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Volume 20, Issue 7, Supplement, Pages S374-S376 (July 2009)


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Reporting Standards for Inferior Vena Caval Filter Placement and Patient Follow-up: Supplement for Temporary and Retrievable/Optional Filters

Steven F. Millward, FRCPCaCorresponding Author Informationemail address, Clement J. Grassi, MDb, Thomas B. Kinney, MDc, Sanjoy Kundu, MDd, Gary J. Becker, MDe, John F. Cardella, MDf, Louis G. Martin, MDg, James E. Silberzweig, MDh, David Sacks, MDi, Technology Assessment Committee of the Society of Interventional Radiology

Received 21 December 2004; accepted 21 December 2004.

Article Outline

Patient Assessment

Device Assessment

Procedural Assessment

Placement Problems

Filter Retrieval/Removal

Follow-up Assessment

Acknowledgment

References

Copyright

THIS Standards document is intended as a Supplement to the Recommended Reporting Standards for Vena Cava Filter Placement and Patient Follow-up, published in 1999 (1). Since 1999, there has been increased interest in non-permanent vena cava filters, with both increased research and clinical use of these devices. Several such devices are now approved for use in Europe, Canada, and the United States. The previous Standards did address several issues related specifically to non-permanent filters: this document contains additional issues that have arisen in the interval.

Although there is a large number of publications regarding vena cava filters, the literature is generally limited, with few good prospective studies, and even fewer randomized controlled trials (2). A randomized trial published in 1998 (3) demonstrated the “initial efficacy of filters for the prevention of pulmonary embolism.” However, prevention of pulmonary embolism (PE) appeared to be short-lived, and was counterbalanced by an increased risk of recurrent deep-vein thrombosis (DVT) in the patients receiving filters (3). The data published in this trial, which was based on 2-year follow-up, resulted in increased interest in non-permanent filters. Of note, further follow-up data from the same trial showed continued filter protection against PE with no increase in post-thrombotic syndrome at 8 years (4).

Patient Assessment 

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Data regarding general patient information, the method of diagnosis of DVT or PE, risk factors for thrombosis, and the indications for filter placement, should all be described according to the previous Standards (1). Any additional indications should be specifically addressed, as should any contraindications (5). In addition the protocol must state if the filter was placed with the intention that it would be retrieved, or if it was intended as a permanent filter, or if this was not determined. If filter retrieval was planned the rationale for this should be described: in particular the reasons why the patient may no longer require a filter, and could benefit from filter retrieval should be included.

Device Assessment 

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The manufacturer and type of filter should be recorded, along with a description of the delivery system and the technique of placement. The size of the introducer system should be specified. The device should be categorized as either a Temporary Filter or a Retrievable/Optional Filter if possible (6). A Temporary Filter is attached to a wire or catheter that either protrudes from the skin entry site, or may be buried in the adjacent subcutaneous tissues (6, 7). Consequently, this type of filter must generally be removed. A Retrievable/Optional Filter is similar to a conventional filter, but it has additional features allowing removal from the body [such as a retrieval hook (6, 8, 9), a specifically designed removal device (10), or struts/fixation hooks that can be removed from the vena cava wall after endothelialization has occurred (7, 10)]. These features should be described. Any drug coating, or other technique used to influence incorporation of the device into the vena cava must be described in detail (11).

The reason for device selection should be noted as described in the previous Standards (1). In addition the following points should also be addressed: (i) was the device selected because retrieval/removal was planned? (ii) was a device that was designed to be a permanent filter modified for non-permanent use (12, 13)? In a large series where several different devices were used, all data must be collected and reported for each type of filter.

Procedural Assessment 

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This should be described according to the Standards (1).

Placement Problems 

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In addition to the requirements of the previous Standards (1), it should be noted if filter placement was adequate to permit filter retrieval. Any complication should be described as Minor or Major according to the SIR Standards of Practice Committee Classification (5).

Filter Retrieval/Removal 

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The results of retrieval must be expressed according to the protocol described in “Patient Assessment,” and any changes in the medical condition of the patient, or other factors, that led to a change in the protocol must be described. The removal device should be described. The manufacturer, the size of the system, the type of removal device, and a brief description of the device and the method of use should be included. The requirements under “Procedural Assessment” in the Standards document (1) should be followed, but additional points that must be addressed are listed in the Table. All complications should be described and classified as Minor or Major.

Reporting Criteria for Filter Retrieval

1. Anticoagulant medications: Specify type and duration of use
2. Implantation period
3. Filters not retrieved: Specify reasons
4. Site of venous access for retrieval
5. Imaging of vena cava prior to retrieval: Include imaging technique, position of filter and trapped emboli
6. Complication or technical difficulty during retrieval: Describe any additional equipment or techniques used
7. Imaging of vena cava following retrieval: Include imaging technique and evidence of vena caval injury

With regard to the implantation period, the maximum implantation period of the device according to the manufacturer should be stated. If filters were retrieved after a longer implantation period than is recommended by the manufacturer, this must be stated. Relevant human and/or animal data regarding implantation times should be briefly described. If filter repositioning was undertaken in an attempt to prolong the implantation period (14), the technique and rationale should be described.

In addition to those listed in the Table, the following details should be addressed: (i) were imaging tests used to evaluate the venous system for DVT prior to filter removal? (ii) the position of the filter at the time of retrieval, or on follow-up imaging, should be compared to the position immediately following placement, (iii) if trapped emboli were identified within the filter, or removed with it, this should be documented along with an estimate of the size of the emboli, (iv) any pharmacological or mechanical thrombolytic techniques used to remove trapped emboli should be described, (v) if trapped emboli were removed what measures were taken to prevent and diagnose recurrent PE? (vi) an indication of the amount of force required to retrieve the filter may be included (14), (vii) radiation dose (fluoroscopy time if radiation dose is not available) and the type and dose of contrast agent used should also be recorded (15, 16), (viii) if retrieved filters were submitted for histologic or bacteriologic evaluation the results should be reported (17).

Follow-up Assessment 

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The previous Standards document should be followed, both for patients from who filters were retrieved and for those where filters were left in permanently (1). The methods used (both pre- and postfilter retrieval) to diagnose and exclude DVT, PE and chronic venous insufficiency, and the results of these investigations, should be included. If the venous access site used for filter retrieval was evaluated for thrombosis, it is recommended that the results of this imaging be reported. In addition, if placement of a second filter was required the type of filter and the reason for choosing it should be described. Complications should be classified as Minor or Major.

Acknowledgments 

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Dr. Steven F. Mill-ward authored the first draft of this document and served as topic leaders during the subsequent revisions of the draft. Dr. Clement J. Grassi is chair of the SIR Technology Assessment Committee and Dr. David Sacks is SIR Standards Division Councilor. All other authors are listed alphabetically. Other members of the Technology Assessment Committees who participated in the development of this clinical practice guideline are (listed alphabetically): John Dean Barr, MD, John J. Borsa, MD, Patricia E. Cole, PhD, MD, William B. Crenshaw, MD, Michael D. Dake, MD, Chieh-Min Fan, MD, S. Nahum Goldberg, MD, Ziv Haskal, MD, Randall T. Higashida, MD, Lindsay Machan, MD, Nilesh H.Patel, MD, David A. Phillips, MD, Dheeraj Rajan, MD, John H. Rundback, MD, Curtis W. Bakal, MD, Curtis A. Lewis, MD, and Kenneth S. Rholl, MD.

References 

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1. 1Greenfield LJ, Rutherford RBParticipants in the Vena Caval Filter Conference. Recommended reporting standards for vena caval filter placement and patient follow-up. J Vasc Interv Radiol. 1999;10:1013–1019. Full-Text PDF (718 KB) | CrossRef

2. 2Girard P, Stern JB, Parent F. Medical literature and vena cava filters: so far so weak. Chest. 2002;122:963;927. MEDLINE | CrossRef

3. 3Decousus 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. N Engl J Med. 1998;338:409–415. MEDLINE | CrossRef

4. 4Decousus H. Eight-year follow-up of a randomized trial investigating vena caval filters in the prevention of PE in patients presenting a proximal DVT: The PREPIC trial. J Thromb Haemost. 2003;1(suppl 1):OC440.

5. 5Grassi CJ, Swan TL, Cardella JF, et al. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol. 2001;12:137–141. Full Text | Full-Text PDF (91 KB) | CrossRef

6. 6Millward SF. Temporary and retrievable inferior vena cava filters: current status. J Vasc Interv Radiol. 1998;9:381–387. Full-Text PDF (6684 KB) | CrossRef

7. 7Bovyn 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. Abstract | Full-Text PDF (1502 KB) | CrossRef

8. 8Darcy MD, Smith TP, Hunter DW, Castaneda-Zuniga W, Lund G, Amplatz K. Short-term prophylaxis of pulmonary embolism by using a retrievable vena cava filter. AJR Am J Roentgenol. 1986;147:836–838.

9. 9Millward SF, Oliva VL, Bell SD, et al. Gunther Tulip retrievable vena cava filter: results from the registry of the Canadian Interventional Radiology Association. J Vasc Interv Radiol. 2001;12:1053–1058. Abstract | Full Text | Full-Text PDF (457 KB) | CrossRef

10. 10Asch MR. Initial experience in humans with a new retrievable inferior vena cava filter. Radiology. 2002;225:835–844. MEDLINE | CrossRef

11. 11De Gregorio MA, Gimeno MJ, Lostale F, et al. Retrievability of uncoated versus Paclitaxel-coated Gunther-Tulip IVC filters in an animal model. J Vasc Interv Radiol. 2004;15:719–726. Abstract | Full Text | Full-Text PDF (1525 KB)

12. 12Cope C, Baum RA, Duszak RA, et al. Temporary use of a Bird's Nest filter during iliocaval thrombolysis. Radiology. 1996;198:765–767. MEDLINE

13. 13Nutting C, Coldwell D. Use of a TrapEase device as a temporary caval filter. J Vasc Interv Radiol. 2001;12:991–993. Abstract | Full Text | Full-Text PDF (434 KB) | CrossRef

14. 14De Gregorio MA, Gamboa P, Gimeno MJ, et al. The Gunther Tulip retrievable filter: prolonged temporary filtration by repositioning within the inferior vena cava. J Vasc Interv Radiol. 2003;14:1259–1265. Abstract | Full Text | Full-Text PDF (1517 KB)

15. 15Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for recording patient radiation dose in the medical record. J Vasc Interv Radiol. 2004;15:423–429. Full Text | Full-Text PDF (87 KB)

16. 16Omary RA, Bettmann MA, Cardella JF, et al. Quality improvement guidelines for the reporting and archiving of interventional radiology procedures. J Vasc Interv Radiol. 2002;13:879–881. Full Text | Full-Text PDF (47 KB) | CrossRef

17. 17Neeman Z, Auerbach A, Wood BJ. Letter: metastatic involvement of a retrieved inferior vena cava filter. J Vasc Interv Radiol. 2003;14:1585. Full Text | Full-Text PDF (311 KB) | CrossRef

a Department of Diagnostic Imaging, Peterborough Regional Health Centre, One Hospital Drive, Peterborough, Ontario, K9J 7C6, Canada and the University of Western Ontario, London, Canada

b Department of Radiology, Lahey Clinic Medical Center, Burlington, Massachusetts

c UCSD Medical Center, San Diego, California

d Department of Medical Imaging, Scarborough General Hospital, Richmond Hill, Canada

e Image-Guided Intervention, Cancer Imaging Program (NCI), Bethesda, Maryland

f Department of Radiology, University of Colorado Health Sciences Center, Denver, Colorado

g Department of Radiology, Emory University Hospital, Atlanta, Georgia

h St. Luke's Roosevelt Hospital Center, New York, New York

i The Reading Hospital and Medical Center, Reading, Pennsylvania

Corresponding Author InformationAddress correspondence to S.F.M.

 J.E.S. is an independent consultant for Cordis. None of the other authors have identified a conflict of interest.

 This article first appeared in J Vasc Interv Radiol 2005; 16:441–443.

PII: S1051-0443(09)00306-6

doi:10.1016/j.jvir.2009.04.009


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