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432 Chapter 46/Permanent Vena Cava Filters: Indications, Filter Types, and Results

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41. Becker DM, Philbrick JT, Selby JB. Inferior vena cava ﬁ lters: Indications, safety, effectiveness, Arch Intern Med. 1992. 152: 1985–

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42. Murphy TP, Trerotola SO, Vogelzang RL. Vena caval ﬁ lters for the prevention of pulmonary embolism, N Engl J Med. 1998. 339: 46–

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45. Athanasoulis CA, Kaufman JA, Halpern EF, Waltman AC, Geller SC, Fan CM. Inferior vena caval ﬁ lters: Review of a 26-year single-center clinical experience, Radiology. 2000. 216: 54–66.

46. Nunn CR, Neuzil D, Naslund T et al. Cost-effective method for bedside insertion of vena caval ﬁ lters in trauma patients, J Trauma.

1997. 43: 752–758.

47. Matsumura JS, Morasch MD. Filter placement by ultrasound technique at the bedside, Seminars Vasc Surg. 2000. 13: 199–203.

48. Conners MS, Becker S, Guzman RJ, Passman MA, Pierce R, Kelly T, Naslund TC. Duplex scan-directed placement of inferior vena cava ﬁ lters: A ﬁ ve-year institutional experience, J Vasc Surg. 2002. 35: 286–291.

49. Corriere MA, Passman MA, Guzman RJ, Dattilo JB, Naslund TC. Comparison of bedside transabdominal duplex ultrasound versus contrast venography for inferior vena cava ﬁ lter placement: What is the best imaging modality, Ann Vasc Surg. 2005. 19: 229–234.

50. Oppat WF, Chiou AC, Matsumura JS. Intravascular ultrasoundguided vena cava ﬁ lter placement, J Endovasc Surg. 1999. 6: 285–

287.

51. Garrett JV, Passman MA, Guzman RJ, Dattilo JB, Naslund TC. Expanding options for bedside placement of inferior vena cava ﬁ lters with intravascular ultrasound when transabdominal duplex ultrasound imaging is inadequate, Ann Vasc Surg. 2004. 18: 329–334.

52. Wellons ED, Matsuura JH, Shuler FW, Franklin JS, Rosenthal D. Bedside intravascular ultrasound-guided vena cava ﬁ lter placement, J Vasc Surg. 2003. 38: 455–457.

53. Holtzman RB, Lottenberg L, Bass T, Saridakis A, Bennett VJ, Carrillo EH. Comparison of carbon dioxide and iodinated contrast for cavography prior to inferior vena cava ﬁ lter placement, Am J Surg.

2003. 185: 364–368.

54. Brown DB, Pappas JA, Vedantham S, Pilgram TK, Olsen RV, Duncan JR. Gadolinium, carbon dioxide, and iodinated contrast material for planning inferior vena cava ﬁ lter placement: A prospective trial, J Vasc Interv Radiol. 2003. 14: 1017–1022.

55. Davison BD, Grassi CJ. TrapEase inferior vena cava ﬁ lter placed via the basilic arm vein: A new antecubital access, J Vasc Interv Radiol.

2002. 13: 107–109.

56. Ricco J, Dubreuil F, Renaud P et al. The LGM Vena-Tech caval ﬁ lter: Results of multicenter study, Ann Vasc Surg. 1995. 9(suppl): S89– S100.

57. Stone PA, AbuRahma AF, Hass SM, Hofeldt MJ, Zimmerman WB, Deel JT, Deluca JA. TrapEase inferior vena cava ﬁ lter placement: Use of subclavian vein, Vasc Endovasc Surg. 2004. 38: 505–509.

58. Greenﬁ eld LJ, Proctor MC. Supra-renal ﬁ lter placement, J Vasc Surg.

1998. 28: 432–438.

59. Matchett WJ, Jones MP, McFarland DR, Ferris EJ. Suprarenal vena caval ﬁ lter placement: Follow-up of four ﬁ lter types in 22 patients, J Vasc Interv Radiol. 1998. 9: 588–593.

60. David W, Gross WS, Colaiuta E, Gonda R, Osher D, Lanuti S. Pulmonary embolus after vena cava ﬁ lter placement, Am Surg. 1999. 65: 341–346.

61. Streiff MB. Vena caval ﬁ lters: A comprehensive review, Blood. 2000. 95: 3669–3677.

62. Hoffman MJ, Greenﬁ eld LJ. Central venous septic thrombosis managed by superior vena cava Greenﬁ eld ﬁ lter and venous thrombectomy: A case report, J Vasc Surg. 1986. 4: 606–611.

63. Pais SO, Orchis DF, Mirvis Se. Superior vena caval placement of Kimray-Greenﬁ eld ﬁ lter, Radiology. 1987. 165: 385–386.

64. Owen EWJ, Schoettle GPJ, Harrington OB. Placement of a Greenﬁ eld ﬁ lter in the superior vena cava, Ann Thorac Surg. 1992. 53: 896–

897.

65. Ascher E, Hinforani A, Tsemekhin A, Yorkovich W, Gunduz Y. Lessons learned from a 6-year clinical experience with superior vena cava Greenﬁ eld ﬁ lters, J Vasc Surg. 2000. 32: 881–887.

66. Lidagoster MI, Widman WE, Chevinski AH. Superior vena caval occlusion after ﬁ lter insertion, J Vasc Surg. 1994. 20: 158–159.

67. Greenﬁ eld LJ. Vena cava interruption: Devices and results. In: Bergan JJ, Yao JST, eds. Venous Disorders, 1991. Philadelphia, PA: WB Saunders Company.

68. Greenﬁ eld LJ, Michna BA. Twelve-year clinical experience with the Greenﬁ eld vena cava ﬁ lter, Surgery. 1988. 104: 706–712.

69. Gomez GA, Cutler BS, Wheeler HB. Transvenous interruption of the inferior vena cava, Surgery. 1983. 93: 612–619.

70. Chimochowski GE, Evans RH, Zarins CK et al. Greenﬁ eld ﬁ lter versus Mobin-Uddin umbrella: The continuing quest for the ideal method of vena caval interruption, J Thorac Cardiovasc Surg. 1980. 79: 358–365.

71. Greenﬁ eld LJ, Proctor MC. Twenty-year clinical experience with the Greenﬁ eld ﬁ lter, Cardiovasc Surg. 1995. 3: 199–205.

72. Greenﬁ eld LJ, Cho KJ, Proctor MC et al. Late results of suprarenal Greenﬁ eld vena cava ﬁ lter placement, Arch Surg. 1992. 127: 969–

973.

73. Greenﬁ eld LJ, Whitehill TA. New developments in caval interruption: Current indications and new techniques for ﬁ lter placement. In: Veith FJ, ed. Current Critical Problems in Vascular Surgery, Vol. 4, 113–121. 1992. St. Louis, MO:Quality Medical Publishing.

74. Greenﬁ eld LJ, Cho KH, Proctor M et al. Results of a multicenter study of the modiﬁ ed hook-titanium Greenﬁ eld ﬁ lter, J Vasc Surg. 1991. 14: 253–257.

75. Greenﬁ eld LJ, Proctor MC, Cho KH et al. Extended evaluation of the titanium Greenﬁ eld vena caval ﬁ lter, J Vasc Surg. 1994. 20: 458–

464.

76. Cho KJ, Greenﬁ eld LJ, Proctor MC et al. Evaluation of a new percutaneous stainless steel Greenﬁ eld ﬁ lter, J Vasc Interv Radiol. 1997. 8: 181–187.

77. Roehm JOF Jr, Gianturco C, Barth MH et al. Percutaneous transcatheter ﬁ lter for the inferior vena cava: A new device for treatment of patients with pulmonary embolism, Radiology. 1984. 150: 255–

257.

78. Roehm JOF Jr, Johnsrude IS, Barth MH et al. The bird’s nest inferior vena cava ﬁ lter: Progress report, Radiology. 1988. 168: 745–749.

79. McCowan TC, Ferris EJ, Keifsteck JE et al. Retrieval of dislodged bird’s nest inferior vena caval ﬁ lters, J Vasc Intervent Radiol. 1988. 3: 179–183.

80. Nicholson AA, Ettles DF, Paddon AJ, Dyet JF. Long-term follow-up of the bird’s nest IVC ﬁ lter, Clin Radiol. 1999. 54: 759–764.

81. Campbell JJ, Calcagno D. Aortic pseudoaneurysm from aortic penetration with a bird’s nest vena cava ﬁ lter, J Vasc Surg. 2003. 38: 596–599.

82. Lord RS, Benn I. Early and late results after bird’s nest ﬁ lter placement in the inferior vena cava: Clinical and duplex ultrasound follow up, Aust N Z J Surg. 1994. 64: 106–114.

83. Simm M, Athanasoulis Ca, Kim D et al. Simon nitinol inferior vena cava ﬁ lter: Initial clinical experience, Radiology. 1989. 172: 99–

103.

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84. Dorfman GS. Percutaneous inferior vena caval ﬁ lters, Radiology.

1990. 174: 987–992.

85. Poletti PA, Becker CD, Prina L et al. Long-term results of the Simon nitinol inferior vena cava ﬁ lter, Eur Radiol. 1998. 8: 289–294.

86. Wolfe F, Thurnher S, Lammer J. Simon nitinol vena cava ﬁ lters: Effectiveness and complications, Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr. 2001. 173: 924–930.

87. Ricco JB, Crochet D, Sebilotte P et al. Percutaneous transvenous caval interruption with the “LGM” ﬁ lter: Early results of a multicenter trial, Ann Vasc Surg. 1988. 3: 242–247.

88. Murphy TP, Dorfman GS, Yedlicka JW, McCowan TC, Vogelzang RL, Hunter DW et al. LGM vena cava ﬁ lter: Objective evaluation of early results, J Vasc Interv Radiol. 1991. 2: 107–115.

89. Millward SF, Marsh JI, Peterson RA et al. LGM (Vena Tech) vena cava ﬁ lter: Clinical experience in 64 patients, J Vasc Interv Radiol.

1991. 2: 429–433.

90. Crochet DP, Stora O, Ferry D et al. Vena Tech-LGM ﬁ lter: Long-term results of a prospective study, Radiology. 1993. 188: 857–860.

91. Crochet DP, Brunel P, Trogrlic S et al. Long-term follow-up of Vena Tech-LGM ﬁ lter: Predictors and frequency of caval occlusion, J Vasc Interv Radiol. 1999. 10: 137–142.

92. Kinney TB. Update on inferior vena cava ﬁ lters, J Vasc Interv Radiol.

2003. 14: 425–440.

93. Tay KH, Martin ML, Webb JG, Machan LS. Repeated Gunther Tulip inferior vena cava ﬁ lter repositioning to prolong implantation time, J Vasc Intervent Radiol. 2002. 13: 509–512.

94. Millward SF, Oliva VL, Bell SD et al. Gunther Tulip retrievable vena cava ﬁ lter: Results from the Registry of the Canadian Interventional Radiology Association, J Vasc Interv Radiol. 2001. 12: 1053–

1058.

95. Rousseau H, Perreault P, Otal P et al. The 6-F nitinol TrapEase inferior vena cava ﬁ lter: Results of a prospective multicenter trial, J Vasc Interv Radiol. 2001. 12: 299–304.

96. Schutzer R, Ascher E, Hingorani A et al. Preliminary results of the new 6F TrapEase inferior vena cava ﬁ lter, Ann Vasc Surg. 2003. 17: 103–106.

97. Porcellini M, Stassano P, Musumeci A, Bracale G. Intracardiac migration of nitinol TrapEase vena cava ﬁ lter and paradoxical embolism, Eur J Cardiothorac Surg. 2002. 22: 460–461.

98. Greenﬁ eld LJ, Proctor MC. The percutaneous Greenﬁ eld ﬁ lter: Outcomes and practice patterns, J Vasc Surg. 2000. 32: 888–893.

99. Neuerburg JM, Funther RW, Vorwerk D et al. Results of a multicenter study of the retrievable Tulip vena cava ﬁ lter: Early clinical experience, Cardiovasc Intervent Radiol. 1997. 20: 10–16.

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CHAPTER

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Complications of Vena Cava Filters

TERESA L. CARMAN, MOBEEN A. SHEIKH, and LINDA M. GRAHAM

BACKGROUND

Venous thromboembolism (VTE) is optimally treated by anticoagulation. When anticoagulation must be withheld, inferior vena cava interruption affords protection against major embolic events likely to be life threatening. Inferior vena cava (IVC) interruption historically has progressed from cava ligation to plication, caval clips, surgically inserted caval umbrellas and ﬁ lters, and ﬁ nally to percutaneously inserted ﬁ lters. Complications associated with the historic methods of caval interruption and devices have driven, and will continue to encourage, the modiﬁ cation and design of devices that have limited endothelial cell interactions, require smaller deployment tools, and use imaging friendly materials with reduced thrombogenicity.

Currently available devices include permanent ﬁ lters that once deployed remain in place indeﬁ nitely and optionally retrievable ﬁ lters that may be left in place permanently or may be removed within a speciﬁ ed time frame (weeks to months depending on the device). Retrievable ﬁ lters are similar in appearance and design to permanent ﬁ lters, but have modiﬁ cations to the caval attachment sites and/or hooks at one end to facilitate their removal. They have been designed to take advantage of the effectiveness of a permanent ﬁ lter and yet minimize the complications of a long-term indwelling vascular device. The underlying premise for retrievable ﬁ lters is based on the concept that absolute contraindications to systemic anticoagulation may be short-lived and the longterm outcomes of IVC ﬁ lters may not necessarily be as benign as previously considered. This is particularly true for young patients who may require an IVC ﬁ lter, thus exposing them to a lifetime of risk of developing a ﬁ lter-related complication and the risk associated with anticoagulation (if feasible) to prevent ﬁ lter thrombosis. The decision regarding

the use of a permanent or optionally retrievable ﬁ lter must be made individually for each patient.

Current accepted indications for IVC ﬁ lter use include contraindications to anticoagulation (active bleeding or recent hemorrhage), complications of anticoagulation, or thromboembolism (pulmonary embolism or recurrent/propagation of deep venous thrombosis [DVT]) despite adequate anticoagulation. expanded to include relative indications including individuals with extensive pulmonary embolism (PE) or venous thrombosis such as free-ﬂ oating thrombus, patients undergoing venous thrombolysis, patients with signiﬁ cant underlying cardiopulmonary disease in whom pulmonary embolism may pose a signiﬁ cant threat to survival, and patients undergoing pulmonary thromboendarterectomy. In some centers IVC ﬁ lters are used for primary prophylaxis against pulmonary embolism for patients who have sustained major trauma and cannot receive recommended pharmacologic or mechanical regimens for prophylaxis, or as adjuvant prophylaxis in patients undergoing high-risk procedures with an increased risk for venous thromboembolism.2 With these indications in mind it is important to recognize that an IVC ﬁ lter does not treat venous thromboembolism but rather protects that patient from the most serious adverse event, massive, fatal pulmonary embolism. Most physicians would agree that anticoagulation should be commenced despite the presence of a ﬁ lter when deemed safe. However, there are no recommendations regarding the duration of anticoagulation in this setting.

Filter placement for VTE treatment as well as prophylaxis has increased. In a recent population based study of IVC ﬁ lter use in California, 9665 IVC ﬁ lters were placed over a four-year period, from 1991 to 1995. During this period there was a 40% increase in the number of ICV ﬁ lters

These accepted indications are frequently

The Vein Book

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placed, from 1446 in 1991 to 2447 in 1995. Overall, 6.6% (4044/61,188) of patients admitted with a principal diagnosis of VTE received an IVC ﬁ lter. Sixty percent (5621/9665) of the ﬁ lters in this study were deployed in patients lacking a primary diagnosis of VTE (i.e., used for primary or secondary VTE prophylaxis).3 Stein et al. analyzed the National Hospital Discharge Survey (NHDS) database for information on IVC ﬁ lter use over a 21-year period. The number of IVC ﬁ lters inserted increased from 2000 in 1979 to 49,000 in 1999. In 1999, 45% of ﬁ lters were placed in patients with DVT, 36% in patients with PE, and 19% of IVC ﬁ lters were placed in patients without a coded diagnosis for VTE.4 Registries of patients treated for VTE have demonstrated IVC ﬁ lter insertion rates of 2% in Spain compared to 14% in a U.S. study.

5,6

In the U.S. study, 33% of IVC ﬁ lters were inserted for primary treatment for DVT and 17% were placed for indications other than the three currently accepted indications for IVC ﬁ lter use.6 The robust use of IVC ﬁ lters for prophylaxis and for relative indications is interesting in view of the lack of comparative data or prospective, randomized trials regarding IVC ﬁ lter use. Indeed most of the literature on the use and complications of IVC ﬁ lters is derived from case series, retrospective studies, or prospective trials enrolling fewer than 100 patients.

Several comprehensive reviews of IVC ﬁ lters and ﬁ lter complications have been published detailing the design, deployment, and complications of both the permanent and optionally retrievable ﬁ lters.

8–11

The use and complications of the stainless steel Greenﬁ eld ﬁ lter and its modiﬁ ed designs have been studied more thoroughly than other ﬁ lters. Considerably less literature is published regarding the most recently approved permanent ﬁ lter, the TrapEase, or the optionally retrievable ﬁ lters, the Günther-Tulip, OptEase, and Recovery ﬁ lters. One can only assume that these ﬁ lters will have the same success and complication rates as the devices that have a longer history of use. Certainly IVC ﬁ lters appear to prevent major pulmonary embolism in patients with DVT; however, complications related to IVC ﬁ lter use are not negligible. Complications may include venous thrombotic events, deployment and positioning issues, insertion site complications, and migration after placement. Table 47.1 lists complications documented with permanent or optionally retrievable IVC ﬁ lters. There are no large case series or comparable studies examining the true rates of complications by ﬁ lter type. It is also important to note that there is usually no radiologic follow-up after ﬁ lter placement and many complications, such as minor degrees of ﬁ lter migration, limited penetration through the caval wall, or even minor compromise of the structural integrity of the ﬁ lter, may be clinically silent. Currently, there are no guidelines for identifying patients who should undergo radiographic follow-up post vena caval ﬁ lter placement. Major complications related to IVC ﬁ lters, such as migration or signiﬁ cant caval perforation, are relatively rare. Life-

TABLE 47.1 Complications Related to Inferior Vena

Cava Filters

Venous thromboembolism Recurrent deep venous thrombosis Thrombus propagation Recurrent pulmonary embolism Insertion site thrombosis Insertion site complications Insertion site thrombosis Hematoma/hemorrhage Infection Deployment complications Tilting Malposition in the incorrect vein/vessel Failure to fully deploy Device complications Strut fracture Guidewire entrapment Migration (proximally or distally) Extrusion through the vena cava to adjacent structures Retrieval complications Failure to retrieve Device fracture Retained struts/hooks

threatening complications are uncommon. Four (0.16%) ﬁ lter-related deaths were noted in one review.12 The most common complications are thrombosis including recurrent DVT, PE, IVC, or ﬁ lter thrombosis and insertion site thrombosis. For this reason, when a short-term contraindication to anticoagulation has resolved, some practitioners advocate long-term anticoagulation in patients with vena caval ﬁ lters.

Although retrospective studies examining the use of anticoagulation following IVC ﬁ lter placement have not demonstrated decreased incidence of recurrent DVT,13 recurrent venous thromboembolism is clearly the most common complication of IVC ﬁ lters. Because of this, anticoagulation should be initiated when possible even after an IVC ﬁ lter has been placed. Guidelines have been published regarding current anticoagulation recommendations. It is unclear at this time whether the presence of an IVC ﬁ lter should extend the duration of anticoagulation for a particular clinical situ-

For now, the duration of anticoagulation must be

ation. individualized for each patient.

THROMBOTIC COMPLICATIONS

Unfortunately, thrombotic complications after IVC ﬁ lter placement have not been studied thoroughly. The only prospective, randomized trial of IVC ﬁ lter outcomes was performed by the PREPIC study group. Four hundred patients with proximal DVT at risk for PE were randomized to receive an IVC ﬁ lter followed by anticoagulation or to

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TABLE 47.2 Two-Year and Eight-Year Results of the PREPIC

Trial of IVC Filter Use to Prevent Pulmonary Embolism

Recurrent DVTa Symptomatic PE

2 Years 8 Years 2 Years 8 Years Filter 20.8% 35.7% 3.4% 6.2% No Filter 11.6% 27.5% 6.3% 15.1% P 0.02 0.16 0.042 0.008

DVT = deep venous thrombosis; bPE = pulmonary embolism.

15,16

anticoagulation alone (either unfractionated heparin or lowmolecular weight heparin followed by vitamin K antagonists). Two reports addressing recurrent DVT, pulmonary embolism, IVC thrombosis, and post-thrombotic changes were published.

15,16

There was no signiﬁ cant difference in the duration of anticoagulation between the two groups.16 At both two and eight years of follow-up there was a signiﬁ cantly increased risk of recurrent DVT in patients with an IVC ﬁ lter compared to patients without ﬁ lters (see Table

47.2). At two years there was no difference in the rate of symptomatic pulmonary embolism between the groups; however, by eight years of follow-up there was a 63% decrease in the risk of recurrent PE in patients receiving an IVC ﬁ lter compared to patients without (see Table

15,16

47.2).

Deep Venous Thrombosis

Recurrent deep venous thrombosis after IVC ﬁ lter placement may include propagation of an existing thrombus into additional venous segments, involvement of a new venous segment including the contralateral limb, or insertion site thrombosis. A comprehensive review of IVC ﬁ lters by Streiff in 2000 compiled the reported complications from available ﬁ lters including the stainless steel Greenﬁ eld (SSG), titanium Greenﬁ eld (TG), Bird’s Nest (BN), Simon Nitinol (SN), and VenaTech (VT).9 Most included studies were either retrospective reviews or prospective follow-up performed by chart review, questionnaires, or clinic visits as opposed to serial radiographic surveillance. In Streiff’s review the SSG and the BN ﬁ lters had the lowest rates of recurrent deep venous thrombosis, 5.9% and 6%, respectively.9 The highest rates of DVT have been seen with the TG (22.7%), the VT (32%), and the TrapEase (45.7%). However, these results were generated from small studies with very few enrolled patients.

Since there are no prospective comparative studies of IVC ﬁ lters, it is difﬁ cult to determine whether the risk of recurrent venous thrombosis relates to the presence of a ﬁ lter or if speciﬁ c design issues are related to thrombogenesis. The PREPIC trial, which used the VenaTech and the Titanium Greenﬁ eld ﬁ lters in 56% and 26.5% of patients, respectively, documented increased risk of recurrent symp-

9,10

tomatic DVT in patients with ﬁ lters compared to patients

without a ﬁ lter.

Although is unlikely that comparative studies of speciﬁ c devices will be performed, further study of ﬁ lter design and thrombosis may help clarify factors contributing to thrombosis.

Deep venous thrombosis at the insertion site has been documented following IVC ﬁ lter placement. With routine surveillance, insertion site thrombosis has been identiﬁ ed in 14 to 64% of patients. Since IVC ﬁ lters may be inserted by femoral, jugular, or brachial routes, insertion site thrombosis may occur in an unprotected venous bed.9 The newer lowproﬁ le delivery systems being developed may decrease the risk for insertion site thrombosis. To document the actual frequency of this complication, however, studies will need to incorporate routine surveillance of the insertion site into protocols.

Post-Thrombotic Syndrome

After a DVT, clinical symptoms of the post-thrombotic syndrome increase over time. At eight years follow-up, postthrombotic symptoms are observed in approximately 70% of patients with or without IVC ﬁ lter placement.15 Given the high rate of post-thrombotic complications in patients with VTE, recurrent symptoms of discomfort, erythema, edema, and increased warmth are not uncommon. If recurrent deep venous thrombosis is suspected, patients should undergo further evaluation. Imaging with venous duplex ultrasound or venogram may be used to determine whether the patient has had proximal or distal propagation of existing thrombus or recurrent DVT in a new venous segment. In some cases determining the age or chronicity of the thrombus is difﬁ cult. In this setting D-dimer measurement may assist in making this determination. Compression stockings are recommended following a DVT with or without IVC ﬁ lter placement to decrease the risk of post-thrombotic syndrome symptoms.

Pulmonary Embolism

IVC ﬁ lter placement is one method of managing DVT and preventing PE in patients unable to be anticoagulated. However, despite IVC interruption, pulmonary embolism may occur. The origin of pulmonary emboli in this setting includes propagation of thrombus proximal to the IVC ﬁ lter (see Figure 47.1), small emboli that pass through the ﬁ lter, emboli from unprotected venous beds including the upper extremity, or embolism through developed pelvic or abdominal veins or collaterals such as the azygous or ovarian vein. Cumulative rates of recurrent symptomatic PE in the PREPIC trial were 1.1%, 3.4%, and 6.2% at 12 days, two years, and eight years follow-up, respectively. Two patients (1%) suffered fatal PE. and Kinney, 40 studies of the SSG ﬁ lter demonstrated a

15,16

From the reviews by Streiff

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FIGURE 47.1 Thrombus both within and above a ﬁ lter (inset) demon-

strated by venogram in a patient who developed massive pulmonary embolism despite the presence of an infrarenal Recovery ﬁ lter. A suprarenal Günther-Tulip ﬁ lter was placed to protect against further embolism until anticoagulation could be initiated.

composite rate of pulmonary embolism of 2.6%, with a range between 0 to 9%.

9,10

The composite rates for the other available ﬁ lters were TG 3.1% (range 0–3.8%), BN 2.9% (range 0–4.2%), SN 3.8% (range 0–5.3%), and VT 3.4% (range 0–8%). The rates of fatal pulmonary embolism were between

0.3% in the VT series up to 1.9% for the SN ﬁ lter.

9,10

Athanasoulis et al. documented a fatal PE rate of 3.7% following ﬁ lter insertion in a 26-year review of their IVC ﬁ lter experience.17 No recurrent PE was documented in the single trial using the TrapEase ﬁ lter.18 The rates reported for recurrent symptomatic pulmonary embolism and fatal pulmonary embolism are not negligible. Studies have not addressed clinical conditions likely to predispose to this complication.

In a patient with suspected pulmonary embolism, PE protocol chest computed tomography (CT), pulmonary angiography, or ventilation/perfusion nuclear medicine lung scanning should be performed. If the diagnosis is conﬁ rmed, the source of the event should also be identiﬁ ed. IVC ﬁ lter thrombosis can be investigated using contrast enhanced abdominal CT with venous phase imaging or contrast vena cavography. Duplex ultrasound of unprotected venous beds should also be performed to evaluate other potential sources of embolism.

FIGURE 47.2 Chronic IVC and ﬁ lter thrombosis demonstrated below a

TrapEase ﬁ lter. Collateral venous drainage is noted.

Inferior Vena Cava Thrombosis or Occlusion

IVC thrombosis may result from innate thrombogenicity of the ﬁ lter, trapped emboli within the ﬁ lter, or propagation of thrombus through the venous system up to and including the ﬁ lter (see Figure 47.2). The PREPIC trial documented symptomatic IVC thrombosis in 13% of patients after eight years of follow-up.16 Other reports have documented IVC ﬁ lter thrombosis rates from 0 to 31%. Once again the SSG and BN ﬁ lters have documented the lowest rates of IVC thrombosis, 3.6% and 3.9%, respectively. The highest rates of IVC thrombosis occurred with the VT ﬁ lter, 11.2%.9 In initial studies, the TrapEase ﬁ lter had a documented IVC ﬁ lter thrombosis rate at six months of 3.1%.

Studies of optionally retrievable ﬁ lters have documented IVC thrombosis in 0 to 9.6% of patients with the GüntherTulip ﬁ lters.

11,19

In addition, thrombus trapped within the ﬁ lter at attempted retrieval has been documented in 10% of Günther-Tulip and 22% of Recovery ﬁ lters, suggesting the ﬁ lters may have performed well in preventing pulmonary emboli,11 but this could lead to eventual caval thrombosis if the ﬁ lter is not removed. Longer follow-up is required to determine if the rates of IVC thrombosis in optionally

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INSERTION SITE COMPLICATIONS

Insertion site complications after ﬁ lter placement have perhaps the most varied manifestations. These complications occur in 4 to 11% of all ﬁ lter insertions.10 Some are site dependent, and others may be directly related to the device delivery system. Insertion site complications range from minor bleeding to major complications that may be the source of signiﬁ cant morbidity and, in fact, mortality. Death related to IVC ﬁ lter insertion has been reported to occur in

0.12%.

Most of the complications are similar to other procedures in which central venous access is obtained; bleeding (major or minor), arteriovenous ﬁ stula, infections, vessel damage/ rupture, and access site thrombosis. Some of the vascular complications at the access site are considered to be directly related to the proﬁ le of the delivery system. This has been a major reason for the development of the newer ﬁ lter types, such as the TrapEase, with a lower proﬁ le delivery system, which limits the size of the venipuncture and potentially decreases these complications. The internal jugular vein is often a preferred site of access but, due to its anatomic proximity to vital structures, complications related to access at this site may have devastating consequences. Stroke caused by inadvertent carotid puncture, pneumothorax, vocal cord paralysis caused by damage to the recurrent laryngeal nerve, arrhythmia, and air embolism all have been documented.

FIGURE 47.3 Bilateral iliac vein stents in a patient with chronic venous

occlusion following Bird’s Nest and Greenﬁ eld ﬁ lter placement.

retrievable ﬁ lters will remain constant or increase over time.

When IVC thrombosis is identiﬁ ed, or if the source of the pulmonary embolism is suspected or documented to be due to thrombosis proximal to the ﬁ lter, management must be individualized. One option is placement of a more proximal vena caval ﬁ lter, typically suprarenal placement (see Figures 47.1 and 47.3). The major concern in this setting is the continued propagation of the thrombus with the potential for involvement of the renal veins. In the hands of a skilled interventionalist, ﬁ lter thrombosis can be managed by endovascular techniques (see Figure 47.3). Mechanical and pharmacologic thrombolysis may be used to restore patency of the IVC ﬁ lter.

20–22

Other endovascular techniques including balloon maceration of the thrombus or stent placement to collapse the ﬁ lter and exclude it from the IVC have been reported.

20,23

DEPLOYMENT COMPLICATIONS

Complications that may occur at the time of ﬁ lter placement are largely dependent upon the equipment used to deploy the ﬁ lter as well as the ﬁ lter type. These complications may be generalized into tilting or malposition, incorrect anatomical placement, or failure of the device to fully deploy at its intended site. The incorrect deployment of a ﬁ lter has many clinical implications and possible secondary complications. An incorrectly deployed ﬁ lter may not achieve the desired effect of protection from pulmonary embolism and yet exposes the patient to all the complications of the procedure, the potential for migration, as well as subsequent complications of thrombosis as previously discussed. In addition, the patient and the physician may derive a false sense of security knowing a ﬁ lter has been placed despite the suboptimal deployment.

Malpositioning

Filter malpositioning or tilting is a complication of vena caval ﬁ lter insertion that theoretically may result in inadequate protection from pulmonary embolism. For permanent ﬁ lters, this traditionally is managed with either observation

440 Chapter 47/Complications of Vena Cava Filters

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or additional ﬁ lter placement, typically in the suprarenal position. In a single-center study of 486 patients undergoing duplex ultrasound-guided (n = 435) or intravascular ultrasound (IVUS)-guided (n = 51) IVC ﬁ lter insertion by Corriere et al., 12 patients (2.4%) had inadequate positioning as determined by postoperative radiography.24 Two of these patients had no further ﬁ lter manipulation, three had a second ﬁ lter placed under ﬂ uoroscopic guidance, and ﬁ ve patients had ﬁ lters retrieved and repositioned under ﬂ uoroscopic guidance. All ﬁ ve patients undergoing retrieval and repositioning in this series had Greenﬁ eld ﬁ lters, which are not traditionally regarded as retrievable. This manipulation was possible with advanced endovascular techniques.24 In another long-term study of Greenﬁ eld ﬁ lters followed by abdominal radiography, Messmer et al. reported ﬁ ve patients (7%) in whom the ﬁ lter was at an angle of more than 16 degrees from the vertical.25 A change in ﬁ lter angle may result from displacement of a strut into the right renal vein as well as from physiologic changes.25 Retrievable ﬁ lters typically are manipulated at the time of insertion to achieve minimal tilting. In the review by Stein et al., 12% of Günther-Tulip ﬁ lters were tilted. In one small study of Recovery ﬁ lters, 6% demonstrated tilting.

The effect of IVC ﬁ lter tilt and asymmetry on ﬁ lter function is considered controversial. The clinical concerns include reduced protection from emboli due to a larger space between the struts allowing transit of thrombi as well as a potential for increased thrombogenicity due to ﬂ ow disturbances from the asymmetric ﬁ lter struts along the vessel wall. A study conducted by Katsamouris et al. demonstrated when centered, the original Greenﬁ eld IVC ﬁ lter allowed passage of small clots, and eccentric positioning (deﬁ ned as >14º) allowed small and large clots to pass through.26 Another study by Greenﬁ eld and Proctor showed that alignment only assumed importance when the IVC is larger than 22 mm.27 A clinical study evaluated recurrent PE and caval thrombosis in patients with titanium Greenﬁ eld IVC ﬁ lters and a subgroup that had ﬁ lter asymmetry, deﬁ ned by strut pattern in the cava. Out of a total of 738 ﬁ lters, asymmetry was found in 42 cases (5%). A total of three of 35 patients (8.6%) with asymmetric ﬁ lters had recurrent PE compared to 11 episodes of recurrent PE (3.3%) among 338 patients with symmetric IVC ﬁ lters.

The difference was not statisti-

cally signiﬁ cant.

Although it is difﬁ cult to know exactly how tilting or malpositioning affects the functioning of a given device in view of the lack of routine clinical follow-up; device modiﬁ cations have been used to reduce this complication. The currently available Greenﬁ eld ﬁ lters use a guidewire deployment system designed to promote mid-line deployment. The TrapEase and OptEase devices have adopted a symmetric ﬁ lter design to optimize vertical deployment. Modiﬁ cations such as a dual level ﬁ lter design have also been used to provide more efﬁ cient thrombus trapping.

Inadvertent Deployment in an

Incorrect Vessel

There are reports in the literature documenting ﬁ lter deployment in the incorrect vessel or location. In some cases this may be due to anomalous venous anatomy, emphasizing the importance of vena caval imaging prior to ﬁ lter deployment. Imaging has historically been performed by venography/cavography using iodinated contrast, gadolinium, or occasionally carbon dioxide. More recent reports have focused on using duplex ultrasound or IVUS, which may allow for bedside insertion in patients who are critically ill or if transportation is difﬁ cult due to extensive spine or orthopedic injuries. Vena cava anomalies such as megacava (>30 mm), small caliber cava, congenital absence of the vena cava, double cava, left-sided vena cava, or thrombus within the cava may be documented. Renal vein abnormalities such as circumaortic veins, retroaortic veins, multiple renal veins, or congenital absence of the kidneys may also be documented. In one study, anatomical variation or IVC thrombosis was documented in 9.6% of patients prior to deployment that warranted an adjustment in the deployment strategy in 4% of patients.

The usual site of ﬁ lter deployment is the infrarenal IVC. There are clinical situations that may warrant the placement of the ﬁ lter in locations other than the infrarenal inferior vena cava. Suprarenal IVC and superior vena cava (SVC) deployments are discussed elsewhere in the chapter. There are other untraditional locations of ﬁ lter placement such as the iliac vein in patients with a mega cava >40 mm. This of course does not constitute an inadvertent misplacement. However, misplaced ﬁ lter deployment has been documented in the right atrium,17 the innominate vein,29 above the renal veins, juxtaposed to the renal veins, or partially within a renal vein,17 and in the iliac vein.30 Although a misplaced ﬁ lter is an unusual complication and in most cases is tolerated without clinical effect, serious consequences may occur in some settings and the utmost care should be used to avoid inadvertent deployments.

Failure to Deploy

The failure of vena caval ﬁ lters to deploy fully is discussed frequently, but rarely documented in the literature (see Figure 47.4). Although this complication may manifest as ﬁ lter migration or even embolization, most cases are well tolerated without clinical consequence. Partial deployment usually has been attributed to a malfunction of the ﬁ lter itself that occurs on a case-by-case basis and is not necessarily design speciﬁ c. In one study of VenaTech ﬁ lters, major complications of placement occurred in three patients, all when the right internal jugular vein was used for introduction. One ﬁ lter was inadvertently placed in the right renal vein and two of the ﬁ lters failed to open fully.

Deployment

Migration 441

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unibody style, are less likely to have fracture complications. Although retained ﬁ lter struts or hooks (depending upon ﬁ lter design) are theoretical complications of optionally retrievable ﬁ lters, there are no reports of clinical series that address these complications.

Guidewire entrapment is another device-related complication that may occur at the time of ﬁ lter placement or when a wire is passed through the ﬁ lter for central access. In one in vitro study, the TrapEase ﬁ lter entrapped 3.0-mm and

1.5-mm J-tipped guidewires, whereas the VenaTech LP (low proﬁ le) and Günther Tulip ﬁ lters did not.32 Another study described entrapment of both the 1.5-J and 3-J guidewires by the stainless steel Greenﬁ eld and VenaTech LGM devices.33 The 1.5-J guidewire became entrapped regardless of engagement pattern, whereas the 3-J became entrapped only when engaged in the hole in the apex of the SSG and VT ﬁ lters. In a series of SVC ﬁ lters, 56% of patients had subsequent central access without complications.34 In another series one ﬁ lter was dislodged during central line placement and repositioned into the innominate vein.29 Displacement into an iliac vein should be an uncommon complication. This complication may be avoidable if ﬂ uoroscopy is used during central access in patients with residing ﬁ lters. Retrieval of an entrapped guidewire can be a technically challenging proposition. There have been isolated reports in

FIGURE 47.4 Partial deployment of this Greenﬁ eld ﬁ lter was docu-

mented by abdominal radiograph.

the literature of using a snare and other such endovascular devices for percutaneous retrieval.

complications with the Greenﬁ eld ﬁ lter and modiﬁ ed designs have been documented in another series.17 The TrapEase ﬁ lter has not demonstrated failure to deploy; however, ﬁ lter shortening and maldeployment has been documented.18 In many cases the failure to open fully can be addressed at the time of ﬁ lter placement. There are rare reports of endovascular manipulation of under or partially deployed ﬁ lters.

DEVICE COMPLICATIONS

Impetuses for the development of different delivery systems and different ﬁ lter designs are complications that are device and equipment speciﬁ c. Strut fracture due to compromise of the structural integrity of the ﬁ lter is one concern. It is a rare complication; however, strut fracture has been documented for most ﬁ lter designs.17 To date there are no large comparative case series among ﬁ lter types speciﬁ cally addressing this issue. Usually the identiﬁ cation of a strut fracture is a serendipitous discovery during radiological imaging performed for entirely different clinical indications. Clinical issues may arise when a fractured strut is extruded through the IVC into adjacent structures. The most vulnerable points for fracture are welded seams. To this extent ﬁ lters such as the TrapEase, which are laser cut in a

MIGRATION

Filters are long-term intravascular devices that are subject to a number of external forces that may change their position as well as dimensions over time.35 These changes can result clinically in ﬁ lter migration or penetration/extrusion through the vessel wall. Case series have documented migration in all ﬁ lter types.8 The VenaTech ﬁ lter appears to be most affected by this complication; up to 18% migrated in one study.8 Migration may be either cephalad and caudal; typically movement >20 mm is considered clinically signiﬁ cant. In a long-term study of 69 patients with a Greenﬁ eld IVC ﬁ lter in place for one to nine years evaluated with supine abdominal radiographs, the ﬁ lter span diameter had increased by 3 to 11 mm in 22 (32%) patients, and had decreased by 3 to 18 mm in six patients (9%). Twenty patients (29%) had caudal migration of 3 to 18 mm, and four (6%) had cephalad migration.

In some cases migration to clinically signiﬁ cant structures such as the intrahepatic IVC (see Figure 47.5) or the right atrium may occur.17 A number of case reports describe serious complications of cephalad embolization to the heart, including pericardial tamponade and intracardiac migration with life-threatening arrhythmias. ﬁ lters has been attempted using endovascular techniques.

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