Subscribe to RSS
DOI: 10.1055/s-0036-1583208
Evidence-Based Evaluation of Inferior Vena Cava Filter Complications Based on Filter Type
Publication History
Publication Date:
10 May 2016 (online)

Abstract
Many inferior vena cava (IVC) filter types, along with their specific risks and complications, are not recognized. The purpose of this study was to evaluate the various FDA-approved IVC filter types to determine device-specific risks, as a way to help identify patients who may benefit from ongoing follow-up versus prompt filter retrieval. An evidence-based electronic search (FDA Premarket Notification, MEDLINE, FDA MAUDE) was performed to identify all IVC filter types and device-specific complications from 1980 to 2014. Twenty-three IVC filter types (14 retrievable, 9 permanent) were identified. The devices were categorized as follows: conical (n = 14), conical with umbrella (n = 1), conical with cylindrical element (n = 2), biconical with cylindrical element (n = 2), helical (n = 1), spiral (n = 1), and complex (n = 1). Purely conical filters were associated with the highest reported risks of penetration (90–100%). Filters with cylindrical or umbrella elements were associated with the highest reported risk of IVC thrombosis (30–50%). Conical Bard filters were associated with the highest reported risks of fracture (40%). The various FDA-approved IVC filter types were evaluated for device-specific complications based on best current evidence. This information can be used to guide and optimize clinical management in patients with indwelling IVC filters.
-
References
- 1 Duszak Jr R, Parker L, Levin DC, Rao VM. Placement and removal of inferior vena cava filters: national trends in the Medicare population. J Am Coll Radiol 2011; 8 (7) 483-489
- 2 Stein PD, Kayali F, Olson RE. Twenty-one-year trends in the use of inferior vena cava filters. Arch Intern Med 2004; 164 (14) 1541-1545
- 3 Smouse BJ. Is market growth of vena cava filters justified?. Endovasc Today 2010; 74-77
- 4 Food and Drug Administration. Removing Retrievable Inferior Vena Cava Filters: Initial Communication. Published August 9, 2010. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm . Accessed July 30, 2015
- 5 Food and Drug Administration. 510(K) Premarket Notification Database. Published 2014. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm . Accessed January 1, 2015
- 6 Caplin DM, Nikolic B, Kalva SP, Ganguli S, Saad WE, Zuckerman DA ; 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
- 7 Durack JC, Westphalen AC, Kekulawela S , et al. Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters. Cardiovasc Intervent Radiol 2012; 35 (2) 299-308
- 8 Food and Drug Administration. MAUDE - Manufacturer and User Facility Device Experience Database. Published 2014. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm . Accessed January 1, 2015
- 9 Bakal CW, Silberzweig JE. Vascular and Interventional Radiology: Principles and Practice. New York, NY: Thieme; 2011
- 10 Tam MD, Spain J, Lieber M, Geisinger M, Sands MJ, Wang W. Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. J Vasc Interv Radiol 2012; 23 (2) 199-205.e1
- 11 Nicholson W, Nicholson WJ, Tolerico P , et al. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Arch Intern Med 2010; 170 (20) 1827-1831
- 12 Hull JE, Robertson SW. Bard Recovery filter: evaluation and management of vena cava limb perforation, fracture, and migration. J Vasc Interv Radiol 2009; 20 (1) 52-60
- 13 Vijay K, Hughes JA, Burdette AS , et al. Fractured Bard Recovery, G2, and G2 express inferior vena cava filters: incidence, clinical consequences, and outcomes of removal attempts. J Vasc Interv Radiol 2012; 23 (2) 188-194
- 14 Kalva SP, Athanasoulis CA, Fan CM , et al. “Recovery” vena cava filter: experience in 96 patients. Cardiovasc Intervent Radiol 2006; 29 (4) 559-564
- 15 Binkert CA, Drooz AT, Caridi JG , et al. Technical success and safety of retrieval of the G2 filter in a prospective, multicenter study. J Vasc Interv Radiol 2009; 20 (11) 1449-1453
- 16 An T, Moon E, Bullen J , et al. Prevalence and clinical consequences of fracture and fragment migration of the Bard G2 filter: imaging and clinical follow-up in 684 implantations. J Vasc Interv Radiol 2014; 25 (6) 941-948
- 17 Poletti PA, Becker CD, Prina L , et al. Long-term results of the Simon nitinol inferior vena cava filter. Eur Radiol 1998; 8 (2) 289-294
- 18 McCowan TC, Ferris EJ, Carver DK, Molpus WM. Complications of the nitinol vena caval filter. J Vasc Interv Radiol 1992; 3 (2) 401-408
- 19 Sano M, Unno N, Yamamoto N, Tanaka H, Konno H. Frequent fracture of TrapEase inferior vena cava filters: a long-term follow-up assessment. Arch Intern Med 2012; 172 (2) 189-191
- 20 Cantwell CP, Pennypacker J, Singh H, Scorza LB, Waybill PN, Lynch FC. Comparison of the recovery and G2 filter as retrievable inferior vena cava filters. J Vasc Interv Radiol 2009; 20 (9) 1193-1199
- 21 Binkert CA, Sasadeusz K, Stavropoulos SW. Retrievability of the recovery vena cava filter after dwell times longer than 180 days. J Vasc Interv Radiol 2006; 17 (2, Pt 1): 299-302
- 22 Charles HW, Black M, Kovacs S , et al. G2 inferior vena cava filter: retrievability and safety. J Vasc Interv Radiol 2009; 20 (8) 1046-1051
- 23 Lynch FC, Kekulawela S. Removal of the G2 filter: differences between implantation times greater and less than 180 days. J Vasc Interv Radiol 2009; 20 (9) 1200-1209
- 24 Marquess JS, Burke CT, Beecham AH , et al. Factors associated with failed retrieval of the Günther Tulip inferior vena cava filter. J Vasc Interv Radiol 2008; 19 (9) 1321-1327
- 25 Smouse HB, Rosenthal D, Thuong VH , et al. Long-term retrieval success rate profile for the Günther Tulip vena cava filter. J Vasc Interv Radiol 2009; 20 (7) 871-877 , quiz 878
- 26 Wicky S, Doenz F, Meuwly J-Y, Portier F, Schnyder P, Denys A. Clinical experience with retrievable Günther Tulip vena cava filters. J Endovasc Ther 2003; 10 (5) 994-1000
- 27 Xiao L, Huang DS, Shen J, Tong JJ. Introducer curving technique for the prevention of tilting of transfemoral Günther Tulip inferior vena cava filter. Korean J Radiol 2012; 13 (4) 483-491
- 28 Greenfield LJ, Peyton R, Crute S, Barnes R. Greenfield vena caval filter experience: late results in 156 patients. Arch Surg 1981; 116 (11) 1451-1456
- 29 Messmer JM, Greenfield LJ. Greenfield caval filters: long-term radiographic follow-up study. Radiology 1985; 156 (3) 613-618
- 30 Kinney TB, Rose SC, Weingarten KE, Valji K, Oglevie SB, Roberts AC. IVC filter tilt and asymmetry: comparison of the over-the-wire stainless-steel and titanium Greenfield IVC filters. J Vasc Interv Radiol 1997; 8 (6) 1029-1037
- 31 Johnson SP, Raiken DP, Grebe PJ, Diffin DC, Leyendecker JR. Single institution prospective evaluation of the over-the-wire Greenfield vena caval filter. J Vasc Interv Radiol 1998; 9 (5) 766-773
- 32 Sweeney TJ, Van Aman ME. Deployment problems with the titanium Greenfield filter. J Vasc Interv Radiol 1993; 4 (5) 691-694
- 33 Wittenberg G, Kueppers V, Tschammler A, Scheppach W, Kenn W, Hahn D. Long-term results of vena cava filters: experiences with the LGM and the Titanium Greenfield devices. Cardiovasc Intervent Radiol 1998; 21 (3) 225-229
- 34 Nicholson AA, Ettles DF, Paddon AJ, Dyet JF. Long-term follow-up of the bird's nest IVC filter. Clin Radiol 1999; 54 (11) 759-764
- 35 McLoney ED, Krishnasamy VP, Castle JC, Yang X, Guy G. Complications of Celect, Günther tulip, and Greenfield inferior vena cava filters on CT follow-up: a single-institution experience. J Vasc Interv Radiol 2013; 24 (11) 1723-1729
- 36 Hoffer EK, Mueller RJ, Luciano MR, Lee NN, Michaels AT, Gemery JM. Safety and efficacy of the Gunther Tulip retrievable vena cava filter: midterm outcomes. Cardiovasc Intervent Radiol 2013; 36 (4) 998-1005
- 37 Olorunsola OG, Kohi MP, Fidelman N , et al. Caval penetration by retrievable inferior vena cava filters: a retrospective comparison of Option and Günther Tulip filters. J Vasc Interv Radiol 2013; 24 (4) 566-571
- 38 Zhou D, Spain J, Moon E, Mclennan G, Sands MJ, Wang W. Retrospective review of 120 Celect inferior vena cava filter retrievals: experience at a single institution. J Vasc Interv Radiol 2012; 23 (12) 1557-1563
- 39 Sangwaiya MJ, Marentis TC, Walker TG, Stecker M, Wicky ST, Kalva SP. Safety and effectiveness of the celect inferior vena cava filter: preliminary results. J Vasc Interv Radiol 2009; 20 (9) 1188-1192
- 40 Greenfield LJ, Cho KJ, Proctor M , et al. Results of a multicenter study of the modified hook-titanium Greenfield filter. J Vasc Surg 1991; 14 (3) 253-257
- 41 Ferris EJ, McCowan TC, Carver DK, McFarland DR. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients. Radiology 1993; 188 (3) 851-856
- 42 Greenfield LJ, Cho KJ, Pais SO, Van Aman M. Preliminary clinical experience with the titanium Greenfield vena caval filter. Arch Surg 1989; 124 (6) 657-659
- 43 Hoppe H, Nutting CW, Smouse HR , et al. Günther Tulip filter retrievability multicenter study including CT follow-up: final report. J Vasc Interv Radiol 2006; 17 (6) 1017-1023
- 44 Millward SF, Peterson RA, Moher D , et al. LGM (Vena Tech) vena caval filter: experience at a single institution. J Vasc Interv Radiol 1994; 5 (2) 351-356
- 45 Crochet DP, Brunel P, Trogrlic S, Grossetëte R, Auget J-L, Dary C. Long-term follow-up of Vena Tech-LGM filter: predictors and frequency of caval occlusion. J Vasc Interv Radiol 1999; 10 (2, Pt 1): 137-142
- 46 Corriere MA, Sauve KJ, Ayerdi J , et al. Vena cava filters and inferior vena cava thrombosis. J Vasc Surg 2007; 45 (4) 789-794
- 47 Simon M, Athanasoulis CA, Kim D , et al. Simon nitinol inferior vena cava filter: initial clinical experience. Work in progress. Radiology 1989; 172 (1) 99-103
- 48 Kim D, Edelman RR, Margolin CJ , et al. The Simon nitinol filter: evaluation by MR and ultrasound. Angiology 1992; 43 (7) 541-548
- 49 Grassi CJ, Matsumoto AH, Teitelbaum GP. Vena caval occlusion after Simon nitinol filter placement: identification with MR imaging in patients with malignancy. J Vasc Interv Radiol 1992; 3 (3) 535-539
- 50 Food and Drug Administration. Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication. Published 2014. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm . Accessed January 1, 2015
- 51 Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M, Cavanaugh Jr KJ. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord 2013; 1 (4) 376-384
- 52 Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol 2011; 22 (11) 1522-1530.e3
- 53 Meyer A, Schönleben F, Heinz M, Lang W. Perforated inferior vena cava filters as the cause of unclear abdominal pain. Ann Vasc Surg 2013; 27 (3) 354.e9-354.e12
- 54 Pellerin O, di Primio M, Sanchez O, Meyer G, Sapoval M. Successful retrieval of 29 ALN inferior vena cava filters at a mean of 25.6 months after placement. J Vasc Interv Radiol 2013; 24 (2) 284-288
- 55 Pellerin O, Barral FG, Lions C, Novelli L, Beregi JP, Sapoval M. Early and late retrieval of the ALN removable vena cava filter: results from a multicenter study. Cardiovasc Intervent Radiol 2008; 31 (5) 889-896
- 56 Kuo WT, Robertson SW, Odegaard JI, Hofmann LV. Complex retrieval of fractured, embedded, and penetrating inferior vena cava filters: a prospective study with histologic and electron microscopic analysis. J Vasc Interv Radiol 2013; 24 (5) 622-630.e1 , quiz 631
- 57 Mismetti P, Rivron-Guillot K, Quenet S , et al. A prospective long-term study of 220 patients with a retrievable vena cava filter for secondary prevention of venous thromboembolism. Chest 2007; 131 (1) 223-229
- 58 Imberti D, Bianchi M, Farina A, Siragusa S, Silingardi M, Ageno W. Clinical experience with retrievable vena cava filters: results of a prospective observational multicenter study. J Thromb Haemost 2005; 3 (7) 1370-1375
- 59 Caronno R, Piffaretti G, Tozzi M , et al. Mid-term experience with the ALN retrievable inferior vena cava filter. European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 2006; 32 (5) 596-9
- 60 Zhu X, Tam MDBS, Bartholomew J, Newman JS, Sands MJ, Wang W. Retrievability and device-related complications of the G2 filter: a retrospective study of 139 filter retrievals. J Vasc Interv Radiol 2011; 22 (6) 806-812
- 61 Oliva VL, Perreault P, Giroux M-F, Bouchard L, Therasse E, Soulez G. Recovery G2 inferior vena cava filter: technical success and safety of retrieval. J Vasc Interv Radiol 2008; 19 (6) 884-889
- 62 Kuo WT, Robertson SW. Bard Denali IVC filter fracture and embolization resulting in cardiac tamponade: a device failure analysis. Journal of vascular and interventional radiology. J Vasc Interv Radiol 2014; ; In press
- 63 Stavropoulos SW, Sing RF, Elmasri F , et al; DENALI Trial Investigators. The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter. J Vasc Interv Radiol 2014; 25 (10) 1497-1505 , 1505.e1
- 64 Awh MH, Taylor FC, Lu CT. Spontaneous fracture of a Vena-Tech inferior vena caval filter. AJR Am J Roentgenol 1991; 157 (1) 177-178
- 65 Ricco J-B, Dubreuil F, Reynaud P , et al. The LGM Vena-Tech caval filter: results of a multicenter study. Ann Vasc Surg 1995; 9 (Suppl): S89-S100
- 66 Murphy TP, Dorfman GS, Yedlicka JW ,et al. LGM vena cava filter: objective evaluation of early results. J Vasc Interv Radiol 1991; 2 (1) 107-115
- 67 Le Blanche AF, Benazzouz A, Reynaud P , et al. The VenaTech LP permanent caval filter: effectiveness and safety in the prevention of pulmonary embolism–a European multicenter study. Journal of vascular and interventional radiology. J Vasc Interv Radiol 2008; 19 (4) 509-515
- 68 Taheri SA, Kulaylat MN, Johnson E, Hoover E. A complication of the Greenfield filter: fracture and distal migration of two struts—a case report. J Vasc Surg 1992; 16 (1) 96-99
- 69 Carabasi III RA, Moritz MJ, Jarrell BE. Complications encountered with the use of the Greenfield filter. Am J Surg 1987; 154 (2) 163-168
- 70 Wingerd M, Bernhard VM, Maddison F, Towne JB. Comparison of caval filters in the management of venous thromboembolism. Arch Surg 1978; 113 (11) 1264-1271
- 71 Greenfield LJ, Michna BA. Twelve-year clinical experience with the Greenfield vena caval filter. Surgery 1988; 104 (4) 706-712
- 72 Greenfield LJ, Proctor MC. Twenty-year clinical experience with the Greenfield filter. Cardiovasc Surg 1995; 3 (2) 199-205
- 73 Greenfield LJ, Proctor MC. The percutaneous greenfield filter: outcomes and practice patterns. J Vasc Surg 2000; 32 (5) 888-893
- 74 Cho KJ, Greenfield LJ, Proctor MC , et al. Evaluation of a new percutaneous stainless steel Greenfield filter. J Vasc Interv Radiol 1997; 8 (2) 181-187
- 75 Greenfield LJ, Proctor MC, Cho KJ , et al. Extended evaluation of the titanium Greenfield vena caval filter. J Vasc Surg 1994; 20 (3) 458-464 , discussion 464–465
- 76 Wang W, Zhou D, Obuchowski N, Spain J, An T, Moon E. Fracture and migration of Celect inferior vena cava filters: a retrospective review of 741 consecutive implantations. J Vasc Interv Radiol 2013; 24 (11) 1719-1722
- 77 Lyon SM, Riojas GE, Uberoi R , et al. Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry. J Vasc Interv Radiol 2009; 20 (11) 1441-1448
- 78 Roehm Jr JO, Johnsrude IS, Barth MH, Gianturco C. The bird's nest inferior vena cava filter: progress report. Radiology 1988; 168 (3) 745-749
- 79 Ziegler JW, Dietrich GJ, Cohen SA, Sterling K, Duncan J, Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter. J Vasc Interv Radiol 2008; 19 (8) 1165-1170
- 80 Oliva VL, Szatmari F, Giroux M-F, Flemming BK, Cohen SA, Soulez G. The Jonas study: evaluation of the retrievability of the Cordis OptEase inferior vena cava filter. J Vasc Interv Radiol 2005; 16 (11) 1439-1445, quiz 1445
- 81 Rosenthal D, Swischuk JL, Cohen SA, Wellons ED. OptEase retrievable inferior vena cava filter: initial multicenter experience. Vascular 2005; 13 (5) 286-289
- 82 Kalva SP, Wicky S, Waltman AC, Athanasoulis CA. TrapEase vena cava filter: experience in 751 patients. J Endovasc Ther 2006; 13 (3) 365-372
- 83 Liu WC, Do YS, Choo SW , et al. The mid-term efficacy and safety of a permanent nitinol IVC filter(TrapEase). Korean J Radiol 2005; 6 (2) 110-116
- 84 Rousseau H, Perreault P, Otal P , et al. The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial. J Vasc Interv Radiol 2001; 12 (3) 299-304
- 85 Kalva SP, Marentis TC, Yeddula K, Somarouthu B, Wicky S, Stecker MS. Long-term safety and effectiveness of the “OptEase” vena cava filter. Cardiovasc Intervent Radiol 2011; 34 (2) 331-337
- 86 Usoh F, Hingorani A, Ascher E , et al. Prospective randomized study comparing the clinical outcomes between inferior vena cava Greenfield and TrapEase filters. J Vasc Surg 2010; 52 (2) 394-399
- 87 Johnson MS, Nemcek Jr AA, Benenati JF , et al. The safety and effectiveness of the retrievable option inferior vena cava filter: a United States prospective multicenter clinical study. J Vasc Interv Radiol 2010; 21 (8) 1173-1184
- 88 Smouse HB, Mendes R, Bosiers M, Van Ha TG, Crabtree T, Investigators R ; RETRIEVE Investigators. The RETRIEVE trial: safety and effectiveness of the retrievable crux vena cava filter. J Vasc Interv Radiol 2013; 24 (5) 609-621