Clinical UM Guideline

 

Subject: Vena Cava Filters
Guideline #:  CG-SURG-59 Publish Date:    12/27/2017
Status: Revised Last Review Date:    11/02/2017

Description

This document addresses the clinical use of vena cava filters in the management of acute venous thromboembolism (pulmonary embolism [PE] and deep venous thrombosis [DVT]).

Clinical Indications

Medically Necessary:

  1. Vena cava filter placement is considered medically necessary for any of the following indications:
    1. Individual has a confirmed acute venous thromboembolism (pulmonary embolism [PE] or proximal deep vein thrombosis [DVT]) and a documented contraindication to anticoagulation therapy, including any of the following:
      1. Active bleeding or severe bleeding diathesis (hypocoagulopathy); or
      2. Recent major surgery in the past 30 days; or
      3. Severe thrombocytopenia (that is, platelet count less than 50,000/mm3 [50 x 109/L]); or
      4. History of intracranial bleeding; or
      5. History of active major bleeding when anticoagulated within therapeutic range; or
    2. Individual has a confirmed acute venous thromboembolism (PE or proximal DVT) and any of the following:
      1. Individual has a documented failure to respond to therapeutic-level anticoagulation therapy (for example, history of development of pulmonary embolism or recurrent deep venous thrombosis while on therapeutic-level anticoagulation therapy); or
      2. Individual has poor cardiopulmonary reserve or chronic thromboembolic pulmonary hypertension; or
    3. Individual has major trauma (for example, closed head injury, facial trauma with evidence of bony fracture or brain injury, multiple long bone or pelvic fractures, or spinal cord injury) and is unable to receive pharmacologic anticoagulation due to high risk of bleeding.
  2. Retrieval (removal) of a vena cava filter is considered medically necessary when any of the following criteria are met:
    1. The indication for the vena cava filter no longer exists; or
    2. The indication for the vena cava filter is time-limited (for example, a short-term contraindication to anticoagulation therapy); or
    3. The individual has a filter-related adverse event or complications (such as filter fracture, filter occlusion, or pulmonary embolism due to the device).

Not Medically Necessary:

  1. Prophylactic use of a vena cava filter is considered not medically necessary if the above criteria are not met and for all other conditions including, but not limited to, prevention of venous thromboembolism in individuals undergoing bariatric surgery.
  2. Use of a vena cava filter as an adjunct to anticoagulation therapy is considered not medically necessary.
Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

37191

Insertion of intravascular vena cava filter, endovascular approach including vascular access, vessel selection, and radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy), when performed

37192

Repositioning of intravascular vena cava filter, endovascular approach including vascular access, vessel selection, and radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy), when performed

37193

Retrieval (removal) of intravascular vena cava filter, endovascular approach including vascular access, vessel selection, and radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy), when performed

 

 

ICD-10 Procedure

 

02HV3DZ

Insertion of intraluminal device into superior vena cava, percutaneous approach

02PY3DZ

Removal of intraluminal device from great vessel, percutaneous approach

02WY3DZ

Revision of intraluminal device in great vessel, percutaneous approach

06H03DZ

Insertion of intraluminal device into inferior vena cava, percutaneous approach

06PY3DZ

Removal of intraluminal device from lower vein, percutaneous approach

06WY3DZ

Revision of intraluminal device in lower vein, percutaneous approach

 

 

ICD-10 Diagnosis

 

I26.01-I26.99

Pulmonary embolism

I81

Portal vein thrombosis

I82.210-I82.221

Embolism and thrombosis of superior/inferior vena cava

I82.290-I82.291

Embolism and thrombosis of other thoracic veins

I82.3

Embolism and thrombosis of renal vein

I82.401-I82.429

Acute embolism and thrombosis of deep veins of lower extremity (unspecified, femoral, iliac)

I82.491-I82.499

Acute embolism and thrombosis of other specified deep vein of lower extremity

I82.4Y1-I82.4Y9

Acute embolism and thrombosis of unspecified deep veins of proximal lower extremity

I82.501-I82.529

Chronic embolism and thrombosis of deep veins of lower extremity (unspecified, femoral, iliac)

I82.591-I82.599

Chronic embolism and thrombosis of other specified deep vein of lower extremity

I82.5Y1-I82.5Y9

Chronic embolism and thrombosis of unspecified deep veins of proximal lower extremity

S02.0XXA-S02.92XS

Fracture of skull and facial bones

S06.0X0A-S06.9X9S

Intracranial injury

S07.0XXA-S07.9XXS

Crushing injury of head

S14.0XXA-S14.9XXS

Injury of nerves and spinal cord at neck level

S24.0XXA-S24.9XXS

Injury of nerves and spinal cord at thoracic level

S32.10XA-S32.9XXS

Fracture of pelvis

S34.01XA-S34.9XXS

Injury of lumbar and sacral spinal cord and nerves at abdomen, lower back and pelvis level

S72.001A-S72.92XS

Fracture of femur

S82.101A-S82.499S

Fracture of tibia, fibula

Discussion/General Information

The medically necessary criteria within this document are based on a review of the peer-reviewed medical literature and the following evidence-based practice guidelines and specialty medical society guidance documents:

Prevalence of the Condition

According to the Society of Interventional Radiology (SIR) Standards of Practice Committee (Caplin, 2011):

Pulmonary embolism (PE) continues to be a major cause of morbidity and mortality in the United States. Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year, and 50,000 to 200,000 fatalities per year are directly attributable to PE. The current preferred treatment for deep vein thrombosis (DVT) and PE is anticoagulation. However, as many as 20% of these patients will have recurrent PE despite adequate anticoagulation.

The ACR Appropriateness Criteria for the radiologic management of inferior vena cava (IVC) filters (Kinney, 2012) addresses the published studies on the treatment of venous thromboembolism stating:

Pulmonary embolus (PE) and deep venous thrombosis (DVT) represent the clinical spectrum of venous thromboembolism (VTE)…Recent studies have emphasized that a significant number of medicine and surgery patients are not receiving adequate prophylaxis against VTE. More than 50% are at risk of VTE, and only half of those patients are receiving prophylaxis.

Description of the Technology: VC Filters

Vena cava filters are interventional medical devices most often implanted into the IVC vein just below the kidneys or, less commonly, in the superior vena cava. An IVC filter is a small cone-shaped device designed to capture an embolism, a blood clot that has broken loose from one of the deep veins in the legs and moves to the heart and lungs.

Two types of IVC filters are generally available: permanent and retrievable (temporary). According to the SIR guidelines (Caplin, 2011):

IVC filters labeled as retrievable by the United States Food and Drug Administration are also labeled for permanent placement. Retrievable filters may be placed with the intent of either temporary or permanent filtration. Removal of retrievable IVC filters may be accomplished in those cases in which the indication was for prophylaxis and prevention of PE with temporary contraindication to anticoagulation. Filters placed with the intent of subsequent retrieval may be left in place permanently for any of several reasons (eg, continuing need for filtration, thrombus on the filter, inability to retrieve the filter). Data for the feasibility of filter retrieval vary widely among devices and centers. Filters that are not retrieved function as permanent filters.

Placement of an IVC filter may be performed as an outpatient or inpatient procedure; however, most filter placements occur in the inpatient hospital setting because of ongoing medical therapy for acute thromboembolic disease or underlying illness (Caplin, 2011). An IVC filter is typically implanted using fluoroscopy to guide the final position of the filter, or placed using transabdominal or intravascular ultrasound. Knowledge of the normal and variant anatomy of the vena cava is important for successful placement of an IVC filter and prevention of complications. Although IVC filter placement protects the pulmonary vascular bed, it does not lessen the thrombotic predisposition or the incidence of lower extremity VTE. Thus, the IVC filter is typically removed once the bleeding risk is low and anticoagulation therapy is initiated (Kearon, 2012).

A scientific statement from the American Heart Association (AHA) (Jaff, 2011) on the management of massive and submassive PE, iliofemoral deep vein thrombosis (IFDVT), and chronic thromboembolic pulmonary hypertension includes recommendations for IVC filters in the setting of acute PE. Removal of a retrievable IVC filter is considered “…when initial indications no longer exist or contraindications to anticoagulation have resolved.” The AHA statement also recommends placement of a permanent, nonretrievable IVC filter in an individual with IFDVT who has a long-term contraindication to or a complication of anticoagulation therapy (Class IIa; Level of Evidence C), symptomatic PE despite therapeutic-level anticoagulation, or severe cardiorespiratory compromise. For an individual with IFDVT with a time-limited indication for an IVC filter (for example, a short-term contraindication to anticoagulant therapy or poor cardiopulmonary status), “placement of a retrievable IVC filter is reasonable” (Class IIa, Level of Evidence C [based on expert consensus, limited data on the feasibility of filter placement and retrieval, and limited data on the associated short-term clinical outcomes]). Finally, individuals “who receive retrievable IVC filters should be evaluated periodically for filter retrieval within the specific filter’s retrieval window (Class I; Level of Evidence C).”

Additionally, the SIR guidelines (Caplin, 2011) suggest that placement of filters “for temporary use and possible future retrieval may be considered when any of the following situations exist”:

  1. PE and/or DVT and transient inability to anticoagulate;
  2. Prophylactic prevention of PE in patients at high risk; and
  3. The use of retrievable filters should also be considered in pediatric and young adult patients, as the long-term effects and durability of the devices are not precisely known. Currently, there are no filters specifically designed for use in children. The safety and efficacy of vena cava filters in children have not been firmly established. Case reports and series have described the placement and removal of filters in children, but their long-term effect is unclear. The threshold for these indications is 95%. When fewer than 95% of procedures are performed for these indications, the process of patient selection should be reviewed according to institutional policy.

Indications for VC Filter Placement

Clinical risk factors for VTE include acute medical illness, atherosclerosis, cancer, decreased mobility, estrogen therapy, genetic disorders, obesity, pregnancy, major surgery, thrombophilic disorders, and trauma. Some of these risks are transient, such as major surgery and trauma, whereas others are permanent (Molvar, 2012). Routine use of IVC filters is not recommended for the treatment and prophylaxis of VTE. The primary treatment option for acute VTE is anticoagulation therapy and may include unfractionated heparin, low molecular weight heparin (LMWH), fondaparinux, and direct oral anticoagulants (DOACs). DOACs are as effective as conventional therapy with LMWH and vitamin K antagonists. Thrombolytic therapy is reserved for massive PE or extensive DVT (Streiff, 2016). (Note: See Definitions section for anticoagulant therapy by drug class). VTE therapy includes rapid initial anticoagulation to reduce the risk of clot propagation, long-term anticoagulation to reduce the risk of VTE recurrence, and discontinuation of anticoagulation therapy when the risk of treatment exceeds the risk of recurrent VTE (Kearon, 2012; Kearon, 2016). The typical duration of anticoagulation therapy is at least 3 months; however, in some individuals, anticoagulation therapy is associated with a risk of major hemorrhage. In a subset of individuals, anticoagulation therapy is either contraindicated or ineffective. For these individuals, treatment with an IVC filter may be considered for prevention of clinically significant PE (Decousus, 1998).

Treatment with anticoagulants remains standard therapy for individuals with VTE. Placement of an IVC filter is reserved for individuals with acute VTE and contraindications to anticoagulation therapy. The only widely accepted and validated indications for IVC filter placement are: 1) absolute contraindication(s) to therapeutic anticoagulation; 2) failure of anticoagulation when there is acute proximal venous thrombosis; and 3) life-threatening hemorrhage on anticoagulation therapy (Jaff, 2011; Kearon, 2016; Meissner, 2011; Zektser, 2016). Generally agreed upon absolute (and relative) contraindications to anticoagulation therapy for the treatment of acute VTE are variable in the peer-reviewed medical literature and current practice guidelines. Some authors suggest that contraindications to anticoagulation therapy may be divided into two subtypes: event-related contraindications (such as, active or prior bleeding, high-risk bleeding surgery, history of intracranial hemorrhage, and major trauma) and patient-related contraindications (such as, patient refusal/preference, inability to adhere to/monitor therapy, frequent falls/frailty, and others).

Current specialty medical society and professional medical groups have published guidelines for the placement of IVC filters. Recommendations in these guidelines agree that IVC filter placement is indicated in individuals with acute VTE and contraindications to anticoagulation therapy; however, due to the paucity of prospective, randomized controlled trials, these guidelines are not based on level one evidence. There is no consensus on the role of IVC filters in reducing mortality or recurrent PE in individuals with other conditions, such as individuals with VTE despite anticoagulation, individuals with recent VTE requiring anticoagulation while awaiting surgery, or use as primary prevention in high-risk individuals.

The ninth edition of the ACCP evidenced-based clinical practice guideline on antithrombotic therapy for VTE disease and prevention of thrombosis (Kearon, 2012) states that individuals who have an IVC filter inserted should receive a conventional course of anticoagulation (for example, parenteral and long-term anticoagulation) if the contraindication to anticoagulation therapy resolves. “The duration of anticoagulation, therefore, will vary according to whether the DVT was provoked by a temporary risk factor, was unprovoked, or was associated with cancer, and may be influenced by the patient’s ongoing risk of bleeding and preferences.” This recommendation “…is weaker than for anticoagulation of most patients with VTE because the risks of bleeding may remain elevated, and the patient’s risk of recurrence is expected to be lower if the acute episode of thrombosis occurred remotely.” The ACCP considers the evidence to be “moderate” for IVC filter use in individuals with acute proximal DVT who cannot be treated with anticoagulation, “…because of serious imprecision and indirectness (ie, extrapolated from the PREPIC study in which patients were routinely treated with anticoagulants; this indirectness, however, is minor).” The ACCP recommendations are summarized as follows (Grade 1: strong; Grade 2: weak; based on high- (Grade A), moderate- (Grade B), and low- (Grade C) quality evidence):

2.13.1. In patients with acute DVT of the leg, we recommend against the use of an IVC filter in addition to anticoagulants (Grade 1B).
2.13.2. In patients with acute proximal DVT of the leg and contraindication to anticoagulation, we recommend the use of an IVC filter (Grade 1B).
2.13.3. In patients with acute proximal DVT of the leg and an IVC filter inserted as an alternative to anticoagulation, we suggest a conventional course of anticoagulant therapy if their risk of bleeding resolves (Grade 2B).

For the initial treatment of PE (as previously noted in the above section 2.13.1-2.13.3), the ACCP guideline (Kearon, 2012) recommends use of IVC filters instead of initial anticoagulant therapy in individuals with acute PE if there is an unacceptable risk of bleeding or as an adjunct to anticoagulation. “As in DVT, no randomized trials or prospective cohort studies have evaluated IVC filters as sole therapy for acute PE” (that is, without concurrent anticoagulation, as studied in the PREPIC trial). If an individual has an acute PE and a short-term contraindication to anticoagulation, provided there is no proximal DVT on ultrasound, the guideline recommends that it is reasonable to not insert an IVC filter immediately; “serial ultrasound examinations can be performed to ensure that the patient remains free of proximal DVT while anticoagulation is withheld.” In addition, the guideline states there is “uncertainty about the risk and benefits of inserting IVC filters as an adjunct to anticoagulant and thrombolytic therapy in patients with PE and hypotension.” The guideline cites outcomes reported from individuals with hemodynamic compromise in the International Cooperative Pulmonary Embolism Registry, where insertion of an IVC filter was associated with a reduction of early recurrent PE and death (Kucher, 2006); thus, the ACCP recommendation against insertion of an IVC filter in individuals with acute PE who are treated with anticoagulants “may not apply to this select subgroup of patients.” The ACCP recommendations for use of IVC filters for the initial treatment of PE are summarized as follows:

5.9.1. In patients with acute PE who are treated with anticoagulants, we recommend against the use of an IVC filter (Grade 1B).
5.9.2. In patients with acute PE and contraindication to anticoagulation, we recommend the use of an IVC filter (Grade 1B).
5.9.3. In patients with acute PE and an IVC filter inserted as an alternative to anticoagulation, we suggest a conventional course of anticoagulant therapy if their risk of bleeding resolves (Grade 2B).

In 2016, the ACCP updated guidelines on antithrombotic therapy for VTE disease confirmed the earlier recommendations (Kearon, 2012), stating “In patients with acute DVT or PE who are treated with anticoagulants, we recommend against the use of an inferior vena cava (IVC) filter (Grade 1B)” (Kearon, 2016). Since publication of the PREPIC trial results (Decousus, 1998; PREPIC, 2005), the ACCP guideline states that “several registries have suggested that IVC filters can reduce mortality in patients with acute VTE, although this evidence has been questioned” (eg, Muriel, 2014; Prasad, 2013; Stein, 2012; Stein, 2014). In 2015, Mismetti and colleagues published outcomes of the PREPIC 2 randomized, open-label, controlled study that found that placement of an IVC filter for 3 months did not reduce recurrent PE, including fatal PE, in anticoagulated individuals with PE and DVT who had additional risk factors for recurrent VTE. The outcomes of this trial are consistent with the current ACCP recommendations; however, the guidelines states:

…because it is uncertain if there is benefit to placement of an IVC filter in anticoagulated patients with severe PE (eg, with hypotension), and this is done by some experts, our recommendation against insertion of an IVC filter in patients with acute PE who are anticoagulated may not apply to this select subgroup of patients.

The SIR guidelines (revised by the ACR in collaboration with SIR) (Caplin, 2011) for the performance of IVC filter placement for the prevention of PE includes indications for therapeutic placement of an IVC filter in the presence of documented thromboembolic disease, that is, individuals with evidence of PE or IVC, iliac, or femoropopliteal DVT, and one of more of the following:

The SIR guidelines do not delineate absolute or relative contraindications to anticoagulation therapy for the treatment of acute VTE.

The SIR guidelines (Caplin, 2011) also recommend IVC filter placement for prophylactic indications (that is, cases without current thromboembolic disease) in the following settings:

The AHA (Jaff, 2011) has published a scientific statement that includes recommendations for placement of an IVC filter in the setting of acute PE:

Nicolaides and colleagues (2016), on behalf of the Cardiovascular Disease Educational and Research Trust, European Venous Forum, North American Thrombosis Forum, and International Union of Angiology and Union Internationale du Phlebologie, categorized indications for IVC filter insertion as absolute, relative, and prophylactic, with the term “prophylactic” used to describe “the indication for patients at risk who have no identifiable pulmonary embolism (PE) or deep venous thrombosis.” Absolute indications for IVC filter insertion in individuals with VTE include: (1) venous thromboembolic complications associated with a contraindication to anticoagulation, (2) documented failure of anticoagulation, and (3) complications of anticoagulation. Relative indications are those in individuals with existing VTE and at high risk of PE despite anticoagulation or, when the risk of bleeding complications would be high with anticoagulation, including large free-floating thrombus in the vena cava, massive PE, and DVT in individuals with limited cardiopulmonary reserve or who are suspected to be noncompliant with anticoagulation. Prophylactic indications occur in individuals who have neither DVT nor PE but in whom the perceived risk of VTE is high and the efficacy of alternative forms of prophylaxis is considered poor or associated with high bleeding risk. The level of evidence to support of these indications for IVC filter placement are as follows:

There is currently lack of consensus among the guidelines concerning IVC filter placement for use in individuals with VTE despite anticoagulation, recent VTE requiring anticoagulation for surgery, proximal DVT and poor cardiac reserve, free-floating DVT, and primary prevention in high-risk individuals.

Risk Factors for Bleeding and Contraindications to Anticoagulation Therapy

The risk of bleeding from anticoagulation therapy depends upon the degree of anticoagulation and the presence of pre-existing risk factors for bleeding.

Clinical Prediction Scores

Several bleeding risk scores have been developed and validated, mostly in individuals receiving warfarin for atrial fibrillation. In general, these scores are not thought to perform significantly better than clinical judgment based on careful consideration of the individual’s characteristics. One benefit of these scoring systems is the identification of potentially modifiable risk factors that could reduce the risk of bleeding if remedied.

The HAS-BLED bleeding risk score, which has only been validated in individuals with atrial fibrillation receiving warfarin (Lip, 2011; Pisters, 2010; Roland, 2013), ranges from 0-9, with a score of ≥ 3 considered to be at high risk of bleeding with anticoagulation. The individual clinical characteristics/components of the HAS-BLED bleeding risk score are defined as follows (Pisters, 2010):

The VTE-BLEED bleeding prediction score was developed by post hoc analysis of the pooled RE-COVER studies, two double-blind randomized trials that evaluated dabigatran versus standard treatment in 5107 individuals with VTE (Klok, 2016). External validation of the VTE-BLEED score for predicting major bleeding in stable anticoagulated (after day 30) individuals with VTE was evaluated in a post hoc study of the randomized, double-blind, double dummy Hokusai-VTE study (Buller, 2013) that compared edoxaban to warfarin anticoagulation in 8420 individuals with VTE (Klok, 2017). Individuals identified as high risk by VTE-BLEED score had a four-fold increased risk of bleeding during the chronic phase of treatment.

Major Bleeding and Recent Major Bleeding

Major bleeding is variably defined among studies. However, in the setting of VTE, major bleeding is generally defined by the International Society on Thrombosis and Hemostasis (ISTH) as any overt bleeding causing a drop in the hemoglobin level of at least 2g/dL, leading to transfusion of two or more units of whole blood or red cells, occurring in a critical location (eg, intracranial, intraspinal, or retroperitoneal), or leading to death (Schulman 2005).

The risk of major bleeding varies by type and dose of anticoagulation therapy. Results from randomized studies have suggested that the DOACs may be associated with a higher risk of gastrointestinal bleeding compared with warfarin.

The ACCP guidelines (Kearon, 2016) identify risk factors for bleeding with anticoagulant therapy and estimate the risk of major bleeding in low-, moderate-, and high-risk categories. These risk factors include: age > 65 years, age > 75 years, previous bleeding, cancer, metastatic cancer, renal failure, liver failure, thrombocytopenia, previous stroke, diabetes, anemia, antiplatelet therapy, poor anticoagulant control, comorbidity and reduced functional capacity, recent surgery, frequent falls, alcohol abuse, and nonsteroidal anti-inflammatory drug use. Additionally, the guideline states most studies assessing risk factors for bleeding include individuals were who were on vitamin K antagonist (VKA) therapy. Several observations are noted concerning risk factors for bleeding with anticoagulation therapy:

According to Nieto and colleagues (2006), individuals with “major bleeding who subsequently develop clinically apparent VTE present a particularly difficult therapeutic dilemma, because they are perceived to be at substantial risk of recurrent fatal PE in the absence of treatment, and of recurrent hemorrhage if treated with anticoagulants.” There is currently a lack of high quality evidence in the form of randomized controlled trials that identifies individuals who may be at low-, medium-, or high risk for bleeding with VTE therapy and, which presenting conditions would be considered at high risk for bleeding with VTE therapy and consequently, an absolute contraindication to anticoagulation therapy.

Neito and colleagues (2006) retrospectively evaluated data from individuals participating in the RIETE registry who experienced recent major bleeding less than 30 days prior to VTE. The authors assessed the influence of the site of bleeding and time elapsed to VTE at the 3 month follow-up period. The vast majority (99.8%) of participants received either anticoagulant or thrombolytic drugs as initial therapy; only 21 (0.17%) participants did not receive either. Within this group, 7 participants were treated with an IVC filter only. Of 12,294 enrolled participants, 306 (2.5%) had recent major bleeding, reported as: 1) gastrointestinal tract (n=116, 38%) (n=22, cancer; n=18, gastroduodenal ulcer; n=12, erosive gastritis; n=28, other; n=36, non-specified); 2) intracranial (n=94, 31%) (n=46, intracranial hemorrhage; n=21, trauma; n=14, subarachnoid hemorrhage; n=13, other); and 3) all other sites (n=96, including urinary, uterine, and muscular). Of these participants, 103 had developed VTE less than 14 days after major bleeding, 137 had VTE greater than 14 days later, and for 66 participants, the time was unknown. During the study period, 19 (6.2%) participants with recent bleeding rebled (8 died); 13 of 19 (68%) participants died during the first 2 weeks. Multivariate analysis confirmed that participants with recent gastrointestinal bleeding had an increased risk for both major rebleeding (hazard ratio [HR] 2.8; 95% confidence interval [CI], 1.4-5.3) and death (HR 1.9; 95% CI, 1.2-3.1) compared to those with no recent bleeding. Those who bled in other sites had an increased risk only for death (HR 2.0; 95% CI, 1.2-3.3). An elapsed time of less than 2 weeks from bleeding to the index VTE event was also associated with an increased risk for major rebleeding (HR 2.4; 95% CI, 1.2-5.0) and death (HR 2.8; 95% CI, 1.8-4.5). As this data is derived from an observational study, it was not designed to address questions regarding the relative efficacy and safety of different modalities of therapy. However, the data suggests that the incidence of new bleeding or death varies according to the site of prior bleeding and the elapsed time until VTE diagnosis. This information may provide some support for the association between recent major bleeding and poor outcomes in individuals who develop subsequent VTE. However, the authors state that any conclusions about the relationship between the site of prior bleeding and the incidence of new bleeding or death must be interpreted with caution.

Gastrointestinal Bleeding

The risk of gastrointestinal bleeding for individuals treated with anticoagulants is estimated to be 1.5%-5% a year, and higher in elderly persons with associated comorbidities and with treatment with anti-platelet drugs and NSAIDs. Possible gastrointestinal contraindications to the use of anticoagulants are active major bleeding, active ulcers, hemorrhagic angiodysplasia, and recurrent bleeding with the need for transfusion. Most gastrointestinal contraindications are temporary, and although a past gastrointestinal bleed confers a risk of recurrence with anticoagulant use, it does not necessarily indicate an absolute contraindication to future anticoagulant use.

The timing to restart anticoagulants has not been well studied, and gastrointestinal practice guidelines do not specifically address this issue. Based on limited evidence, some authors have suggested that warfarin can be resumed in the second week after the bleeding event (Radaelli, 2015). Other authors have made similar suggestions, that therapeutic anticoagulants can be reinitiated as early as 7 days after cessation of active gastrointestinal bleeding and treatment of the causal lesion (Streiff, 2016).

Varying definitions of gastrointestinal bleeding across studies may contribute to the wide range of bleeding rates reported. A systematic review and meta-analysis determined the risk of thromboembolism, recurrent gastrointestinal bleeding and mortality for individuals on long-term anticoagulation therapy who experienced gastrointestinal bleeding based on whether anticoagulation therapy was resumed (Chai-Adisaksopha, 2015). The resumption of warfarin was associated with a significant reduction in thromboembolic events (HR 0.68; 95% CI, 0.52 to 0.88; p<0.004, I(²)=82%). There was not a statistically significant increase in recurrent gastrointestinal bleeding for individuals who restarted warfarin compared to those who did not (HR 1.20; 95% CI, 0.97 to 1.48; p=0.10, I(²)=0%). The resumption of warfarin was associated with a significant reduction in mortality (HR 0.76; 95% CI, 0.66 to 0.88; p<0.001, I(²)=87%). This meta-analysis demonstrated that resumption of warfarin following interruption due to gastrointestinal bleeding was associated with a reduction in thromboembolic events and mortality without a statistically significant increase in recurrent gastrointestinal bleeding.

Surgery

In individuals receiving anticoagulation therapy, the management of surgical procedures is challenging because interrupting anticoagulation for the procedure transiently increases the risk of VTE as the risk of bleeding associated with the procedure is increased by the anticoagulation for VTE prevention. There is a balance between preventing excessive bleeding and reducing the risk of VTE. The thromboembolic risk is greater in the immediate time period after a thromboembolic event, and declines with time. The perioperative risk of VTE is greatest in individuals with a DVT or PE within the prior 3 months and in those with a history of VTE associated with high-risk inherited thrombophilia. The risk is highest within the initial 3 to 4 weeks, diminishing over the next 2 months. Therefore, individuals who require surgery within the first 3 months after an episode of VTE will likely benefit, if possible, from delaying the surgery. Additional considerations relate to the specific anticoagulant the individual is receiving. For individuals with recent VTE, the risk may be based on the interval since the diagnosis of VTE. Bleeding risk is determined by type of surgery needed and individual’s comorbidities. A higher bleeding risk requires a greater need for perioperative hemostasis and a longer period of anticoagulation interruption.

The risk of bleeding is dominated by the type of surgery or invasive procedure. High bleeding risk surgery has been defined as a 2-day risk of major bleeding of 2%-4%, and low bleeding risk surgery as a 2-day risk of major bleeding of 0%-2%. Examples of high risk surgery include coronary artery bypass graft, kidney biopsy and any procedure lasting more than 45 minutes.

Neuraxial, intracranial and cardiac procedures may be considered very high risk with the concern that the location of potential bleeding increases the risk of serious complications. Examples of low bleeding risk procedures include minor skin surgery, dental extractions, and carpal tunnel repair.

Recent surgery has been identified in the literature as a risk factor for bleeding with anticoagulation therapy, however, the definition of “recent” is ill-defined. The 2016 ACCP guidelines (Kearon, 2016) state that recent surgery as a risk factor for bleeding with anticoagulation therapy is important for parental anticoagulation (eg, first 10 days), but less important for long-term or extended anticoagulation therapy.

In the event of a recent surgical procedure, the timing of initiation of anticoagulation will vary according to the bleeding risk posed by the procedure. A temporary vena cava filter may be considered in cases of high bleeding risk surgery when anticoagulation therapy may be delayed for a few days.

White and colleagues (2016) reported on a retrospective analysis of observational data obtained from all noncancer patients admitted to nonfederal California hospitals for acute VTE from 2005 to 2010. The study population was stratified by the presence or absence of a contraindication to anticoagulation therapy, defined as active bleeding (classified as intracranial, gastrointestinal, or other [including epistaxis, hemopericardium, hematuria, hemorrhage from the throat, hemoptysis, and vascular disorders of the kidney]) or major surgery (either during the hospital stay or within 3 days prior to admission to the hospital), as identified by ICD-9 codes. Hematuria and epistaxis were included as “other bleed” only if there was coding for greater than or equal to one blood transfusion. Principal study outcomes were death within 30 and 90 days, recurrent VTE manifested as PE (with or without DVT), or DVT alone within 1 year of hospital discharge. A recurrent VTE event after the index admission was defined by a hospital readmission or an emergency department visit with a principal diagnosis of acute DVT or PE or by a diagnosis of acute VTE during a subsequent hospitalization that was within the specified follow-up time period. Among 80,697 individuals without a contraindication to anticoagulation, vena cava filter use (n=7762, 9.6%) did not significantly reduce the 30-day risk of death (HR 1.12; 95% CI, 0.98-1.28). However, in individuals with active bleeding, vena cava filter (n=1095, 36.3%) placement reduced the 30-day risk of death by 32% (HR 0.68; 95% CI, 0.52-0.88) and the 90-day risk by 27% (HR 0.73; 95% CI, 0.59-0.90). Among 1445 individuals who underwent major surgery, vena cava filter use (n=489, 33.8%) did not reduce mortality (HR 1.1; 95% CI, 0.71-1.77). Subgroup analysis identified that vena cava filter use did not reduce the risk of subsequent PE.

Intracranial Hemorrhage (ICH)

According to van der Hulle and colleagues (2014), ICH accounts for 8.7% of major bleeds, and is associated with a mortality risk of approximately 46%. Most major bleeds occur during the first weeks of VKA therapy because of an underlying bleeding predisposition. In the absence of randomized clinical trials, there is limited evidence to suggest that individuals are at high risk for bleeding or recurrent ICH after resumption of anticoagulation therapy following anticoagulation-associated ICH.

Murthy and colleagues (2017) performed a systematic review and meta-analysis evaluating the association of anticoagulation resumption with the subsequent risk of ICH recurrence and thromboembolism. The meta-analysis evaluated eight eligible cohort studies including 5306 adults (mean age, 69-78 years) with anticoagulation-associated ICH. Four studies included participants with intraparenchymal hemorrhage as the index ICH; the other four studies included participants with subdural and subarachnoid hemorrhages. Data on stroke risk factors were not available in four studies. The most common indication for anticoagulation treatment before the onset of ICH was atrial fibrillation (234.7%-77.8%), prosthetic heart valve (2.6%-27.8%), VTE (7.9%-20.8%), and previous ischemic stroke (3.7%-71.8%). Reinitiation of anticoagulation occurred at a median of 10 to 39 days. Four studies did not report the exact timing of resumption of anticoagulation, but the majority of participants were prescribed anticoagulation within the first 3 months after ICH. The anticoagulate agent of choice was oral VKA in all eight studies, with the exception of two studies in which some participants were administered non-VKA oral anticoagulants. Outcome measures included thromboembolic events (stroke and myocardial infarction) and recurrence of ICH. Random-effects models were used to assess the strength of association between anticoagulation resumption and outcomes. A total of six studies with 2044 participants with ICH were included in the analysis of the association between anticoagulant therapy and thromboembolic complications. Anticoagulation therapy was restarted in 786 (38.4%) participants with a total follow-up for incident thromboembolic complications of 861 person-years. Anticoagulation therapy was not restarted in the remaining 1258 (61.6%) participants who were followed for a total of 1258 person-years for thromboembolic complications. The rate of thromboembolic events in participants on anticoagulation therapy was 6.7% compared with a 17.6% rate for participants not restarted on anticoagulation therapy. Of the 5306 ICH participants in the eight studies, 1899 (35.8%) were restarted on anticoagulation therapy. Reinitiation of anticoagulation was associated with a significantly lower risk of thromboembolic complications (pooled relative risk [RR] 0.34; 95% CI, 0.25-0.45; q=5.12; p=0.28 for heterogeneity). There was no evidence of increased risk of recurrent ICH after reinstatement of anticoagulation therapy; however, there was significant heterogeneity among included studies (pooled RR 1.01; 95% CI, 0.58-1.77; q=24.68; p<0.001 for heterogeneity). The authors state this data suggests that resumption of anticoagulation therapy is associated with a lower risk of thromboembolic events such as stroke and myocardial infarction, with no apparent “heightened risk” of ICH recurrence with administration of anticoagulation medications. Limitations of this study include the lack of data on baseline hematoma volume; thus, anticoagulation therapy may have been reinstated in participants with smaller hematomas. In addition, not all studies provided data on hematoma location or whether the ICH was a first-time bleed or recurrent hemorrhage. These factors could have confounded the results, as participants at higher perceived risk may have been less likely to be restarted on anticoagulation. Difference in study design and timing of resumption of anticoagulation therapy may have accounted for the significant heterogeneity when a random-effects model was used to assess the strength of association between anticoagulation resumption and outcomes.

A large retrospective cohort study of warfarin-associated ICH suggested that resumption of warfarin between 10 and 30 weeks was associated with the lowest risk of recurrent ICH and thromboembolism (Majeed, 2010).

Concurrent Use of VC Filters and Anticoagulation Therapy in Acute DVT or PE

Studies suggest there is lack of benefit to use of IVC filters in addition to anticoagulation in individuals with acute VTE already on anticoagulation with no absolute contraindications (Decousus, 1998; Kearon, 2012; Kearon, 2016; Mismetti, 2015; PREPIC Study Group, 2005). The current ACCP guidelines for antithrombotic therapy for VTE disease (Kearon, 2016) recommend against the routine use of IVC filters in individuals with acute DVT or PE who are being treated with anticoagulation therapy (Grade 1B; Strong recommendation, based on moderate quality evidence). This recommendation is primarily based on the findings of the Prevention du Risque d’Embolie Pulmonaire par Interruption Cave (PREPIC) trial where 400 participants with proximal DVT or PE were randomized to either anticoagulation alone or anticoagulation plus IVC filter placement. The 8-year follow-up study (PREPIC Study Group, 2005) of participants from the initial 2-year PREPIC study (Decousus, 1998) reported that placement of a permanent IVC filter was associated with a reduction in the initial rate of PE, an increase in the rate of DVT, did not influence VTE (DVT and PE combined), and no difference in mortality. The subsequently published PREPIC 2 randomized, open-label, controlled trial (Mismetti, 2015) examined the adjuvant role of IVC filters in 399 individuals with acute PE at high risk for recurrence (that is, age over 75 years, active cancer, chronic respiratory failure, DVT involving segment, bilateral DVT, or evidence of right biventricular strain or myocardial injury). Study participants received either anticoagulation therapy alone or anticoagulation therapy plus an IVC filter. In the IVC filter group (n=193 successful insertions), filters were successfully retrieved at 3 months from placement in 153 of the 164 participants in whom retrieval was attempted. The investigators found no difference at 3 or 6 months in outcomes including rates of recurrent VTE or mortality between the 2 groups (that is, no reduction in recurrent PE, including fatal PE, recurrent DVT, major bleeding, or death), concluding that these findings do not support vena cava filter use in individuals who can be treated with anticoagulation therapy. This evidence is consistent with the earlier ACCP recommendations (Kearon, 2012); however, the ACCP guidelines state:

…because it is uncertain if there is benefit to placement of an IVC filter in anticoagulated patients with severe PE (eg, with hypotension), and this is done by some experts, our recommendation against insertion of an IVC filter in patients with acute PE who are anticoagulated may not apply to this select subgroup of patients.

As all participants in the PREPIC trial received anticoagulation therapy, the trial outcomes provide minimal guidance in IVC filter placement in individuals who are unable to be treated with anticoagulation therapy. In addition, the ACCP guidelines do not compare the results of the PREPIC and PREPIC 2 studies because of differences in the type of filters used, the duration of filter placement, and differences in the length of follow-up (Kearon, 2016).

In a population-based VTE observational study, Spencer and colleagues (2010) reported similar results to the PREPIC trial. At 3 years, a nonstatistically significant lower rate of PE was reported for participants treated with an IVC filter (1.7%) compared with those without an IVC filter (5.3%; p=0.18). The incidence of recurrent DVT was 21% for participants treated with an IVC filter and 14.9% for those treated without an IVC filter (p=0.009).

To date, no clinical trial has reported outcomes from directly comparing the effectiveness of anticoagulation therapy alone with IVC filter placement for the treatment of individuals with acute DVT or PE.

Prophylactic Placement of VC Filters

In a Cochrane review, Young and colleagues (2010) evaluated the controlled clinical trials and randomised controlled trials (RCTs) examining the efficacy of vena cava filters in preventing PE. The two studies eligible for inclusion in the review involved a total of 529 participants (Decousus, 1998; Fullen, 1973). The open quasi-randomised trial of 129 participants with traumatic hip fractures showed a reduction in PE but not mortality over a 34 day period in the filter group (Fullen, 1973). Outcomes from the PREPIC trial (Decousus, 1998) were analyzed with the authors reporting that permanent vena cava filters prevented PE at 8 years. Although there was no reduction in mortality, the authors stated “…this reflected an older study population; the majority of deaths were due to cancer or cardiovascular causes. There was an increased incidence of (DVT) in the filter group. Adverse events were not reported.” The authors concluded that no recommendations for vena cava filter use can be drawn from the two studies, stating:

One study showed a reduction in PE rates but not mortality, but was subject to significant biases. The PREPIC study lacked statistical power to detect a reduction in PE over shorter and more clinically significant time periods. However, the trial demonstrated that permanent VCFs were associated with an increased risk of long term lower limb DVT. There is a paucity of VCFs outcome evidence when used within currently approved indications and a lack of trials on retrievable filters. Further trials are needed to assess vena caval filter safety and effectiveness.

Severe Injury/Trauma

Individuals who experience trauma are at “high risk for VTE due to endothelial damage, hypercoagulability from activation of acute-phase proteins, and prolonged immobility…” (Molvar, 2012). It is estimated that PE is the cause of death in 20% of severely injured persons, making it the third most common cause of death in those who survive the initial 24 hours (Molvar, 2012). Individuals at highest risk include those with severe head injury and coma, spinal cord injuries with neurological deficit, and pelvic and long bone fractures (Rogers, 1993). Additionally, high-risk trauma patients often carry contraindications to anticoagulation and/or mechanical compression devices.

Haut and colleagues (2014) performed a systematic review and meta-analysis of eight studies (n=4592 subjects) published through July 2012 comparing treatment with or without prophylactic IVC filter placement in preventing PE, fatal PE, and mortality in trauma subjects. Seven of the eight studies were observational; six of the eight studies were published more than 20 years ago. No studies included comparisons of current practice, such as use of retrievable filters or newer anticoagulation therapies. The evidence showed a consistent reduction of PE (RR 0.20; 95% CI, 0.06-0.70; I(2)=0%) and fatal PE (RR 0.09; 95% CI, 0.01-0.81; I(2)=0%) with IVC filter placement, without any statistical heterogeneity. There was no significant difference found in the incidence of DVT (RR 1.75; 95% CI, 0.50-6.19; p=0.38; I(2)=56.8%) or mortality (RR 0.70; 95% CI, 0.40-1.23; I(2)=6.7%). The authors reported the number needed to treat to prevent one additional PE with IVC filters was estimated to range from 109 (95% CI, 93-190) to 962 (95% CI, 819-2565), depending on the baseline PE risk. Although the strength of evidence was low, the authors concluded that in severely injured individuals who are unable to receive pharmacologic prophylaxis due to high bleeding risk, there is a cohort of individuals who would likely benefit from a retrievable IVC filter with a lower incidence of PE and fatal PE.

As previously noted, the SIR guidelines (Caplin, 2011), include recommendations for prophylactic placement of an IVC filter in individuals without current thromboembolic disease in the following settings: 1) severe trauma without documented PE or DVT; 2) closed head injury; 3) spinal cord injury; 4) multiple long-bone or pelvic fractures; and 5) individuals at high risk (for example, immobilized or in an intensive care unit). The level of evidence cited in support of these recommendations includes a textbook on vascular and interventional radiology (1999), three review articles (1995, 1996, and 2005), three retrospective case series (1985, 1993, and 2008), and a report from a multidisciplinary consensus panel that developed a research agenda for IVC filters (2009).

VC Filter Placement in Special Populations

Bariatric Surgery

The clinical utility of IVC filter placement in individuals undergoing bariatric surgery is unclear. Traditional methods of thromboprophylaxis used during bariatric surgery procedures includes sequential calf compression devices and perioperative LMWH.

Rowland and colleagues (2015) performed a systematic review of the literature on the use of IVC filters for the prevention of VTE in obese individuals undergoing bariatric surgery. A total of 18 studies with highly heterogeneous data were included in the review. No randomized controlled trials were found. The evaluable data from controlled cohort studies suggested that those individuals who have an IVC filter inserted preoperatively may be at higher risk of developing DVT and PE. A small cohort of individuals with multiple risk factors for VTE benefitted from reduced PE-related mortality after preoperative IVC filter insertion. A total of 12 case series reporting VTE outcomes from 497 individuals who underwent preoperative IVC filter insertion and demonstrated DVT rates of 0% to 20.8% and PE rates ranging from 0% to 6.4%. The review concluded that there was no evidence to suggest the potential benefits of IVC filters outweighed the significant risks of therapy when placed preoperatively in individuals undergoing bariatric surgery.

IFDVT and Catheter-Directed Thrombolysis (CDT)

The Society for Vascular Surgery and the American Venous Forum addresses the use of periprocedural IVC filters in a clinical practice guideline on early thrombus removal strategies for acute DVT (Meissner, 2012). The guideline recommends against routine use of IVC filters (permanent or temporary) in conjunction with catheter-directed pharmacologic thrombolysis of the iliofemoral venous segments (Grade of recommendation, 1: Strong; Quality of evidence: C. Low or very low). However, the guideline suggests that the relative risks versus benefits of periprocedural retrievable IVC filter placement should be considered in individuals undergoing pharmacomechanical thrombolysis and those with thrombus extending into the IVC or having markedly limited cardiopulmonary reserve (Grade of recommendation, 2: Weak; Quality of evidence: C. Low or very low).

The AHA scientific statement (Jaff, 2011) recommends against periprocedural IVC filter placement for most individuals with IFDVT undergoing drug-only infusion CDT. Preprocedure placement and postprocedure removal of retrievable IVC filters “may be reasonable in carefully selected IFDVT patients undergoing pharmacomechanical CDT or stand-alone percutaneous mechanical thrombectomy (PMT), depending on the thrombus extent, patient factors such as baseline cardiopulmonary status, and the specific clot-removal methods that will be used.”

Pregnancy

The American College of Obstetricians and Gynecologists (ACOG) practice guidelines recommend insertion of a temporary IVC filter in pregnant women with acute VTE and contraindications to anticoagulant therapy (Branch, 2012; McLintock, 2012), or in those with recurrent VTE despite therapeutic anticoagulation (James, 2011). The ACCP guidance for the treatment and prevention of obstetric-associated VTE (Bates, 2012) states that insertion of a temporary IVC filter is best restricted to women with proven DVT who have recurrent PE despite adequate anticoagulation.

Cancer-Associated Venous Thromboembolic Disease

The National Comprehensive Cancer Network (NCCN®) clinical practice guideline in oncology for cancer-associated venous thromboembolic disease treatment algorithm (V1.2017) includes a category 2A recommendation for placement of an IVC filter (“retrievable filter preferred. Consider permanent filters only for rare patients with permanent contraindications to anticoagulation”) for a DVT located in the pelvic/iliac/IVC or femoral/popliteal vein and the individual has a “contraindication to anticoagulation.” If the contraindication to prophylactic or therapeutic anticoagulation treatment persists or DVT is likely to recur, the algorithm recommends to “re-evaluate regularly for change in status.”

The NCCN guideline (2017) cites absolute and relative contraindications to prophylactic or therapeutic anticoagulation therapy specific to cancer-associated venous thromboembolic disease as follows:

Absolute:

Relative:

The NCCN guideline (2017) includes a category 2A recommendation for treatment of acute PE when the individual has a contraindication to anticoagulation stating, “Consider IVC filter (retrievable filter preferred) ± embolectomy. Consider permanent filters only for rare patients with permanent contraindications to anticoagulation. It is unclear if IVC filter placement is beneficial in the absence of lower extremity, IVC, or pelvic DCT.” An individual should be followed frequently for a change in clinical status, with evaluation to determine if the contraindication to anticoagulation therapy persists or resolved. If the individual tolerates anticoagulation therapy, the guideline recommends IVC filter removal.

For the perioperative management of anticoagulation and antithrombotic therapy in an “at-risk population,” (that is, “cancer patients on anticoagulants requiring surgery”), for emergent surgery, reversal of anticoagulation should occur prior to surgery. The NCCN guideline includes a category 2A recommendation to “consider IVC filter (retrieval filter preferred) if venous thromboembolism (eg, lower-extremity DVT ± PE) occurred within 1 month of surgery” or “postoperative anticoagulation based on bleeding risk.” A perioperative thromboembolism risk assessment evaluates if the individual is at low, moderate, or high risk for bleeding when considering IVC filter placement.

Complications of VC Filter Placement and Removal

In a systematic review of the literature, Angel and colleagues (2011) reported an estimated 1.3% incidence of PE following retrievable IVC filter placement. Complications related to IVC filters include those associated with filter placement, such as bleeding or infection at the puncture site, allergic reaction to contrast or other medications used during placement, malposition of the filter, pneumothorax, air embolism, inadvertent carotid artery puncture, or other technical issues such as, guidewire entrapment within the filter. Postprocedure complications of IVC placement include those at the access site (such as, acute venous thrombosis, hematoma, or arteriovenous fistula), and longer-term complications, such as filter erosion, migration or embolization, caval perforation, chronic thrombosis, recurrent thromboembolism, or consequences of filter retrieval (Wu, 2014).

Other Considerations

In 2014, the U.S. Food and Drug Administration (FDA) posted an initial communication concerning removal of retrievable IVC filters after receiving reports of adverse events and product problems associated with IVC filters. Some of these events led to adverse clinical outcomes and may be related to how long the filter has been implanted. The FDA states “for patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided.” The FDA has expressed concerned that retrievable IVC filters, when placed for a short-term risk of PE, are not always removed once the risk subsides. Thus, the FDA has made the following recommendations:

FDA Decision Analysis

The FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters. Filter manufacturers are given two option for data collection: 1) participating in the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, an independent national clinical study that will examine the use of IVC filters in the prevention of PE; or 2) conducting postmarket surveillance (522 studies). The FDA plans to use the data gathered from the PRESERVE study and the 522 studies to assist the FDA, manufacturers, and health care professionals: 1) assess the use and safety profile of these devices; 2) understand evolving patterns of clinical use of IVC filters; and 3) ultimately improve patients care.

The PRESERVE study is a multicenter, prospective, open-label, non-randomized observational study of commercially available IVC filters from six manufacturers placed in individuals for the prevention of PE. The study enrollment will be approximately 1800 IVC filter subjects at up to 60 sites in the United States. Subjects will be evaluated at procedure, and at 3, 6, 12, 18 and 24 months post-procedure. The composite safety endpoint is freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, DVT, and perioperative serious adverse event. The composite effectiveness endpoint is procedural and technical success without occurrence of clinically significant PE. The estimated study completion date is May 2019.

A recent study by Reddy and colleagues (2017) assessed the national utilization rates of IVC filter placement in the United States and the impact of the FDA advisory. Although a significant reduction in IVC filter use was reported following the FDA advisory, implantation rates across the United States remain high. The authors note that “Given the short- and long-term complications associated with IVC filter placement, the use of these devices should be mostly reserved for those patients with an absolute indication like active bleeding.”

Definitions

Absolute contraindication: A condition exists for not performing a particular diagnostic or therapeutic procedure that is so compelling that performing the particular treatment or procedure could result in a life-threatening situation and is absolutely inadvisable without exception or qualification (that is, must be avoided).

Anticoagulation: The process of hindering or reducing the ability of the blood to clot; the use of an anticoagulant drug to prevent the formation of blood clots.

Anticoagulants/anticoagulant therapy: Drugs used to reduce the ability of the blood to clot. Different types of anticoagulant therapy, each with a different mechanism of action used to treat conditions with a high risk of forming blood clots, include the following (by drug class):

Deep vein thrombosis (DVT): A blood clot that forms in a vein deep in the body.

Inferior vena cava (IVC): The largest vein in the human body formed by the union of the two common iliac veins at the level of the fifth lumbar vertebra that returns blood to the right atrium of the heart from below the diaphragm.

IVC filter: A small device that traps large clot fragments and prevents them from traveling through the vena cava vein to the heart and lungs.

Permanent IVC filter placement: Permanent placement is deployment in those situations in which lifelong protection against thromboembolic episodes is needed (Caplin, 2011).

Pulmonary embolus/embolism (PE): An obstruction of a pulmonary artery (blood vessel in the lungs) or one of its branches, usually due to a blood clot that develops in a vein of the leg or pelvis and travels to the lungs. A PE is marked by labored breathing, chest pain, fainting, rapid heart rate, cyanosis, shock, and sometimes death. A pulmonary embolus is most often caused by a blood clot that develops in a vein outside the lungs.

Relative contraindication: A condition that makes a particular treatment or procedure possibly inadvisable unless the treatment or procedure is absolutely necessary. Consideration is given to perform the treatment or procedure if the benefits outweigh the risks.

Temporary IVC filter placement: Temporary placement is deployment in those situations in which time-limited protection against thromboembolic episodes is needed (Caplin, 2011).

Thrombus: A clot of blood formed within a blood vessel that remains attached to its place of origin.

Unprovoked DVT or PE: A DVT or PE associated with no apparent clinical risk factors.

Venous thromboembolism (VTE): A blood clot that forms in a vein and migrates (travels) to another location.

References

Peer Reviewed Publications:

  1. Angel LF, Tapson V, Galgon RE, et al. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011; 22(11):1522-1530.
  2. Bikdeli B, Wang Y, Minges KE, et al. Vena caval filter utilization and outcomes in pulmonary embolism: Medicare hospitalizations from 1999 to 2010. J Am Coll Cardiol. 2016; 67(9):1027-1035.
  3. Buller HR, Decousus H, Grosso MA, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013; 369:1406-1415.
  4. Chai-Adisaksopha C, Hillis C, Monreal M, et al. Thromboembolic events, recurrent bleeding and mortality after resuming anticoagulant following gastrointestinal bleeding. A meta-analysis. Thromb Haemost. 2015; 114(4):819-825.
  5. Decousus H, Leizorovicz A, Parent F, et al. A clinical trial of vena caval filters 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 Med. 1998; 338:409-415.
  6. Fullen WD, Miller EH, Steele WF, McDonough JJ. Prophylactic vena caval interruption in hip fractures. J Trauma. 1973; 13(5):403-410.
  7. Haut ER, Garcia LJ, Shihab HM, et al. The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis. JAMA Surg. 2014; 149(2):194-202.
  8. Klok FA, Barco S, Konstantinides SV. External validation of the VTE-BLEED score for predicting major bleeding in stable anticoagulated patients with venous thromboembolism. Thromb Haemost. 2017; 117(6):1164-1170.
  9. Klok FA, Hosel V, Clemens A, et al. Prediction of bleeding events in patients with venous thromboembolism on stable anticoagulation treatment. Eur Respir J. 2016; 48(5):1369-1376.
  10. Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation. 2006; 113(4):577-582.
  11. Mismetti P, Laporte S, Pellerin O, et al. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. JAMA. 2015; 313:1627-1635.
  12. Muriel A, Jimenez D, Aujesky D, et al. Survival effects of inferior vena cava filter in patients with acute symptomatic venous thromboembolism and a significant bleeding risk. J Am Coll Cardiol. 2014; 63(16):1675-1683.
  13. Murthy SB, Gupta A, Merkler AE, et al. Restarting anticoagulant therapy after intracranial hemorrhage: a systematic review and meta-analysis. Stroke. 2017; 48(6):1594-1600.
  14. Nieto JA, Bruscas MJ, Ruiz-Ribo D, et al. Acute venous thromboembolism in patients with recent major bleeding. The influence of the site of bleeding and the time elapsed on outcome. J Thromb Haemost. 2006; 4(11):2367-2372.
  15. Ozturk C, Ganiyusufoglu K, Alanay A, et al. Efficacy of prophylactic placement of inferior vena cava filter in patients undergoing spinal surgery. Spine (Phila Pa 1976). 2010; 35(20):1893.
  16. Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess one-year risk of major bleeding in atrial fibrillation patients: the Euro Heart Survey. Chest. 2010; 138:1093-1100.
  17. Poli D, Antonucci E, Dentali F, et al. Intracranial hemorrhage recurrence on vitamin K antagonist: severity of the first episode and HASBLED score fail to identify high-risk patients from the CHIRONE study. Blood Coagul Fibrinolysis. 2017; 28(1):62-65.
  18. Prasad V, Rho J, Cifu A. The inferior vena cava filter: how could a medical device be so well accepted without any evidence of efficacy? JAMA Intern Med. 2013; 173(7):493-495; discussion 495.
  19. PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d’Embolie Pulmonaire par Interruption Cave) randomized study. Circulation. 2005; 112:416-422.
  20. Radaelli F, Dentali F, Repici A, et al. Management of anticoagulation in patients with acute gastrointestinal bleeding. Dig Liver Dis. 2015; 47(8):621-627.
  21. Reddy S, Lakhter V, Zack CJ, et al. Association between contemporary trends in inferior vena cava filter placement and the 2010 US Food and Drug Administration Advisory. JAMA Intern Med. 2017 Jul 10. [Epub ahead of print].
  22. Rogers FB, Shackford SR, Wilson J, et al. Prophylactic vena cava filter insertion in severely injured trauma patients: indications and preliminary results. J Trauma 1993; 35(4):637-641; discussion 641–642.
  23. Roldan V, Marin F, Manzano-Fernandez S, et al. The HAS-BLED score has better prediction accuracy for major bleeding than CHADS2 or CHA2DS2-VASc scores in anticoagulated patients with atrial fibrillation. J Am Coll Cardiol. 2013; 62(23):2199-2204.
  24. Rowland SP, Dharmarajah B, Moore HM, et al. Inferior vena cava filters for prevention of venous thromboembolism in obese patients undergoing bariatric surgery: a systematic review. Ann Surg. 2015; 261(1):35-45.
  25. Spencer FA, Bates SM, Goldberg RJ, et al. A population-based study of inferior vena cava filters in patients with acute venous thromboembolism. Arch Intern Med. 2010; 170(16):1456-1462.
  26. Streiff MB, Agnelli G, Connors JM, et al. Guidance for the treatment of deep vein thrombosis and pulmonary embolism. J Thromb Thrombolysis. 2016; 41(1):32-67.
  27. Stein PD, Matta F. Vena cava filters in unstable elderly patients with acute pulmonary embolism. Am J Med. 2014; 127(3):222-2255.
  28. Stein PD, Matta F, Keyes DC, Willyerd GL. Impact of vena cava filters on in-hospital case fatality rate from pulmonary embolism. Am J Med. 2012; 125(5):478-484.
  29. van der Hulle T, Kooiman J, den Exter PL, et al. Effectiveness and safety of novel oral anticoagulants as compared with vitamin K antagonists in the treatment of acute symptomatic venous thromboembolism: a systematic review and meta-analysis. J Thromb Haemost. 2014; 12(3):320-328.
  30. Weinberg I, Kaufman J, Jaff MR. Inferior vena cava filters. JACC Cardiovasc Interv. 2013; 6(6):539-547.
  31. Wells PS, Forgie MA, Rodger MA. Treatment of venous thromboembolism. JAMA. 2014; 311(7):717-728. Erratum in: JAMA. 2014; 311(24):2545.
  32. White RH, Brunson A, Romano PS, et al. Outcomes after vena cava filter use in non-cancer patients with acute venous thromboembolism: a population-based study. Circulation. 2016; 33:2018-2029.
  33. Wu A, Helo N, Moon E, et al. Strategies for prevention of iatrogenic inferior vena cava filter entrapment and dislodgement during central venous catheter placement. J Vasc Surg. 2014; 59(1):255-259.
  34. Zektser M, Bartal C, Zeller L, et al. Effectiveness of inferior vena cava filters without anticoagulation therapy for prophylaxis of recurrent pulmonary embolism. Rambam Maimonides Med J. 2016; 7(3).

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Bates SM, Greer IA, Middeldorp S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: antithrombotic therapy and prevention of thrombosis, 9th ed. American College of Chest Physicians Evidence -Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e691S-e736S.
  2. Branch DW, Holmgren C, Goldberg JD. Committee on Practice Bulletins - Obstetrics, American College of Obstetricians and Gynecologists.  Practice Bulletin No. 132: Antiphospholipid syndrome. Obstet Gynecol. 2012; 120(6):1514-1521.
  3. Caplin DM, Nikolic B, Kalva SP, et al; Society of Interventional Radiology Standards of Practice Committee. Quality improvement guidelines for the performance of inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol. 2011; 22(11):1499-1506.
  4. Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e24S-e43S. Erratum in: Chest. 2012; 141(5):1369 and Chest. 2013; 144(2):721.
  5. Jaff MR, McMurtry MS, Archer SL, et al; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011; 123(16):1788-1830. [Erratum in: Circulation. 2012; 126(7):e104. Circulation. 2012; 125(11):e495].
  6. James A. Committee on Practice Bulletins - Obstetrics, American College of Obstetricians and Gynecologists. Practice Bulletin No. 123: Thromboembolism in pregnancy. Obstet Gynecol. 2011; 118(3):718-729.
  7. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e419S-e494S.
  8. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016; 149:315-352.
  9. Kinney TB, Aryafar H, Ray CE  Jr, et al; Expert Panel on Interventional Radiology. American College of Radiology. ACR Appropriateness Criteria®: Radiologic management of inferior vena cava filters. 2012. Available at: https://acsearch.acr.org/docs/69342/Narrative/. Accessed on September 29, 2017.
  10. Kaufman JA, Kinney TB, Streiff MB, et al. Guidelines for the use of retrievable and convertible vena cava filters: report from the Society of Interventional Radiology multidisciplinary consensus conference. J Vasc Interv Radiol. 2006; 17(3):449-459.
  11. McLintock C, Brighton T, Chunilal S, et al; Councils of the Society of Obstetric Medicine of Australia and New Zealand.; Australasian Society of Thrombosis and Haemostasis. Recommendations for the diagnosis and treatment of deep venous thrombosis and pulmonary embolism in pregnancy and the postpartum period. Aust N Z J Obstet Gynaecol. 2012; 52(1):14-22.
  12. Meissner MH, Gloviczki P, Comerota AJ, et al; Society for Vascular Surgery; American Venous Forum. Early thrombus removal strategies for acute deep venous thrombosis: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2012; 55(5):1449-1462.
  13. Nicolaides A, Hull RD, Fareed J; Cardiovascular Disease Educational and Research Trust; European Venous Forum; North American Thrombosis Forum; International Union of Angiology and Union Internationale du Phlebologie. Inferior vena cava filters. Clin Appl Thromb Hemost. 2013 (Reaffirmed September 2016); 19(2):204-205.
  14. NCCN Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on September 29, 2017.
    • Cancer Associated Venous Thromboembolic Disease (V1.2017). Revised June 23, 2017.
  15. Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005; 3(4):692-694.
  16. Young T, Tang H, Hughes R. Vena caval filters for the prevention of pulmonary embolism. Cochrane Database Syst Rev. 2010;(2):CD006212.
Websites for Additional Information
  1. Radiological Society of North America, Inc. (RSNA). RadiologyInfo.org. Inferior vena cava filter placement and removal. Available at: https://www.radiologyinfo.org/en/info.cfm?pg=VenaCavaFilter. Accessed on September 29, 2017.
Index

Vena cava filter

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Revised

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Clarified NMN statement for use of prophylactic use of a vena cava filter, adding “…and for all other conditions including, but not limited to, prevention of venous thromboembolism in individuals undergoing bariatric surgery.” Updated References, Websites for Additional Information, and Index sections.

New

09/13/2017

MPTAC review. Initial document development.