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442 Chapter 47/Complications of Vena Cava Filters
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appear in the literature. These are rare, usually reportable,
complications of fi lter placement.
RETRIEVAL COMPLICATIONS
The optionally retrievable fi lters, the Günther-Tulip,
OptEase, and Recovery fi lters, differ in shape, contact with
the IVC wall, and recommended dwell time. Each of these
fi lters is approved by the FDA for retrievable use. When
used as an optionally retrievable fi lter, two visits to the
interventional suite are required; initially for placement and
when indicated for removal. This creates a potential for
increased numbers of complications related to venous access
FIGURE 47.5 VenaTech fi lter with migration to the level of the intra-
hepatic inferior vena cava demonstrated on CT scan.
However, because of the unusual location, retrieval may
require extraordinary measures such as placement on cardiopulmonary bypass, circulatory arrest, and even open surgical procedures. Occasionally, embolization is considered
to have occurred because of a large thrombus burden
entrapped within the fi lter.
19,35
Routine clinical follow-up
and serial radiographic surveillance has not been advocated
following IVC fi lter placement, so migration usually is identifi ed serendipitously unless a serious clinical consequence
occurs.
EXTRUSION
Most fi lters will have some change in dimension following placement.35 Extrusion of the fi lter struts through the
caval wall is a near-universal phenomenon.
to determine the long-term clinical and radiographic outcome
of patients who undergo insertion of a Bird’s Nest fi lter,
perforation of the caval wall was universal but not clinically
39
symptomatic.
Strut extrusion usually does not assume
clinical importance until there is involvement of adjacent
structures and associated clinical complications.
There are a number of case reports in the literature detailing individual clinical experiences and unusual complications resulting from strut or even fi lter extrusion from the
IVC. Reports of small bowel obstruction occurring as a
result of volvulus occurring around an extruded fi lter strut,40
a fragmented IVC fi lter penetrating the aorta and causing a
small infrarenal aortic pseudoaneurysm,41 hydronephrosis
caused by transcaval penetration of a Bird’s Nest fi lter,42
laceration of a lumbar artery by a stainless steel Greenfi eld
fi lter strut that resulted in a near fatal hemorrhage43 and
upper gastrointestinal bleeding secondary to Bird’s Nest
inferior vena caval fi lter migration into the duodenum44
8,35,38
In a study
as well as an entirely new category of complications related
to the explantation of devices. Furthermore, explantation
complications can be of a serious nature (e.g., caval
perforation).
The maximal dwell time for retrievable fi lters when safe
retrieval is possible has not yet been evaluated. Binkert et
al.45 have reported the retrieval of such a type of fi lter at 317
days without complication on follow-up venogram. Compared to the Recovery fi lter, the recommended time to
removal is relatively short for the Günther-Tulip and OptEase
fi lters. Repeated repositioning has been used to prolong the
deployment of these devices.46 Most of the optionally retrievable fi lters are relatively new, and little to no data are available on their long-term performance when used as permanent
fi lters. Although most retrievable IVC fi lters are placed in
patients with a well-defi ned, short-term risk for VTE and
contraindications to anticoagulation, the percentage of
retrievable fi lters actually removed is less than 50%.47 The
most common reason stated for not retrieving a fi lter is due
to caval or fi lter thrombus or continued contraindication to
anticoagulation. All retrieved fi lters have strands of organized thrombus on the fi lter struts. The presence of small
thrombi does not dictate the need to abort the retrieval, but
larger thrombi preclude fi lter removal. Given the large
numbers of these fi lters remaining in situ, data on the poten-
tial longer term complications of these fi lters should be
emerging.
Data on failed retrievals based on technical diffi culties
are sparse. Most limited case series of the various fi lter types
report successful snaring and device retrieval with no caval
injuries.
48,49
In one series, retrieval failure was related to
device angulation within the vena cava that precluded safe
capture.48 Diffi culties with retrieval may be encountered
more frequently with longer dwell times, but data are lacking
at present.
SPECIAL CONSIDERATIONS
There are identifi ed patient populations in whom IVC
fi lter use generates special consideration. These include
Special Considerations 443
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trauma patients, children, pregnant women, and patients
with septicemia. In the trauma population IVC fi lter placement has gained popularity as a mechanism of both primary
and secondary prophylaxis. The body of literature regarding
fi lter use in this setting is growing. On the other hand, very
few studies focus on fi lter placement in children, during
pregnancy, or in patients with septicemia.
In most clinical settings fi lters are deployed into the
infrarenal IVC. However, placement in the suprarenal IVC
or SVC has also been used. Suprarenal placement may be
indicated in some clinical settings or may occur inadvertently during deployment. SVC positioning has been
employed to protect against embolism from upper extremity
DVT.
Trauma
The use of IVC fi lters for primary prophylaxis in trauma
patients has increased, especially when sequential compression or pharmacologic therapy is contraindicated; for
example, vertebral fracture or spinal cord injury, multiple
lower extremity fractures, and closed head injury. The use
of IVC fi lters for primary prophylaxis in this setting is open
to controversy. Analysis of 450,375 patients registered in the
American College of Surgeons National Trauma Data Bank
identifi ed a VTE (DVT, PE, or both) rate of 0.36%. Mortality
rate in patients with PE was 18.7%. A total of 3883 patients
had IVC fi lters placed; 83% were prophylactic. This analysis
also identifi ed risk factors for VTE including age ≥40 (OR
2.29), pelvic or lower extremity fracture (OR 2.93 and 3.16,
respectively), spinal cord injury with paralysis (OR 3.39),
head injury (OR 2.59), > three days of ventilator dependency
(OR 10.62), venous injury (OR 7.93), shock (OR 1.95), and
major surgery (OR 4.32).50 Yet data regarding IVC fi lter use
in the trauma setting are based solely on case series reports
and retrospective registry studies. Girard et al. reviewed 16
case series published before 1999 with a total of 1112 trauma
patients.51 Pulmonary embolism occurred following IVC
fi lter placement in 0 to 3.9% of cases. Fatal pulmonary
embolism was documented in a single patient in each of two
studies. DVT was identifi ed in 0 to 20.6% of patients. IVC
thrombosis or occlusion occurred in 0 to 6.7% of cases.
Insertion site thrombosis and procedural complications were
identifi ed in 0 to 5.7% and 0 to 4.6% of cases, respectively.
The results do not support the general use of fi lters in all
trauma patients, but since this review encompassed reports
prior to 1999, the use of newer, low profi le devices may
demonstrate more favorable results. Furthermore, selected
use of fi lters in high-risk subgroups of trauma patients may
be appropriate.
Optionally retrievable fi lters have also been used in the
trauma population. In recently published series, recurrent
DVT was documented in 2.9% and 8.6%; and in one study,
insertion-site DVT was documented in 1.9%.
30,52
51
Filter
retrieval was successful in 51% and 66% of patients. If the
practice of permanent or optionally retrievable fi lter placement for primary prophylaxis in the trauma population is to
be supported, further systematic study is required.
Children
Thromboembolic events are less frequent in children than
adults. When present, the options for therapy remain the
same. The potential for growth and increased life-expectancy for children raises concerns regarding the use of IVC
fi lters. One study has published results of IVC fi lter placement in 15 children with clinical follow-up. No insertion
complications including insertion site thrombosis, no migration, and no fi lter-related mortality occurred. During followup, one patient demonstrated post-thrombotic syndrome
symptoms and three patients had common femoral vein
refl ux, but no recurrent PE occurred.53 In another study of
eight patients; three patients died. The remaining fi ve
patients, followed up to 13 months, demonstrated no fi lter
migration, IVC occlusion or thrombosis, or symptomatic
pulmonary embolism.54 From the limited data available, IVC
fi lter placement in children may serve as a useful management tool in patients with a contraindication to anticoagulation. Children do not appear to have an increased risk of
complications compared to other study groups.
Septicemia
Infectious complications of IVC fi lters appear as case
reports,55 but there is a paucity of data regarding this complication. Indeed the single retrospective publication of IVC
fi lter placement in patients with septicemia demonstrated no
need for fi lter retrieval due to infectious complications.56
Documented 30-day survival was 67%. Filter complications
included caval occlusion (1%), recurrent nonfatal PE (1%),
recurrent DVT (2.9%), and procedure/deployment complications in 8.6% of patients.56 Rare case reports of IVC fi lter
infection should not sway the decision to place an IVC fi lter
when clinically indicated in patients with septicemia.
Suprarenal Filter Placement
Suprarenal IVC fi lter placement may be indicated when
the infrarenal IVC size is too large to accommodate a fi lter
(>40 mm), if thrombus in the IVC precludes infrarenal placement, or in cases of fi lter occlusion or thrombosis. Suprarenal placement historically has been advocated in women
who are pregnant or of child-bearing age although there is
very little literature to support this practice. Occasionally
IVC fi lters may be required in patients following renal transplant. In this setting even using usual deployment techniques, the IVC fi lter will be in a suprarenal position.
Juxtarenal or suprarenal IVC fi lter placement may also occur
444 Chapter 47/Complications of Vena Cava Filters
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inadvertently during attempted infrarenal caval fi lter placement. Concern surrounds suprarenal IVC fi lter placement
due to the risk for IVC thrombosis or thrombus propagation
and the potential for fatal renal vein thrombosis. This complication has been seen; however, it appears to be relatively
54,57
rare.
From one survey of cancer patients with suprarenal
IVC fi lter placement, two of 13 patients developed renal
vein thrombosis.
57
Greenfi eld et al. reviewed data on 148 suprarenal IVC
fi lters and compared outcomes to 1932 infrarenal IVC fi lters
placed during the same period.58 Overall there was no statistically signifi cant difference in the complication rates
between the two fi lter groups. Recurrent PE was documented
in 8% and 4% of suprarenal IVC and infrarenal IVC fi lters,
respectively. Caval occlusion was found in 5% of patients.
There were no renal complications.58 Forty-six IVC fi lters
that were inadvertently placed in the suprarenal IVC, juxtarenal IVC, or renal vein were compared to patients with
IVC fi lters.17 No differences in fi lter effi cacy were identifi ed.
PE after fi lter placement was identifi ed in 7% of patients,
but renal complications were not discussed.17 Although
suprarenal IVC fi lter placement does not appear to be complicated by a preponderance of renal vein thrombosis, in
patients with advanced malignancy, a single functioning
kidney, chronic kidney disease, or previous renal vein
thrombosis, suprarenal IVC fi lter placement should be
avoided if possible.
Superior Vena Cava Filters
Patients with upper extremity DVT who have a contraindication to anticoagulation or experience pulmonary embolism despite adequate anticoagulation have very limited
treatment options. SVC fi lter placement has been studied in
this setting.
ment, or fracture was identifi ed in 41 patients (median
follow-up 12 weeks). No clinical symptoms of SVC syndrome were identifi ed. Central venous catheters or SwanGanz catheters were subsequently placed in 56% of patients
without complication. One patient had subsequent PE related
to left lower extremity DVT.
their experience in 72 patients with SVC fi lter placement.
During the index hospitalization, 47% of patients died of
causes unrelated to the SVC fi lter or VTE. No migration was
identifi ed by follow-up radiographs. One fi lter was displaced
into the innominate vein by a guidewire during central line
placement. No clinical evidence for PE or SVC thrombosis
was documented.29 Upper extremity DVT is not free of
typical thromboembolic complications. SVC fi lter placement may be an alternative form of management in this
clinical setting. However, the relative increase in the use of
indwelling catheters and transvenous devices such as pacemakers and defi brillators may make permanent deployment
of a fi lter in this position less favorable. Optionally retriev-
29,34
In one series, no fi lter migration, dislodge-
34
Greenfi eld et al. reviewed
able fi lters may have a role in this setting, but data are
lacking at present.
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34. Spence LD, Gironta MG, Malde HM, Mickolick CT, Geisinger MA,
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PR, Nesto RW. Misplaced caval fi lter and subsequent pericardial tamponade, Ann Thorac Surg. 1991. 51: 299–300; discussion 301.
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38. Hoekstra A, Hoogeveen Y, Elstrodt JM, Tiebosch AT. Vena cava fi lter
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39. Starok MS, Common AA. Follow-up after insertion of Bird’s Nest
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44. al Zahrani HA. Bird’s nest inferior vena caval fi lter migration into the
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48. Lam RC, Bush RL, Lin PH, Lumsden AB. Early technical and clinical
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Bormanis J, Wells PS. Gunther Tulip fi lter: Preliminary clinical experience with retrieval, J Vasc Interv Radiol. 2000. 11: 75–82.
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CHAPTER
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48
Temporary Filters and Prophylactic Indications
ROBERT B. RUTHERFORD
There has been a four-fold increase in the use of vena cava
fi lters (VCFs) over the last 15 years. It began with the wide
availability of percutaneous fi lter placement using low
profi le devices and carriers, but this trend has also been
associated with a steady increase in the use of prophylactic
indications, which now dominate numerically over therapeutic indications. A preceding chapter has dealt with permanent fi lters, whose indications and results are relatively
well established, but recently a number of temporary or
retrievable fi lter devices have been introduced, and their use
is also increasing. In certain respects two of these upward
trends, in prophylactic indications and the use of retrievable
vena cava fi lters (RVCFs), are linked in that both are most
commonly used in dealing with patients who have not had
a pulmonary embolus (PE) but who are considered to be at
high risk of this dreaded complication, yet only for a limited
period of time. This chapter will appraise both of these burgeoning practices, and the available evidence regarding
these remarkable shifts in the use of VCFs.
THE RATIONALE BEHIND THE USE OF
TEMPORARY OR RETRIEVABLE VCFs
The preceding chapter dealt with the complications of
vena cava fi lters, which, it will be seen, provide part of the
justifi cation for using temporary or retrievable fi lters
(RVCFs). The justifi cation for using RVCFs is based on two
oft-related circumstances: 1) the risk of PE is limited in
duration in a number of patient categories and 2) the complications associated with leaving a VCF in situ can be signifi cant over time. The latter consideration is particularly
pertinent in otherwise healthy younger patients with an
extended longevity outlook who would be at risk of these
problems for many years.
This was just a theoretical position until a randomized
prospective trial suggested that this was indeed the case. The
PREPIC trial (Prevention du Risque d’Embolie Pulmonaire
par Interruption Cave)1 has been widely quoted as evidence
to support the use of temporary/retrievable fi lters. This trial
randomized 400 patients with proximal DVT and a variety
of indications for VCF placement into no fi lter and fi lter
groups, both receiving heparin (contraindication to anticoagulant therapy [AC Rx] was not represented). The choice
of fi lter used was optional and included Vena Tech LGM,
Titanium Greenfi eld, Cardial, or Bird’s Nest. After 12 days,
there was a signifi cant protection against PE by the fi lters
(1.1% vs. 4.8%, p = 0.03) and a very suggestive advantage
against fatal PE (0.0% vs. 2.0%, p = 0.12). At two years, the
protection against PE (3.4% vs. 6.3%, p = 0.16) and fatal
PE (0.5% vs. 2.5%, p = 0.21) appeared to persist, but statistical signifi cance was lost because of diminishing numbers of
patients. However, at two years, there was a signifi cantly
higher rate of DVT among the fi lter group (21% vs. 12%,
p = 0.02). The conclusion was that although fi lters protected
against PE, they carried a higher risk of later DVT. Whether
this late DVT risk was related to the thrombogenicity of
some of the fi lters used, and/or associated caval thrombosis
due to disturbed fl ow or intimal changes is not known and
the results were not analyzed relative to fi lter type. Followup data at fi ve and eight years
terms of DVT, but statistical signifi cance, though close, was
lost ( p = 0.06 at fi ve years and p = 0.08 at eight years).
Some have used these late follow-up data to claim that
there is not a long-term risk of DVT associated with leaving
in VCFs, whereas others have countered that the trends are
still clear but that, like many long-term studies, the loss of
2,3
showed the same trends in
The Vein Book
447
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448 Chapter 48/Temporary Filters and Prophylactic Indications
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FIGURE 48.1 Four temporary, retrievable IVC fi lters are shown in a panel A. The OptEase (Johnson & Johnson,
Cordis Endovascular); B. The Gunther Tulip (Cook); C. The Recovery (Bard Peripheral Vascular Inc., Tempe Arizona);
and D. The Tempofi lter II (B. Braun, Boulogne, France).
patients to follow-up undermines statistical signifi cance.
Nevertheless, this study added great impetus to the development of temporary, retrievable fi lters for prophylactic indications representing a limited duration of risk of PE.
CURRENTLY AVAILABLE TEMPORARY OR
RETRIEVABLE VENA CAVA FILTERS
It is not the purpose of this chapter to compare individual
fi lters. Nevertheless, specifi c fi lters will be mentioned in the
discussion that follows; therefore they should be identifi ed
here. Currently, of the temporary or retrievable fi lters, the
Gunther Tulip (Cook), the OptEase (Cordis), and the Recovery 4 (Bard) have been approved by the FDA in the United
States, and the Tempofi lter II (Braun), the ALN (ALN fi lter),
and the SafeFlo (Rafael) are available in Europe, under CE
Mark, and at least in the case of the former, in Asia and
South America as well. The fi rst four of these are shown in
Figure 48.1.
PROBLEMS WITH CURRENT
RETRIEVABLE VENA CAVA FILTERS
In spite of the impressive technological advances associated with the development of RVCFs, there are still a number
of limiting factors that deserve to be pointed out. Removal
of many if not most of the current temporary fi lters becomes
increasingly diffi cult with passage of time because of thrombus in the fi lter and/or adherence at points of endothelial
contact. As a result many have simply been left in. Throm-
Problems with Current Retrievable Vena Cava Filters 449
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bus in a fi lter can be interpreted as good (a potential PE
has been trapped) or bad (device thrombogenicity). This
problem in retrieving temporary fi lters may have resulted in
renaming them optional fi lters, meaning that they can be
used as either temporary/retrievable fi lters or left in as permanent fi lters. This implies that it is quite permissible (i.e.,
no signifi cant penalty) to leave them in. This name change
may be a marketing ploy because, as of this writing, no good
long-term outcome data on these new optional fi lters has
been published to justify leaving them indefi nitely (e.g., low
rates of recurrent PE, fi lter migration, fi lter or caval thrombosis, distal DVT, etc.). The design goal of a fi lter that
optionally can be used either as a temporary fi lter (i.e., left
in longer, as long as the temporary need for protection persists, then safely retrieved) or as a permanent fi lter (that can
be safely left in indefi nitely), is a worthy one, but reported
experiences suggest that most of the current temporary
fi lters can be left in only a few weeks or months before
encountering increasing problems with either contained
thrombus or contact point endothelialization, either of
which can compromise retrievability. Instructions with some
retrievable devices advise removal in 14 or 21 days; others
give less specifi c advice, but two have suggested permissible
indwelling times of up to three months. The evidence on this
aspect deserves further consideration.
The reported experience with the greatest claim regarding
the safe duration before retrieving a temporary VCF has
been with the Recovery (Bard) device,4 which concluded
that it “demonstrates the feasibility and safety of retrieval
up to 134 days after implantation.” In 24 of 32 patients
(75%), the fi lters were retrieved between fi ve and 134 days
(mean 53 days!). Clot was present in seven (22%), in two
large enough to be presumed to be trapped emboli, and presented diffi culties with removal. Four patients were alive
with their fi lters still in; three died with fi lters in place, and
in one the fi lter was removed surgically.
The Tempofi lter II (B. Braun) has a similar suggested
safe removal time as the Bard Recovery device (i.e., up to
three months). Data from a multicenter French study that
support this claim has been submitted for publication. This
device differs from the others in that introduction and withdrawal is through a tethered catheter with a subcutaneous
anchoring device. Thus, leaving it in is not an option but its
overall design facilitates the retrieval process.
In a recent report of this approach in multiple trauma
victims, by Rosenthal et al.,
5
using the Optease retrievable
fi lter (Cordis Endovascular) and ICU bedside insertion under
ultrasound guidance, the fi lters were successfully placed in
91 of 94 patients, but successfully retrieved in only 31 of 91
(34%) between fi ve to 25 days (mean 19 days). Removal
caused a 0.5 cm defect in the caval wall of one patient but
without contrast extravasation. Of the 44 fi lters left in, 41
were not removed “because of the severity of the injury
prevented—initiation of—anticoagulation prophylaxis,” but
three were left in because of trapped thrombi. One patient
had a PE after fi lter removal.
One makeshift solution to this problem has been to repo-
6
sition the fi lter every 12 to 14 days. Offner et al.
reported
repositioning the fi lter every 12 days if it was not ready to
be retrieved. But this was done in less than one-quarter
(9/44) of patients, and in three patients the fi lter could not
be removed because of either trapped clot (n = 2) or angulation (one case).
A Spanish experience with the Gunther Tulip7 also
reported repositioning as a way of achieving a longer
indwelling time than the recommended 14 days. They used
this strategy in 26% of 87 patients. Seventy of 88 fi lters
(almost 80%) eventually had their fi lters removed. The
mean indwelling time was 34.8 days; the average number of
repositionings was 1.5, and the mean repositioning interval
13.8 days. Eighteen patients had their VCFs left in permanently: in one, fi xation in the IVC prevented removal
at 16 days; two were left in because of large entrapped
thrombus; and all had “varying amounts of fi brous and
fi brotic material adhering to the fi lter struts.” Focal tears,
associated with intramural hematomas as large as 10 mm
in diameter, were visualized angiographically after fi lter
removal, but there were no transmural lacerations or contrast
extravasations.
Finally, it should be pointed out that each intervention to
change fi lter position or retrieve the VCF is, to a degree,
invasive and presents some risk of patient harm. These
retrieval procedures represent an additional cost ($3000–
$5000), which is not currently reimbursed in the United
States.8 This begs the issue: if there is a permanent fi lter that
can be left in for long periods of time without signifi cant
penalty, why not use it rather than a retrievable VCF? The
results of the PREPIC trial were not stratifi ed for the different permanent fi lters used (some of which may have been
described in the previous two chapters). Nevertheless, one
of the de-vices used, the Titanium Greenfi eld fi lter, was a
low-profi le version of the original stainless steel Greenfi eld
fi lter, which has reported excellent 12- and 20-year results
in terms of recurrent PE, caval patency, and DVT,
9,10
and
which has since been supplemented by an over-the-wire
stainless steel Greenfi eld. Both of these low-profi le, permanent fi lters appear to mimic the performance of their prede-
11,12
cessor.
Pending the correction of existing problems with
current RVCFs, an alternative strategy then is to use permanent fi lters even for prophylactic reasons, which is currently
the majority practice. The duration of safe indwelling time
was recognized as a signifi cant limitation of temporary
fi lters in a survey of North American and European practices
conducted by B. Braun, being identifi ed as a major issue by
40% of those using RVCFs, and the majority of those continuing to use only permanent fi lters gave this as a major
reason (B. Braun, personal communication). A minor objection to persisting with this approach is that there is a small
450 Chapter 48/Temporary Filters and Prophylactic Indications
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but defi nite need, even in the best permanent fi lter, for repositioning or retrieval on occasion.
So, in summary, many if not most of the current temporary fi lters develop progressive problems with entrapped
thrombus and endothelial incorporation with time, suffi cient
to compromising their retrievability. The safe removal time
recommended by the manufacturer for different devices
varies from three weeks to three months but is not well
documented by reported data. Early removal of the device
because of these limitations has resulted in PEs occurring
after removal. Repositioning, to extend the safe indwelling
time, has met with only limited success. Further design
modifi cations may well be needed to extend the reliable time
for completely safe removal. If this were extended to somewhere between six weeks and three months it would greatly
widen RVCF application. As matters stand, retrievable
RVCFs have not replaced permanent VCFs, even for prophylactic indications.
PROPHYLACTIC INDICATIONS:
CRITICAL APPRAISAL
The major and steady increases in the use of prophylactic
indications over the last three or four decades, to the point
where it clearly dominates over therapeutic indications, have
a number of likely reasons, but because all the conditions
for which VCFs are being applied were all present by the
time effective permanent VCFs were available, in the late
1960s, it seems appropriate to question the justifi cation for
such a large increase, particularly since there does not appear
to be good data-based evidence for most prophylactic indications. Some general statements can be made about prophylactic indications in some respects but in other respects,
it is necessary to focus on individual categorical prophylactic indications to pinpoint key issues.
CHANGES IN REFERRAL
PATTERNS AND SPECIALIST
PERFORMING THE PROCEDURE
The placement of VCFs, in the period after well-designed
permanent devices were developed and available, was performed through remote cut-down under general or local
anesthesia with sedation, with a then-acceptably low procedural morbidity and mortality, the latter usually being attributable to intercurrent disease rather than operative
misadventures. What percutaneous placement of the newer
low-profi le devices offered was the avoidance of open
surgery, empirically attractive to referring physicians.
Although vascular surgeons continued to participate in these
trends and introduce new technology and technical
approaches, percutaneous placement increasingly opened
the door to other interventionalists (e.g., an interventional
radiologist, cardiologist, or other specialist with catheter
skills). In addition, the referring physicians more often were
those without a primary interest in the management of VTE
and AC therapy (e.g., an oncologist, trauma surgeon, bariatric surgeon, orthopedic surgeon, neurosurgeon). This
combination of less knowledgeable, less critical physician
referrals and ready acceptance by service-oriented interventionalists may have played a major role in liberalizing the
indications for prophylactic VCF use.
LACK OF ADEQUATE EVIDENCE
ON WHICH TO BASE DECISIONS
REGARDING VCF USE
These changing referring physician-interventionalist
arrangements may not only have resulted in an apparent lack
of critical appraisal of expanding indications but a dearth of
critical outcome assessments. In a Medline search of 568
references from 1975 to 2000 on VCFs, Girard et al.13 found
that 65% either were retrospective studies (33.3%) or case
reports (31.7%), that 12.9% were animal or in vitro experiments, and only 7.4% were prospective studies. Only 16
studies involved more than 100 cases and there was only
one randomized study. In contrast, 47.4% of 531 references
on heparin in VTE were randomized prospective trials. This
is a striking contrast and should serve as a challenge to those
involved with VCF placement to come up with higher level
data on which to base current practice.
ISSUES WITH INDIVIDUAL
PROPHYLACTIC INDICATIONS
Each prophylactic indication category deserves individual comment in terms of VCF use.
Multiple Trauma
Multiple long bone fractures, severe closed head injuries,
vertebral spine injuries with and without cord injury, pelvic
or acetabular fractures, associated major direct venous
trauma, and essentially any other multiple system trauma
predicted to require extended period of immobilization are
generally considered to be reasonable prophylactic indications for inserting a VCF, but each subgroup deserves clearer
defi nition. Severe, multisystem trauma is associated with
periods of hypercoagulability, and in some instances,
involves direct or indirect venous trauma or endothelial
damage. These types of trauma are known to be associated
with a high risk of VTE and AC Rx is usually contraindicated. Intermittent pneumatic compression (IPC) and/or
Issues with Individual Prophylactic Indications 451
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duplex surveillance (DS) is another prophylactic measure to
be considered, and IVC fi lter placement is appropriate only
when this is not practical or deemed effective. It is important
to note that these patients need protection only until they are
ambulatory or AC therapy can be instituted.
Although the justifi cation for temporary caval fi ltration
relates to the limited duration of the need for protection, it
is spurred by the fact that most trauma patients are young
and their expected longevity is great relative to the duration
of this need. Nevertheless, the duration of risk may be quite
long in many of these types of trauma relative to the safe
indwelling time of most current retrievable fi lters. In such
cases, with predictably long immobilization (e.g., spinal
fractures, pelvic fractures, multiple long bone fractures), it
might be better to use a permanent fi lter, the one with the
best long-term performance record.
VCFs have been reported to be effective for this category
of prophylactic use. Langhan et al.14 reported a 99.5% effectiveness but also reported a 12.8% rate of DVT, after fi lter
insertion, with an additional 10.3% in those followed later.
However, only 47% returned for follow-up (a problem with
trauma patients), and the fi lter was visualized in only 52%
of those. On a survey questionnaire of the others, 27 had leg
swelling, 14 had other extremity symptoms, nine had shortness of breath, seven had chest pain, and four had venous
skin changes. It cannot be determined, from such a followup, how many of these reported problems could have
refl ected VTE. There were three nonfatal fi lter complications, but all 27 deaths were attributed to the trauma, not the
VCF. Clearly, the protection against PE was excellent but,
much like the PREPIC trial,1 there appears to be a penalty
for this approach in the form of DVT.
In a more recent report of this approach in multiple
trauma victims, Rosenthal et al.5 reported that the fi lters
were successfully placed with 96.8% technical success.
None of the 19 deaths was reportedly from VCF placement,
and there were complications in only 5.3%. One patient had
a PE after fi lter removal. Follow-up in this study was short
and the incidence of DVT was not documented. In another
evaluation of this approach from a trauma center, Duperier
15
et al.
reported a low rate of insertion complications in 133
consecutive multiple trauma patients, but “DVT was
observed in 30% of patients despite 92% being on prophylaxis”; 26% were de novo. In this experience, the fi lter was
inserted an average of 6.8 +/− 0.6 (SE) days after trauma.
In the previously cited experience of Langhan,14 the mean
insertion day was 6. This delay in insertion of the VCF in
earlier trauma experiences, before the practice of bedside
fi lter insertion under ultrasound guidance, reinforces the
potential value of this relatively recent capability.
One critical appraisal of the prophylactic use of VCFs in
trauma patients has been recently been reported by Knudsen
16
In an analysis of 1,602 episodes of VTE from the
et al.
American College of Surgeons National Trauma Data Bank,
they observed that 90% had at least one of nine accepted
risk factors, and found the following factors correlated signifi cantly with outcome: age (>40), lower extremity fracture,
a high trauma score, head injury, prolonged ventilator
support (> three days), venous injury, and major operative
procedure. Eighty-six percent had prophylactic IVC fi lters
placed, but 11% had no identifi able risk factors. They concluded that 1) patients who need VTE prophylaxis after
trauma can be identifi ed by risk factors and 2) the use of
prophylactic IVC fi lters in trauma patients should be
reexamined.
Patients with Neurological
Problems Resulting in Paralysis or
Prolonged Immobilization
Paralyzed or otherwise immobilized patients are at high
risk for VTE, but many can be managed by anticoagulant
therapy. In those in whom anticoagulants are contraindicated, if the limbs are accessible (i.e., not injured or encumbered), intermittent pneumatic compression (IPC) and
duplex surveillance (DS) can be used, and may be effective.
There are, however, patients in whom AC therapy is contraindicated or in whom the limbs are not accessible for IPC
or DS (e.g., closed head or acute cord injuries associated
with long bone fractures) in which VCFs may be justifi ed.
Outside of this exemplary exception, other forms of prophylaxis probably should be used with some form of surveillance for DVT added.
Two recent articles attest to this generic advice. Maxwell
et al.17 studied 111 spinal cord–injured patients from a registry of 8,269 trauma admissions, and found that using these
other means of prophylaxis, there was an overall incidence
of DVT and PE of 9.0% and 1.8%, respectively, but with no
deaths. Mean hospital stay was 23 days and DS was performed an average of 2.3 +/− 2.1 times. The incidence of
DVT and PE with low molecular weight (LMW) heparin
alone was 11.1% and 2.8%, respectively, but when this was
combined with DS, it was only 7.4% and 0%, respectively,
so the latter combination was recommended. By comparison, in a subgroup with long bone fractures, the incidence
of DVT was 37.5%. They concluded that IVC fi lters were
needed only in spinal cord injury patients with associated
long bone fractures, in those with detected DVT or its
progression under surveillance, or when AC therapy was
contraindicated.
This agrees with guidelines developed by a committee of
neurosurgeons
alone is insuffi cient and recommended rotating beds, IPC,
and DS in addition, with VCF inserted only if DVT was
detected. Thus, recent opinion appears to suggest that the
role of VCFs in this category should be limited to those who
develop DVT despite other forms of prophylaxis.
18
who agreed that low-dose LMW heparin
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