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The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial.

https://arctichealth.org/en/permalink/ahliterature195125
Source
J Vasc Interv Radiol. 2001 Mar;12(3):299-304
Publication Type
Article
Date
Mar-2001
Author
H. Rousseau
P. Perreault
P. Otal
L. Stockx
J. Golzarian
V. Oliva
P. Reynaud
F. Raat
F. Szatmari
G. Santoro
G. Emanuelli
M. Nonent
Y. Hoogeveen
Author Affiliation
Radiology Department, CHU Rangueil, Toulouse, France. rousseau.h@chu-toulouse.fr
Source
J Vasc Interv Radiol. 2001 Mar;12(3):299-304
Date
Mar-2001
Language
English
Publication Type
Article
Keywords
Aged
Alloys
Canada
Equipment Design
Europe
Female
Follow-Up Studies
Humans
Male
Prospective Studies
Pulmonary Embolism - prevention & control
Risk
Time Factors
Vena Cava Filters - adverse effects
Venous Thrombosis - epidemiology
Abstract
The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up.
A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine.
The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process.
This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for use in patients with thromboembolic disease at high risk of PE.
PubMed ID
11287505 View in PubMed
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