The mid-term efficacy and safety of a permanent nitinol IVC filter(TrapEase).
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.


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.


CONCLUSIONS
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.
Liu
Wei Chiang
WC
Department of Radiology, Sung-Ae General Hospital, Seoul, Korea.
Do
Young Soo
YS
Choo
Sung Wook
SW
Kim
Dong-Ik
DI
Kim
Young Wook
YW
Kim
Duk-Kyung
DK
Shin
Sung Wook
SW
Park
Kwang Bo
KB
Jeon
Yong Hwan
YH
Choo
In-Wook
IW
D000328:Adult; D000368:Aged; D000497:Alloys; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000517:prevention & control*; D012449:Safety; D013923:Thromboembolism / Q000150:complications; D016896:Treatment Outcome; D016306:Vena Cava Filters; D014682:Vena Cava, Inferior; D020246:Venous Thrombosis / Q000150:complications*
D000497:Alloys; C013616:nitinol