Category Archives: Device

Death Knell For The IVC Filter

March 28, 2024 The Trauma Pro Leave a comment

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:

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.
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.

Complications, Device

Air Embolism From an Intraosseous (IO) Line

February 27, 2024 The Trauma Pro Leave a comment

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!

Complications, Device

Should I Apply Compression Devices To Patients With DVT?

December 26, 2023 The Trauma Pro Leave a comment

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.

Device

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

August 2, 2022 The Trauma Pro Leave a comment

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

Device

REBOA: A Comparison Of The Hardware From Two Companies

January 22, 2021 The Trauma Pro Leave a comment

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

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