Inferior vena cava filters for protection against pulmonary embolism begin to show more risk than benefit between 29 and 54 days after implantation and should be removed, according to an FDA Safety Communication: "Removing Retrievable Inferior Vena Cava Filters," issued this May by the U. S. Food and Drug Administration.
This communication was an update of an August 2010 statement directed toward "physicians who implant inferior vena cava filters and clinicians responsible for the ongoing care of patients with these devices." According to the update, it was issued to include information on recently published research and postmarket surveillance studies for these devices.
The FDA developed a quantitative decision analysis using data available in the literature to assess whether there was a time period during which the risk of having an IVC filter in place outweighed the benefits.
The decision analysis (Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism) was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013 (1:376-84). The article PDF is available at the FDA site.
The mathematical model indicated that if the patient’s transient risk for pulmonary embolism had passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation, according to the FDA.
The FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States to address safety questions that remain unanswered for both permanent and retrievable filters.
The FDA gave manufacturers two options for data collection. The first was participation in the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, an independent national clinical study to examine the use of IVC filters in the prevention of pulmonary embolism. Other manufacturers are conducting postmarket surveillance (522 studies).
The data gathered from the PRESERVE study and the 522 studies will help the FDA, manufacturers, and health care professionals assess the use and safety profile of these devices and understand evolving patterns of clinical use of IVC filters, according to the communication.