Tag Archives: DVT

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, 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 level of VTE risk, which is then balanced with bleeding risk from 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.

An age old question surfaced on my own patient rounds recently. 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.
Abstracts, Complications

Best Of AAST #8: Duplex Screening For DVT

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To screen on not to screen, that is the question. If you do more testing, you will find more cases. But does it make a difference clinically? Sounds like some of the questions coming up in our current discussion of the Coronavirus. But that’s what we really need to know.

The group at Intermountain Medical Center in Salt Lake City performed a 2 ½ year randomized, prospective study of screening duplex ultrasound of the lower extremities vs no screening study. They used the Risk Assessment Profile (RAP) developed by Greenfield, first published in 2000. Any patient at moderate or higher risk for DVT (RAP score >5) was enrolled in the study. They were randomized into two groups: a screening group who received duplex scans on days 1, 3, 7, and then weekly, and a “no routine screening” group. All patients received chemoprophylaxis per the trauma service’s existing protocol.

The RAP score is a 17 factor scale that assigns a specific number of points based on underlying medical conditions, iatrogenic factors like central lines or transfusions, injury-related factors, and age.

Here are the factoids:

  • A total of 3,236 trauma patients were identified, and the 1,989 who were at moderate or higher risk for DVT were evenly randomized to screening vs no screening
  • There were no differences in age, sex, BMI, mechanism, ISS, or length of stay between the two groups
  • The incidence of DVT was 15% in the screened group vs 1.7% in the no screening group

The authors concluded that screening diagnoses more DVT, most of which is below the knee. And they also noted that screening identified DVT more often than clinical exam alone, but does not result in fewer PE or deaths. They suggest that more work needs to be done to identify exactly who benefits from duplex screening the most.

Here are my comments:

Finally, an easy to follow and well-designed study! But I think some of the results may be missing from the abstract. That section cuts off in the middle of some of the statistics, and there is no mention of the clot location or PE/mortality rates mentioned in the conclusion.

I also worry that a thousand patients in each group may not be enough. We are working with low incidence end points like PE and death, and this is an association study with many potential confounders/factors that may not have been recorded. I generally like to see the ability to detect a minimum of a 2x effect. So if the incidence of PE is 1.5%, I like to see the ability to detect a difference if the other group is 3%.

And speaking of study size. The RAP score was first described in 1997 and was a pilot study. They drew their conclusions from only 53 patients, and the only risk factor that they could show that was a statistically significant predictor of DVT was age. They concluded that surveillance of patients with RAP > 5 was warranted. This abstract builds upon this work, but is trying to say that maybe we don’t need to do duplex scans.

Here are my questions for the presenter and authors:

  • Is there some text missing from the end of the results section of the abstract? It seems to end unexpectedly, and some things are mentioned in the conclusions that are not in the results.
  • Why did you choose the RAP score? There are other risk assessment tools available out there. What is so special about RAP?
  • Is your sample size large enough to detect differences in incidence of PE or death? My back of the envelope calculations suggest at least 1,500 patients would be needed in each group.
  • How long did you follow patients to determine if they had PE or death? Until they were discharged? Later than that?  This makes a big difference in the eventual incidence of these outcomes.
  • Based on what you found, is there any value to treating asymptomatic proximal DVT? It sounds like you are saying that screening is not needed at all because PE and death are the same. Isn’t there value in treating proximal DVT if you find it?

This abstract certainly got me thinking! I am looking forward to the presentation and discussion of this abstract!

Reference: Head in the sand? The value of routine duplex ultrasound screening for venous thromboembolism in the trauma patient: a randomized Vanguard trial. AAST 2020, Oral Abstract #16.

Complications

How To Predict Venous Thromboembolism In Pediatric Trauma

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As with adults a decade ago, the incidence of venous thromboembolism (VTE) in children is now on the rise. Whereas adult VTE occurs in more than 20% of adult trauma patients without appropriate prophylaxis, it is only about 1% in kids, but increasing. There was a big push in the early 2000′s to develop screening criteria and appropriate methods to prevent VTE. But since the incidence in children was so low, there was no impetus to do the same for children.

The group at OHSU in Portland worked with a number of other US trauma centers, and created some logistic regression equations based on a large dataset from the NTDB. The authors developed and tested 5 different models, each more complex than the last. They ultimately selected a model that provided the best fit with the fewest number of variables.

The tool consists of a list of risk factors, each with an assigned point value. The total point value is then identified on a chart of the regression equation, which shows the risk of VTE in percent.

Here are the factors:

Note that the highest risk factors are age >= 13, ICU admission, and major surgery.

And here is the regression chart:

Bottom line: This is a nice tool, and it’s time for some clinical validation. So now all we have to do is figure out how much risk is too much, and determine which prophylactic tools to use at what level. The key to making this clinically usable is to have a readily available “VTE Risk Calculator” available at your fingertips to do the grunt work. Hmm, maybe I’ll chat with the authors and help develop one!

Reference: A Clinical Tool for the Prediction of Venous Thromboembolism in Pediatric Trauma Patients. JAMA Surg 151(1):50-57, 2016.

Procedures

The IVC Filter In Trauma: Why?

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The inferior vena cava (IVC) filter has been around in one form or another for over 40 years. One would think that we would have figured everything about it out by now. But no!  The filter has evolved through a number of iterations and form factors over the years. The existing studies, in general, give us piecemeal information on the utility and safety of the device.

One of the major innovations with this technology came with the development of a removable filter. Take a look at the product below. Note the hook at the top and the (relatively) blunt tips of the feet. This allows a metal sheath to be slipped over the filter while in place in the IVC. The legs collapse, and the entire thing can be removed via the internal jugular vein.

ivc-filter-complications1

The availability of the removable filter led the American College of Chest Physicians to recommend their placement in patients with known pulmonary embolism (PE) or proximal deep venous thrombosis (DVT) in patients with contraindications to anticoagulation. Unfortunately, this has been generalized by some trauma professionals over the years to include any trauma patients at high risk for DVT or PE, but who don’t actually have them yet.

One would think that, given the appearance of one of these filters, they would be protective and clots would get caught up in the legs and be unable to travel to the lungs as a PE. Previous studies have taught us that this is not necessarily the case. Plus, the filter can’t stop clots that originate in the upper extremities from becoming an embolism. And there are quite a few papers that have demonstrated the short- and long-term complications, including clot at and below the filter as well as post-phlebitic syndrome in the lower extremities.

A study from Boston University reviewed their 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 (!)

Bottom line: Hopefully, it’s becoming obvious to all that the era of the IVC filter has come and gone. There are many studies that show the downside of placement. And there are several (including this one) that show how forgetful we are about taking them out when no longer needed. And, of course, they are expensive. But the final straw is that they do not seem to protect our patients like we thought (hoped?) they would. It’s time to reconsider those DVT/PE protocols and think really hard about whether we should be inserting IVC filters in trauma patients at all.

Tomorrow: a look at trends in filter insertion and retrieval.

Related post:

Reference: 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.

Pharmacy

DVT Prophylaxis At Home: Do Our Patients Do What They Are Told?

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Deep venous thrombosis (DVT) is a big potential problem for many trauma patients, particularly those with orthopedic injuries. Patients at high risk are frequently given a prophylaxis regimen to take home after discharge while they are still at higher risk for clots. The particular choice of medication typically comes down to oral (warfarin or aspirin) vs injectable (low molecular weight heparin (LMWH)).

There is quite a bit of literature on patient compliance with their medication routines, or should I say noncompliance? The group at ShockTrauma in Baltimore evaluated how well orthopedic surgery patients adhered to their prescribed DVT prophylaxis schedule after discharge.

They conducted a randomized, prospective trial on all patients who underwent operative management of extremity or pelvic fractures. These patients were prescribed either oral low dose aspirin (81mg) or subcutaneous injections of LMWH (30mg bid). All completed a standardized 8-question tool to gauge their compliance with the medication regimen. Nicely, a power analysis was performed to identify the minimum number of patients needed to achieve statistical significance ( 126 total patients).

Here are the factoids:

  • Of 1450 potential patients undergoing operative fracture fixation, 329 were eligible for the study. All but 150 were excluded primarily due to no need for prophylaxis or inability to contact.
  • Overall adherence to the prophylaxis plan was fairly high, with 65% of patients having high adherence, 21% medium, and 20% low.
  • A quarter of the LMWH patients felt “hassled” by their regimen, while only 9% of the aspirin group did
  • LMWH prophylaxis was associated with low or medium adherence
  • Having to self-administer the prophylactic agent, being a male, and young was also associated with lower compliance

Bottom line: Interesting study. And unfortunately it suggests that our patients don’t always do what they are told, especially if they have to stick themselves with needles. So they may not be getting the prophylaxis we think they are. Furthermore, we’re not even sure if aspirin (or LMWH for that matter) make a difference in the incidence of death or major pulmonary embolism in these patients.

There are a lot of opportunities for mayhem in this study. A third of the enrolled patients were not even compliant with completing the survey. This is certainly a source of bias, and most likely suggests that the overall compliance rates would have been even lower if they had. 

Keep in mind the risk factors for compliance (age, sex, drug route) when deciding how and what to provide for DVT prophylaxis. Your patient may not be doing what you assume they are!