Inferior vena cava (IVC) filters are often used as alternatives to anticoagulant therapy for the prevention of pulmonary embolism. Although IVC filters were first introduced in1969 in the form of the Mobin-Uddin system,1 controversy continues to surround its use. Clinical editor in chief of Vascular Disease Management Frank J. Criado, MD, FACS, FSVM, describes a 2010 FDA safety communication about IVC filters in the editorial for the January 2013 issue of VDM.2 In the warning letter, the FDA advised clinicians implanting the devices to remove them as soon as protection against pulmonary embolism is no longer needed.
After the alert was published, the perception grew that IVC filters were not safe. This spurred the creation of a task force of members of the Society of Interventional Radiology and the Society of Vascular Surgery. The task force ultimately designed a study that will take place, called PRESERVE (PREdicting the Safety and Effectiveness of InferioR Vena Cava Filters).
“PRESERVE will be timely, and it will hopefully address and resolve some of the most critical aspects surrounding this important area of interventional medicine. First and foremost, we need definitive answers on the issues of safety and efficacy as well as on-label and off-label usage,” writes Dr. Criado. “With any luck, we may get them within the next 2 to 3 years. I will keep my fingers crossed.”
- Patel SH, Patel R. Inferior vena cava filters for recurrent thrombosis. Tex Heart Inst J. 2007;34(2):187–194. www.ncbi.nlm.nih.gov/pmc/articles/PMC1894721/
- Criado FJ. The PRESERVE IVC filter study: a step in the right direction. Vascular Dis Manag. 2013;10(1):E1. www.vasculardiseasemanagement.com/content/preserve-ivc-filter-study-step-right-direction