Clinical research study
Long-duration temporary vena cava filter: A prospective 104-case multicenter study

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Background

Nonpermanent caval filters are placed in critical thromboembolic situations in which anticoagulation therapy is transiently contraindicated, ineffective, or the source of complications. The purpose of this study was to assess the safety and effectiveness of a second-generation long-duration temporary caval filter in these situations and compare its utility with that of other temporary filters.

Methods

This prospective study, including patients who underwent temporary caval filtration with the Tempofilter II, was conducted in nine European centers. All filters were successfully implanted. The filter was removed when the indication for caval filtration ceased.

Results

A total of 104 filters were inserted in 103 patients with an average age of 60 ± 15.5 years (range, 22-92 years). Most patients (85%) had pulmonary embolism, deep venous thrombosis, or both. The main indications for caval filter placement were complications of or contraindications to anticoagulation therapy (n = 85; 82.5%) or for ineffectiveness of anticoagulation therapy (n = 12; 11.7%). The average duration of implantation was 29.5 ± 14.0 days (range, 2-86 days). One filter migrated in the right atrium, followed by pulmonary embolism. No other case of pulmonary embolism or of infectious or mechanical complications related to the filter was observed. Thrombus was trapped within the filter in 24 cases (23.3%). All filters but one were removed, regardless of whether thrombus had been trapped. Retrieval was always successful after implantation periods up to 12 weeks. In 16 cases (15.5%), the filter was replaced by a permanent filter.

Conclusions

The Tempofilter II is safe, effective, and useful in critical thromboembolic situations. It offers a valuable alternative to retrievable optional filters.

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Competition of interest: Dr Bovyn is a 50% co-owner of a patent related to the concept of the temporary filter Tempofilter II. This patent is used under license by the B. Braun Medical SAS Company, which pays royalties to him. He does not own stocks or shares or have options in the company. Drs Ricco, Reynaud, and Le Blache have been paid a consulting fee from B. Braun Medical SAS Company. These services have been subject to agreements consistent with French and European Union legislation stipulating the fees received, which have been submitted to the National Council of the Order of French Doctors. Drs Ricco, Reynaud, and Le Blache have no shares in B. Braun Medical SAS Company and no other financial interest with the company apart from what has been mentioned previously. They have no conflict of interest, be it of a medical or intellectual nature. This article has been written by them in total independence. All of them have free access to the totality of the data concerning this study, and the authors accept total responsibility for this publication.

Gilles Bovyn is a 50% co-owner of a patent related to the temporary filter Tempofilter II. This patent is used under license by the B|Braun Medical SAS Company which pays royalties to him. He doesn’t own stocks, shares or have options in the company.

Jean-Baptiste Ricco, Philippe Reynaud, and Alain-Ferdinand Le Blanche, have been paid a consulting fee from B|Braun Medical SAS Company. These services have been subject to agreements consistent with French and European Union legislation. They have no shares in B|Braun Medical SAS Company and no other financial interest with the company apart from what has been mentioned previously.

Copyright © 2006 The Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.