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The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial
H Rousseau1, P Perreault, P Otal
1Radiology Department, CHU Rangueil, Toulouse, France. rousseau.h@chu-toulouse.fr
Insights
The new Cordis TrapEase nitinol inferior vena cava filter shows high safety and effectiveness in preventing pulmonary embolism (PE) in high-risk patients. This permanent filter demonstrated a 100% clinical success rate at six months with minimal complications.
Area of Science:
- Cardiovascular Medicine
- Interventional Radiology
- Medical Device Technology
Background:
- Pulmonary embolism (PE) poses a significant risk to patients with deep vein thrombosis (DVT) or contraindications to anticoagulation.
- Inferior vena cava (IVC) filters are crucial for preventing PE in high-risk individuals.
- The development of safe and effective permanent IVC filters is an ongoing area of research.
Purpose of the Study:
- To evaluate the initial results of the new 6-F symmetrically designed permanent nitinol Cordis TrapEase IVC filter.
- To assess the filter's effectiveness, stability, and rate of caval occlusion over a 6-month follow-up period.
- To determine the safety and complication profile of this novel IVC filter in a high-risk patient population.
Main Methods:
- A prospective, multicenter study involving 65 patients at high risk of PE across 12 European and Canadian centers.
- Patients received the Cordis TrapEase permanent IVC filter for indications including recurrent thromboembolism or anticoagulation complications.
- Follow-up assessments included clinical examinations, plain film, Doppler ultrasound, CT scans, and nuclear medicine.
Main Results:
- Achieved a technical success rate of 95.4% and a 100% clinical success rate at 6 months, with no symptomatic PE events.
- Demonstrated zero cases of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation.
- Reported two cases of filter thrombosis, one symptomatic and successfully treated, and one asymptomatic with spontaneous recanalization.
Conclusions:
- The Cordis TrapEase nitinol permanent IVC filter is a safe and effective device for patients with thromboembolic disease at high risk of PE.
- The filter exhibits a low overall complication rate, supporting its clinical utility.
- This study provides the first multicenter prospective data on the performance of the Cordis TrapEase IVC filter.
Purpose:
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.
Materials And Methods:
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.
Results:
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.
Conclusion:
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.