Korean J Radiol.  2005 Jun;6(2):110-116. 10.3348/kjr.2005.6.2.110.

The Mid-Term Efficacy and Safety of a Permanent Nitinol IVC Filter (TrapEase)

• Liu WC
• Do YS
• Choo SW
• Kim DI
• Kim YW
• Kim DK
• Shin SW
• Park KB
• Jeon YH
• Choo IW

• KMID: 1783184
• DOI: http://doi.org/10.3348/kjr.2005.6.2.110

Abstract

OBJECTIVE
1) To evaluate the mid-term efficacy and safety of a permanent nitinol inferior vena cava (IVC) filter; 2) to evaluate filter effectiveness, filter stability and caval occlusion. MATERIALS AND METHODS: A prospective evaluation of the TrapEase IVC filter was performed on 42 patients (eight men, 34 women) ranging in age from 22 to 78 years (mean age 66 years). All patients were ill with a high risk of pulmonary embolism (PE). Indications for filter placement were: 1) deep vein thrombosis with recurrent thromboembolism; 2) and/or free-floating thrombus with contraindication to anticoagulation; and 3) complications in achieving adequate anticoagulation. Follow-up evaluations (mean: 15.4 months, range: 2 to 28 months) were performed at 6- and 12-month intervals after the procedure and included clinical histories, chart reviews, plain film, Doppler ultrasounds, and contrasted abdominal CT scans. RESULTS: In follow-up evaluations, the data analysis revealed no cases of symptomatic PE. There were no cases of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study, there was one case of filter thrombosis; early symptomatic thrombosis that was successfully treated in the hospital. Of the 42 subjects, eight died. These deaths were not related to the filter device or the implantation procedure, but to the underlying disease. CONCLUSION: This study demonstrates that the TrapEase permanent IVC filter is a safe and an effective device with low complication rates and is best used in patients with thromboembolic disease with a high risk of PE.

Keyword

Pulmonary thromboembolism; IVC Filter; IVC thrombosis

MeSH Terms

Adult
Aged
*Alloys
Equipment Design
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prospective Studies
Pulmonary Embolism/*prevention & control
Safety
Thromboembolism/complications
Treatment Outcome
*Vena Cava Filters
Vena Cava, Inferior
Venous Thrombosis/*complications

Figure

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  Fig. 1 A, B. Frontal (A) and lateral (B) views of the TrapEase inferior vena cava filter.

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  Fig. 2 A. A 42-old women with Behcet disease had symptomatic inferior vena cava obstruction after inferior vena cava filter placement (black arrow). B. Thrombus was still detected at 1-month follow-up CT (black arrow). C. Patient underwent anticoagulation therapy during the entire follow-up period. The thrombus was completely resolved at 6-month follow-up CT (white arrow).

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  Fig. 3 A. A 64-old women had symptomatic pulmonary thromboembolism (white arrow). B. Patient underwent anticoagulation therapy during the entire follow-up period, the pulmonary embolism completely resolved at 1-year follow-up (white arrow).

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  Fig. 4 A, B. Abdominal CT demonstrates normal central placement of inferior vena cava filter without wall penetration or tilt (black and white arrow).

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