Clinical outcome and complications of temporary inferior vena cava filter placement

Article Outline

• Abstract
• Methods
  • Indication for filter insertion
    • Contraindication to anticoagulation therapy
    • Thrombolytic therapy
    • Perioperative implantation
    • Pregnancy associated with DVT
    • Prophylactic implantation in absence of DVT
• Results
  • Outcome
  • Complications
• Discussion
• Conclusion
• Author contributions
• References
• Copyright

Objective

We evaluated the current clinical experience of temporary inferior vena cava (IVC) filter placement and its related complications.

Methods

From January 2000 to December 2005, we enrolled 33 patients (8 men and 25 women) who underwent percutaneous insertion of a temporary IVC filter in the Department of Vascular Surgery of Tokyo University Hospital. Deep vein thrombosis (DVT) was proven in 78.8% of the patients. The indications for filter insertion were contraindication to anticoagulation therapy (9.1%), thrombolytic therapy (12.1%), perioperative prophylactic implantation (84.8%), pregnancy with DVT (3.0%), and prophylactic implantation in the absence of DVT (15.2%). A Neuhaus Protect was used in 13 patients, and an Antheor was used in 20 patients.

Results

The mean ± SD duration of filter placement was 10.6 ± 7.0 days. There was no case of pulmonary embolism during filter protection and retraction. Filter thrombosis (capture of thrombus) was observed in four patients (12.1%), who then received additional thrombolytic therapy. Thrombi were dissolved by thrombolysis in three, one of whom had replacement with a permanent filter. The thrombus was not dissolved in one patient and was removed under venotomy at the insertion site. Major filter-related complications occurred in nine patients (27.3%), including filter dislocation in four patients (12.1%), catheter fracture in three (9.1%), and catheter-related infection in one (3.0%). In a patient with giant ovarian cancer, the IVC was nearly occluded with massive thrombus around the filter 2 days after operation, and the vena cava was then ligated under open laparotomy. No patients died during filter protection and retraction.

Conclusions

Temporary IVC filters were effective for the prevention of fatal pulmonary embolism. However, our experience of a high incidence of complications related to temporary filters suggests that this device has limited indications and supports the need for innovative design of temporary filters.

Anticoagulation therapy has been the standard treatment for patients with deep vein thrombosis (DVT) and pulmonary embolism.¹, ², ³, ⁴, ⁵ Permanent inferior vena cava (IVC) filters have been in clinical use since 1967⁶ and have gained acceptance for the prevention of pulmonary embolism arising from DVT of the lower extremity. A randomized controlled study in Europe indicated that a permanent IVC filter decreased the incidence of short-term pulmonary embolism but increased the long-term incidence of recurrent DVT.⁷ Previous studies showed that permanent IVC filters were associated with increased risk of complications such as IVC thrombosis,⁸ recurrent venous thromboembolism,⁷ thrombophlebitis, and venous stasis disease.⁹, ¹⁰

Temporary IVC filters, connected to the outside through a tethering catheter, are designed to avoid the long-term adverse outcomes of permanent filters and are used in Europe and Japan. The Food and Drug Administration has not yet approved them for use in the United States. A retrievable filter can be used as a temporary or as a permanent filter, whereas a temporary filter is used only as a temporary protection device against pulmonary embolism.

The indications for insertion of a temporary IVC filter are not well established. Because no data are available from prospective, randomized controlled studies, the use of temporary IVC filters is still controversial.¹¹, ¹² In this study, we reviewed the clinical experience of temporary IVC filter insertion at our institution, especially with regard to its complications.

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Methods 

From January 2000 to December 2005, we enrolled 33 patients (8 men and 25 women) who underwent percutaneous insertion of a temporary IVC filter. The procedures were performed in the Department of Vascular Surgery of Tokyo University Hospital. The patients’ characteristics are listed in Table I. The mean ± SD age at the time of filter insertion was 47.8 ± 13.1 years (range, 17 to 81 years). DVT was evaluated by duplex scanning or computed tomography (CT), and pulmonary embolism was evaluated by CT or pulmonary ventilation/perfusion scan. At the time of filter implantation, 26 patients (78.8%) had proven DVT. DVT was present up to the inferior vena cava in 4 patients, the iliac vein in 9, the femoral vein in 6, the popliteal vein in 3, and the calf vein in 4. Pulmonary embolism was detected in 12 of these patients before filter insertion. We examined thrombophilia and all coagulation parameters, including protein C, protein S, antithrombin III, lupus anticoagulant antibodies, and anticardiolipin antibodies.

Table I. Patient characteristics

Number of patients	33
Age ± SD (range), years	47.8±13.1 (17-81)
Sex
Male	8
Female	25
Deep vein thrombosis	26(78.8%)
Pulmonary embolism	12(36.4%)
Malignant disease	14(42.4%)
Thrombophilia	11(33.3%)

Indication for filter insertion 

Filters were inserted for a variety of indications, and informed consent was obtained for all filter placements.

In three patients (9.1%) with DVT and intracranial bleeding, a temporary IVC filter was inserted because of a transient contraindication to anticoagulation therapy related to a risk of bleeding.

In four patients (12.1%) with acute DVT (the IVC in 2 patients, the iliac vein in 1, and the calf vein in 1) and pulmonary embolism, systemic thrombolytic therapy using urokinase was performed under protection with a temporary IVC filter to prevent recurrent pulmonary embolism.

Perioperative insertion was performed in 28 patients (84.8%). These patients included one with renal cell carcinoma associated with renal vein thrombosis and five with prophylactic implantation in the absence of DVT as mentioned below. All of these filters were inserted preoperatively.

One pregnant patient (3.0%) who developed DVT during the last trimester of pregnancy received a temporary IVC filter before delivery.

Five filters (15.2%) were placed in the absence of DVT before or during a high-risk situation and during a temporary contraindication to full anticoagulation. These filters were all inserted perioperatively.

All filters were inserted percutaneously through a sheath via the internal jugular vein, subclavian vein, or femoral vein. We used a Neuhaus Protect (Toray Medical, Tokyo, Japan) in 13 patients and a Antheor (Boston Scientific, Watertown, Mass) in 20 patients as a temporary IVC filter (Fig 1, A and B).

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• Fig 1. 

  A, Neuhaus Protect filter. B, Antheor filter.

Anticoagulation therapy was administered during filter placement in all patients in whom it was not contraindicated. We administered intravenous dose-adjusted heparin to maintain an activated partial thromboplastin time at 1.5 to 2 times the control value. In perioperative cases, heparin anticoagulant therapy was stopped for at least 6 hours before the operation and was restarted when the risk of bleeding had decreased.

We used CT to examine the entrapment of thrombi in the filter 5 to 7 days after insertion and re-examined this by vena cavography before explantation. The filter was removed if there was no capture of large thrombi detected that could develop into pulmonary embolism. When a large thrombus was detected in the filter, we performed thrombolytic therapy using catheter-directed administration of urokinase in cases in which it was not contraindicated.

All patients were followed-up as outpatients for at least 6 months after removal of the filter. We examined the early outcome and complications resulting from temporary IVC filter placement.

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Results 

Outcome 

The temporary IVC filters were placed in the infrarenal IVC in 31 patients and in the suprarenal IVC in two. The mean ± SD duration of filter placement was 10.6 ± 7 days. Eleven patients had thrombophilia, including eight with protein S deficiency, two with both anticardiolipin antibodies and lupus anticoagulant antibodies, and one with anticardiolipin antibodies only.

A large thrombus was captured in the filter in four patients (12.1%) (Table II), and we performed catheter-directed thrombolytic therapy using a continuous infusion of urokinase. The thrombus was dissolved in three patients, and in one of these patients the temporary IVC filter was replaced with a permanent filter. The thrombus did not dissolve in one patient and was captured rigidly, so the thrombus inside the filter was pulled back outside together with the catheter through a small venotomy in the jugular vein in the insertion site without protection.

Table II. Outcome

Duration of placement	10.6±7.0 days
Filter thrombosis	4 (12.1%)	3resolvedbycatheter-directed thrombolytic therapy;
		1 removed under venotomy at the insertion site
Pulmonary embolism	0	During filter protection and retraction

There was no case of pulmonary embolism during filter protection and retraction.

Complications 

No major problems occurred with filter insertion, including bleeding. One patient who underwent filter insertion through the jugular approach complained of dysesthesia at the insertion site after filter retraction. Nine patients (27.2%) experienced major and minor complications problems during filter protection and retraction (Table III).

Table III. Complications during filter placement

DVT, Deep vein thrombosis; IVC, inferior vena cava; M, male; F, female; N, Neuhaus Protect; A, Antheor.

IVC thrombosis developed from the iliac vein to the proximal side of the filter in a patient with large ovarian cancer 2 days after operation despite anticoagulation therapy, and the vena cava was nearly occluded with massive thrombus. Although catheter-directed thrombolytic therapy using urokinase was performed, the thrombus was not dissolved and the vena cava remained occluded. Because it was impossible to explant the temporary filter in this situation, the vena cava was ligated at the infrarenal level proximal to the large thrombus and then the catheter was cut and explanted under open laparotomy.

Major dislocation of the catheter by more than one vertebral body occurred in four patients (12.1%); one was in the right atrium (Fig 2), one was in the suprarenal IVC, and two were in the iliac vein. All of these filters were inserted preoperatively, and filter dislocation was detected after operation in all cases. These filters were removed without adverse sequelae.

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• Fig 2. 

  Image from a patient with giant ovarian cancer in whom the temporary filter was inserted in a suprarenal IVC preoperatively. This vena cavogram shows the filter migration to the atrium after operation. Arrowhead shows filter in the atrium.

Infection related to the catheter occurred in one patient (3.0%) with endometriosis before operation. The catheter was explanted and the operation postponed because of catheter-related fever. Three months later, the scheduled operation was uneventfully performed under protection with a temporary filter.

Fracture of the catheter was observed in three patients (9.1%); two with a Neuhaus Protect filter and one with an Antheor. The fracture was observed in the shaft of the central catheter in the Neuhaus Protect and at the connection site between the main catheter and side port in the Antheor. In these cases, the temporary IVC filter was replaced with another one without further complications.

Complications such as fatal pulmonary embolism, hemorrhage at the insertion site, or retroperitoneal bleeding were not observed. In addition, no patient had a fatal complication related to implantation of the temporary filter. During the follow-up period, neither pulmonary embolism nor other filter-related complications were observed after filter retraction.

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Discussion 

The only randomized, controlled trial regarding permanent IVC filters has been reported by Decousus et al.⁷ This report indicated that in high-risk patients with proximal DVT, the initial beneficial effect of an IVC filter together with anticoagulants for the prevention of pulmonary embolism was counterbalanced by an excess of recurrent DVT, without any difference in mortality. Therefore, only absolute contraindications and documented failure of anticoagulation therapy in patients with acute venous thromboembolism represent obvious and widely accepted indications for IVC interruption.¹³

A temporary IVC filter can be left in place for a short term to cover a high-risk period for venous thromboembolism. The indwell time for the temporary filters we used is up to 2 weeks, as recommended by the manufacturers, whereas the indwell time for other temporary filters, such as a Tempofilter (B. Braun, Melsungen, Germany), is longer. They are designed and tailored to avoid the disadvantage of permanent systems, such as perforation, penetration, and caval occlusion, and to provide comparable protection against pulmonary embolism.⁹ Several studies have demonstrated equal effectiveness of permanent and temporary filters in clot capture.¹⁴, ¹⁵ Temporary IVC filters were inserted in younger patients, in whom implantation of a permanent filter should be avoided. Indeed, the average age of the patients in the present study was 47.8 years.

Despite theoretical advantages of a temporary IVC filter, the effectiveness of temporary filters is still very controversial. The main points of criticism are the handling of thrombi captured in the filter before explantation, the danger of filter explantation under endothelialization with prolonged implantation,¹⁶ dislocation of the filter or catheter during filter placement, and the lack of clearly defined indications for filter insertion.

Most of the patients in the present study had proven DVT before filter insertion. In cases of perioperative prophylactic insertion, a temporary filter is generally implanted until adequate ambulation or a candidate for anticoagulation prophylaxis, but there are no criteria for the duration of filter placement. Endothelialization has been shown to cause explantation problems after 12 days,¹⁷ and the risk of endothelialization increases the longer the filter remains in place. In fact, we experienced many cases in which the duration of placement had to be extended because of residual DVT.

A high rate of thrombus capture may lead to the problem of thrombi caught in the filter, which are detected on pre-explantation CT or cavography. The rate of 12.1% in our study is comparable with the previous report of 16%.¹² The decision whether to cautiously pull back the filter or to perform additional thrombolytic treatment is made according to the thrombus size and general status of the patient with respect to previous pulmonary embolism. In general, thrombi <1 cm in diameter are able to be retracted with the filter.

Several options can be used to overcome the problem with larger thrombi. Although additional thrombolysis can be performed to dissolve thrombi in the filter, thrombolytic therapy is generally contraindicated or should be performed using low-dose urokinase perioperatively. An alternative strategy to implant a second filter—temporary, retrievable, or permanent—can be helpful in these situations. However, because a temporary IVC filter must be explanted, it is always difficult to make the optimal decision in this conflicting situation. In the present study, thrombi were found in the filter in 12.1% of patients, and they were all in patients with DVT; however, we have no evidence that all of these arose from peripheral thrombosis.

Filter dislocation occurred in 12.1% of patients. Lorch et al¹⁴ reported that the rate of dislocation was 4.8% for temporary filters, whereas that in the present study was higher. The explanation for this result is that the number of patients was small, and further, most of our patients were perioperative or ambulant cases. Although dislocation within a few centimeters along the vena cava is probably not significant, migration into other anatomic regions or tilting may result in additional complications, including pulmonary embolism.

A previous study revealed the problem of the tethering catheter shaft of a Tempofilter.¹⁸ Crimping of the tethering shaft caused cephalic migration of the filter into the right atrium. The catheter of the temporary filters used at our institution is stiffer than the Tempofilter and is hard to buckle, whereas dislocation of the catheter itself often arises from loosening of the fixation of the insertion site because of the stiffness of the catheter itself. Adequate fixation of the catheter is important, whereas filter dislocation might be inevitable except in patients on absolute bed rest.

We inserted most of the temporary filters through the jugular approach. The femoral approach is related to catheter infection and dislocation, and this approach is impossible if thrombus extends up to the iliac vein or vena cava. On the other hand, Linsenmaier et al¹⁹ stated that filters should be introduced through the right common femoral vein whenever possible because introduction through the jugular or brachial vein is associated with a high rate of complications, including upper vein and central vein thrombosis. Another reason to avoid the jugular approach is that captured thrombi can become a serious problem. Pulling back the device through the right heart creates the risk of iatrogenic pulmonary embolism.²⁰ Our impression is that both approaches have some disadvantages whenever we use this type of temporary IVC filter.

The temporary IVC filter was replaced with a permanent filter in one case. In cases like this, implantation of a retrievable-optional filter that can be used as a temporary or, if necessary, as a permanent filter would be beneficial. These devices are implanted in a manner similar to that for a permanent filter and retrieved through a new venous access with a snare, such as the Gunther Tulip filter (Cook, Bloomington, Ind),²¹ or they remain connected to a catheter that is fixed subcutaneously, such as the Tempofilter.²²

Definite indications for the placement of a temporary IVC filter have not been established. Linsenmaier et al¹⁷ advocated the following indications for a temporary IVC filter: the existence of DVT and a temporary contraindication for anticoagulation, recurrent pulmonary embolism despite adequate anticoagulation therapy, high risk of pulmonary embolism in cases of severe trauma and high perioperative risk, and other prophylactic purposes.

Although temporary filters have been extensively used in Europe, particularly during thrombolytic treatment of DVT; the use of such filters during thrombolysis has been questioned because favorable outcomes have occurred when thrombolysis has been performed without filter protection,²³ and temporary IVC filters do not seem to decrease the risk of a fatal pulmonary embolism under ultra-high-dose streptokinase thrombolytic therapy.¹² Moreover, the results obtained with temporary filters for other indications have not been as good as expected.¹¹, ¹² Because there are no data available from prospective, randomized controlled studies, the use of temporary IVC filters is still controversial. However, as we broaden the indications for IVC filter placement, particularly for prophylactic filters, it is also our responsibility to monitor the indications for filter placement and the effectiveness of using temporary filters. In the present study, there was no case of fatal pulmonary embolism and no patient died of a filter-related complication.

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Conclusion 

The concept of a temporary IVC filter is reasonable in specific high-risk situations, but the indication for insertion has to be defined further. Randomized, controlled trials are needed to investigate the benefits, adverse effects, and effectiveness of temporary IVC filters. Temporary IVC filters are widely used especially in Japan, because the insertion procedure is easy. However, because temporary IVC filter insertion is not a treatment but merely a prophylactic procedure to prevent pulmonary embolism, the relatively high incidence of filter-related complications is not acceptable. These data regarding various complications related to temporary filters suggest that this device has limited indications in the clinical setting. Further, the design of this type of temporary IVC filter should be tailored for safer handling or the concept should be radically modified. Retrievable optional filters are a recent strategy potentially offering a better solution and a reasonable alternative to temporary IVC filters, if the retrieval procedure is easy to perform and the rate of filter-related complications is sufficiently low.

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Author contributions 

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References 

1. Barritt DW , Jordan SC . Anticoagulant drugs in the treatment of pulmonary embolism. A controlled trial . Lancet . 1960;1:1309–1312
   • View In Article
   • MEDLINE
2. Coon WW , Willis PW . Recurrence of venous thromboembolism . Surgery . 1973;73:823–827
   • View In Article
   • MEDLINE
3. Lagerstedt CI , Olsson CG , Fagher BO , Oqvist BW , Albrechtsson U . Need for long-term anticoagulant treatment in symptomatic calf-vein thrombosis . Lancet . 1985;2:515–518
   • View In Article
   • MEDLINE
4. Prevention of venous thrombosis and pulmonary embolism. NIH Consensus Development . JAMA . 1986;256:744–749
   • View In Article
   • MEDLINE
5. Brandjes DP , Heijboer H , Buller HR , de Rijk M , Jagt H , ten Cate JW . Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal-vein thrombosis . N Engl J Med . 1992;327:1485–1489
   • View In Article
   • MEDLINE
   • CrossRef
6. Mobin-Uddin K , Smith PE , Martines LO , Lombardo CR , Jude JR . A vena cava filter for the prevention of pulmonary embolus . Surg Forum . 1967;18:209–211
   • View In Article
7. Decousus H , Leizorovicz A , Parent F , Page Y , Tardy B , Girard P , et al.   A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis . N Engl J Med . 1998;338:409–415
   • View In Article
   • MEDLINE
   • CrossRef
8. Tardy B , Mismetti P , Page Y , Decousus H , Da Costa A , Zeni F , et al.   Symptomatic inferior vena cava filter thrombosis (clinical study of 30 consecutive cases) . Eur Respir J . 1996;9:2012–2016
   • View In Article
   • MEDLINE
   • CrossRef
9. Ferris EJ , McCowan TC , Carver DK , McFarland DR . Percutaneous inferior vena caval filters (follow-up of seven designs in 320 patients) . Radiology . 1993;188:851–856
   • View In Article
   • MEDLINE
10. Greenfield LJ , Proctor MC , Michaels AJ , Taheri PA . Prophylactic vena caval filters in trauma (the rest of the story) . J Vasc Surg . 2000;32:490–497
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (61 KB)
    • CrossRef
11. Millward SF . Temporary and retrievable inferior vena cava filters (current status) . J Vasc Interv Radiol . 1998;9:381–387
    • View In Article
    • Full-Text PDF (579 KB)
    • CrossRef
12. Lorch H , Welger D , Wagner V , Hillner B , Strecker EP , Herrmann H , et al.   Current practice of temporary vena cava filter insertion (a multicenter registry) . J Vasc Interv Radiol . 2000;11:83–88
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (145 KB)
    • CrossRef
13. Buller HR , Agnelli G , Hull RD , Hyers TM , Prins MH , Raskob GE . Antithrombotic therapy for venous thromboembolic disease (the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy) . Chest . 2004;126(Suppl):401S–428S
    • View In Article
    • MEDLINE
    • CrossRef
14. Lorch H , Zwaan M , Kulke C , Weiss HD . In vitro studies of temporary vena cava filters . Cardiovasc Intervent Radiol . 1998;21:146–150
    • View In Article
    • MEDLINE
    • CrossRef
15. Neuerburg J , Haupt-Pichler A , Katterbach FJ , Eilers R , Siess T , Buro K , et al.   Determining the effectiveness of percutaneous cava filters (experimental studies) . Röfo . 1996;164:331–337
    • View In Article
16. Burbridge BE , Walker DR , Millward SF . Incorporation of the Gunther temporary inferior vena cava filter into the caval wall . J Vasc Interv Radiol . 1996;7:289–290
    • View In Article
    • Full-Text PDF (1217 KB)
    • CrossRef
17. Linsenmaier U , Rieger J , Schenk F , Rock C , Mangel E , Pfeifer KJ . Indications, management, and complications of temporary inferior vena cava filters . Cardiovasc Intervent Radiol . 1998;21:464–469
    • View In Article
    • MEDLINE
    • CrossRef
18. Kelly IM , Boyd CS . Buckling of the tethering catheter causes migration of a temporary caval filter to the right atrium . Clin Radiol . 1999;54:398–401
    • View In Article
    • Abstract
    • Full-Text PDF (417 KB)
    • CrossRef
19. Linsenmaier U , Rieger J , Rock C , Waydhas C , Pfeifer KJ . Prophylactic use of temporary inferior vena cava filters (Indications, preliminary results) . Radiology . 1996;201:284
    • View In Article
20. Linsenmaier U , Rieger J , Rock C , Waydhas C , Mangel E , Rock C , et al.   Preliminary experience with temporary inferior vena cava filters (Indications, management, and complications) . Radiology . 1995;197:213
    • View In Article
    • MEDLINE
21. Neuerburg JM , Gunther RW , Vorwerk D , Dondelinger RF , Jager H , Lackner KJ , et al.   Results of a multicenter study of the retrievable Tulip Vena Cava Filter (early clinical experience) . Cardiovasc Intervent Radiol . 1997;20:10–16
    • View In Article
    • MEDLINE
    • CrossRef
22. Bovyn G , Gory P , Reynaud P , Ricco JB . The Tempofilter (a multicenter study of a new temporary caval filter implantable for up to six weeks) . Ann Vasc Surg . 1997;11:520–528
    • View In Article
    • Abstract
    • Full-Text PDF (1502 KB)
    • CrossRef
23. Mewissen MW , Seabrook GR , Meissner MH , Cynamon J , Labropoulos N , Haughton SH . Catheter-directed thrombolysis for lower extremity deep venous thrombosis (report of a national multicenter registry) . Radiology . 1999;211:39–49
    • View In Article
    • MEDLINE