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Editorials: Point and Counterpoint |

COUNTERPOINT: Do the Benefits Outweigh the Risks for Most Patients Under Consideration for Inferior Vena Cava Filters? No FREE TO VIEW

Mark L. Lessne, MD; Ronald F. Sing, DO, FCCP
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: The authors have reported to CHEST the following: R. F. S. has received educational grant support from CR Bard, Cook Medical, Volcano Medical, and Argon Medical. None declared (M. L. L.).

aVascular and Interventional Specialists of Charlotte Radiology, Carolinas HealthCare System, Charlotte, NC

bDepartment of Trauma Surgery, Carolinas HealthCare System, Charlotte, NC

CORRESPONDENCE TO: Mark L. Lessne, MD, 1701 East Blvd, Charlotte, NC 28203


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;150(6):1182-1184. doi:10.1016/j.chest.2016.08.1477
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Published online

Since the Mobin-Uddin umbrella launched in the late 1960s, the implantation of inferior vena cava (IVC) filters has vastly outpaced the quality evidence for their use. In 2012, approximately 250,000 IVC filters were placed in the United States, representing nearly a 1,300-fold increase in 30 years and 25 times the number that were placed in five European countries with comparable total population size.,,,,,, However, despite these staggering volumes, and contrary to expectation, the number of deaths related to venous thromboembolic events (VTEs) in equivalent population sizes were similar in the United States and Europe. We are left asking: what explains the United States’ obsession with IVC filters?

IVC filters are placed either for therapeutic indication (prevention of pulmonary embolism [PE] in patients with VTE) or for prophylactic reasons (prevention of PE in patients deemed high risk for PE, but without concurrent VTE)., Although the best—albeit imperfect—evidence supporting IVC filter use is for its therapeutic indications, less than one-half of filters are placed for these reasons: the remaining devices are placed for prophylactic indications.,,,,,

Multiple professional societies have attempted to offer guidance regarding the appropriate use of IVC filters, with the American College of Chest Physicians and Society of Interventional Radiology guidelines among the most often referenced. However, even between these guidelines, great discrepancy exists: the American College of Chest Physicians accepts only therapeutic indications as appropriate, whereas the Society of Interventional Radiology allows prophylactic ones., Much of the weight of these clinical guidelines rests on the shoulders of the oft-quoted Prevention du Risque d'Embolie Pulmonaire par Interruption Cave (PREPIC) study, the most robust randomized controlled trial investigating the utility of IVC filters. This study demonstrated, at 8-year follow-up, a reduction of PE in patients with IVC filters compared with a control group, but with increased DVT and no mortality difference. However, our heavy reliance on this trial only obfuscates the clinical horizon and overestimates our practical insight into the utility of IVC filters. In the PREPIC trial, anticoagulation was administered to all patients—one-half of which remained anticoagulated at 8-year follow-up—an unusual strategy in real-world practice and one that may have suppressed what would have been an even higher rate of DVT in patients with IVC filters. Additionally, determination of PE was largely based on physician phone calls at follow-up, facilitating the detection of subclinical PE and almost certainly leading to an overestimation of clinically significant PE reduction risk. Most glaringly, the PREPIC trial used exclusively permanent filters, which are now largely considered anachronistic and placed in < 25% of patients.

Permanent IVC filters were historically classified by the US Food and Drug Administration as higher-risk class III devices; however, in 2003, the US Food and Drug Administration reduced this designation to a lower-risk class II. This effective deregulation allowed manufacturers to obtain market approval for optional filters as a cleared medical device, erroneously granting equivalency of these new filters to the decades old permanent filters previously available. IVC filter manufacturers submit only a premarket notification, known as a 510(k), that, once approved, allows marketing of retrievable filters as “permanent filters with an option for retrieval,” inaccurately reflecting the significant discrepancy in designs between permanent filters and those that are specifically designed to have “a less secure implantation to facilitate retrieval.”,,,

In fact, the availability of optional IVC filters has led to their skyrocketing use based on the fallacy that these devices offer the best of both filter worlds: short-term protection from PE while obviating long-term retention of a foreign body. This has resulted in a plummeting threshold for filter placement despite consistent demonstration that optional filters are infrequently removed and may be less safe than permanent filters.,,

The PREPIC trial—despite its flaws—at least provides some randomized controlled data addressing the therapeutic use of IVC filters. Prophylactic indications for IVC filters—which again, constitute > 50% of all filter placements—have far less evidence justifying their use, which is generally pieced together from case reports or retrospective reviews.,, In an expert panel review of IVC filters placed in a metropolitan area, appropriate use of IVC filtration was agreed on in only approximately one-half of cases; notably, these cases were from approximately 15 years ago and, given the trend of filter use, almost assuredly paint a far more optimistic picture than if the study were repeated today.

These potentially unnecessary procedures come not only at the risk of no gained benefit, but with risk for harm. Aside from the potential physical harm incurred by IVC filters, which includes filter fracture, perforation, migration, and IVC thrombosis (much of which is based on self-reported adverse events, and almost certainly underreported), the cost of IVC implantation was estimated at $300 million in 2012 (not inclusive of costs from complications, malpractice claims, surveillance, and retrieval—or failed retrieval).,,,,,,,,

So, why are so many filters placed in the United States? There are interesting correlative data to consider: the use of IVC filters is geographically disparate, being greatest in Northeastern United States and lowest in the west; filter implantation is directly related to the number of paid malpractice claims and annual liability premiums and is lowest where the population is least insured.,,, These points suggest a—hopefully—subconscious medicolegal and financial drive behind the surge in IVC filter implantation. A more optimistic explanation may be related to physician confusion: given the lack of consensus among professional society guidelines, how can we expect uniformity among thousands of physicians placing IVC filters? Even the most stringent guidelines offered by the American College of Chest Physicians vaguely reference high risk for bleeding as a consideration for IVC filtration, but nowhere is high risk explicated. In fact, even the ubiquitous term contraindication to anticoagulation is not well defined and widely open to interpretation. To that point, many patients labeled as having a contraindication to anticoagulation requiring the implantation of an IVC filter are anticoagulated shortly after filter placement, questioning the utility of the IVC filter in the first place.,,,,

With these considerations in mind, there is little doubt that the benefits do not outweigh the risks for most patients under consideration for IVC filters. That argued, there exists, almost certainly, a population of patients in whom IVC filters confer a clinically significant benefit; unfortunately, until this group is better defined, filters placed for appropriate indications are becoming as scarce as the evidence justifying the rest.

Supplementary Data

Andreoli J.M. .Lewandowski R.J. .Vogelzang R.L. .Ryu R.K. . Comparison of complication rates associated with permanent and retrievable inferior vena cava filters: a review of the MAUDE database. J Vasc Interv Radiol. 2014;25:1181-1185 [PubMed]journal. [CrossRef] [PubMed]
 
Lee M.J. .Valenti D. .de Gregorio M.A. .Minocha J. .Rimon U. .Pellerin O. . The CIRSE Retrievable IVC Filter Registry: retrieval success rates in practice. Cardiovasc Intervent Radiol. 2015;38:1502-1507 [PubMed]journal. [CrossRef] [PubMed]
 
Kumar V. .Slovut D.P. . Vena cava filters. Vasc Dis Manag. 2014;11:- [PubMed]journal
 
Lessne M.L. .Rinaldi M.J. .Sing R.F. . Vena cava filter options: what’s on the horizon? Expert Rev Cardiovasc Ther. 2016;14:415-421 [PubMed]journal. [CrossRef] [PubMed]
 
Eifler A.C. .Lewandowski R.J. .Gupta R. .et al Optional or permanent: clinical factors that optimize inferior vena cava filter utilization. J Vasc Interv Radiol. 2013;24:35-40 [PubMed]journal. [CrossRef] [PubMed]
 
Alkhouli M. .Bashir R. . Inferior vena cava filters in the United States: Less is more. Int J Cardiol. 2014;177:742-743 [PubMed]journal. [CrossRef] [PubMed]
 
Wang S.L. .Lloyd A.J. . Clinical review: inferior vena cava filters in the age of patient-centered outcomes. Ann Med. 2013;45:474-481 [PubMed]journal. [CrossRef] [PubMed]
 
Caplin D.M. .Nikolic B. .Kalva S.P. .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 [PubMed]journal. [PubMed]
 
Kearon C. .Akl E.A. .Ornelas J. .et al Antithrombotic therapy for VTE disease. Chest. 2016;149:315-352 [PubMed]journal. [CrossRef] [PubMed]
 
Duszak R. .Parker L. .Levin D.C. .Rao V.M. . Placement and removal of inferior vena cava filters: national trends in the Medicare population. J Am Coll Radiol. 2011;8:483-489 [PubMed]journal. [CrossRef] [PubMed]
 
Angel L.F. .Tapson V. .Galgon R.E. .Restrepo M.I. .Kaufman J. . Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22:1522-1530.e3 [PubMed]journal. [CrossRef] [PubMed]
 
Baadh A.S. .Zikria J.F. .Rivoli S. .Graham R.E. .Javit D. .Ansell J.E. . Indications for inferior vena cava filter placement: Do physicians comply with guidelines? J Vasc Interv Radiol. 2012;23:989-995 [PubMed]journal. [CrossRef] [PubMed]
 
Kearon C. .Akl E.A. .Comerota A.J. .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-e494S [PubMed]journal. [CrossRef] [PubMed]
 
The 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 [PubMed]journal. [CrossRef] [PubMed]
 
Arous E.J. .Messina L.M. . Temporary inferior vena cava filters: How do we move forward? Chest. 2016;149:1143-1145 [PubMed]journal. [CrossRef] [PubMed]
 
Wehrenberg-Klee E. .Stavropoulos S.W. . Inferior vena cava filters for primary prophylaxis: When are they indicated? Semin Intervent Radiol. 2012;29:29-35 [PubMed]journal. [CrossRef] [PubMed]
 
Sing R.F. .Fischer P.E. . Inferior vena cava filters: indications and management. Curr Opin Cardiol. 2013;28:625-631 [PubMed]journal. [CrossRef] [PubMed]
 
Spencer F.A. .Bates S.M. .Goldberg R.J. .et al A population-based study of inferior vena cava filters in patients with acute venous thromboembolism. Arch Intern Med. 2010;170:1456-1462 [PubMed]journal. [PubMed]
 
Sarosiek S. .Crowther M. .Sloan J.M. . 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;173:513-517 [PubMed]journal. [CrossRef] [PubMed]
 
Muriel A. .Jiménez 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;63:1675-1683 [PubMed]journal. [CrossRef] [PubMed]
 

Figures

Tables

References

Andreoli J.M. .Lewandowski R.J. .Vogelzang R.L. .Ryu R.K. . Comparison of complication rates associated with permanent and retrievable inferior vena cava filters: a review of the MAUDE database. J Vasc Interv Radiol. 2014;25:1181-1185 [PubMed]journal. [CrossRef] [PubMed]
 
Lee M.J. .Valenti D. .de Gregorio M.A. .Minocha J. .Rimon U. .Pellerin O. . The CIRSE Retrievable IVC Filter Registry: retrieval success rates in practice. Cardiovasc Intervent Radiol. 2015;38:1502-1507 [PubMed]journal. [CrossRef] [PubMed]
 
Kumar V. .Slovut D.P. . Vena cava filters. Vasc Dis Manag. 2014;11:- [PubMed]journal
 
Lessne M.L. .Rinaldi M.J. .Sing R.F. . Vena cava filter options: what’s on the horizon? Expert Rev Cardiovasc Ther. 2016;14:415-421 [PubMed]journal. [CrossRef] [PubMed]
 
Eifler A.C. .Lewandowski R.J. .Gupta R. .et al Optional or permanent: clinical factors that optimize inferior vena cava filter utilization. J Vasc Interv Radiol. 2013;24:35-40 [PubMed]journal. [CrossRef] [PubMed]
 
Alkhouli M. .Bashir R. . Inferior vena cava filters in the United States: Less is more. Int J Cardiol. 2014;177:742-743 [PubMed]journal. [CrossRef] [PubMed]
 
Wang S.L. .Lloyd A.J. . Clinical review: inferior vena cava filters in the age of patient-centered outcomes. Ann Med. 2013;45:474-481 [PubMed]journal. [CrossRef] [PubMed]
 
Caplin D.M. .Nikolic B. .Kalva S.P. .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 [PubMed]journal. [PubMed]
 
Kearon C. .Akl E.A. .Ornelas J. .et al Antithrombotic therapy for VTE disease. Chest. 2016;149:315-352 [PubMed]journal. [CrossRef] [PubMed]
 
Duszak R. .Parker L. .Levin D.C. .Rao V.M. . Placement and removal of inferior vena cava filters: national trends in the Medicare population. J Am Coll Radiol. 2011;8:483-489 [PubMed]journal. [CrossRef] [PubMed]
 
Angel L.F. .Tapson V. .Galgon R.E. .Restrepo M.I. .Kaufman J. . Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22:1522-1530.e3 [PubMed]journal. [CrossRef] [PubMed]
 
Baadh A.S. .Zikria J.F. .Rivoli S. .Graham R.E. .Javit D. .Ansell J.E. . Indications for inferior vena cava filter placement: Do physicians comply with guidelines? J Vasc Interv Radiol. 2012;23:989-995 [PubMed]journal. [CrossRef] [PubMed]
 
Kearon C. .Akl E.A. .Comerota A.J. .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-e494S [PubMed]journal. [CrossRef] [PubMed]
 
The 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 [PubMed]journal. [CrossRef] [PubMed]
 
Arous E.J. .Messina L.M. . Temporary inferior vena cava filters: How do we move forward? Chest. 2016;149:1143-1145 [PubMed]journal. [CrossRef] [PubMed]
 
Wehrenberg-Klee E. .Stavropoulos S.W. . Inferior vena cava filters for primary prophylaxis: When are they indicated? Semin Intervent Radiol. 2012;29:29-35 [PubMed]journal. [CrossRef] [PubMed]
 
Sing R.F. .Fischer P.E. . Inferior vena cava filters: indications and management. Curr Opin Cardiol. 2013;28:625-631 [PubMed]journal. [CrossRef] [PubMed]
 
Spencer F.A. .Bates S.M. .Goldberg R.J. .et al A population-based study of inferior vena cava filters in patients with acute venous thromboembolism. Arch Intern Med. 2010;170:1456-1462 [PubMed]journal. [PubMed]
 
Sarosiek S. .Crowther M. .Sloan J.M. . 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;173:513-517 [PubMed]journal. [CrossRef] [PubMed]
 
Muriel A. .Jiménez 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;63:1675-1683 [PubMed]journal. [CrossRef] [PubMed]
 
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