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The Tempofilter: a multicenter study of a new temporary caval filter implantable for up to six weeks
1Service de Chirurgie Vasculaire, Centre Hospitalier, Saint-Brieuc, France.
Insights
The Tempofilter is a safe and effective temporary caval filter for preventing pulmonary embolism. It offers a longer implantation time than conventional filters, making it ideal for high-risk patients.
Area of Science:
- Vascular Surgery
- Cardiology
- Medical Devices
Background:
- Pulmonary embolism (PE) poses a significant risk, especially in patients with deep venous thrombosis (DVT) or contraindications to anticoagulation.
- Temporary caval filters are used to prevent PE in high-risk individuals.
Purpose of the Study:
- To evaluate the safety, efficacy, and usability of the Tempofilter, a new temporary caval filter.
- To assess the Tempofilter's performance for temporary protection against PE.
Main Methods:
- A multicenter study enrolled 66 patients at high risk for PE.
- The Tempofilter was implanted for a mean duration of 29.9 days.
- Patient outcomes, including PE, filter thrombosis, and complications, were monitored.
Main Results:
- No pulmonary embolism occurred during the implantation period.
- Minor filter-related complications were observed, with filter migration in 7.5% of cases, which did not lead to complications.
- Partial filter thrombosis occurred in 15% of cases but did not impede filter removal.
Conclusions:
- The Tempofilter is safe, easy to use, and effective in preventing PE.
- Its longer maximum implantation time is a key advantage over conventional temporary filters.
- The Tempofilter is suitable for temporary PE protection, particularly in surgical settings and for younger patients.
Abstract:
A multicenter study was conducted to evaluate a new temporary caval filter (Tempofilter) designed to be implanted for up to 6 weeks. A total of 66 patients with a mean age of 51.8 years were enrolled in the study. All had documented high risk of pulmonary embolism: severe deep venous thrombosis in 89.5% of cases and previous symptomatic pulmonary embolism in 65% of cases. Filter placement was performed in association with a surgical or obstetrical procedure in 68.5% of cases. The indication for filter placement was contraindication to or failure of anticoagulant therapy in 85% of the cases. The mean duration of implantation was 29.9 days. Pulmonary embolism was not observed during the implantation period. Partial thrombosis of the filter was observed in 15% of cases due to trapping of clots by the filter. Thrombosis did not hinder filter removal when attempted. Filter-related complications were minor. Filter migration occurred in only 7.5% of cases. Migration never led to complications and did not hinder filter removal. In all cases migration was due to specific, preventable causes. The results of this study show that the Tempofilter is not only safe and easy to use but also effective in preventing pulmonary embolism. A significantly longer maximum implantation time is a major advantage of the Tempofilter over conventional temporary filters. We believe that this filter can be used for temporary protection against the risk of pulmonary embolism particularly in young patients and in a surgical setting.