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)

Affiliations
  • 1Department of Radiology, Sung-Ae General Hospital, korea. ysdo@smc.samsung.co.kr
  • 2Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, korea.
  • 3Department of Surgery, Cardiovascular Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, korea.
  • 4Department of Internal Medicine, Cardiovascular Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, korea.

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
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