lesion progresses. Long-term anti-platelet medication may be required.
  • Grade III (pseudoaneurysm). Initial heparin therapy is preferred unless contraindicated. Stable pseudoaneurysms should be followed with CTA every 6 months. If the lesion enlarges, then surgical repair should be carried out in accessible injuries or stenting in inaccessible ones.
  • Grade IV (occlusion). Heparin therapy should be initiated unless contraindicated. Patients who do not suffer a catastrophic stroke may do well with followup antithrombotic therapy. Endovascular treatment does not appear to be helpful.
  • Grade V (transection with extravasation). This lesion is frequently fatal, and the bleeding must be addressed using the best available technique. For lesions that are surgically accessible, the patient should undergo the appropriate vascular procedure. Inaccessible injuries should undergo angiographic treatment and may require embolization to control bleeding without regard for the possibility of stroke.

References:

  1. Scott WW, Sharp S, Figueroa SA, et al. Clinical and radiographic outcomes following traumatic Grade 1 and 2 carotid artery injuries: a 10-year ret-rospective analysis from a Level I trauma center. J Neurosurg 122:1196, 2015.
  2. Scott WW, Sharp S, Figueroa SA, et al. Clinical and radiographic outcomes following traumatic Grade 3 and 4 carotid artery injuries: a 10-year ret-rospective analysis from a Level 1 trauma center. J Neurosurg 122:610, 2015.
  3. Scott WW, Sharp S, Figueroa SA, et al. Clinical and radiological outcomes following traumatic Grade 1 and 2 vertebral artery injuries: a 10-year retrospective analysis from a Level 1 trauma cen-ter. J Neurosurg 121:450, 2015.
  4. Scott WW, Sharp S, Figueroa SA, et al. Clinical and radiological outcomes following traumatic Grade 3 and 4 vertebral artery injuries: a 10-year retrospective analysis from a Level I trauma center. The Parkland Carotid and Vertebral Artery Injury Survey. J Neurosurg 122:1202, 2015.
Print Friendly, PDF & Email
Complications

How To Grade BCVI

Leave a comment

In my last post, I reviewed the three screening systems for blunt carotid and vertebral artery injury (BCVI). Today, we’ll look at grading them.

Only 10 years ago, it was a major production to identify BCVI. CT angiography was still in its early days, and scanner resolution and radiologist experience were major issues that impacted accuracy.

We’ve come a long way in a relatively short period of time, and current day scanners now have more than adequate resolution. It’s also more common to have a radiologist with special skills reading these studies, the neuroradiologist. For these reasons, CT angiography has become the standard for diagnosis. It is also the most cost-effective. Only in very rare cases do we need to obtain a conventional contrast angiogram.

Once the study has been obtained, it’s time to identify and classify the injury. The Denver group is also responsible for bringing us the grading system for BCVI. See the diagram below.

Here are the details:

Grade I: A mild intimal irregularity is seen. Note the abnormally narrowed area, representing a small intimal injury, possibly with a small amount of clot.

Grade II: This grade has several presentations. There may be an intraluminal thrombosis/hematoma with (left) or without (right) an intimal flap, or a flap alone (center).

Grade III: There is a full-thickness injury to the vessel with a contained extraluminal extravasation (pseudoaneurysm)

Grade IV: The vessel is completely occluded by flap or thrombus

Grade V: The artery is transected and freely extravasating

Here’s a nice diagram:

Remember, we always grade things for a reason! Ultimately, the injury grade will translate into the selection of treatment. We’ll cover that in my next post.

Reference: Blunt carotid arterial injuries: implications of a new grading scale. J Trauma. 1999;47(5): 845-53.

Print Friendly, PDF & Email
Complications, Head

Screening For BCVI

Leave a comment

In my last post, I described how common we think blunt carotid and vertebral injury (BCVI) really is. Today, I’ll review how we screen for this condition.

Currently, there are three systems in use: Denver, Expanded Denver, and Modified Memphis. Let’s look at each in detail.

Denver BCVI Screening

There is an original Denver screening system, and a more recent modification. The original system was divided into mechanism, physical signs, and radiographic findings. It was rather rudimentary and evolved into the following which uses both signs and symptoms, and high-risk factors.

Signs and symptoms

  • potential arterial hemorrhage from the neck, nose, or mouth
  • cervical bruit in patients <50 years of age
  • expanding cervical hematoma
  • focal neurologic deficit (transient ischemic attack, hemiparesis, vertebrobasilar symptoms, Horner syndrome) incongruous with head CT findings
  • stroke on CT

Risk factors

  • Le Fort II or III mid-face fractures
  • Cervical spine fractures (including subluxations), especially fractures involving transverse foramen or C1-C3 Vertebrae
  • Basilar skull fracture and involvement of carotid canal
  • Diffuse axonal injury with GCS <8
  • Near hanging with anoxic brain injury
  • Seat belt sign (or other soft tissue neck injury) especially if significant associated swelling or altered level of consciousness

The Denver group reviewed their criteria in 2012 and found that 20% of the patients who had identified BCVI did not meet any of their criteria. And obviously, this number cannot include those who were never symptomatic and therefore never discovered.

Based on their analysis, they added several additional risk factors to the original system:

  • Mandible fracture
  • Complex skull fracture/basilar skull fracture/occipital condyle fracture
  • TBI with thoracic injuries
  • Scalp degloving
  • Thoracic vascular injuries
  • Blunt cardiac rupture

The downside of these modifications is that they are a little more complicated to identify. The original criteria were fairly straightforward yes/no items. But “TBI with thoracic injuries?” Both the TBI part and the thoracic injury part are very vague. This modification casts a wider net for BCVI, but the holes in the net are much larger.

Memphis BCVI Screening

Let’s move on to the modified Memphis system for identifying BCVI. It consists of seven findings that overlap significantly with the Denver criteria. The underlined phrases indicated the modifications that were applied to the original criteria.

  • base of skull fracture with involvement of the carotid canal
  • base of skull fracture with involvement of petrous temporal bone
  • cervical spine fracture (including subluxation, transverse foramen involvement, and upper cervical spine fracture)
  • neurological exam findings not explained by neuroimaging
  • Horner syndrome
  • Le Fort II or III fracture pattern
  • neck soft tissue injury (e.g. seatbelt sign, hanging, hematoma)

Interestingly, these modifications were first described in an abstract which was never published as a paper. Yet somehow, they stuck with us.

So there are now two or three possible systems to choose from when deciding to screen your blunt trauma patient. Which one is best?

Let’s go back to the AAST abstract presented by the Birmingham group this year that I mentioned previously. Not only did they determine a more accurate incidence, but they also tested the three major screening systems to see how each fared. See Table 1.

Look at these numbers closely. When any of these systems were applied and the screen was negative, the actual percentage of patients who still actually had the injury ranged from about 25% to 50%! Basically, it was a coin toss with the exception of the Expanded Denver criteria performing a little better.

If you are a patient and you actually have the injury, how often does any screening system pick it up? Oh, about one in five times. Again, this is not what we want to see.

So what to do? The Expanded Denver screen has a lower false negative rate, but the total number of positive screens, and hence the number of studies performed, doubles when it is used.

Here’s how I think about it. BCVI is more common than we thought in major blunt trauma. If not identified, a catastrophic stroke may occur. Current screening systems successfully flag only 50% of patients for imaging. So in my opinion, we need to consider imaging every patient who is already slated to receive a head and cervical spine CT after major blunt trauma! At least until we have a more selective (and reliable) set of screening criteria.

References:

  • (Denver) Optimizing screening for blunt cerebrovascular injuries. Am J Surg. 1999;178:517–522.
  • (Expanded Denver) Blunt cerebrovascular injuries: Redefining screening criteria in the era of noninvasive diagnosis. J Trauma 2012;72(2):330-337.
  • (Memphis) Prospective screening for blunt cerebrovascular injuries: analysis of diagnostic modalities and outcomes. Ann Surg. 2002, 236 (3): 386-393.
  • (Modified Memphis) Diagnosis of carotid and vertebral artery injury in major trauma with head injury. Crit care. 2010;14(supp1):S100.
Print Friendly, PDF & Email