Authors

EAST Practice Parameter Workgroup for DVT Prophylaxis

Frederick B. Rogers, MD, FACS
University of Vermont Department of Surgery
Director of Trauma and Critical Care
Fletcher Allen Heath Care
Burlington, VT

Mark D. Cipolle, MD, Ph.D.
Surgical Practice Center
Allentown, PA

George Velmahos, MD, Ph.D.
Department of Surgery, Division of Trauma and Critical Care
University of Southern California
Los Angeles, CA

Grace Rozycki, MD
Emory USM, Department of Surgery
Atlanta, GA

I. Statement of the Problem

Venacavalinterruption is a form of PE prophylaxis that is being used more frequently in trauma patients. Patients with ongoing bleeding or those with recent brain, spinal cord or ocular injury will not tolerate even minor amounts of bleeding. Furthermore, multiply injured patients often have extremity injuries which preclude the use of sequential compression devices (SCDs). The decision to place a “prophylactic”venacavafilter in a trauma patient requires a fundamental understanding of the risk:benefit ratio.The data included in this review indicate the risk:benefit ratio is favorable in a high-risk trauma patient.Therefore, the problem becomes defining the “high-risk” patient and the short and long-term complication rates ofvenacavalinterruption.

The literature is somewhat difficult to interpret because each author differs in their definition of a “prophylactic”venacavafilter.It is probably more accurate to use the terms “traditional” and “extended” indications forvenacavafilter placement. This review is designed to examine the data available for the use ofvenacavafilters for “extended” indications in the trauma patient, that is, filter placement early after injury, before the patient has clinical orradiographicevidence of a DVT or PE.

II. Process

AMedlinesearch from 1980 to 1999 showed ten articles when “venacavafilter” was cross-referenced with “trauma”.An additional personal review of the literature revealed seven additional articles and two abstracts that address extended indications ofvenacavafilter placement in trauma patients. Also, there were four articles that specifically addressed complications and long-term follow up withvenacavafilters which are included in this review.

III. Recommendations

A. Level I

There is a large body of evidence not reviewed in this section to support insertion of avenacavafilter for “traditional” indications in trauma patients.These indications include:

• Recurrent PE despite fullanticoagulation,
• Proximal DVT and contraindications to fullanticoagulation,
• Proximal DVT and major bleeding while on full anticoagulation,
• Progression ofiliofemoralclot despiteanticoagulation (rare).

B. Level II

“Extended” indications for prophylacticvenacavafilter placement in apatientwithestablishedDVT or PE include:

• Large free-floating thrombus in theiliacvein or IVC,
• Following massive PE in which recurrentembolimay prove fatal,
• During/after surgical embolectomy.

C. Level III

Insertion of a “prophylactic”venacavalfilter should be considered in very high risk trauma patients.

1. Who cannot receive anticoagulation because of increased bleeding risk, and
2. Have one or more of the following injury patterns:
   1. Severe closed head injury (GCS < 8),
   2. Incomplete spinal cord injury with para or quadriplegia,
   3. Complex pelvic fractures with associated long-bone fractures,
   4. Multiple long-bone fractures,

Patients at high risk for bleeding complications for 5 to 10 days after injury would include those withintracranialhemorrhage, ocular injury with associated hemorrhage, solidintraabdominalorgan injury (ie. liver, spleen, kidney), and/or pelvic orretroperitonealhematomarequiring transfusion.Other risk factors for bleeding include cirrhosis, active peptic ulcer disease, end-stage renal disease, andcoagulopathydue to injury, medication, or congenital/hereditary.

IV. Scientific Foundation

The placement of a venacavafilter in a trauma patient who does not have an established DVT or PE is certainly controversial. There is no question that venacavafilters are efficacious. They prevent the occurrence of PE from lower extremity DVT with about a 98% success rate.^[1] The real issue is defining who should receive these filters, and whether it is without significant complications and cost-effective.There is no data at this point to address the latter, and some recent papers do address the risk factor issue.

Several recent studies have reported on the use of venacavalfilters for extended indications. Goluekeand coworkers^[2] reported on 21 filters placed prophylactically before total joint replacement. All patients also received low dose heparin, aspirin, and, when possible, graduated compression stockings.There were no filter-related complications or episodes of PE in this group. Likewise, Webb et al. in 1992 reported their results of using a “prophylactic” filter in 24 of 52 patients undergoing acetabular fracture repair with sufficient risk factors.^[3] They had no insertion complications. Four patients had leg edema, one with phlegmasia, and no PEs. In the 27 patients who did not receive a filter, there were 2 PEs, one of which was fatal. Rohrer and coworkers reported on the use of vena caval filters for “extended” indications in 66 patients (many of whom were trauma patients).^[4] There was only one fatal PE in this group, and 22 patients had no documented DVT before filter insertion. The recurrent nonfatal PE rate was 3%, and symptomatic occlusion of the IVC occurred 4.5% of the time in this study. Major limitations of this study include the retrospective design, inability to distinguish outcomes in the 21 patients with VCF used as prophylaxis from the 45 others, and unspecified follow-up duration. Jarrell and coworkers^[5] reported a favorable experience with 21 Greenfield filters that were placed in spinal-cord-injured patients with documented DVT or PE and a “traditional” indication for filter insertion.There was only one PE death in this group and two instances of IVC thrombus, both of which were well tolerated.

There are now several reports in the literature of the use of “prophylactic” venacavalfilters for extended indications in trauma patients.^{[5] [6] [8] [9] [10] [11] [12] [13] [14] [15] [20] [22] [23] [24] [25] [26]} To date. 14 studies have reported on inferior vena cava (IVC) filter insertion in trauma patients. Five of these studies^{[8] [9] [10] [22] [23]} demonstrated a demonstrated a significant reduction in the indicence of PE in their trauma population compared to historical controls. None of these studies were Level I studies, however. Further McMurty et al ^[25] in a retrospective review of 299 patients who had prophylactic filters placed over an 8 year period, failed to demonstrate an overall decrease in their trauma population compared to historical controls. There have been minimal insertion and short-term complications reported; one-year patency rates ranged from 82% to 96%,^{[9] [11]} and two-year patency rates have been reported in 96%^[9] of prophylactic filters inserted in trauma patients.Moreover, there does not seem to be a higher DVT rate in prophylactic filter patients compared to non-filter patients.^{[7] [8]} A recent followup study with a minimal of 5 years followup in 199 patients showed that the filters are well tolerated, patients can go on to active life, and their was a minimal migration or caval thromboses in the patients studied.^[26] The efficacy ofvenacava filters preventingPEs is not an issue. The long-range complications and cost-effectiveness of this therapy does need to be studied.

The decision to place a prophylactic filter in a trauma patient requires a fundamental understanding of its risk-benefit ratio. The data would indicate that the risk-benefit ratio is favorable in the high-risk trauma patients.The problem is defining the high-risk patient.One trauma study^[14] identified four injury patterns that accounted for 92% of PEs: (1) spinal cord injury with Paraplegia or quadriplegia, (2) severe closed head injury with a Glasgow Coma Score ? 8, (3) age > 55 years with isolated long bone fractures, and (4) complex pelvic fractures associated with long bone fractures. Another retrospective review including 9,721 patients^[12] showed that the high risk categories include head injury plus spinal cord injury, head injury plus long bone fracture, severe pelvic fracture plus long bone fracture, and multiple long bone fractures. These authors estimate that if they would have utilized a prophylactic filter in these 2% of patients, there would have been a very dramatic reduction in PE. They suggested that patients with an estimated risk of PE of 2% to 5%, despite prophylaxis, are reasonable candidates for prophylactic vena caval filter placement, especially if conventional prophylactic measures cannot be used. Many years of experience with the Greenfield filter indicate that it has a patency rate of about 96%, a recurrent PE rate of 3% to 5%, and a caval penetration rate of about 2%. ^[7] These are reasonable complication rates, but multiplied over the lifetime of a young patient, these rates could become important.There is one study that indicates a significant amount of chronic venous insufficiency in long-term follow up of prophylactic filter patients.^[15]However, there was no non-filter group to compare to, so it is not clear if the filter was the cause of this chronic venous insufficiency in this very high risk group.

More recently, interest and experience have been gaining for the many types of retrievable filters. Much of this early work has been done in Europe.^{[27] [28] [29]} The use of retrievable filters are particularly appealing to trauma surgeons whose patients are at high risk for PE for a relatively short period of time. Technical problems with theretrievable filters have prevented their widespread application at the present time.Nevertheless, they may have potential in the future. A recent survey of 620 trauma surgeons across the United States revealed that the potentialremovability of filters would significantly increase (P < .01) prophylactic filter placement from 29% to 53%.

V. Summary

There is no Class I literature to support insertion of avenacavafilter in a trauma patient without an established DVT or PE. There is starting to accumulate a fair amount of Class II and III data which may support its use in “high-risk” trauma patients without a documented occurrence of a DVT or PE.At this time, we recommend consideration of IVC filter insertion in patients without a documented DVT or PE who meet high -risk criteria and cannot beanticoagulated.

VI. Future Investigation

There is an obvious need of Class I randomized, prospective controlled data to either support or refute the use ofvenacavalinterruption in trauma patients. Such studies need to enroll only high risk patients with a sufficiently high enough PE rate to attempt to prove filter efficacy and improve outcome in the patients who receive a truly prophylacticvenacavafilter. This study would need to be large andmulticenterin nature. The pilot portion of such a study has been completed, and the largemulticentertrial should involve many investigators from trauma associations. Other important unresolved issues include the following:

• Dovenacavafilters significantly reduce the incidence of clinically important PE in patients who receive “optimal” prophylaxis?
• If so, can a group of patients be identified who have a high failure rate with “optimal” prophylaxis?
• What are the short-term and long-term complications ofvenacavafilter insertion used as primary prophylaxis in trauma patients?
• Is vena cava filter insertion cost-effective?

VII. References

1. Greenfield LJ, MichnaBA: Twelve-year clinical experience with the Greenfield venacavalfilter.Surgery 104:706-12, 1988
2. GoluekePJ, Garrett WV, Thompson JE, etal: Interruption of the venacavaby means of the Greenfield filter: Expanding the indications. Surgery 103:111-7, 1988
3. Webb LX, Rush PT, Fuller SB, etal: Greenfield filter prophylaxis of pulmonary embolism in patients undergoing surgery for acetabularfracture. J Orthop Trauma 6:139 -45, 1992
4. RohrerMJ, ScheidlerMG, Wheeler HB, etal: Extended indications for placement of inferior venacavafilter. J Vasc Surgery 10:44-50, 1989
5. JarrellBE, PosuniakE, Roberts J, etal: A new method of management using the Kim-Ray Greenfield filter for deep venous thrombosis and pulmonary embolism in spinal cord injury. Surg Gynecol Obstet 157:316-20, 1983
6. CipolleM, MarcinczykM, Pasquale M, etal: Prophylactic venacavalfilters reduce pulmonary embolism in trauma patients. [Abstract] Critical Care Medicine 23:A93, 1995
7. Greenfield LJ: Post traumathromboembolismprophylaxis. Eighth Annual American Venous Forum, 1996
8. Rodriguez JL, Lopez JM, Proctor MC, etal: Early placement of prophylactic venacavalfilters in injured patients at high risk for pulmonary embolism. J Trauma 40:797-804, 1996
9. Rogers FB, ShackfordSR, RicciMA, etal: Routine prophylactic venacavafilter insertion in severely injured trauma patients decreases the incidence of pulmonary embolism. J Am Coll Surg 180:641-7, 1995
10. RosenthalD, McKinseyJF, Levy AM, etal: Use of the Greenfield filter in patients with major trauma. CardioVasc Surg 2:52-5, 1994
11. Wilson JT, Rogers FB, Wald SL, etal: Prophylactic venacavafilter insertion in patients with traumatic spinal cord injury: Preliminary results. Neurosurgery 35:234-9, 1994
12. Winchell RJ, Hoyt DB, Walsh JC, etal: Risk factors associated with pulmonary embolism despite routine prophylaxis: Implications for improved protection. J Trauma 37:600-6, 1994
13. ZolfaghariD, Johnson B, WeireterLJ, etal: Expanded use of inferior venacavafilters in the trauma population. Surgery Annual 27:99-105, 1995
14. Rogers FB, ShackfordSR, Wilson J, etal: Prophylactic venacavafilter insertion in severely injured trauma patients: Indications and preliminary results. J Trauma 35:637-42, 1993
15. Patton JH Jr, Fabian TC, Croce MA, etal: Prophylactic Greenfield filter: Acute complications and long-term follow up. J Trauma 41:231-7, 1996
16. CarabasiRA III, Moritz MJ, JarrellBE: Complications encountered with the use of the Greenfield filter. Am J Surg 154:163-8, 1987
17. Greenfield LJ, ChoKJ, Proctor MC, etal: Late results of suprarenalGreenfield venacavafilter placement. Arch Surg 127:969-73, 1992
18. Ferris EJ, McCowanTC, Carver DK, etal: Percutaneousinferior venacavafilters: Follow-up of seven designs in 320 patients. Radiology 188:851-6, 1993
19. Leach TA, PastenaJA, Swan KG: Surgical prophylaxis for pulmonary embolism. Am Surg60:292-5, 1994
20. NunnCR, NeuzilD, NaslundT, Bass JG, Jenkins JM, Pierce R, etal. Cost-effective method for bedside insertion of venacavafilters in trauma patients. J Trauma 1997;45:752-758.
21. TolaJC, HotzmanR, LottenbergL. Bedside placement of inferior venacavafilters in the intensive care unit. American Surg. 1999;65:833-837.
22. KhansariniaS, Dennis JW, VeldenzHC, Butcher JL, HartlandL. Prophylactic Greenfield filter placement in selected high-risk trauma patients. J Vasc Surg 1995;22: 235-236.
23. GosinJS, Graham AM, CioccaRG, Hammond JS. Efficacy of prophylactic venacavafilters in high-risk trauma patients. Ann Vasc Surg 1997;11:100-105.
24. HeadrickJR, Barker DE, Pate LM, Horne K, Russell WL, Burns RP. The role of ultrasonographyand inferior venacavafilter placement in high-risk trauma patients. Am Surg1997;63:1-8.
25. McMurtryAL, OwingsJT, Anderson JT, BattistellaFD, GosselinR. Increase use of prophylactic venacavafilters in trauma patients failed to decrease overall incidence of pulmonary embolism. J Am Coll Surg 1999;189:314-20.
26. SekharanJ, Dennis JW, Miranda FE, VeldenzHC, DovganPS, FrykbergER. Long term follow up of prophylactic greenfield filters in multisystemtrauma patients. J Trauma 2000; 49: 374
27. LorchH, WelgerD, Wagner V, etal: Current practice of temporary venacavafilter insertion: a multicentreregistry. J Vasc. Intervent. Rad. 2000; 11:83-88.
28. NeuerburgJM, Gunther RW, VorwerkD, DondelingerF, JagerH, LacknerKJ, etal. Results of a multicenterstudy of the retrievable tulip venacavafilter: early clinical experience.CardiovascIntervent Radiol 1997;20:10-16.
29. BovynG, Gory P, ReynaudP, RiccoJB. The tempofilter: a multicenterstudy of a new temporary cavalfilter implantable for up to six weeks. Ann Vasc Surg 1997;11:520-528.

Table

Deep Venous Thrombosis (DVT) in Trauma: A Literature Review

VENA CAVA FILTERS - “Traditional” Indications

VENA CAVA FILTERS -“Extended” Indications: Trauma

TEMPORARY FILTERS: