Multicenter Trial Studies B. Braun's Vena Tech Convertible Vena Cava Filter
August 23, 2017—Findings from a study that sought to demonstrate rates of successful filter conversion and 6-month major device-related adverse events in patients with converted caval filters were published by Eric J. Hohenwalter, MD, et al online ahead of print in Journal of Vascular and Interventional Radiology (JVIR). The multicenter, prospective, single-arm study was conducted under an investigational device exemption to evaluate the Vena Tech Convertible vena cava filter (B. Braun Interventional Systems, Inc.).
As summarized in JVIR, the study was performed at 11 sites and enrolled 149 patients who underwent device implantation. Patients included those with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16).
When the patient was no longer at risk for pulmonary embolism, as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implantation.
The investigators reported that all implantations were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). The mean time from placement to conversion was 130.7 days (range, 15–391 days). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7–135 minutes). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications.
The Vena Tech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate, but further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients, converted the investigators in JVIR.