Who Needs an IVC Filter?

Venous thromboembolism (VTE) is estimated to account for 60,000-100,000 deaths per year in the United States, most often due to pulmonary embolism.1 The mainstay of therapy is anticoagulation, which comes at the cost of increased risk of bleeding that cannot be tolerated in some patients. Use of a physical barrier to prevent thrombus migration was first proposed in 1865 by Armand Trousseau.2 In the 1930s, the connection between deep vein thrombosis (DVT) and pulmonary embolism (PE) was reported by John Homans and femoral vein ligation was suggested as treatment and prevention of fatal VTE events.3 Marion "Bill" de Weese is credited with the first partial luminal interruption of the inferior vena cava (IVC) to prevent PE by creating a harp-grid network out of interrupted silk sutures that could catch emboli.4 In the 1960s and 1970s, filters that could be introduced via short venotomy were popularized and followed by percutaneous filters – their use has expanded over the decades despite very real complications and harms for patients.5 The FDA released a warning in response to a reported high fracture rate with the Bard Recover inferior vena cava filter (IVCF) in 2010.6 This resulted in a reduction in IVCF use, and widespread public awareness of risks associated with IVCF. However, higher than expected implantation rates persist.7 The purpose of this analysis is to evaluate who may benefit from IVCF implantation, considering the risks of filter complications and the lack of alternative treatment options for VTE patients with contraindications for anticoagulation.

Providers today operate under a number of limitations with respect to the data and guidelines surrounding use of IVCF. There are only two prospective randomized control trials investigating permanent and retrievable IVCF, respectively, in patients with acute thromboembolism: the Prevention due Risque d'Embolique Pulmonaire par Interruption Cave (PREPIC) Study and PREPIC2 Study.8,9 The remaining body of evidence is a mix of observational data and cohort studies. Additionally, the various societal guideline statements on the use of IVCF is conflicting (Table 1). The only universally accepted indication for IVCF placement remains patients with an acute thromboembolism and an absolute contraindication to anticoagulation.10-16

Table 1: Guideline Recommendations Regarding the Use of Inferior Vena Cava Filters

Indication for IVCF placement Society Recommendation
Acute VTE and absolute contraindication to AC ACCP10,11
AHA14
ESC15
SIR12
ACR13
Support (Grade 1B)
Class I, LOE B
Class IIa, LOE C
Absolute Indication
Usually Appropriate
Anticoagulation failure AHA
ACR
ESC
SIR
Class IIa, LOE C
Usually Appropriate
Class IIa, LOE C
Absolute Indication
VTE with Poor Cardiopulmonary Reserve AHA
ACR
SIR
Class IIb, LOE C
May be Appropriate
Relative Indication
Adjunct to thrombolysis in patients with submassive/massive PE ACCP
AHA
ESC
SIR
Against (Grade 1B)
Class III, LOE C
Class III, LOE A
Relative Indication
Prophylaxis in high-risk patients (e.g. spinal cord injury, trauma) ACCP
SIR
ACR
ConSCI28
EAST25
Against (2012)
Prophylactic Indication
May be Appropriate
Against (Grade 1C)
Prophylactic Placement (Level III)
Free-floating Caval or Iliac Thrombus SIR Relative Indication
Iliocaval DVT undergoing thrombolysis SIR
ACR
Relative Indication
May be Appropriate

The PREPIC studies evaluated the role of IVCF in patients receiving systemic anticoagulation. The first PREPIC study enrolled 400 patients with proximal DVT, with and without symptoms of PE, who were randomized to permanent IVCF with anticoagulation versus anticoagulation alone for at least 3 months.8 The follow up at 2 years and 8 years was identical: a lower rate of symptomatic PE was noted in the IVCF group (6.2% vs 15.1%, p = 0.008), which was offset by a higher rate of symptomatic DVT with IVCF placement (35.7% vs 27.5%, p = 0.042). There was no difference in mortality between the groups. PREPIC 2 evaluated the performance of retrievable IVCF (ALN, ALN Implants Chirurgicaux) as a randomized open-label, blinded endpoint trial that enrolled patients with acute, symptomatic PE and associated lower limb DVT with at least one criterion for severity (Table 2).9

Table 2: Inclusion and Exclusion Criteria for the PREPIC 2 Study9

Inclusion Criteria Exclusion Criteria
18 years or older
Symptomatic PE associated with DVT or superficial vein thrombosis

One Additional Criterion for severity:
  • Age >75 years
  • Active cancer
  • Chronic cardiac or respiratory insufficiency
  • Ischemic stroke with leg paralysis within 6 months (but >3 days) before randomization
  • Iliocaval DVT or bilateral DVT
  • At least 1 sign of right ventricular dysfunction or myocardial injury (RV dilation or pulmonary hypertension on echocardiography, elevated biomarkers including brain natriuretic peptide, N-terminal pro-brain natriuretic peptide or cardiac troponin T or I)
  • Cannot tolerate anticoagulation or had a recurrent VTE on anticoagulation
  • IVCF already inserted
  • Thrombosis in the vena cava does not allow IVCF placement
  • Received full-dose anticoagulation for >72 hours before randomization
  • Non-cancer surgery within the last 3 months
  • Cancer surgery within the last 10 days
  • Allergy to iodinated contrast
  • Serum Creatinine > 2.04 mg/dl per liter
  • Life expectancy < 6 months
  • Pregnancy

At 6 months follow-up, there was no significant difference in recurrent fatal PE between the filter and non-filter groups (3% vs 1.5%; RR with filter, 2.00; 95%CI 0.51 – 7.89; p = 0.5); all events occurred prior to IVCF retrieval at 3 months follow-up. Filter thrombosis occurred in 3 patients; there was no other difference in outcomes between groups. Notably, three-fourths of the population did not have identifiable, reversible risk factors (i.e. unprovoked VTE) and two-thirds had at least one sign of right ventricular dysfunction based on imaging or biomarkers. According to current definitions, the population therefore represented patients with low to intermediate risk PE.13 In this setting, these studies support that IVCF do not provide additional protection in patients receiving anticoagulation.

Use of IVCF in patients with significant bleeding risk is perhaps the only indication that does not generate significant controversy among providers, however data to support IVCF use in this setting is sparse. Prospective cohort data from RIETE (Computerized Registry of Patients With Venous Thromboembolism) reported that placement of IVCF compared to anticoagulation alone was associated with a lower risk of PE-related death (1.7% vs 4.9%, p = 0.12) and higher risk of VTE at 30 days (6.1% vs 0.6%, p < 0.001) in propensity score-matched patients presenting with VTE and a high bleeding risk as determined by the local investigator.17 Design limitations prevent any conclusions on a causal effect of this outcome, however in the absence of alternatives it seems reasonable to offer IVCF to patients with a high bleeding risk. Failure of anticoagulation is often raised as a potential indication for placement of IVCF, however, many cases of recurrent VTE do not represent anticoagulation failure but rather inadequate anticoagulation (e.g. sub-therapeutic dosing, patient-related factors leading to increased thrombosis).18-20 Thus, these cases should prompt the provider to first consider adherence to medication, underlying malignancy or thrombophilia (e.g. antiphospholipid antibody syndrome, heparin-induced thrombocytopenia) and if there truly is a recurrent VTE (See Figure 1). In the event that new VTE is confirmed, therapy should be adjusted prior to consideration of IVCF placement.11

Figure 1: Algorithm for Management of Patients with Suspected Anticoagulation Failure

  1. Confirm there actually is a new VTE
  2. Confirm adherence to medication, or appropriate dosing of medication
  3. Consider underlying thrombophilic state:
    1. Malignancy
    2. Antiphospholipid antibody syndrome
    3. Heparin induced thrombocytopenia
  • Patient on DOAC, vitamin-K antagonist?
    • Switch to low molecular weight heparin
  • Patient on low-molecular weight heparin?
    • Increase weight-based dose by 20-25%

The data for IVCF is less robust in patients with poor cardio-pulmonary reserve, including intermediate-high and high-risk PE. Stein et al performed a retrospective analysis of over 2 million patients from the United States Nationwide Inpatient Sample to determine in-hospital all-cause case fatality rate according to the use of IVCF in across categories of PE patients (e.g. stable, unstable, and those who received lytic therapy).21 The greatest benefit was observed in the unstable patient that did not receive lytic therapy, which demonstrated a 35% reduction in-hospital case fatality rate in patients that received IVCF (p<0.001; NNT = 5, 95% CI: 5-6). This is in line with other studies like the International Cooperative Pulmonary Embolism Registry (ICOPER), which also demonstrated a protective effect of IVCF in patients with massive PE.22 In patients undergoing surgical embolectomy for acute PE, there is a high rate of post-operative PE, which may be fatal in the context of underlying RV failure. Case series have shown a protective effect of IVC filters in this setting, prompting many centers to routinely place IVCF pre- or peri-operatively in patients undergoing pulmonary embolectomy.10,23,24 Similar practice was historically observed in patients with chronic thromboembolic pulmonary hypertension (CTEPH), however, a recent prospective registry data showed that presence of an IVCF in 40% of patients undergoing pulmonary endarterectomy did not influence long-term survival, leading practitioners to abandon routine placement for peri-operative protection.25

It is likely that some higher risk patients with VTE benefit from the added protection of IVCF in the setting of a vulnerable RV, however, this decision should be made on a case-by-case basis. Involvement of a multidisciplinary discussion through a VTE team such as PERT (Pulmonary Embolism Response Team) may help facilitate these decisions. Emerging data has shown decreased mortality rate in higher risk PE patients with utilization of PERT, as well as lower IVCF implantation rates.26 The absence of stronger data precludes routine use of IVCF for all patients with poor cardiopulmonary reserve, especially if they are able to receive other therapies, including thrombolysis and anticoagulation. Recent observational data from the National Inpatient Sample database revealed no mortality benefit to IVCF placement in patients with proximal DVT undergoing catheter-directed thrombolysis, but higher hospital charges and longer hospital stay.27

Patients with major trauma are at high risk for VTE especially in absence of thromboprophylaxis with unfractionated heparin or low molecular weight heparin (LMWH).28 The rationale for retrievable IVCF use in this setting to offer protection during a high-risk period for bleeding and VTE in trauma patients that may not be able to receive anticoagulation. However, data from one Level I trauma center suggests that IVCF placement for this indication most often occurs after the contraindication to anticoagulation has passed and most patients could receive appropriate pharmacologic thromboprophylaxis.29 Additionally, a recent multicenter, randomized controlled trial of 240 patients with severe injury and a contraindication to anticoagulation did not demonstrate a lower incidence of pulmonary embolism of death with early IVCF placement as compared to no IVCF.30 Roughly two-thirds of the patients in this trial were started on anticoagulation within 7 days after severe injuries. Symptomatic pulmonary embolism was not identified in any of the patients with IVCF in the remaining one-third of patients with on-going contraindication to anticoagulation but was identified in five patients from the control group (14.7%). Guidelines are directly conflicting with regard to the use of prophylactic IVCF, however it is worth noting that the recommendation by the Eastern Association for the Surgery of Trauma (EAST) in favor of IVCF use has not been updated since 2002.31

The goals of IVCF use across the various scenarios explored above include prevention of thromboembolism in patients that cannot be adequately treated with anticoagulation and to provide a literal safety net for clinically perceived high-risk patients. The use of these devices has proliferated with transition from permanent to retrievable IVCF, however actual retrieval rates remain very sub-optimal even after initiation of anticoagulation.32 The majority of complications (Figure 2), including thrombosis, post-thrombotic syndrome, migration, embolization or penetration of struts/device, and filter fracture occur out of the acute implantation period and are directly related to IVCF dwell times.32,33 New investigations into bioconvertible IVCF, which convert from a filtering to non-filtering configuration after 60 days, as an alternative to overcome these complications are promising.34

Figure 2

Figure 2
Figure 2: (a) CT angiogram demonstrating a tilted IVCF perforating through the hepatic artery with struts in the aorta and abutting the lumbar vertebrae (b) Venogram demonstrating a filling defect consistent with thrombus (arrow) within the vena cava filter

The available data today supports circumspect use of IVCF in patients that cannot receive systemic anticoagulation, and on a case-by-case basis for patients with poor cardiopulmonary reserve particularly if they cannot receive more advanced rescue therapies like thrombolysis or if they are undergoing embolectomy for acute PE. When considering IVCF implantation, the risks and benefits should be weighed for each individual case, with recognition that the best way to avoid IVCF complication is to avoid implantation unless deemed truly necessary.

References

  1. White RH. The epidemiology of venous thromboembolism. Circulation 2003;107:I4-8.
  2. Trousseau A. "Plegmasia alba dolens". In: A. T, ed. Clinique Medicale de L'Hotel-Dieu de Paris. Paris France: Jean Baptiste Bailliere, 1865:654-712.
  3. Homans J. Thrombosis of the deep veins of the lower leg, causing pulmonary embolism. N Engl J Med 1934;211:993-997.
  4. DeWeese JA. Treatment of venous disease--the innovators. J Vasc Surg 1994;20:675-83.
  5. Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med 2004;164:1541-45.
  6. Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication (FDA website). 2014. Available at: https://www.classlawgroup.com/wp-content/uploads/2015/07/IVC-2.pdf . Accessed 01/31/2020.
  7. Reddy S, Lakhter V, Zack CJ, Zhao H, Chatterjee S, Bashir R. Association between contemporary trends in inferior vena cava filter placement and the 2010 US Food and Drug Administration Advisory. JAMA Intern Med 2017;177:1373-74.
  8. Group PS. 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;112:416-22.
  9. 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;313:1627-35.
  10. 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:e419S-e496S.
  11. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST Guideline and Expert Panel Report. Chest 2016;149:315-52.
  12. 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;17:449-59.
  13. Konstantinides SV, Torbicki A, Agnelli G et al. 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J 2014;35:3033-69.
  14. Expert Panel on Interventional R, Minocha J, Smith AM, et al. ACR Appropriateness Criteria® radiologic management of venous thromboembolism-inferior vena cava filters. J Am Coll Radiol 2019;16:S214-S226.
  15. Jaff MR, McMurtry MS, Archer SL, et al. 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;123:1788-830.
  16. Konstantinides SV, Meyer G. The 2019 ESC Guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J 2019;40:3453-55.
  17. 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;63:1675-83.
  18. Schulman S, Zondag M, Linkins L, et al. Recurrent venous thromboembolism in anticoagulated patients with cancer: management and short-term prognosis. J Thromb Haemost 2015;13:1010-18.
  19. van Es J, Cheung YW, van Es N. et al. Short-term prognosis of breakthrough venous thromboembolism in anticoagulated patients. Thromb Res 2020;187:125-30.
  20. van Es N, Coppens M, Schulman S, Middeldorp S, Buller HR. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood 2014;124:1968-75.
  21. 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;125:478-84.
  22. Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation 2006;113:577-82.
  23. Aklog L, Williams CS, Byrne JG, Goldhaber SZ. Acute pulmonary embolectomy: a contemporary approach. Circulation 2002;105:1416-19.
  24. Greelish JP, Leacche M, Solenkova NS, Ahmad RM, Byrne JG. Improved midterm outcomes for type A (central) pulmonary emboli treated surgically. J Thorac Cardiovasc Surg 2011;142:1423-9.
  25. Delcroix M, Lang I, Pepke-Zaba J et al. Long-term outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. Circulation 2016;133:859-71.
  26. Chaudhury P, Gadre S, Schneider E, et al. Impact of multidisciplinary pulmonary embolism response team availability on management and outcomes. Am J Cardiol 2019;124:1465-69.
  27. Akhtar OS, Lakhter V, Zack CJ, et al. Contemporary trends and comparative outcomes with adjunctive inferior vena cava filter placement in patients undergoing catheter-directed thrombolysis for deep vein thrombosis in the United States: insights from the National Inpatient Sample. JACC Cardiovasc Interv 2018;11:1390-97.
  28. Geerts WH, Code KI, Jay RM, Chen E, Szalai JP. A prospective study of venous thromboembolism after major trauma. N Engl J Med 1994;331:1601-6.
  29. Sarosiek S, Crowther M, Sloan JM. Indications, complications, and management of inferior vena cava filters: the experience in 952 patients at an academic hospital with a level I trauma center. JAMA Intern Med 2013;173:513-17.
  30. Ho KM, Rao S, Honeybul S, et al. A multicenter trial of vena cava filters in severely injured patients. N Engl J Med 2019;381:328-37.
  31. Rogers FB, Cipolle MD, Velmahos G, Rozycki G, Luchette FA. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma 2002;53:142-64.
  32. Weinberg I, Abtahian F, Debiasi R, et al. Effect of delayed inferior vena cava filter retrieval after early initiation of anticoagulation. Am J Cardiol 2014;113:389-94.
  33. Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M, Cavanaugh KJ Jr. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord 2013;1:376-84.
  34. Dake MD, Murphy TP, Kramer, AH et al. Final two-year outcomes for the sentry bioconvertible inferior vena cava filter in patients requiring temporary protection from pulmonary embolism. J Vasc Interv Radiol 2020;31:221-230e3.

Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism

Keywords: Aneurysm, Vena Cava Filters, Vena Cava, Inferior, Propensity Score, Follow-Up Studies, Pulmonary Embolism, Thrombosis, Venous Thrombosis, Trauma Centers, Heparin, Heparin, Low-Molecular-Weight, Retrospective Studies, Control Groups, Length of Stay, Inpatients, Hospital Charges, Anticoagulants, Prospective Studies, Medication Adherence, Risk Factors, Antiphospholipid Syndrome, Femoral Vein, Venous Thromboembolism, Ventricular Dysfunction, Right


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