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20 Vena Cava Filter
20.2.3 Studies andRegistries
20.2.3.1 Updated Trends inInferior Vena Cava Filter Use
intheUnited States
Using the Nationwide Inpatient Sample (NIS), Olanipekun et al. [12] analyzed
IVCF placements from 2010 to 2019 stratied by indications to evaluate the impact
of the FDA guidelines on the temporal trends in IVCF utilization for VTE treatment.
A total of 823,717 IVCFs were placed over the study period, of which 644,663
(78.3%) were for VTE treatment and 179,054 (21.7%) were for prophylaxis indications. The median age for both categories of patients was 68years. The total number
of IVCFs placed for all indications decreased from 129,616in 2010 to 58,465in
2019, with an aggregate decline rate of −8.4%. The decline rate was higher between
2014 and 2019 than between 2010 and 2014 (−11.6% vs −7.2%). From 2010 to
2019, IVCF placement for VTE treatment and prophylaxis trended downward at
rates of −7.9% and −10.2%, respectively. Inferior vena cava lters (IVCF) are associated with medical complications. The 2010 and 2014 FDA safety warnings
appeared to have synergistically contributed to a signicant decline in IVCF utilization rates from 2010–2019 in the US. IVC lter placements in patients without
venous thromboembolism (VTE) declined at a higher rate than VTE.
20.2.3.2 IVC Filters inSeverely Injured Patients
To analyze state and nationwide temporal trends in VCF placement and PE occurrence from 2003 to 2015, a retrospective trauma cohort study was conducted by
Cook etal. [13]. Data from the Pennsylvania Trauma Outcome Study (PTOS), the
National Trauma Data Bank (NTDB), and the National (Nationwide) Inpatient
Sample (NIS) databases were used. Of patients receiving a lter (11,405 in the
PTOS, 71029in the NTDB, and 189,957in the NIS), most were prophylactic VCFs
(93.6% in the PTOS, 93.5% in the NTDB, and 93.3% in the NIS). Unadjusted and
adjusted temporal trends for the PTOS and NTDB showed initial increases in lter
placement followed by signicant declines (unadjusted reductions in VCF placement rates, 76.8% in the PTOS and 53.3% in the NTDB). The NIS demonstrated a
similar unadjusted trend, with a slight increase and modest decline (22.2%) in VCF
placement rates over time; however, adjusted trends showed a slight but signicant
increase in lter rates. Adjusted PE rates for the PTOS and NTDB showed signicant initial increases followed by slight decreases, with limited variation during the
declining lter use periods. The NIS showed an initial increase in PE rates followed
by a period of stagnation. Despite a precipitous decline of VCF use in trauma, PE
rates remained unchanged during this period. Taking this association into consideration, VCFs may have limited utility in inuencing rates of PE.
Gilligan etal. [14] performed a retrospective study using data from the National
Trauma Data Bank (2005–2014). In total, 65,482 VCFs were placed by 448 centers.
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Twenty centers (4.3%) placed no VCFs. The greatest predictors of VCF placement
were deep vein thrombosis, spinal cord paralysis, and major procedure. The strongest negative predictor of VCF placement was admission during the year 2014. PE
occurred in 7.5% of patients with a VCF and in 0.4% of patients who did not receive
a VCF.Substantial variation in practice in VCF placement was seen.
Sabharwal etal. [15] determined the prevalence and variation of inferior vena
cava lter (IVCF) use in the spine trauma population and evaluated patient and
facility level factors associated with their use. Of the 120,920 patients identied
with spinal injuries, 2.4% received prophylactic IVCF.Of the 13,273 patients with
operatively treated spinal injuries, 8.2% received prophylactic IVCF.Of the 7770
patients with spinal cord injury (SCI), 10.8% received prophylactic IVCF. The
interquartile ranges of placement rates among centers demonstrated greater than
ten-fold variation. Based on multivariate logistic regression, ISS score>12 demonstrated the strongest association with prophylactic IVCF (adjusted OR= 4.908).
Even in the subpopulations perceived to be at highest risk for VTE (operatively
treated spinal injuries, SCI), prophylactic IVCF use is relatively uncommon (8.2%
and 10.8% respectively) but wide variation in their use was observed among centers.
20.2.3.3 IVC Filter Placement inPatients
withCatheter-Based Thrombolysis
Akhtar etal. [16] investigated the contemporary trends and comparative effectiveness of adjunctive inferior vena cava lter (IVCF) placement in patients undergoing
catheter-directed thrombolysis (CDT) for treatment of proximal lower extremity or
caval deep vein thrombosis. The National Inpatient Sample database was used. Of
the 7119 patients treated with CDT, 2421 (34%) received IVCFs. There was no
signicant difference in in-hospital mortality (0.7% vs 1.0%; p=0.20), procedurerelated hemorrhage (1.4% vs. 1.0%; p=0.23), or intracranial hemorrhage (0.7% vs.
0.6%; p= 0.70) between the IVCF (n =2259) and no-IVCF (n = 2259) groups,
respectively. This nationwide observational study suggests that one-third of all
patients undergoing CDT receive IVCFs. IVCF use was not associated with a
decrease in in-hospital mortality but was associated with higher inpatient charges
and longer length of stay (Table20.1).
20.2.3.4 Stenting across Inferior Vena Cava Filters
A subset of patients presenting with acute or chronic iliocaval obstruction will have
an indwelling inferior vena cava (IVC) lter in place. Endovascular techniques have
been described for removing IVC lters before stenting. However, removal failures
can result in catastrophic complications. Stenting across indwelling IVC lters has
been proposed as an alternative to complex removal. The purpose of a study
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Table 20.1 Outcome of patients undergoing catheter-directed thrombolysis with or without
inferior vena cava lter placement. Propensity score matched comparison (according to [16])
No IVC lter
Parameter
Death, n (%) 23 (1.0) 15 (0.7) 0.20
Blood transfusion, n (%) 237 (10.5) 255 (11.3) 0.37
Gastrointestinal bleeding, n (%) 44 (1.9) 32 (1.4) 0.17
Intracranial haemorrhage, n (%) 13 (0.6) 15 (0.7) 0.70
Haematoma, n (%) 47 (2.1) 76 (3.4) 0.009
Procedure-related haemorrhage, n (%) 23 (1.0) 32 (1.4) 0.23
Charges, US $ 92,881±80,194 104,049±75,572 <
Peripheral angioplasty, n (%) 1329 (58.8) 1394 (61.7) 0.048
Peripheral stent, n (%) 634 (28.1) 673 (29.8) 0.20
Procedure-related renal failure, n (%) 8 (0.4) 4 (0.2) 0.25
Acute renal failure, n (%) 188 (8.3) 195 (8.6) 0.71
Transient ischemic attack, n (%) 2 (0.1) 1 (0.04) 0.57
Embolic stroke, n (%) 2 (0.1) 2 (0.1) 0.99
Procedure-related cardiac complications,
n (%)
(n=2259)
5 (0.2) 5 (0.2) 0.98
20 Vena Cava Filter
IVC lter
(n=2259) P
0.001
presented by Cherfan etal. [17] was to evaluate whether stenting across an indwelling IVC lter is a safe and effective alternative to removal. A total of 224 consecutive patients were identied, of whom 71 were found to have undergone iliocaval
stenting (age, 48±18 years; 47.9% male). Of the 71 patients, 15 had had stents
placed across an indwelling IVC lter (overstented group) and 56 had not had an
IVC lter present (non-overstented group). For 71 patients who had undergone iliocaval stenting, the primary patency at 30months was 85.6% for the group with
stenting across an inferior vena cava (IVC) lter and 86.1% for the non-overstented
group (P=.78). No adverse events were related to IVC lter crushing, and no differences were found in survival at 30months of follow-up. Stenting across IVC
lters can be a safe and durable alternative to complex removal of chronic and/or
older generation permanent IVC lters. However, it should not yet be recommended
as the reference standard approach owing to the lack of long-term data. The establishment of a registry in addition to multicenter retrospective studies would be crucial to determining the comparative effectiveness and long-term outcomes of this
technique.
20.2.3.5 Prophylactic IVC Filter Prior toBariatric Surgery
Reddy et al. [18] used the National Inpatient Sample database to identify obese
patients who underwent bariatric surgery from January 2005 to September 2015.
Using propensity score matching, outcomes associated with patients receiving prophylactic IVCFs prior to their bariatric surgery were compared with those among
patients who did not receive IVCFs. A total of 258,480 patients underwent bariatric
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surgery, of whom 1047 (0.41%) had prophylactic IVCFs implanted. Patients with
prophylactic IVCFs compared with those without IVCFs had a signicantly higher
rate of the combined endpoint of in-hospital mortality or pulmonary embolism
(1.4% vs. 0.4%; p=0.019). Additionally, prophylactic IVCFs were associated with
higher rates of lower extremity or caval deep vein thrombosis (1.8% vs. 0.3%;
p<0.01), length of stay (median 3days vs. 2days; p<0.01), and hospital charges
(median $63,000 vs. $37,000; p< 0.01). Prophylactic IVCF implantation prior to
bariatric surgery was associated with worse clinical outcomes and increased health
care resource utilization.
20.2.3.6 Filter Retrieval andTemporary IVC Filters
Retrieval of vena cava lters is important for safety as complications increase with
longer dwell times. Mohapatra etal. [19] reviewed Florida state inpatient and ambulatory surgery databases from 2004 to 2014 and searched for patients undergoing inpatient or outpatient IVC lter placement. Each patient was longitudinally tracked to the
time of inpatient or outpatient lter retrieval. During the period, 131,791 IVC lter
placements were identied, with a 50% increase from 2004 to 2010 and a 24% decline
from 2010 to 2014. Mean follow-up after lter placement was 17.3±25.5months.
Only 8637 lters (6.6%) were retrieved. The annual retrieval rate trended upward,
from 3.4% in 2004 to 8.5% in 2013 (P<.001). Retrieval rates were highest in younger
patients (34.0% in patients younger than 20years) and lowest in Medicare patients
(2.5%). Filter retrieval rates were overall signicantly lower than the 30–60% retrieval
rates reported in single center studies. The estimated retrieval rate of 6.6% lag rates
described in the literature and points to publication bias in single-center studies.
Signicant improvements are needed on a national scale to continue to reduce the
number of IVC lters that are placed and to enhance lter retrieval rates in patients
who no longer have an appropriate indication for an indwelling IVC lter.
Brown et al. [20] examined retrieval rates for vena cava lters (VCFs) in a
national cohort. Of 54,766 patients receiving a VCF, 36.9% had pulmonary embolism, 43.9% had deep vein thrombosis only, and 19.2% had no apparent venous
thromboembolism present. Over the 1year of follow-up, the cumulative incidence
of VCF retrieval was 18.4%. Retrieval increased over time from a low of 14.0% in
2010 up to ≈24% in 2014. Initiation of anticoagulation was poorly correlated with
retrieval, with anticoagulation preceding retrieval by a median of 51 days while
those without retrieval had a median of 278days of exposure to anticoagulation.
Despite safety warnings for indwelling VCFs, most remained in place and were
poorly correlated with initiation of anticoagulation. Retrieval rates were strongly
dependent on age, with older patients less likely to have retrieval. The US Food and
Drug Administration has suggested that VCFs be removed once clinically appropriate to avoid complications. These warnings were in response to many reports of
VCF failures including device fractures and penetration of the vena cava that were
associated with indwell time. In order to maximize the net clinical benet of VCFs,
patients should be initiated on anticoagulation once contraindications have abated
and VCFs should be removed.
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20 Vena Cava Filter
Medicare patients aged ≥65 years with index VTE claims between 2015 and
2018 were followed by Williams etal. [21] through 2019 to identify IVCF placements and retrievals. Of 516,978 patients with VTE diagnoses, 5864 (1.1%) had
IVCFs placed, and 1884 (32.1%) of those underwent retrieval procedures. Of those
with IVCFs placed, the median time to IVCF placement from the index VTE diagnosis was 24days (IQR, 1–192days), whereas the median time to IVCF retrieval
from placement was 103 days (IQR, 58–170 days) among those with IVCFs
retrieved. Placement and retrieval rates varied signicantly by demographics,
comorbidity burden, and geographic region. In this large real-world cohort of
Medicare beneciaries with index VTE diagnoses, approximately 1in 91 patients
with VTE (1.1%) underwent IVCF placement, and of those, approximately 1in 3
(32.1%) underwent retrieval procedures. The results indicate inequality in the placement and retrieval of IVCFs in Medicare patients with VTE.
20.2.3.7 Inferior Vena Cava Filter Thrombosis
Using data from the Society for Vascular Surgery Vascular Quality Initiative (VQI)
from 2013 to 2019, King etal. [22] aimed to describe the contemporary rate of IVC
thrombosis after IVCF placement and its associated risk factors. Of 5780 cases with
2years of follow-up available, 78 (1.3%) had developed IVCF thrombosis. Five
independent factors were associated with IVCF thrombosis: new/propagated deep
vein thrombosis at follow-up, internal jugular venous access, venous thromboembolism on admission, a temporary IVCF placed, and the lack of antiplatelet therapy at
follow-up. In a subgroup analysis of those who had received an IVCF for VTE,
similar factors were predictive of IVCF thrombosis, including a lack of follow-up
antiplatelet therapy (hazard ratio, 4.4; P = .002). The rate of IVCF thrombosis
remained low in a contemporary database. The results from the present study suggest that antiplatelet therapy should be administered after IVCF placement to
decrease the risk of IVCF thrombosis.
20.2.3.8 Effect ofFilter Placement Position
A single center study examined the relationship between the position of the IVC
lter in the vena cava and the short- and long-term complications [23]. The hypothesis was that IVC lters placed more caudally to the lowest renal vein would have a
greater risk of IVC thrombosis. The nal cohort consisted of 1230 patients. Most
lters were placed immediately (<20mm) inferior to the caudal renal vein (group
B, n=787; 64.0%), followed by >20mm inferior to this level (group C, n=265;
21.5%). Placement superior the caudal renal vein was the least common placement
position (group A, n=178; 14.5%). Short-term DVT and PE occurred in 4.2% and
2.0% of all patients, respectively, and long-term DVT and PE occurred in 10.6%
and 3.0%, respectively. Although a pattern of increasing thrombosis with more
References
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inferior placement was found, the difference between groups was not statistically
signicant (group A, 1.5%; group B, 1.8%; group C, 2.5%; P=.638). No cases of
device-related mortality occurred. All-cause mortality after a mean follow-up of
2.6 ± 2.3 years was 41.3% and did not vary signicantly between the groups
(P=.051). Multivariate logistic regression revealed that placement position did not
predict for short- or long-term deep vein thrombosis, pulmonary embolism, IVC
thrombosis, or all-cause mortality after adjustment for the baseline patient characteristics. Complications of inferior vena cava lter placement are rare and the placement position relative to the renal veins did not affect the outcomes in this study.
20.3 Conclusions forClinical Practice
1. In the initial treatment of VTE, inferior vena cava lters may be considered when
anticoagulant treatment is contraindicated or, in the case of pulmonary embolism, when recurrence occurs under optimal anticoagulation.
2. In patients with acute VTE (DVT, PE) who are being treated with therapeutic
anticoagulation, routine placement of an IVC lter is not indicated.
3. IVC lters should be considered in cases of pulmonary embolism recurrence
despite therapeutic anticoagulation.
4. Remove the IVC lter when anticoagulation treatment is no longer contraindi-
cated and has been established. Patients should be initiated on anticoagulation
once contraindications have abated and VCFs should be removed.
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7. Shariff M, Kumar A, Adalja D, Doshi R.Inferior vena cava lters reduce symptomatic but not
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Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval lters in
the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis.
Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J
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10. Mismetti P, Laporte S, Pellerin O, PREPIC2 Study Group, etal. Effect of a retrievable inferior
vena cava lter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary
embolism: a randomized clinical trial. JAMA. 2015;313:1627–35.
11. Ho KM, Rao S, Honeybul S, etal. A multicenter trial of vena cava lters in severely injured
patients. N Engl J Med. 2019;381:328–37.
12. Olanipekun T, Ritchie C, Abe T, Effoe V, Chris-Olaiya A, Biney I, Erben YM, Guru P, Sanghavi
D.Updated trends in inferior vena cava lter use by indication in the United States after Food
and Drug Administration safety warnings: a decade analysis from 2010 to 2019. J Endovasc
Ther. 2023:15266028231156089. https://doi.org/10.1177/15266028231156089. Epub ahead
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13. Cook AD, Gross BW, Osler TM, Rittenhouse KJ, Bradburn EH, Shackford SR, Rogers
FB.Vena cava lter use in trauma and rates of pulmonary embolism, 2003-2015. JAMA Surg.
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14. Gilligan TC, Cook AD, Hosmer DW, Hunter DC, Vernon TM, Weinberg JA, Ward J, Rogers
FB.Practice variation in vena cava lter use among trauma Centers in the National Trauma
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15. Sabharwal S, Fox AD, Vives MJ.The use of inferior vena cava lters in spine trauma: a nationwide study using the National Trauma Data Bank. J Spinal Cord Med. 2019;42:228–35.
16. Akhtar OS, Lakhter V, Zack CJ, Hussain H, Aggarwal V, Oliveros E, Brailovsky Y, Zhao H,
Dhanisetty R, Charalel RA, Zhao M, Bashir R.Contemporary trends and comparative outcomes with adjunctive inferior vena cava lter placement in patients undergoing catheterdirected thrombolysis for deep vein thrombosis in the United States: insights from the national
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inpatient sample. JACC Cardiovasc Interv. 2019;12:1153–60.
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associated with retrieval in a large US cohort. J Am Heart Assoc. 2017;6:e006708.
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20 Vena Cava Filter
Chapter 21
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Venous Leg Ulcers
21.1 Guidelines
21.1.1 Society forVascular Surgery andtheAmerican
Venous Forum
The clinical practice guidelines of the Society for Vascular Surgery and the American
Venous Forum recommend for the management of venous leg ulcers among
others [1]:
• We suggest use of a standard denition of venous ulcer as an open skin lesion of
the leg or foot that occurs in an area affected by venous hypertension. (Best
practice)
• We recommend that for all patients with suspected leg ulcers tting the denition
of venous leg ulcer, clinical evaluation for evidence of chronic venous disease be
performed. (Best practice)
• We recommend identication of medical conditions that affect ulcer healing and
other non-venous causes of ulcers. (Best practice)
• We suggest against routine culture of venous leg ulcers and only to obtain wound
culture specimens when clinical evidence of infection is present. (Grade 2 recommendation; Level of evidence C)
• We recommend wound biopsy for leg ulcers that do not improve with standard
wound and compression therapy after 4–6weeks of treatment and for all ulcers
with atypical features. (Grade 1 recommendation; Level of evidence C)
• We suggest laboratory evaluation for thrombophilia for patients with a history of
recurrent venous thrombosis and chronic recurrent venous leg ulcers. (Grade 2
recommendation; Level of evidence C)
Switzerland AG 2023
E. S. Debus, R. T. Grundmann, Evidence-based Therapy in Vascular Surgery,
https://doi.org/10.1007/978-3-031-47397-5_21
441© The Author(s), under exclusive license to Springer Nature
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21 Venous Leg Ulcers
• We recommend arterial pulse examination and measurement of ankle-brachial
index on all patients with venous leg ulcer. (Grade 1 recommendation; Level of
evidence B)
• We recommend comprehensive venous duplex ultrasound examination of the
lower extremity in all patients with suspected venous leg ulcer. (Grade 1 recommendation; Level of evidence B)
• We suggest selective computed tomography venography, magnetic resonance
venography, contrast venography, and/or intravascular ultrasound in patients
with suspected venous leg ulceration if additional advanced venous diagnosis is
required for thrombotic or nonthrombotic iliac vein obstruction or for operative
planning before open or endovenous interventions. (Grade 2 recommendation;
Level of evidence C)
• We recommend that all patients with venous leg ulcer be classied on the basis
of venous disease classication assessment, including clinical CEAP, revised
Venous Clinical Severity Score, and venous disease-specic quality of life
assessment. (Best practice)
21.1.1.1 Wound Care
• We suggest that venous leg ulcers be cleansed initially and at each dressing
change with a neutral, nonirritating, nontoxic solution, performed with a minimum of chemical or mechanical trauma. (Grade 2 recommendation; Level of
evidence C)
• We recommend that venous leg ulcers receive thorough débridement at their ini-
tial evaluation to remove obvious necrotic tissue, excessive bacterial burden, and
cellular burden of dead and senescent cells. (Grade 1 recommendation; Level of
evidence B). We suggest that additional maintenance débridement be performed
to maintain the appearance and readiness of the wound bed for healing. (Grade 2
recommendation; Level of evidence B)
• We recommend that local anaesthesia (topical or local injection) be administered
to minimize discomfort associated with surgical venous leg ulcer débridement.
In selected cases, regional block or general anesthesia may be required. (Grade 1
recommendation; Level of evidence B)
• We recommend that surgical débridement be performed for venous leg ulcers
with slough, nonviable tissue, or eschar. Serial wound assessment is important in
determining the need for repeated débridement. (Grade 1 recommendation;
Level of evidence B)
• We suggest hydrosurgical débridement as an alternative to standard surgical
débridement of venous leg ulcers. (Grade 2 recommendation; Level of evidence B)
• We suggest against ultrasonic débridement over surgical débridement in the
treatment of venous leg ulcers. (Grade 2 recommendation; Level of evidence C)
• We suggest enzymatic débridement of venous leg ulcers when no clinician
trained in surgical débridement is available to débride the wound. (Grade 2 recommendation; Level of evidence C)
21.1 Guidelines
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• We do not suggest enzymatic débridement over surgical débridement. (Grade 2
recommendation; Level of evidence C)
• We suggest that larval therapy for venous leg ulcers can be used as an alternative
to surgical débridement. (Grade 2 recommendation; Level of evidence B)
21.1.1.2 Primary Wound Dressing
• We suggest applying a topical dressing that will manage venous leg ulcer exu-
date and maintain a moist, warm wound bed. (Grade 2 recommendation; Level
of evidence C)
• We suggest selection of a primary wound dressing that will absorb wound exu-
date produced by the ulcer (alginates, foams) and protect the periulcer skin.
(Grade 2 recommendation; Level of evidence B)
• We recommend against the routine use of topical antimicrobial-containing
dressings in the treatment of noninfected venous leg ulcers. (Grade 2 recommendation; Level of evidence A)
21.1.1.3 Split-Thickness Skin Grafting
• We suggest against split-thickness skin grafting as primary therapy in treatment
of venous leg ulcers. (Grade 2 recommendation; Level of evidence B)
• We suggest split-thickness skin grafting with continued compression for selected
large venous leg ulcers that have failed to show signs of healing with standard
care for 4–6weeks. (Grade 2 recommendation; Level of evidence B)
21.1.1.4 Cellular Therapy
• We suggest the use of cultured allogeneic bilayer skin replacements (with both
epidermal and dermal layers) to increase the chances for healing in patients with
difcult to heal venous leg ulcers in addition to compression therapy in patients
who have failed to show signs of healing after standard therapy for 4–6weeks.
(Grade 2 recommendation; Level of evidence A)
21.1.1.5 Tissue Matrices, Human Tissues, or Other Skin Substitutes
• We suggest the use of a porcine small intestinal submucosa tissue construct in
addition to compression therapy for the treatment of venous leg ulcers that have
failed to show signs of healing after standard therapy for 4–6weeks. (Grade 2
recommendation; Level of evidence B)
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