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Venous Thromboembolism after Retrieval of Inferior Vena Cava Filters
Venous Thromboembolism after Retrieval of Inferior Vena Cava Filters Kivilcim Yavuz, MD1, Serdar Geyik, MD1, Hanno Hoppe, MD, Kenneth J. Kolbeck, MD, PhD, and John A. Kaufman, MD
PURPOSE: To determine the incidence of venous thromboembolism (VTE) after removal of retrievable inferior vena cava (IVC) filters. MATERIALS AND METHODS: Retrospective study was conducted of 67 patients who underwent 72 consecutive filter retrievals at a single institution. Data collected included VTE status at the time of filter placement, anticoagulant medications at the time of filter retrieval and afterward, new or recurrent VTE after filter removal, and insertion of subsequent filters. Patient questionnaires were completed in 50 cases, chart review in all patients. RESULTS: At the time of filter placement, 30 patients had documented VTE, 19 had a history of treated VTE, and 23 were at risk for but had neither previous nor present VTE. Mean duration of follow-up after filter removal was 20.6 months ⴞ 10.9. A total of 52 patients (57 filters) received anticoagulation and/or antiplatelet medications after filter removal. There were two documented episodes of recurrent deep vein thrombosis (2.8% of filters removed), both in patients who had VTE at the time of filter placement and underwent therapeutic anticoagulation at the time of filter removal. One of these patients (1.4% of filters removed) also experienced pulmonary embolism. Of the 23 patients without VTE when the filter was placed, none developed VTE after filter removal. Four patients (5.5% of filters removed) required subsequent permanent filters, three for complications of anticoagulation, one for failure of anticoagulation. CONCLUSIONS: VTE was rare after removal of IVC filters, but was most likely to occur in patients who had VTE at the time of filter placement J Vasc Interv Radiol 2008; 19:504 –508 Abbreviations:
DVT ⫽ deep vein thrombosis, IVC ⫽ inferior vena cava, PE ⫽ pulmonary embolism, VTE ⫽ venous thromboembolism
A variety of complications have been ascribed to permanent inferior vena cava (IVC) filters, including an increased risk of subsequent deep vein thrombosis (DVT) (1– 4). Currently available retrievable filters can provide short-term protection from pulmonary
From the Dotter Interventional Institute, Oregon Health & Science University, Mail Code L-605, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239. Received June 8, 2007; final revision received November 2, 2007; accepted November 14, 2007. Address correspondence to J.A.K; E-mail: kaufmajo@ ohsu.edu
embolism (PE) and then be removed when the patient is no longer at risk of PE (5). Theoretically, removal of retrievable filters from properly selected and treated patients should be associated with a low incidence of filter-related complications, such as subsequent DVT (6). The majority of published reports on retrievable vena cava filters have focused on the retrieval procedure rather than subsequent outcomes (7–10). The purpose of this retrospective study was to evaluate the incidence of new or recurrent venous thromboembolism (VTE; defined as DVT and/or PE) after removal of IVC filters.
1
Current address: Department of Radiology, Hacettepe University Hospital, Ankara, Turkey. J.A.C. has consulted for Bard and has received research support from Cook and Bard. © SIR, 2008 DOI: 10.1016/j.jvir.2007.11.016
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MATERIALS AND METHODS Study Design This retrospective study was conducted at a single center and approved
by the hospital institutional review board. Data collection included a patient questionnaire and chart review. The subset of all filter recipients who had undergone insertion and retrieval of optional (ie, retrievable) IVC filters was identified from the hospital clinical and radiology database. The indications for placement and retrieval of filters, results of IVC imaging performed during placement and at the time of retrieval, procedural complications, filter types and durations of implantation, and imaging data including lower-extremity venous Doppler ultrasonography (US) and pulmonary computed tomographic angiography were recorded. Anticoagulant medications and dosages before and after retrieval were noted. As part of routine clinical practice,
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patients who had retrievable filters placed with the intent to be retrieved were tracked for 6 months after filter placement. The patients, or their primary health care providers, were contacted on a monthly basis by telephone or email by the interventional radiology physician assistant to determine their current VTE status and management. After 6 months, the patient or provider was asked to contact the interventional radiology service should filter removal become feasible. Patients Between July 2001 and October 2004, insertion and retrieval of 72 IVC filters were performed in 67 patients. There were 39 female patients and 28 male patients with an age range of 12– 87 years (mean, 50.6 y ⫾ 16.2). Follow-up For this study, follow-up was obtained from interviews with patients and/or family members and hospital records for each filter placed and removed at the authors’ institution. This follow-up was conducted in addition to routine clinical practice. A standardized data collection form was used for the chart reviews, recording results of imaging studies, and patient interviews. Chart reviews were focused specifically on anticoagulant therapy or prophylaxis, reports and objective documentation of new or recurrent VTE, bleeding complications, and placement of additional IVC filters. A dedicated questionnaire was developed to be easily understood by patients and families (Appendix). The following data were collected during telephone interviews: use of anticoagulation medications after filter removal, objective and subjective evidence of new or recurrent DVT and/or PE, and insertion of subsequent filters after the removal of the first device. When patients had multiple filters placed, data were collected for each device placed and removed. Multiple attempts were made to complete the questionnaire, including contact with the patient by telephone (three attempts), email (three attempts), and regular mail (three attempts). Questionnaires were completed for a total of 50 patients. Of these, 40 were completed by patients
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Table 1 Indications for Retrieved Filters Indications
Filter 1
Filter 2
Absolute or relative contraindication to anticoagulation with documented VTE Complication of anticoagulant therapy, with documented VTE Prophylaxis without current VTE Major trauma, no previous VTE Previously resolved VTE, high-risk surgical procedure No previous VTE, high-risk surgical procedure Prophylaxis with VTE in addition to anticoagulation In association with another procedure (pharmacomechanical thrombectomy for VTE)
21
—
6
—
16 15 6 2 1
— 4 1 — —
via phone interviews, seven by family members via phone interviews, and three by patients via questionnaires returned by mail. Chart reviews and medical records alone were used for follow-up in 17 patients in whom the questionnaire could not be completed. The duration of follow-up was determined from the date of each filter removal to the date of completion of the questionnaire pertaining to that filter, or, when this was not feasible, the last entry in the patient’s medical record. Endpoints Study endpoints were a documented instance of VTE after filter removal, placement of a subsequent filter, or death. Definitions Data for this study were recorded according to the recommended reporting standards for vena cava filters (11).
RESULTS Indications for placement of filters are provided in Table 1. Risk factors for VTE are provided in Table 2. In all 30 filters placed in patients with a diagnosis of acute VTE, objective imaging documentation confirmed DVT, PE, or both. Among the total of 42 filters placed for prophylaxis, 19 filters were placed in 16 patients with histories of VTE (but no current VTE) undergoing major surgical procedures, and a total of 23 were placed in patients without a previous or current diagnosis of VTE (16 in patients with
Table 2 Risk Factors for VTE at the Time of Filter Placement (N ⴝ 72) Risk Factor History of DVT Immobilization Postoperative status Age ⱖ65 y Malignancy Cardiac disease Limb trauma Prothrombotic state Pregnancy/ postpartum status Obesity
No. of Filters* 17 41 3 11 5 1 19 5 1 1
* Many patients had multiple risk factors at the time of filter placement, so the total is greater than 72.
major trauma and seven in patients undergoing major surgical procedures with a high risk of postoperative VTE). Filter types used were Gu¨nther Tulip filters in 54 cases (Cook, Bloomington, Ind), Recovery filters in 14 cases (CR Bard, Tempe, Ariz), and OptEase filters in four cases (Cordis, Warren, NJ). Filter dwell times were 4 –34 days (mean, 13.5 d ⫾ 5.4) for Gu¨nther Tulip filters, 16 –167 days (mean, 72.4 d ⫾ 55.4) for Recovery filters, and 5–21 days (mean, 14.0 d ⫾ 6.7) for OptEase filters. While the filters were in place, there were no instances of symptomatic new or recurrent PE, DVT, or IVC occlusion. However, comprehensive imaging evaluation of asymptomatic patients was not performed. Filters were retrieved when the patients were thought to be at low risk of
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clinically significant PE as a result of anticoagulation status, abatement of risk factors for VTE, or both (6). Patients were selected for filter retrieval by the referring physician in consultation with an interventionalist. All patients with filters placed for prophylactic indications had negative findings on bilateral lower-extremity venous duplex US examinations before filter removal. IVC images obtained before retrieval of filters revealed patent IVCs in all cases. The final decision to retrieve the filter was made by the interventionalist at this time. Small amounts of trapped thrombus were seen within the filters in 13 patients, and the filters were thought to be safe for retrieval by the operator. None of these patients had a subsequent diagnosis of DVT or PE. Findings of all cavograms were normal after retrieval. The overall duration of follow-up after filter removal was 2–39 months (mean, 20.6 months ⫾ 10.9). The durations of follow-up according to filter type were 2–39 months (mean, 24.2 months ⫾ 9.9) for Gu¨nther Tulip filters, 2–13 months (mean, 7.9 months ⫾ 3.5) for Recovery filters, and 9 –22 months (mean, 16.5 months ⫾ 5.6) for OptEase filters. A total of 52 patients (57 filters) were undergoing treatment with some combination of anticoagulation/antiplatelet medications at the time of filter removal. Of these patients, 12 received only short-term low molecular weight heparin (enoxaparin sodium; Sanofi Aventis, Paris, France) for 5–56 days (mean, 19.2 d ⫾ 17.4). Seven patients received short-term enoxaparin therapy (ⱕ2 months) followed by lifelong warfarin therapy. Thirty-one patients were treated with warfarin alone after filter removal: 24 for life, seven on a short-term basis (mean, 9 months ⫾ 7.4; range, 3–24 months). One patient received warfarin for 6 months followed by clopidogrel and aspirin for 1 year, and one patient received clopidogrel and aspirin for 1 year after filter removal. The remainder of the patients (n ⫽ 15) did not receive any anticoagulant or antiplatelet therapy after filter removal. These were trauma patients without VTE or patients undergoing surgical procedures who were at high risk for VTE. Documented VTE after filter removal occurred in two patients (2.8%
of filters). The first patient had a filter placed for right leg DVT in the setting of severe pancreatitis and underwent filter retrieval at 22 days during full anticoagulation. During a second hospital admission 2 months later for complications of pancreatitis, the anticoagulant medication (therapeutic enoxaparin) was inadvertently omitted. Findings of bilateral lower-extremity US studies were negative for DVT at the time of admission. Symptomatic US-proven new bilateral lowerextremity DVT occurred within 1 week, followed by massive PE during resumption of anticoagulation with unfractionated heparin and warfarin. A permanent filter was placed during successful percutaneous treatment of the PE. The second patient with recurrent VTE had her first filter placed for symptomatic PE 5 days after initiation of anticoagulation for her second episode of acute DVT. The filter was retrieved 12 days later when the patient was receiving therapeutic anticoagulation. A diagnosis of factor V–Leiden deficiency was made and she was prescribed lifelong warfarin. Three years after filter retrieval she developed a new acute left leg DVT after a transAtlantic flight. At that time she was noted to have a supratherapeutic International Normalized Ratio of 7, so warfarin was stopped and enoxaparin initiated. She then developed symptomatic hemarthrosis of the left knee. The enoxaparin was discontinued and a second filter was placed. This filter was not removed even though the patient eventually resumed warfarin treatment. Two additional patients required permanent filters after removal of a retrievable filter, both for bleeding complications of anticoagulation. There were no cases of suspected IVC occlusion after filter removal.
DISCUSSION Anticoagulation is the standard therapy for VTE (12). When anticoagulation is contraindicated in patients who have or are at high risk of VTE, vena cava filter placement is accepted as a technique for interruption of the IVC to prevent life-threatening PE (13). However, permanent vena cava filter placement may be associated with an increased risk of DVT and other complications. Decousus et al
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(4,14), in a prospective randomized trial of patients with VTE comparing anticoagulation alone or anticoagulation plus a permanent IVC filter, demonstrated a significantly higher incidence of recurrent DVT in the patients with filters, which was sustained over a period of 8 years. Although the mechanism is unexplained, the belief that filters increase the risk of subsequent DVT is pervasive (15–17). These and other concerns about the longterm complications of vena cava filters have stimulated great interest in the use of retrievable vena cava filters (18). Despite limited data confirming the benefits of these devices, the use of retrievable vena cava filters is increasing (19,20). The literature on retrievable vena cava filters has to date focused on the safety and efficacy of the devices while implanted, and the retrieval procedure (5,21–31). Only a handful of studies have reported follow-up of patients after filter removal. Millward et al (8) reported long-term follow-up (mean, 103 days) of 37 patients after removal of Gu¨nther Tulip filters. Follow-up data were obtained from chart review, referring physician contact, and review of imaging, but rarely through direct patient contact. Data on anticoagulation after filter removal were not provided. One patient with a protein S deficiency had a recurrent DVT 230 days after filter retrieval. Asch et al (7) reported postretrieval clinical follow-up of an average of 223 days in 22 patients with Recovery filters. Clinical care visits were reviewed along with telephone interviews obtained in 20 patients, although the number of patients contacted and the format of data collection were not described. One patient with clinical symptoms suggestive of PE 133 days after filter removal had negative findings on chest CT. No other patients had clinical symptoms or imaging findings suggestive of recurrent or new VTE. Wicky et al (10) reported on 33 patients who underwent anticoagulation with heparin followed by warfarin for 6 months starting 2 hours after Gu¨nther Tulip filter retrieval. Although the details of follow-up were not described, one case of recurrent DVT occurred at 7 months in a patient with a pelvic malignancy. Meier et al (29) reported a 3% incidence (one of 32 patients) of early PE after removal of prophylactic filters in
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trauma patients. The PE occurred in a patient who did not undergo pharmacologic prophylaxis or screening duplex US of the lower extremity veins before filter removal. Follow-up for 12 weeks in the remainder of the patients revealed no additional new cases of VTE. In our study, the mean follow-up after filter removal was 20.58 months (625 days) ⫾ 10.92 for all patients. This is substantially longer than the follow-up durations previously reported in the literature. Extended follow-up is important in patients with VTE, as the incidence of recurrence has been shown to increase over time (32–36). Of the two cases of recurrent VTE in our study, one occurred 3 years after filter removal. Overall, the incidence of recurrent VTE after filter retrieval in our study was 2.8% (two of 72 filters removed). This manifested in one patient with DVT and another with DVT followed by PE. Both these patients had had acute VTE at the time of filter placement. One case of recurrence was arguably a result of physician error when anticoagulation was inadvertently stopped. The other occurred in a patient with a known hypercoagulable syndrome who was receiving lifelong anticoagulation therapy. Of note, at the time of filter removal, no trapped thrombus was seen in the filter of either patient. In the subset of patients with VTE at the time of filter placement, the incidence of recurrent DVT was 6.7% (two of 30 filters removed) and that of PE was 3.3% (one of 30 filters removed). In the study of Decousus et al (14), a randomized prospective study of patients with acute VTE treated with anticoagulation alone or anticoagulation plus a permanent filter, the incidences of recurrent DVT and PE at 2 years were 6.3% and 11.6%, respectively, in patients without filters; and 20.8% and 3.4%, respectively, in patients with filters. Although our study differs substantially from theirs, our rates of recurrent DVT and PE after filter removal in patients with VTE at the time of filter placement compare favorably. Specifically, this subset of patients had a low rate of recurrent DVT after filter removal, which was similar to patients without filters in the study of Decousus et al (14), and a low rate of recurrent PE, similar to
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patients with permanent filters in the study of Decousus et al (14). This suggests that short-term filtration in patients with VTE may protect from early recurrent PE without increasing the long-term risk of recurrent DVT. Patients with transient risk factors for VTE should be at low risk for subsequent or recurrent VTE after filter removal. In our study, 23 filters were placed in patients with no history of VTE and transient risk factors (trauma or high-risk surgery), and 19 filters were placed in patients with histories of VTE undergoing high-risk surgical procedures. None of these patients developed VTE after filter retrieval. Trauma to the access vein has been suggested as an etiology of DVT after filter placement (37). The two recurrent cases of VTE in our patients were thought to be unrelated to filter insertion site thrombosis. In both patients, filter placement was performed via the right femoral vein and retrieval was performed via the right internal jugular vein, but the recurrent DVT was bilateral in one patient and left-sided in the other patient. In the present study, four permanent filters were required after successful retrieval of 72 retrievable filters (5.5% of filters, 6.0% of patients). The indication for the permanent filters was hemorrhagic complication of anticoagulant therapy in the majority of these patients (three of 52 patients receiving anticoagulation; 5.8%). These results are congruent with those described by other investigators, as Millward et al (8) reported placement of permanent filters in 8% of patients for bleeding complications after removal of a retrievable filter. An adequate trial of anticoagulation before filter removal is important, but hemorrhagic complications can occur at any time during treatment with anticoagulation (38). This study has several limitations that are endemic to the filter literature. The data collection was retrospective and from a single institution, the number of patients and occurrences of adverse events is small, and a control group is lacking. Although we were able to report on direct follow-up with 75% of the patients, a substantial percentage for a retrospectively identified patient cohort, recurrent DVT or PE could have been missed in the remaining 25% who had chart follow-up
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only. Nevertheless, our follow-up after filter removal is more comprehensive and of greater duration than in previously reported series. Recurrent VTE was rare after removal of retrievable IVC filters in our study, but only occurred in the subset of patients undergoing treatment for VTE at the time of filter retrieval. Subsequent DVT or PE was not found in patients who had filters placed for prophylactic indications or who had a history of VTE and were free of VTE at the time of filter retrieval. Our results suggest that the risks of recurrent VTE are low after retrievable filter removal in patients who have been adequately treated for VTE or who are no longer at risk for VTE. Selective use of retrievable filters in this manner could reduce the incidence of long-term thrombotic complications of filter use. However, prospective controlled studies are urgently needed to determine the whether there is actual benefit to the use of removal of retrievable vena cava filters. References 1. Athanasoulis CA, Kaufman JA, Halpern EF, Waltman AC, Geller SC, Fan CM. Inferior vena cava filters: review of a 26-year single-center clinical experience. Radiology 2000; 216:54 – 66. 2. Streiff MB. Vena caval filters: a comprehensive review. Blood 2000; 95: 3669 –3677. 3. Kinney T. Update on inferior vena cava filters. J Vasc Interv Radiol 2003; 14:425– 440. 4. PREPIC Investigators. 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. 5. Stein PD, Alnas M, Skaf E, et al. Outcome and complications of retrievable inferior vena cava filters. Am J Cardiol 2004; 94:1090 –1093. 6. Kaufman J, Kinney T, Streiff M, 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 – 459. 7. Asch MR. Initial experience in humans with a new retrievable inferior vena cava filter. Radiology 2002; 225: 835– 844. 8. Millward SF, Oliva VL, Bell SD, et al. Gunther Tulip retrievable vena cava
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filter: results from the registry of the Canadian Interventional Radiology Association. J Vasc Interv Radiol 2001; 12:1053–1058. Oliva VL, Szatmari F, Giroux MF, 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; 16:1439 –1445. Wicky S, Doenz F, Meuwly J, Portier F, Schnyder P, Denys A. Clinical experience with retrievable Gunther Tulip vena cava filters. J Endovasc Ther 2003; 10:994 –1000. Greenfield L, Rutherford R. Recommended reporting standards for vena caval filter placement and patient followup. Vena Caval Filter Consensus Conference. J Vasc Interv Radiol 1999; 10:1013– 1019. Buller H, Agnelli G, Hull R, Hyers T, Prins M, Raskob G. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126(suppl):401S– 428S. Levy J, Duszak R, Akins E, et al. Inferior vena cava filter placement. American College of Radiology. ACR Appropriateness Criteria. Radiology 2000; 215(suppl):981–997. 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. Prevention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med 1998; 338:409 – 415. Stein P, Hull R, Raskob G. Withholding treatment in patients with acute pulmonary embolism who have a high risk of bleeding and negative serial noninvasive leg tests. Am J Med 2000; 109:301–306. Stein P, Kayali F, Olson R. Twentyone-year trends in the use of inferior vena cava filters. Arch Intern Med 2004; 164:1541–1545. Anderson RC, Bussey HI. Retrievable and permanent inferior vena cava fil-
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ters: selected considerations. Pharmacotherapy 2006; 26:1595–1600. Weichman K, Ansell JE. Inferior vena cava filters in venous thromboembolism. Prog Cardiovasc Dis 2006; 49:98 – 105. Morris C, Rogers F, Najarian K, Bhave A, Shackford S. Current trends in vena caval filtration with the introduction of a retrievable filter at a level I trauma center. J Trauma 2004; 57:32– 36. Grande WJ, Trerotola SO, Reilly PM, et al. Experience with the recovery filter as a retrievable inferior vena cava filter. 2005; 16:1189 –1193. Pieri S, Agresti P, Morucci M, de’ Medici L. Optional vena cava filters: preliminary experience with a new vena cava filter. Radiol Med (Torino) 2003; 105:56 – 62. Hoff W, Hoey B, Wainwright G, et al. Early experience with retrievable inferior vena cava filters in high-risk trauma patients. J Am Coll Surg 2004; 199: 869 – 874. Dentali F, Ageno W, Imberti D. Retrievable vena cava filters: clinical experience. Curr Opin Pulm Med 2006; 12:304 –309. Caronno R, Piffaretti G, Tozzi M, et al. Mid-term Experience with the ALN Retrievable Inferior Vena Cava Filter. Eur J Vasc Endovasc Surg 2006; 32: 596 –599. 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; 3:1370 –1375. Antevil JL, Sise MJ, Sack DI, et al. Retrievable vena cava filters for preventing pulmonary embolism in trauma patients: a cautionary tale. J Trauma 2006; 60:35– 40. Rosenthal D, Wellons ED, Lai KM, Bikk A, Henderson VJ. Retrievable inferior vena cava filters: initial clinical results. Ann Vasc Surg 2006; 20:157– 165. Binkert CA, Sasadeusz K, Stavropoulos SW. Retrievability of the recovery
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vena cava filter after dwell times longer than 180 days. J Vasc Interv Radiol. 2006; 17:299 –302. Meier C, Keller IS, Pfiffner R, Labler L, Trentz O, Pfammatter T. Early experience with the retrievable OptEase vena cava filter in high-risk trauma patients. Eur J Vasc Endovasc Surg 2006; 32:589 –592. Ray CE, Mitchell E, Zipser S, Kao EY, Brown CF, Moneta GL. Outcomes with retrievable inferior vena cava filters: a multicenter study. J Vasc Interv Radiol 2006; 17:1595–1604. Hoppe H, Nutting CW, Smouse HR, et al. Gunther Tulip filter retrievability multicenter study including CT followup: final report. J Vasc Interv Radiol 2006; 17:1017–1023. Martinelli I. Risk factors in venous thromboembolism. Thromb Haemost 2001; 86: 395– 403. Heit J. Risk factors for venous thromboembolism. Clin Chest Med 2003; 24: 1–12. Hansson P, Sorbo J, Eriksson H. Recurrent venous thromboembolism after deep vein thrombosis: incidence and risk factors. Arch Intern Med 2000; 160:769 –774. Anderson FA, Spencer FA. Risk factors for venous thromboembolism. Circulation 2003; 107:I-9 –I-16. van Dongen CJ, Vink R, Hutten BA, Buller HR, Prins MH. The incidence of recurrent venous thromboembolism after treatment with vitamin K antagonists in relation to time since first event: a meta-analysis. Arch Intern Med 2003; 163:1285–1293. Blebea J, Wilson R, Waybill P, et al. Deep venous thrombosis after percutaneous insertion of vena caval filters. J Vasc Surg 1999; 30:821– 828. Levine M, Raskob G, Beyth R, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126(suppl):287S–310S.
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APPENDIX: FOLLOW-UP QUESTIONNAIRE FOR PATIENTS WHO HAVE RECEIVED IVC FILTERS 1. Are you on or have you been on any anticoagulation (blood thinning) medication since your filter was removed? ❏ Yes ❏ No If yes: DRUG □ □ □ □ □
DOSE
START DATE
STOP DATE
Coumadin Heparin Enoxaparin Fondaparinux Other
2. Have you had a new blood clot to your lungs (pulmonary embolism) since the filter was taken out? ❏ Yes ❏ No If yes, what was the date: ____________________________ If yes, how did the doctor know that you had a blood clot in your lung? ❏ Symptoms ❏ CT angiography ❏ V/Q scan ❏ Pulmonary arteriography ❏ Subject does not know ❏ Other ______________________________________ 3. Have you had a blood clot in your leg/legs get bigger or developed a new blood clot in the vein in your leg/legs since the filter was removed? ❏ Yes ❏ No If yes, what was the date: ________________________________ If yes, was it in one leg or both legs? ❏ One leg ❏ Both legs If yes, how did the doctor learn about your blood clot? ❏ Symptoms ❏ Ultrasound ❏ CT scan ❏ MR scan ❏ Venogram ❏ Other _______________________________________________ Do you know where in your leg the blood clot was? ❏ IVC ❏ Pelvic vein ❏ Vein in your thigh ❏ Vein around your knee ❏ Vein below your knee ❏ Unknown 4. Have you had a second filter put in? ❏ Yes ❏ No If yes, what was the date? ____________________________________ What type of filter was it? ____________________________________
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Why did they put the second filter in? ❏ Unable to take anticoagulation (blood thinning) drug ❏ Complications related to anticoagulation (blood thinning) drug ❏ Bleeding ❏ Low blood counts (heparin-induced thrombocytopenia) ❏ Other ________________________ ❏ Recurrent blood clot to the lungs ❏ Worsening of blood clot in leg/legs ❏ Prior to surgery ❏ New blood clot in leg/legs ❏ High risk surgical procedure ❏ Bariatric surgery ❏ Orthopedic ❏ Neurosurgery ❏ Other _____________________________________ ❏ Treatment with a clot-dissolving drug ❏ Blood clot in your leg ❏ Blood clot in your lung
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PURPOSE: To determine the incidence of venous thromboembolism (VTE) after removal of retrievable inferior vena cava (IVC) filters. MATERIALS AND METHODS: Retrospective study was conducted of 67 patients who underwent 72 consecutive filter retrievals at a single institution. Data collected included VTE status at the time of filter placement, anticoagulant medications at the time of filter retrieval and afterward, new or recurrent VTE after filter removal, and insertion of subsequent filters. Patient questionnaires were completed in 50 cases, chart review in all patients. RESULTS: At the time of filter placement, 30 patients had documented VTE, 19 had a history of treated VTE, and 23 were at risk for but had neither previous nor present VTE. Mean duration of follow-up after filter removal was 20.6 months ⴞ 10.9. A total of 52 patients (57 filters) received anticoagulation and/or antiplatelet medications after filter removal. There were two documented episodes of recurrent deep vein thrombosis (2.8% of filters removed), both in patients who had VTE at the time of filter placement and underwent therapeutic anticoagulation at the time of filter removal. One of these patients (1.4% of filters removed) also experienced pulmonary embolism. Of the 23 patients without VTE when the filter was placed, none developed VTE after filter removal. Four patients (5.5% of filters removed) required subsequent permanent filters, three for complications of anticoagulation, one for failure of anticoagulation. CONCLUSIONS: VTE was rare after removal of IVC filters, but was most likely to occur in patients who had VTE at the time of filter placement J Vasc Interv Radiol 2008; 19:504 –508 Abbreviations:
DVT ⫽ deep vein thrombosis, IVC ⫽ inferior vena cava, PE ⫽ pulmonary embolism, VTE ⫽ venous thromboembolism
A variety of complications have been ascribed to permanent inferior vena cava (IVC) filters, including an increased risk of subsequent deep vein thrombosis (DVT) (1– 4). Currently available retrievable filters can provide short-term protection from pulmonary
From the Dotter Interventional Institute, Oregon Health & Science University, Mail Code L-605, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239. Received June 8, 2007; final revision received November 2, 2007; accepted November 14, 2007. Address correspondence to J.A.K; E-mail: kaufmajo@ ohsu.edu
embolism (PE) and then be removed when the patient is no longer at risk of PE (5). Theoretically, removal of retrievable filters from properly selected and treated patients should be associated with a low incidence of filter-related complications, such as subsequent DVT (6). The majority of published reports on retrievable vena cava filters have focused on the retrieval procedure rather than subsequent outcomes (7–10). The purpose of this retrospective study was to evaluate the incidence of new or recurrent venous thromboembolism (VTE; defined as DVT and/or PE) after removal of IVC filters.
1
Current address: Department of Radiology, Hacettepe University Hospital, Ankara, Turkey. J.A.C. has consulted for Bard and has received research support from Cook and Bard. © SIR, 2008 DOI: 10.1016/j.jvir.2007.11.016
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MATERIALS AND METHODS Study Design This retrospective study was conducted at a single center and approved
by the hospital institutional review board. Data collection included a patient questionnaire and chart review. The subset of all filter recipients who had undergone insertion and retrieval of optional (ie, retrievable) IVC filters was identified from the hospital clinical and radiology database. The indications for placement and retrieval of filters, results of IVC imaging performed during placement and at the time of retrieval, procedural complications, filter types and durations of implantation, and imaging data including lower-extremity venous Doppler ultrasonography (US) and pulmonary computed tomographic angiography were recorded. Anticoagulant medications and dosages before and after retrieval were noted. As part of routine clinical practice,
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patients who had retrievable filters placed with the intent to be retrieved were tracked for 6 months after filter placement. The patients, or their primary health care providers, were contacted on a monthly basis by telephone or email by the interventional radiology physician assistant to determine their current VTE status and management. After 6 months, the patient or provider was asked to contact the interventional radiology service should filter removal become feasible. Patients Between July 2001 and October 2004, insertion and retrieval of 72 IVC filters were performed in 67 patients. There were 39 female patients and 28 male patients with an age range of 12– 87 years (mean, 50.6 y ⫾ 16.2). Follow-up For this study, follow-up was obtained from interviews with patients and/or family members and hospital records for each filter placed and removed at the authors’ institution. This follow-up was conducted in addition to routine clinical practice. A standardized data collection form was used for the chart reviews, recording results of imaging studies, and patient interviews. Chart reviews were focused specifically on anticoagulant therapy or prophylaxis, reports and objective documentation of new or recurrent VTE, bleeding complications, and placement of additional IVC filters. A dedicated questionnaire was developed to be easily understood by patients and families (Appendix). The following data were collected during telephone interviews: use of anticoagulation medications after filter removal, objective and subjective evidence of new or recurrent DVT and/or PE, and insertion of subsequent filters after the removal of the first device. When patients had multiple filters placed, data were collected for each device placed and removed. Multiple attempts were made to complete the questionnaire, including contact with the patient by telephone (three attempts), email (three attempts), and regular mail (three attempts). Questionnaires were completed for a total of 50 patients. Of these, 40 were completed by patients
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Table 1 Indications for Retrieved Filters Indications
Filter 1
Filter 2
Absolute or relative contraindication to anticoagulation with documented VTE Complication of anticoagulant therapy, with documented VTE Prophylaxis without current VTE Major trauma, no previous VTE Previously resolved VTE, high-risk surgical procedure No previous VTE, high-risk surgical procedure Prophylaxis with VTE in addition to anticoagulation In association with another procedure (pharmacomechanical thrombectomy for VTE)
21
—
6
—
16 15 6 2 1
— 4 1 — —
via phone interviews, seven by family members via phone interviews, and three by patients via questionnaires returned by mail. Chart reviews and medical records alone were used for follow-up in 17 patients in whom the questionnaire could not be completed. The duration of follow-up was determined from the date of each filter removal to the date of completion of the questionnaire pertaining to that filter, or, when this was not feasible, the last entry in the patient’s medical record. Endpoints Study endpoints were a documented instance of VTE after filter removal, placement of a subsequent filter, or death. Definitions Data for this study were recorded according to the recommended reporting standards for vena cava filters (11).
RESULTS Indications for placement of filters are provided in Table 1. Risk factors for VTE are provided in Table 2. In all 30 filters placed in patients with a diagnosis of acute VTE, objective imaging documentation confirmed DVT, PE, or both. Among the total of 42 filters placed for prophylaxis, 19 filters were placed in 16 patients with histories of VTE (but no current VTE) undergoing major surgical procedures, and a total of 23 were placed in patients without a previous or current diagnosis of VTE (16 in patients with
Table 2 Risk Factors for VTE at the Time of Filter Placement (N ⴝ 72) Risk Factor History of DVT Immobilization Postoperative status Age ⱖ65 y Malignancy Cardiac disease Limb trauma Prothrombotic state Pregnancy/ postpartum status Obesity
No. of Filters* 17 41 3 11 5 1 19 5 1 1
* Many patients had multiple risk factors at the time of filter placement, so the total is greater than 72.
major trauma and seven in patients undergoing major surgical procedures with a high risk of postoperative VTE). Filter types used were Gu¨nther Tulip filters in 54 cases (Cook, Bloomington, Ind), Recovery filters in 14 cases (CR Bard, Tempe, Ariz), and OptEase filters in four cases (Cordis, Warren, NJ). Filter dwell times were 4 –34 days (mean, 13.5 d ⫾ 5.4) for Gu¨nther Tulip filters, 16 –167 days (mean, 72.4 d ⫾ 55.4) for Recovery filters, and 5–21 days (mean, 14.0 d ⫾ 6.7) for OptEase filters. While the filters were in place, there were no instances of symptomatic new or recurrent PE, DVT, or IVC occlusion. However, comprehensive imaging evaluation of asymptomatic patients was not performed. Filters were retrieved when the patients were thought to be at low risk of
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clinically significant PE as a result of anticoagulation status, abatement of risk factors for VTE, or both (6). Patients were selected for filter retrieval by the referring physician in consultation with an interventionalist. All patients with filters placed for prophylactic indications had negative findings on bilateral lower-extremity venous duplex US examinations before filter removal. IVC images obtained before retrieval of filters revealed patent IVCs in all cases. The final decision to retrieve the filter was made by the interventionalist at this time. Small amounts of trapped thrombus were seen within the filters in 13 patients, and the filters were thought to be safe for retrieval by the operator. None of these patients had a subsequent diagnosis of DVT or PE. Findings of all cavograms were normal after retrieval. The overall duration of follow-up after filter removal was 2–39 months (mean, 20.6 months ⫾ 10.9). The durations of follow-up according to filter type were 2–39 months (mean, 24.2 months ⫾ 9.9) for Gu¨nther Tulip filters, 2–13 months (mean, 7.9 months ⫾ 3.5) for Recovery filters, and 9 –22 months (mean, 16.5 months ⫾ 5.6) for OptEase filters. A total of 52 patients (57 filters) were undergoing treatment with some combination of anticoagulation/antiplatelet medications at the time of filter removal. Of these patients, 12 received only short-term low molecular weight heparin (enoxaparin sodium; Sanofi Aventis, Paris, France) for 5–56 days (mean, 19.2 d ⫾ 17.4). Seven patients received short-term enoxaparin therapy (ⱕ2 months) followed by lifelong warfarin therapy. Thirty-one patients were treated with warfarin alone after filter removal: 24 for life, seven on a short-term basis (mean, 9 months ⫾ 7.4; range, 3–24 months). One patient received warfarin for 6 months followed by clopidogrel and aspirin for 1 year, and one patient received clopidogrel and aspirin for 1 year after filter removal. The remainder of the patients (n ⫽ 15) did not receive any anticoagulant or antiplatelet therapy after filter removal. These were trauma patients without VTE or patients undergoing surgical procedures who were at high risk for VTE. Documented VTE after filter removal occurred in two patients (2.8%
of filters). The first patient had a filter placed for right leg DVT in the setting of severe pancreatitis and underwent filter retrieval at 22 days during full anticoagulation. During a second hospital admission 2 months later for complications of pancreatitis, the anticoagulant medication (therapeutic enoxaparin) was inadvertently omitted. Findings of bilateral lower-extremity US studies were negative for DVT at the time of admission. Symptomatic US-proven new bilateral lowerextremity DVT occurred within 1 week, followed by massive PE during resumption of anticoagulation with unfractionated heparin and warfarin. A permanent filter was placed during successful percutaneous treatment of the PE. The second patient with recurrent VTE had her first filter placed for symptomatic PE 5 days after initiation of anticoagulation for her second episode of acute DVT. The filter was retrieved 12 days later when the patient was receiving therapeutic anticoagulation. A diagnosis of factor V–Leiden deficiency was made and she was prescribed lifelong warfarin. Three years after filter retrieval she developed a new acute left leg DVT after a transAtlantic flight. At that time she was noted to have a supratherapeutic International Normalized Ratio of 7, so warfarin was stopped and enoxaparin initiated. She then developed symptomatic hemarthrosis of the left knee. The enoxaparin was discontinued and a second filter was placed. This filter was not removed even though the patient eventually resumed warfarin treatment. Two additional patients required permanent filters after removal of a retrievable filter, both for bleeding complications of anticoagulation. There were no cases of suspected IVC occlusion after filter removal.
DISCUSSION Anticoagulation is the standard therapy for VTE (12). When anticoagulation is contraindicated in patients who have or are at high risk of VTE, vena cava filter placement is accepted as a technique for interruption of the IVC to prevent life-threatening PE (13). However, permanent vena cava filter placement may be associated with an increased risk of DVT and other complications. Decousus et al
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(4,14), in a prospective randomized trial of patients with VTE comparing anticoagulation alone or anticoagulation plus a permanent IVC filter, demonstrated a significantly higher incidence of recurrent DVT in the patients with filters, which was sustained over a period of 8 years. Although the mechanism is unexplained, the belief that filters increase the risk of subsequent DVT is pervasive (15–17). These and other concerns about the longterm complications of vena cava filters have stimulated great interest in the use of retrievable vena cava filters (18). Despite limited data confirming the benefits of these devices, the use of retrievable vena cava filters is increasing (19,20). The literature on retrievable vena cava filters has to date focused on the safety and efficacy of the devices while implanted, and the retrieval procedure (5,21–31). Only a handful of studies have reported follow-up of patients after filter removal. Millward et al (8) reported long-term follow-up (mean, 103 days) of 37 patients after removal of Gu¨nther Tulip filters. Follow-up data were obtained from chart review, referring physician contact, and review of imaging, but rarely through direct patient contact. Data on anticoagulation after filter removal were not provided. One patient with a protein S deficiency had a recurrent DVT 230 days after filter retrieval. Asch et al (7) reported postretrieval clinical follow-up of an average of 223 days in 22 patients with Recovery filters. Clinical care visits were reviewed along with telephone interviews obtained in 20 patients, although the number of patients contacted and the format of data collection were not described. One patient with clinical symptoms suggestive of PE 133 days after filter removal had negative findings on chest CT. No other patients had clinical symptoms or imaging findings suggestive of recurrent or new VTE. Wicky et al (10) reported on 33 patients who underwent anticoagulation with heparin followed by warfarin for 6 months starting 2 hours after Gu¨nther Tulip filter retrieval. Although the details of follow-up were not described, one case of recurrent DVT occurred at 7 months in a patient with a pelvic malignancy. Meier et al (29) reported a 3% incidence (one of 32 patients) of early PE after removal of prophylactic filters in
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trauma patients. The PE occurred in a patient who did not undergo pharmacologic prophylaxis or screening duplex US of the lower extremity veins before filter removal. Follow-up for 12 weeks in the remainder of the patients revealed no additional new cases of VTE. In our study, the mean follow-up after filter removal was 20.58 months (625 days) ⫾ 10.92 for all patients. This is substantially longer than the follow-up durations previously reported in the literature. Extended follow-up is important in patients with VTE, as the incidence of recurrence has been shown to increase over time (32–36). Of the two cases of recurrent VTE in our study, one occurred 3 years after filter removal. Overall, the incidence of recurrent VTE after filter retrieval in our study was 2.8% (two of 72 filters removed). This manifested in one patient with DVT and another with DVT followed by PE. Both these patients had had acute VTE at the time of filter placement. One case of recurrence was arguably a result of physician error when anticoagulation was inadvertently stopped. The other occurred in a patient with a known hypercoagulable syndrome who was receiving lifelong anticoagulation therapy. Of note, at the time of filter removal, no trapped thrombus was seen in the filter of either patient. In the subset of patients with VTE at the time of filter placement, the incidence of recurrent DVT was 6.7% (two of 30 filters removed) and that of PE was 3.3% (one of 30 filters removed). In the study of Decousus et al (14), a randomized prospective study of patients with acute VTE treated with anticoagulation alone or anticoagulation plus a permanent filter, the incidences of recurrent DVT and PE at 2 years were 6.3% and 11.6%, respectively, in patients without filters; and 20.8% and 3.4%, respectively, in patients with filters. Although our study differs substantially from theirs, our rates of recurrent DVT and PE after filter removal in patients with VTE at the time of filter placement compare favorably. Specifically, this subset of patients had a low rate of recurrent DVT after filter removal, which was similar to patients without filters in the study of Decousus et al (14), and a low rate of recurrent PE, similar to
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patients with permanent filters in the study of Decousus et al (14). This suggests that short-term filtration in patients with VTE may protect from early recurrent PE without increasing the long-term risk of recurrent DVT. Patients with transient risk factors for VTE should be at low risk for subsequent or recurrent VTE after filter removal. In our study, 23 filters were placed in patients with no history of VTE and transient risk factors (trauma or high-risk surgery), and 19 filters were placed in patients with histories of VTE undergoing high-risk surgical procedures. None of these patients developed VTE after filter retrieval. Trauma to the access vein has been suggested as an etiology of DVT after filter placement (37). The two recurrent cases of VTE in our patients were thought to be unrelated to filter insertion site thrombosis. In both patients, filter placement was performed via the right femoral vein and retrieval was performed via the right internal jugular vein, but the recurrent DVT was bilateral in one patient and left-sided in the other patient. In the present study, four permanent filters were required after successful retrieval of 72 retrievable filters (5.5% of filters, 6.0% of patients). The indication for the permanent filters was hemorrhagic complication of anticoagulant therapy in the majority of these patients (three of 52 patients receiving anticoagulation; 5.8%). These results are congruent with those described by other investigators, as Millward et al (8) reported placement of permanent filters in 8% of patients for bleeding complications after removal of a retrievable filter. An adequate trial of anticoagulation before filter removal is important, but hemorrhagic complications can occur at any time during treatment with anticoagulation (38). This study has several limitations that are endemic to the filter literature. The data collection was retrospective and from a single institution, the number of patients and occurrences of adverse events is small, and a control group is lacking. Although we were able to report on direct follow-up with 75% of the patients, a substantial percentage for a retrospectively identified patient cohort, recurrent DVT or PE could have been missed in the remaining 25% who had chart follow-up
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only. Nevertheless, our follow-up after filter removal is more comprehensive and of greater duration than in previously reported series. Recurrent VTE was rare after removal of retrievable IVC filters in our study, but only occurred in the subset of patients undergoing treatment for VTE at the time of filter retrieval. Subsequent DVT or PE was not found in patients who had filters placed for prophylactic indications or who had a history of VTE and were free of VTE at the time of filter retrieval. Our results suggest that the risks of recurrent VTE are low after retrievable filter removal in patients who have been adequately treated for VTE or who are no longer at risk for VTE. Selective use of retrievable filters in this manner could reduce the incidence of long-term thrombotic complications of filter use. However, prospective controlled studies are urgently needed to determine the whether there is actual benefit to the use of removal of retrievable vena cava filters. References 1. Athanasoulis CA, Kaufman JA, Halpern EF, Waltman AC, Geller SC, Fan CM. Inferior vena cava filters: review of a 26-year single-center clinical experience. Radiology 2000; 216:54 – 66. 2. Streiff MB. Vena caval filters: a comprehensive review. Blood 2000; 95: 3669 –3677. 3. Kinney T. Update on inferior vena cava filters. J Vasc Interv Radiol 2003; 14:425– 440. 4. PREPIC Investigators. 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. 5. Stein PD, Alnas M, Skaf E, et al. Outcome and complications of retrievable inferior vena cava filters. Am J Cardiol 2004; 94:1090 –1093. 6. Kaufman J, Kinney T, Streiff M, 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 – 459. 7. Asch MR. Initial experience in humans with a new retrievable inferior vena cava filter. Radiology 2002; 225: 835– 844. 8. Millward SF, Oliva VL, Bell SD, et al. Gunther Tulip retrievable vena cava
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filter: results from the registry of the Canadian Interventional Radiology Association. J Vasc Interv Radiol 2001; 12:1053–1058. Oliva VL, Szatmari F, Giroux MF, 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; 16:1439 –1445. Wicky S, Doenz F, Meuwly J, Portier F, Schnyder P, Denys A. Clinical experience with retrievable Gunther Tulip vena cava filters. J Endovasc Ther 2003; 10:994 –1000. Greenfield L, Rutherford R. Recommended reporting standards for vena caval filter placement and patient followup. Vena Caval Filter Consensus Conference. J Vasc Interv Radiol 1999; 10:1013– 1019. Buller H, Agnelli G, Hull R, Hyers T, Prins M, Raskob G. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126(suppl):401S– 428S. Levy J, Duszak R, Akins E, et al. Inferior vena cava filter placement. American College of Radiology. ACR Appropriateness Criteria. Radiology 2000; 215(suppl):981–997. 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. Prevention du Risque d’Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med 1998; 338:409 – 415. Stein P, Hull R, Raskob G. Withholding treatment in patients with acute pulmonary embolism who have a high risk of bleeding and negative serial noninvasive leg tests. Am J Med 2000; 109:301–306. Stein P, Kayali F, Olson R. Twentyone-year trends in the use of inferior vena cava filters. Arch Intern Med 2004; 164:1541–1545. Anderson RC, Bussey HI. Retrievable and permanent inferior vena cava fil-
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ters: selected considerations. Pharmacotherapy 2006; 26:1595–1600. Weichman K, Ansell JE. Inferior vena cava filters in venous thromboembolism. Prog Cardiovasc Dis 2006; 49:98 – 105. Morris C, Rogers F, Najarian K, Bhave A, Shackford S. Current trends in vena caval filtration with the introduction of a retrievable filter at a level I trauma center. J Trauma 2004; 57:32– 36. Grande WJ, Trerotola SO, Reilly PM, et al. Experience with the recovery filter as a retrievable inferior vena cava filter. 2005; 16:1189 –1193. Pieri S, Agresti P, Morucci M, de’ Medici L. Optional vena cava filters: preliminary experience with a new vena cava filter. Radiol Med (Torino) 2003; 105:56 – 62. Hoff W, Hoey B, Wainwright G, et al. Early experience with retrievable inferior vena cava filters in high-risk trauma patients. J Am Coll Surg 2004; 199: 869 – 874. Dentali F, Ageno W, Imberti D. Retrievable vena cava filters: clinical experience. Curr Opin Pulm Med 2006; 12:304 –309. Caronno R, Piffaretti G, Tozzi M, et al. Mid-term Experience with the ALN Retrievable Inferior Vena Cava Filter. Eur J Vasc Endovasc Surg 2006; 32: 596 –599. 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; 3:1370 –1375. Antevil JL, Sise MJ, Sack DI, et al. Retrievable vena cava filters for preventing pulmonary embolism in trauma patients: a cautionary tale. J Trauma 2006; 60:35– 40. Rosenthal D, Wellons ED, Lai KM, Bikk A, Henderson VJ. Retrievable inferior vena cava filters: initial clinical results. Ann Vasc Surg 2006; 20:157– 165. Binkert CA, Sasadeusz K, Stavropoulos SW. Retrievability of the recovery
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vena cava filter after dwell times longer than 180 days. J Vasc Interv Radiol. 2006; 17:299 –302. Meier C, Keller IS, Pfiffner R, Labler L, Trentz O, Pfammatter T. Early experience with the retrievable OptEase vena cava filter in high-risk trauma patients. Eur J Vasc Endovasc Surg 2006; 32:589 –592. Ray CE, Mitchell E, Zipser S, Kao EY, Brown CF, Moneta GL. Outcomes with retrievable inferior vena cava filters: a multicenter study. J Vasc Interv Radiol 2006; 17:1595–1604. Hoppe H, Nutting CW, Smouse HR, et al. Gunther Tulip filter retrievability multicenter study including CT followup: final report. J Vasc Interv Radiol 2006; 17:1017–1023. Martinelli I. Risk factors in venous thromboembolism. Thromb Haemost 2001; 86: 395– 403. Heit J. Risk factors for venous thromboembolism. Clin Chest Med 2003; 24: 1–12. Hansson P, Sorbo J, Eriksson H. Recurrent venous thromboembolism after deep vein thrombosis: incidence and risk factors. Arch Intern Med 2000; 160:769 –774. Anderson FA, Spencer FA. Risk factors for venous thromboembolism. Circulation 2003; 107:I-9 –I-16. van Dongen CJ, Vink R, Hutten BA, Buller HR, Prins MH. The incidence of recurrent venous thromboembolism after treatment with vitamin K antagonists in relation to time since first event: a meta-analysis. Arch Intern Med 2003; 163:1285–1293. Blebea J, Wilson R, Waybill P, et al. Deep venous thrombosis after percutaneous insertion of vena caval filters. J Vasc Surg 1999; 30:821– 828. Levine M, Raskob G, Beyth R, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126(suppl):287S–310S.
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APPENDIX: FOLLOW-UP QUESTIONNAIRE FOR PATIENTS WHO HAVE RECEIVED IVC FILTERS 1. Are you on or have you been on any anticoagulation (blood thinning) medication since your filter was removed? ❏ Yes ❏ No If yes: DRUG □ □ □ □ □
DOSE
START DATE
STOP DATE
Coumadin Heparin Enoxaparin Fondaparinux Other
2. Have you had a new blood clot to your lungs (pulmonary embolism) since the filter was taken out? ❏ Yes ❏ No If yes, what was the date: ____________________________ If yes, how did the doctor know that you had a blood clot in your lung? ❏ Symptoms ❏ CT angiography ❏ V/Q scan ❏ Pulmonary arteriography ❏ Subject does not know ❏ Other ______________________________________ 3. Have you had a blood clot in your leg/legs get bigger or developed a new blood clot in the vein in your leg/legs since the filter was removed? ❏ Yes ❏ No If yes, what was the date: ________________________________ If yes, was it in one leg or both legs? ❏ One leg ❏ Both legs If yes, how did the doctor learn about your blood clot? ❏ Symptoms ❏ Ultrasound ❏ CT scan ❏ MR scan ❏ Venogram ❏ Other _______________________________________________ Do you know where in your leg the blood clot was? ❏ IVC ❏ Pelvic vein ❏ Vein in your thigh ❏ Vein around your knee ❏ Vein below your knee ❏ Unknown 4. Have you had a second filter put in? ❏ Yes ❏ No If yes, what was the date? ____________________________________ What type of filter was it? ____________________________________
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Why did they put the second filter in? ❏ Unable to take anticoagulation (blood thinning) drug ❏ Complications related to anticoagulation (blood thinning) drug ❏ Bleeding ❏ Low blood counts (heparin-induced thrombocytopenia) ❏ Other ________________________ ❏ Recurrent blood clot to the lungs ❏ Worsening of blood clot in leg/legs ❏ Prior to surgery ❏ New blood clot in leg/legs ❏ High risk surgical procedure ❏ Bariatric surgery ❏ Orthopedic ❏ Neurosurgery ❏ Other _____________________________________ ❏ Treatment with a clot-dissolving drug ❏ Blood clot in your leg ❏ Blood clot in your lung
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