Background

Inferior vena cava filters (IVCF) were developed with the intent of preventing pulmonary embolism (PE) and reducing venous thromboembolism (VTE) related mortality. Nonetheless, IVCF are not devoid of complications. Serious complications such as IVC thrombosis occur in a non-negligible proportion of patients receiving these devices,¹ more so in several high-risk populations such as metastatic cancer patients.² Nonetheless, in modern practice these devices are inserted for multiple indications ranging from prophylaxis in high-risk patients to prevention of recurrent VTE in patients who cannot receive anticoagulation due to an acute bleed or need for surgery. Similarly, guidelines for IVCF appropriate use also vary among professional societies (Table 1).³ Interestingly, many indications that are deemed appropriate by radiology guidelines and appropriateness criteria are not mentioned as such by other guidelines. Another testament to the variation in the field are variations in use across countries,⁴ states in the United States,⁵ and even across counties within states.⁶

Table 1: Potential Indications for Inferior Vena Cava Filter Insertion

Indication*	Societies that Support this Indication	Societies that Oppose this Indication	Comments
Acute VTE and inability to anticoagulate	ACCP,7 AHA,8 SIR,9,10 ACR11	-	-
Anticoagulation failure	AHA, SIR, ACR	-	-
Hemodynamically unstable patients, as an adjunct to anticoagulation	ACCP, SIR, AHA, ACR	-	The intent is to prevent further hemodynamic decompensation
Massive PE treated with thrombolysis or thrombectomy or during thrombo-endarterectomy	ACCP, SIR, ACR	AHA	-
Prophylaxis in high-risk populations	SIR, ACR	ACCP	Examples of high-risk populations include multi-trauma and spinal cord injury
Mobile thrombus	SIR, ACR	-	-
Iliocaval DVT	SIR, ACR	-	-

Common Indications for IVCF

Currently there is consensus among guidelines that IVCF are indicated for patients who have suffered an acute venous thromboembolic event (VTE) and who cannot receive anticoagulation.^7-11 IVCF are also commonly suggested for patients who are perceived to have failed anticoagulation.^8-10 In clinical practice, some only suggest IVCF when there is evidence for lower extremity clot, while deferring on their use when only PE are present. This practice is not evidence based. Also, while the term "acute" is not well defined across publications, many practitioners use a 3 month cutoff given the known natural history of deep vein thrombosis (DVT) potential for embolization to pulmonary embolism (PE) and risk of recurrence when anticoagulation is held.¹²

The data supporting any and all indications for IVCF are limited. To date, only two randomized trials have been conducted on IVCF use. The first, PREPIC (Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group), randomized 400 patients who suffered acute VTE to anticoagulation alone or anticoagulation and a permanent IVCF.¹³ Follow up was published for 8-year data.¹⁴ This study showed that while IVCF prevented recurrent PE, they did not prevent death, and more DVT occurred in patients who received these devices. The second study, PREPIC 2, utilized retrievable IVCF for a similar comparison.¹⁵ A total of 399 patients with PE associated with DVT were enrolled and randomized to receive anticoagulation only or anticoagulation and a retrievable IVCF. This study enrolled patients who had at least one "high-risk" feature: age >75years old, active cancer, "chronic cardiac or respiratory insufficiency," ischemic stroke with leg paralysis within 6 months, either iliocaval or bilateral DVT, or a sign of right ventricular strain or myocardial injury.¹⁵ Again, IVCF did not show any mortality benefit nor did they result in fewer symptomatic PE during the first 3 months of follow-up. Many of the patients deemed "high-risk" in this publication did not actually exhibit hemodynamic instability and did not have severe RV dysfunction. Thus, the authors used this term in a different manner than that is usually used in clinical practice.

Other Indications for IVCF

IVCF use may be appropriate in patients who are hemodynamically unstable ("to prevent a second hit"). While prospective data are lacking, retrospective and large-database studies have shown benefit for IVCF in this setting. Stein et al. have analyzed data from the National Inpatient Sample and have shown that in patients with massive pulmonary embolism IVCF were associated with reduced mortality.¹⁶ This was true whether thrombolysis was administered or not and across age groups.¹⁷ Importantly, these data are limited as they are both retrospective and limited to discharge codes. Better understanding of the effect of IVCF in this population would require patient-level data. Also, as noted above, PREPIC 2 attempted to offer information regarding high-risk patients; however, researchers' definition of high-risk was not necessarily the same as that used in clinical practice.

Other indications can only be supported by lower, often anecdotal, quality data. Mobile ("free floating") proximal thrombus and "large clot burden" such as ilio-femoral DVT are such indications with the intent of preventing hemodynamic decompensation from embolization.¹⁸ Two other somewhat similar indications include prevention of embolization during catheter directed treatment of DVT and to prevent intra-operative decompensation for patients undergoing pulmonary thrombo-endarterectomy.¹⁹

Prophylactic IVCF use is perhaps the most contentious application of these devices. Several patient categories have been advocated for this indication. These include patients undergoing bariatric surgery,²⁰ multi-trauma patients,^21-23 and patients with spinal cord injury.²⁴ It is important to note that despite the widespread use of IVCF for prophylaxis, there is a growing body of evidence pointing to lack of benefit and actual harm when IVCF are used for these indications.^25,26 Potential negative outcomes of IVCF could occur during implantation (e.g., hematoma or tilting which may result in reduced IVCF efficacy), while the IVCF is indwelling (e.g., IVCF thrombosis) or at the time of retrieval (e.g., IVC perforation).¹

Finally, IVCF have been used to prevent PE during catheter directed treatment of DVT. Nonetheless, many believe this practice should be limited as microemboli will not be trapped by the filter and as the lytic agent and anticoagulation used during the procedure will also prevent major adverse embolic events.²⁷

IVCF Retrieval

Other than appropriate patient selection, perhaps equally important are appropriate surveillance and retrieval. As noted, published retrieval rates in the United States are disappointing, often as low as 30%.²⁸ The Food and Drug Administration has issued a statement mandating practitioners to be responsible for IVCF retrieval and prompting timely retrieval.²⁹

Furthermore, in the current era of accountability, it is important for both providers and payers to be able to measure appropriate use. While in most prominent centers in the United States this is still performed manually (if at all),^28,30 computerized surveillance systems may show promise. In our institution we have implemented such a system that follows IVCF insertion and retrieval. While not all IVCF are retrieved, some remain permanent purposefully after thoughtful deliberation. Other appropriate reasons for non-retrieval such as patient refusal or patient demise are now being documented.

Conclusions

In conclusion, IVCF are likely being over-utilized. Retrieval rates are low and information regarding appropriate use and surveillance are lacking. Use of these devices should be limited to patients with acute VTE who cannot receive anticoagulation. When IVCF are inserted for other indications this should be after much thought and coupled with appropriate documentation. Implementation of system wide mechanisms to ensure appropriate IVCF use, surveillance and retrieval is crucial in order to prevent important clinically relevant complications.

References

1. 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.
2. Mahmood SS, Abtahian F, Fogerty AE, et al. Anticoagulation is associated with decreased inferior vena cava filter-related complications in patients with metastatic carcinoma. Am J Med 2016. [Epub ahead of print]
3. Weinberg I, Kaufman J, Jaff MR. Inferior vena cava filters. JACC Cardiovasc Interv. 2013;6:539-47.
4. Alkhouli M, Bashir R. Inferior vena cava filters in the United States: less is more. Int J Cardiol 2014;177:742-3.
5. 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;67:1027-35.
6. White RH, Geraghty EM, Brunson A, et al. High variation between hospitals in vena cava filter use for venous thromboembolism. JAMA Intern Med 2013;173:506-12.
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;141:419-96.
8. 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;123:1788-1830.
9. 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.
10. Caplin DM, Nikolic B, Kalva SP, et al. Quality improvement guidelines for the performance of inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol 2011;22:1499-1506.
11. Kinney TB, Aryafar H, Ray CE Jr, et al. ACR Appropriateness Criteria radiologic management of inferior vena cava filters. Am Coll Radiol 2012:1-4. https://guidelines.gov/summaries/summary/43868. Accessed September 30, 2016.
12. Boutitie F, Pinede L, Schulman S, et al. Influence of preceding length of anticoagulant treatment and initial presentation of venous thromboembolism on risk of recurrence after stopping treatment: analysis of individual participants' data from seven trials. BMJ. 2011;342:d3036.
13. 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;338:409-15.
14. PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: The PREPIC (Prévention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 2005;112:416-22.
15. 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.
16. Stein PD, Matta F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Am J Med 2012;125:465-70.
17. Stein PD, Matta F. Vena cava filters in unstable elderly patients with acute pulmonary embolism. Am J Med 2014;127:222-5.
18. Pacouret G, Alison D, Pottier J-M, Bertrand P, Charbonnier B. Free-floating thrombus and embolic risk in patients with angiographically confirmed proximal deep vein thrombosis: a prospective study. 1997;157:305-8.
19. Avgerinos ED, Hager ES, Jeyabalan G, Marone L, Makaroun MS, Chaer RA. Inferior vena cava filter placement during thrombolysis for acute iliofemoral deep venous thrombosis. J Vasc Surg Venous Lymphat Disord 2014;2:274-81.
20. 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;261:35-45.
21. 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 2013;149:194-202.
22. Dossett LA, Adams RC, Cotton BA. Unwarranted national variation in the use of prophylactic inferior vena cava filters after trauma: an analysis of the National Trauma Databank. J Trauma 2011;70:1066-70.
23. Rajasekhar A, Lottenberg R, Lottenberg L, Liu H, Ang D. Pulmonary embolism prophylaxis with inferior vena cava filters in trauma patients: A systematic review using the meta-analysis of observational studies in epidemiology (MOOSE) guidelines. J Thromb Thrombolysis 2011;32:40-6.
24. McClendon J, OʼShaughnessy BA, Smith TR, et al. Comprehensive assessment of prophylactic preoperative inferior vena cava filters for major spinal reconstruction in adults. Spine 2012;37:1122-9.
25. Gorman PH, Qadri SF, Rao-Patel A. Prophylactic inferior vena cava (IVC) filter placement may increase the relative risk of deep venous thrombosis after acute spinal cord injury. J Trauma 2009;66:707-12.
26. Maxwell RA, Chavarria-Aguilar M, Cockerham WT, et al. Routine prophylactic vena cava filtration is not indicated after acute spinal cord injury. J Trauma 2002;52:902-6.
27. Jiang J, Tu J, Jia Z, et al. Incidence and outcomes of inferior vena cava filter thrombus during catheter-directed thrombolysis for proximal deep venous thrombosis. Ann Vasc Surg 2016. [Epub ahead of print]
28. Dixon A, Stavropoulos SW. Improving retrieval rates for retrievable inferior vena cava filters. Expert Rev Med Devices 2013;10(:135-41.
29. US Food & Drug Administration. Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm. Accessed September 30, 2016.
30. Minocha J, Idakoji I, Riaz A, et al. Improving inferior vena cava filter retrieval rates: impact of a dedicated inferior vena cava filter clinic. J Vasc Interv Radiol 2010;21:1847-51.

Keywords: Bariatric Surgery, Endarterectomy, Hematoma, Hemodynamics, Neoplasms, Pulmonary Embolism, Radiology, Interventional, Respiratory Insufficiency, Spinal Cord Injuries, Stroke, Thrombectomy, Thrombosis, Vena Cava Filters, Venous Thromboembolism, Venous Thrombosis

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