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Device

REBOA: Is This Shiny Toy Losing It’s Luster?

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REBOA has been around in one form or another for decades. It was first used by vascular surgeons to gain control of pesky bleeding. It began its move into the trauma arena in 2011 with experimental use for major hemorrhage control in swine. After successful trials, it made the jump to humans in 2015.

Its use exploded over the following decade, peaking at 127 publications in 2021.

Trauma centers across the US were clamoring to be the first in their neighborhoods to get it. However, there were a few problems:

  • It was not clear which patients would benefit from its usage.
  • The number of patients who had significant bleeding below the diaphragm or from pelvic fractures was generally low in all but the busiest centers.
  • There were significant vascular complications with disturbing frequency.

So what have we learned after about 2,000 published papers? The Eastern Association for the Surgery of Trauma (EAST) recently published another practice guideline to help us make good decisions. They conducted a systematic review and meta-analysis of 31 studies to answer six questions about REBOA use.

Here are the questions and their answers:

  1. In hemodynamically unstable trauma patients with suspected sub-diaphragmatic bleeding, should REBOA vs. no REBOA be performed before definitive hemostatic procedures to reduce time to definitive intervention, blood transfusion requirements, and mortality?  (12 studies) Unfortunately, the evidence was of low quality due to selection bias, heterogeneity across studies, and wide confidence intervals resulting from small sample sizes. The review committee gave a conditional recommendation against using REBOA for these patients. The only randomized clinical trial available actually showed increased mortality in the REBOA group. The quality of the other studies was not enough to offset this.
  2. In hemodynamically unstable trauma patients with suspected pelvic fractures, should REBOA versus no REBOA be performed, before definitive hemostatic procedures, to decrease time to definitive intervention, blood transfusion requirements, and mortality? (11 studies) Once again, the quality of the papers reviewed was low. Similar to the question above, the committee gave a conditional recommendation against using REBOA in these patients.
  3. In trauma patients with cardiac arrest OR impending cardiac
    arrest due to suspected subdiaphragmatic bleeding, should REBOA versus resuscitative thoracotomy be utilized to increase the rate of return of spontaneous circulation (ROSC), decrease time to aortic occlusion, and decrease mortality?     (13 studies) Although patients receiving REBOA had 4x lower mortality, the quality and confounding factors were so significant that the committee could not make a recommendation for or against REBOA use in this population.
  4. In trauma patients with cardiac arrest due to suspected subdiaphragmatic bleeding, should REBOA versus resuscitative thoracotomy be utilized to increase the rate of ROSC, decrease time to the aortic occlusion, and decrease mortality? (7 papers) This is a bit of slicing and dicing of the question. It applies only to patients in cardiac arrest and excludes those in whom it is “impending.” This reduced confounding data and demonstrated an identifiable decrease in mortality by more than half. Despite poor-quality data, the committee conditionally recommended the use of REBOA in this population.
  5. In hemodynamically unstable patients with subdiaphragmatic
    bleeding of non-traumatic etiology, should REBOA versus no
    REBOA be used prior to definitive hemostatic procedures, to decrease blood transfusion requirements and mortality?     (1 paper) Given that there was only one paper and the quality of the data for analysis was low, the committee could not recommend for or against REBOA use in this group.
  6. In hemodynamically stable patients with anticipated subdiaphragmatic bleeding due to placenta accreta syndrome (PAS), should REBOA vs no REBOA be performed prophylactically, prior to definitive hemostatic procedures, to decrease blood transfusion requirements and blood loss? (12 studies) The number of studies and their quality were very low, but REBOA use decreased packed red cell transfusion requirements by 3 units. The committee conditionally recommended for the use of REBOA for bleeding from placenta accreta. However, they cautioned about the possibility of complications from the procedure.

Bottom line: These recommendations are moving away from recommending REBOA for all cases with severe subdiaphragmatic or pelvic bleeding. In fact, they recommend its use only for patients actually in arrest or with placenta accreta. This last situation is very uncommon (approximately 1 in 400-500 pregnancies) but is increasing slowly over time. About half of these cases result in significant hemorrhage. 

It’s time for most centers to start revising their REBOA protocols (if you have them). For high-volume centers, continue publishing your work to help us fine-tune the use of this valuable, but not invaluable, tool!

Reference: Resuscitative Endovascular Balloon Occlusion of the Aorta in surgical and trauma patients: a systematic review, meta-analysis and practice management guideline from the Eastern Association for the Surgery of Trauma. Trauma Surg Acute Care Open. 2025 Mar 28;10(1):e001730. doi: 10.1136/tsaco-2024-001730. PMID: 40166770; PMCID: PMC11956280.

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Device

Death Knell For The IVC Filter

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IVC filter insertion has been one of the available tools for preventing pulmonary embolism for decades—or so we thought. Its popularity has swung back and forth over the years and has been in the waning stage for quite some time now. This pendulum-like motion offers an opportunity to study effectiveness when coupled with some of the large datasets that are now available to us.

IVC filters have been used in two ways: prophylactically in patients at high risk for pulmonary embolism (PE) who cannot be anticoagulated for some reason and therapeutically once a patient has already suffered one. Over the years, guidelines have changed and have frequently been in conflict. Currently, the American College of Chest Physicians does not recommend IVC filters in trauma patients, and the Eastern Association for the Surgery of Trauma just released a new practice guideline for them.

A previous study from Boston University reviewed its own experience retrospectively over a 9-year period. This cohort study looked at patients with and without filters, matching them for age, sex, race, and injury severity. The authors specifically looked at mortality and used four study periods during the 9-year interval.

Here are the factoids:

  • Over 18,000 patients were admitted during the study period, resulting in 451 with an IVC filter inserted and 1343 matched controls
  • The patients were followed for an average of 4 years after hospitalization
  • Mortality was identical between patients with filters vs the matched controls

dvt-study

  • There was still no difference in mortality, even if the patients with the filter had DVT or PE present when it was inserted
  • Only 8% ever had their “removable” filter removed (!)

And now, there is a paper in press from the Eastern Association for the Surgery of Trauma with their newest practice guideline on IVC filters. They examined the literature on patients with or at risk for venous thromboembolism (VTE) and sought to determine whether IVC filters should be used prophylactically or therapeutically in these situations. They reviewed twenty-one studies, most of which were of the usual low quality.  They drew the following conclusions:

  • IVC filters should not be placed routinely for prophylaxis in patients without DVT who cannot receive chemoprophylaxis.
  • EAST conditionally recommends that IVC filters not be placed in patients with DVT who cannot receive prophylaxis. This recommendation was conditional due to the very poor quality of the few papers available to answer this question.

Bottom line: It looks like the end is near for the IVC filter. However, I can still foresee a few situations where there might be some utility. Consider the case where a patient has DVT, cannot be anticoagulated, and is showering emboli to the lungs. Otherwise, it appears that this device is on its last legs!

References:

  1. Association Between Inferior Vena Cava Filter Insertion
    in Trauma Patients and In-Hospital and Overall Mortality. JAMA Surg, online ahead of print, September 28, 2016.
  2. Role of Vena Cava Filter in the Prophylaxis and Treatment of Venous Thromboembolism in Injured Adult Patients: A  Systematic Review, Meta-Analysis, and Practice Management Guideline from the Eastern Association for the Surgery of Trauma. Journal of Trauma and Acute Care Surgery, Publish Ahead of Print DOI: 10.1097/TA.0000000000004289, 2024.
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Complications, Device

Air Embolism From an Intraosseous (IO) Line

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Intraosseous (IO) lines are a godsend when we are faced with a patient who desperately needs access but has no veins. The tibia is generally easy to locate and the landmarks for insertion are straightforward. They are so easy to insert and use, we sometimes “set it and forget it”, in the words of infomercial guru Ron Popeil.

But complications are possible. The most common is an insertion “miss”, where the fluid then infuses into the knee joint or soft tissues of the leg. Problems can also arise when the tibia is fractured, leading to leakage into the soft tissues. Infection is extremely rare.

This photo shows the inferior vena cava of a patient with bilateral IO line insertions (black bubble at the top of the round IVC).

During transport, one line was inadvertently disconnected and probably entrained some air. There was no adverse clinical effect, but if the problem is not recognized and the line is not closed properly, there could be.

Bottom line: Treat an IO line as carefully as you would a regular IV. You can give anything through it that can be given via a regular IV: crystalloid, blood, drugs. And even air, so be careful!

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Complications, Device

Should I Apply Compression Devices To Patients With DVT?

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Everyone knows that venous thromboembolism (VTE) is a potential problem in hospitalized patients, and especially so in trauma patients. Several groups of them are at higher risk by virtue of the particular injuries they have sustained and the activity restriction caused.

Nearly every trauma program uses some form of screening and prophylaxis in an attempt to reduce the occurrence of this problem, which can result in deep venous thrombosis (DVT) and/or pulmonary embolism (PE). Screening looks at patient factors such as age, obesity, and previous VTE, as well as injury risk factors like spine and pelvic fractures and decreased mobility.

Based on the screening protocol, prophylaxis may be prescribed depending upon the level of VTE risk, which is then balanced with bleeding risk from the brain, solid organ, or other injuries. The choices we have are primarily mechanical vs chemical and consist of compression devices (sequential or not) and various heparins.

But an age-old question continues to resurface: if a patient breaks through their prophylaxis and develops DVT, is it safe to apply compression devices to the extremity?

There has always been the fear that doing things that increase flow in the affected extremity may cause clots to dislodge and ultimately cause a PE. Seems logical, right? But we know that often, our common sense about things is completely wrong.  Couldn’t just moving around cause pieces to break off? A meta-analysis of 13 studies published in 2015 showed that early ambulation was not associated with a higher incidence of new PE. Furthermore, patients who suffered from pain in the affected extremity noted significant improvements with early ambulation.

If ambulation makes the pain better, could the veins be recanalizing more quickly? Another study examined a small group of 72 people with DVT receiving anticoagulants, half of whom were prescribed exercise and compression stockings and the other half stockings only. There was a huge amount of variability in the rates of recanalization, but ultimately, there were no significant differences with or without exercise.

So just lying in bed is not good, and exercise/ambulation may actually make people feel better. But interestingly, bedrest alone does not appear to increase the likelihood of PE! It does decrease the risk of developing problems other than the VTE, like pulmonary complications.

But what about compression devices? Common sense would say that you are intermittently  increasing pressures in the leg veins, which could dislodge any loose clots and send them flying to the lungs, right?

Unfortunately, I couldn’t find a paper from anyone who had the courage to try this. Or perhaps no institutional review board (IRB) would approve it. But the key fact is that every compression device manufacturer includes existing DVT as a contraindication in their product documentation. They don’t have any literature either, so I assume it’s an attempt to limit litigation, just in case.

Bottom line: Walking provides at least as much muscle compression as compression devices. But the simple truth is that we have no solid research that either supports or condemns the use of active compression devices in patients with known DVT. And we probably won’t, ever.

Compression stockings seem to be safe, but they really don’t do much. They are white, but don’t do much more than contribute to hospital clothing fashion. Since the manufacturers define existing DVT as a contraindication, application of their product would be considered an off-label use. So it looks like we cannot in good faith use these devices in patients with diagnosed DVT.

References:

  • Bed Rest versus Early Ambulation with Standard Anticoagulation in The Management of Deep Vein Thrombosis: A Meta-Analysis. PLOS One , April 10, 2015, https://doi.org/10.1371/journal.pone.0121388
  • Bed Rest or Ambulation in the Initial Treatment of Patients With Acute Deep Vein Thrombosis or Pulmonary Embolism: Findings From the RIETE Registry. Chest 127(5):1631-1636, 2005.
  • Does supervised exercise after deep venous thrombosis improve recanalization of occluded vein segments? A randomized study. J Thrombosis Thrombolysis 23:25-30, 2006.
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Device

Fracture Care Of The Future: Traditional Casts vs 3D-Printed Braces

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I’ve been fascinated by 3D printing for at least a decade.  Here are some examples from previous posts:

Unfortunately, practical applications have been relatively limited in the field of trauma.  But a lot has been going on in the background. The trauma research group at Erasmus Medical Center in Rotterdam recently published a systematic review on very practical work using 3D printing to produce casts and splints.

Sounds like a very mundane problem to through high tech at, right? But for those of you who look after patients with fractures that have been casted, you know the problems that can arise. Casts can be too tight. They can be ill-fitting. The patient may have soft tissue injuries that require windows cut into the side of the cast. Additional technology such as electrical stimulators may be indicated to enhance healing.

The old-fashioned way of creating a plaster or fiberglass cast seems crude. It is shaped by hand using skill and a fair amount of guesswork. If it’s just a bit too tight, serious complications may occur. If windows are not cut properly, it can destabilize the entire cast.

The Rotterdam trauma research group performed a systematic review of 12 papers that have been published on the topic of 3D-printed casts used in the treatment of forearm fractures. The authors found that most currently use a technique called fused deposition modeling with a polylactic acid substrate.

Instead of relying on subjective skill and luck to shape the brace, the uninjured forearm is scanned with a 3D scanner. The data is fed to a computer aided design (CAD) workstation and a mirror image is created and further refined. Special features such as soft tissue windows or entry points for bone stimulators can be designed into the brace at that time. Because the strength of polycarbonate exceeds that of plaster and fiberglass, it is possible to create a design with a great deal of open area so the underlying skin can be monitored. And allowances can be made for areas with swelling not present on the control extremity.

The data is then fed to a 3D printer to actually create the cast. Here’s an example:

This design is stronger that a traditional cast, is cool and comfortable, and avoids problems with hidden tissue injury or unrecognized foreign objects dropping into the cast creating major problems.

The use of 3D-printed casts and braces is relatively new and is used in only a few centers. For this reason, we do not have enough numbers to show that it is equivalent to traditional casting. Yet. But as the price continues to drop and use becomes more widespread, it’s only a matter of time before you start seeing these items in your own trauma center.

Reference: Personalize d 3D-printed forearm braces as an alternative for a traditional plaster cast or splint; A systematic review. Injury, in press, July 29, 2022. https://doi.org/10.1016/j.injury.2022.07.020

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