Prospective, Multicenter Trials Assesses Safety of Convertible IVC Filter

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Submitted on Thu, 10/12/2017 - 15:33
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The VenaTech Convertible filter is a safe device and has high-conversion rates, according to the results of a prospective, multicenter trial. Researchers published their findings in the Journal of Vascular and Interventional Radiology.

The filter was designed as an alternative to retrievable inferior vena cava (IVC) filters, which have been linked with reports of complications. The VenaTech Convertible filter is supposed to be “converted” to an open configuration after the risk of venous thromboembolism has passed.

Researchers conducted a multicenter, prospective, single-arm study to evaluate the filter’s conversion rate and the 6-month risk of adverse events. The study took place at 11 sites and included 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation, with high-risk trauma, and for surgical prophylaxis. The patients were implanted with the VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania).

Patients received a clinical assessment of their risk for pulmonary embolism, and an attempt at filter conversion was made if they were no longer at risk. After the conversion, patients were followed up at 30 days, 3 months, and 6 months. If patients did not have a conversion attempt, they were followed up 6 months after the device was implanted.

All of the 149 implants were successful, the researchers reported, although one 7-day migration to the right atrium that necessitated surgical removal. At the time of filter implant, there were no failures of delivery system or embolization of filter components. Additionally, no misalignment with the axis of the IVC occurred.

Patients had their filters converted at a mean of 130.7 days, and the filter conversion had a technical success rate of 92.7%. The mean duration of the conversion procedure was 30.7 minutes.

The authors acknowledged that the study is limited by the small population and somewhat short follow-up period. The study was also not designed to assess efficacy of the IVC filter.

“The VTCF is a new concept in the spectrum of temporary IVC filters and may be especially useful in patients with an indeterminate period of risk,” the authors concluded.

Reference

Hohenwalkter EJ, Stone JR, O’Moore PV, et al. Multicenter trial of the VenaTech Convertible Vena Cava Filter. J Vasc Interv Radiol. 2017;28(10):1353-1362.